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					2005-2006
Research Abstracts
Case Surgery
A compilation of investigations made by Case Surgery Physicians,
research scientists and distinguished colleagues.
                  Surgery




Dear Colleague:

I am pleased to share with you our 2005-2006 research abstracts. The
Department of Surgery provides a unique multi-specialty academic
environment where ideas are exchanged and cooperative research programs are
planned.

The 2005-2006 academic year has been a fruitful and productive one for the
department and it’s members. The work produced has been presented at national
and international forums and published in prestigious journals.

The Department of Surgery will continue to expand it’s research and educational
endeavors in the coming year.

We welcome your interest in our Department’s research and clinical studies. If
you would like additional information, please call 216.844.3209 or visit our web
site at www.casesurgery.com

Sincerely,




Jeffrey L. Ponsky, MD
Oliver H. Payne Professor and Chair
                                                                                                                         Table of Contents
Special thanks to the Case School of Medicine Biologic Research Unit for their
continued support.

Section 1:
Cardiovascular and
Cardiothoracic Surgery
Aortic Coarctation with Anomalous Origin of the Left Main Coronary
Artery From the Right Pulmonary Artery, Two Stage Repair ................................ 1
Yakov Elgudin, MD, Harpreet Singh, MD, Resai Bengur, MD, Ernest Siwik,
MD, Ken Zahka, Md, Hani Hennein, MD

Diamine Extension of Glutaraldehyde Crosslinks Attenuates
Aortic Wall CalcificationIn Rat Subcutaneous Implant Model ............................. 2
Steve J. Schomisch, Jamie M. Andrews, Hani A. Hennein, Alon s. Aharon,
Yakov L. Elgudin

Supravalvular Aortic Stenosis and Multilevel Pulmonary Artery
Stenosis Complicated By the Left Main Coronary Artery Stenosis ........................ 3
Yakov Elgudin, Shivaprakash Seshadri, Ernest Siwik, Hani Hennei

Section 2:
Colorectal Surgery
A Critical Analysis Of Laparoscopic Colectomy At A Single Institution:
Lessons Learned After 1000 Cases .......................................................................... 7
Anthony J. Senagore, MD, Conor P. Delaney, MD

Administration of Alvimopan, A Peripherally Acting MU-Opioid
Receptor (PAM-OR)Antagonist, is Associated with Reduced Rates of
Readmission, Postoperative Procedures, Hospital Length of Stay, and
Cost After Bowel Resection ..................................................................................... 8
Anthony Senagore, MD, MS, MBA, Conor Delaney, MD, PhD,
Bruce Wolff, MD, Eugene Viscusi, MD, Timothy Bell, MHA,
John Fort, MD, MBA

Chemotherapy and Radiation for Squamous Cell Carcinoma of the Anus:
Outcomes in HIV and Non-HIV Patients in the HAART Era ................................ 9
Skitzki J, Reynolds HL, Chipman G, Merlino J, Delaney C,
Remick S, Kinsella T

Colorectal Cancer: Management of Associated Diseases Interferes with
Appropriate Screening and Diagnosis .................................................................. 10
James I. Merlino, Conor P. Delaney, Harry S. Reynolds, Bridget Ermlich,
Mark A. Malangoni




2005-2006 Abstracts                                                                                                  i
Table of Contents
                    Effect of Alvimopan On Gastrointestinal (GI) Recovery Following
                    Resection (SBR) In Patients With and Without Crohn’s Disease (CD):
                    Results Of A Pooled Analysis of 3 Randomized,
                    Placebo-Controlled Trials ............................................................................... 11, 12
                    Bruce Wolff, MD, Eugene Viscusi, MD, Conor Delaney, MD, PhD,
                    Wei Du, PhD, John G. Fort, MD, Lee Techner, DPM

                    Efficacy of Alvimopan, A Mu-Opioid Receptor Antagonist, and Timing
                    Pre-Operative Dosing: Pharmacodynamic and Pharmacokinetic
                    Consideration in Patients Undergoing Open Laparotomy .................................. 13
                    Yehuda Kariv, MD, ER Viscusi, MD, BT Wolff, MD, CP Delaney, MD, PhD,
                    W Du PhD, L Techner, DPM, B Wallin, MD, Alvimopan Postoperative
                    Ileus Study Group

                    GI Recovery After Bowel Resection (BR): Literature Review of
                    Laparoscopic (L) VS Open (O) BR and Comparison with Alvimopan
                    (ALV) Phase III Results ......................................................................................... 14
                    C Delaney MD, A Senagore MD, R Prasad, J Fort MD, W Du PhD,
                    L Techner MD

                    If I Have Surgery, Will I Be Able To Go Home? And Will I Need A Bag? –
                    Predictors Of Surgical Outcome in Malignant Bowel Obstruction ..................... 15
                    W Wang, Y Kariv, J Hammel, JM Church, CP Delaney

                    Incidence of Postoperative Nausea, Vomiting, Nasogastric Tube (NGT)
                     Insertion and Gastrointestinal Recovery (GI-2) in Patients Undergoing
                    Bowel Resection (BR): Results of the Placebo Group in the Alvimopan
                    Phase III Trials ...................................................................................................... 16
                    CP Delaney, MD, PhD, BG Wolff, MD, ER Viscusi, MD, W Du, PhD,
                    L. Techner, DPM, B Wallin, MD, Alvimopan Postoperative Ileus
                    Study Group

                    Multivariate Analysis of Factors Associated with Readmission to
                    Hospital After Intestinal Surgery .......................................................................... 17
                    Y Kariv, W Wang, AJ Senagore, J Hammel, VW Fazio, CP Delaney

                    Post-operative Morbidity Associated with Laparotomy: Results From
                    A Pooled Analysis of Three Randomized Controlled Trials of
                    Alvimopan in the Management of POI ................................................................ 18
                    Conor Delaney MD, PhD, Bruce Wolff MD, Eugene Viscusi MD,
                    Anthony Senagore MD, MBA,Wei Du PhD, Lee Techner DPM,
                    Bruce Wallin MD

                    Randomized Placebo-Controlled Study of Alvimopan in Partial Bowel
                    Resection (BR): Pre-Op Dose Timing, Acceleration of GI Recovery, and
                    Reduction in Length of Hospital Stay ................................................................... 19
                    Kirk Ludwig, Warren Enker, Conor Delaney, Bruce Wolff, Wei Du,
                    Lee Techner




            ii                                                                                                           Case Surgery
                                                                                                                             Table of Contents
Section 3:
General Surgery
A Novel Report Card System to Manage Program Wellness ................................ 23
Jerry M. Shuck, MD, D.Sc, Roy Phitayakorn, MD

A Novel Technique for Management of Endoscopic Gastrotomy
Following Natural Orifice Transvisceral Endoscopic Surgery ............................. 24
Jeffrey Marks M.D., Michael McGee M.D., Michael Rosen M.D., Raymond Onders
M.D., Amitabh Chak M.D., Ashley Faulx M.D., Anthony Ignagni, Steve Schomisch,
Jeffrey Ponsky M.D.

A Reliable Method for Intra-Abdominal Pressure Monitoring During
Natural OrificeTransvisceral Endoscopic Surgery (NOTES) ............................... 25
Michael F. McGee MD, Michael J. Rosen MD, Jeffrey Marks MD,
Amitabh Chak MD,Raymond Onders MD, Ashley Faulx MD,
Anthony Ignagni, Steve Schomisch, Jeffrey Ponsky MD

An Aggressive Surgical Approach is Warranted in the Management of
Cystic Pancreatic Neoplasms ................................................................................ 26
J.M. Hardacre, M.F. McGee, T.A. Stellato, J.A. Schulak

Analysis of Large vs. Small Pheochromocytomas: Operative
Approaches and Patient Outcomes ...................................................................... 27
SM Wilhelm, RA Prinz, AM Barbu, RP Onders, CC Solorzano

Contributions to the Management of Intraabdominal Infections ...................... 28
Mark A. Malangoni, M.D.

Current Status of Minimally Invasive Diaphragm Pacing: Spinal Cord
Injured Patientsand ALS (Lou Gehrig’s Disease) ................................................. 29
Raymond P. Onders, M.D., FACS, Mary Jo Elmo, ACNP,
Rober Schilz, PhD, D.O., Bashar Katirji, M.D., Anthony R. Ignagni

Current Status of Phrenic Nerve Pacing Via Laparoscopically Placed
Intramuscular Electrodes in Tetraplegics .............................................................. 30
Onders, AR Ignagni, AF DiMarco, MJ Elmo, J Road

Diaphragm Pacing in Amyotrophic Lateral Sclerosis:
Early Results Promising ......................................................................................... 31
Raymond P. Onders, M.D., FACS, Mary Jo Elmo, ACNP,
Robert Schilz, PhD, D.O., Bashar Katirji, M.D., Anthony R. Ignagni

Diaphragm Pacing in the Ventilator Dependant Spinal Cord
Injured Patient .......................................................................................................32
Mary Jo Elmo, ACNP, Raymond P. Onders, MD, Anthony R. Ignagni




2005-2006 Abstracts                                                                                                         iii
Table of Contents
                    Diaphragm Pacing with Natural Orifice Transvisceral Endoscopic
                    Surgery (NOTES): Potential For Difficult to Wean Intensive Care Unit
                    (ICU) Patients ........................................................................................................33
                    Raymond Onders MD, Michael McGee MD, Jeffrey Marks MD,
                    Anthony Ignagni MS, Michael Rosen MD, Amitabh Chak MD,
                    Ashley Fauix MD, Robert Schilz DO, Steve Schomisch BS,
                    Jeffrey Ponsky MD

                    Does the Addition of Glutamine to Enteral Feeds Affect
                    Patient Mortality? ..................................................................................................34
                    Alison Saalwachter Schulman, MD, Fate F. Willcutts, MS, RD, CNSD,
                    Jeffrey A. Claridge, MD, Heather L. Evans, MD, MS,
                    Amy E. Radigan, RD, CNSD, Kelly B. O’Donnell, MS, RD, CNSD,
                    Jeremy R. Camden, BA, Tae W. Chong, MD, Shannon T. McElearney, MD,
                    Robert L. Smith, MD, Leo M. Gazoni, MD, Heidi-Marie A. Farinhold, MD,
                    Cara C. Heuser, MD, Stuart M. Lowson, MD, Bruce D. Schirmer, MD, FACS,
                    Robert G. Sawyer, MD, FACS

                    Early Results of Laparoscopic Motor Point Diaphragm Pacing in
                    Amyotrophic Lateral Sclerosis: Can Exogenous Electrical Stimulation
                    Impact Respiratory Failure? ................................................................................. 35
                    RP Onders, AR Ignagni, B Katirji, R Schilz, MJ Elmo

                    Endoluminal Surgery: Past, Present and Future .................................................. 36
                    JL Ponsky, MD

                    Endoscopic Placement and Fixation of a Temporary Self-Expanding
                    Plastic Stent For an Anastomotic Dehiscence and Stricture ................................ 37
                    Jeffrey Marks, Amitabh Chak, Victor Chen, Jeffrey Ponsky

                    Evaluation and Management of Incidental Thyroid Nodules in Patients
                    with Another Primary Malignancy ...................................................................... 38
                    Scott M. Wilhelm, MD, Ann V. Robinson, Smitha A. Krishnamurthi, MD,
                    Harry L. Reynolds, MD

                    Expert Witness Testimony: The Problem and
                    Recommendations for Oversight and Reform ............................. 39, 40, 41, 42, 43
                    Christopher R. McHenry, MD, Walter L. Biffl, M.D.,
                    William C. Chapman, M.D., David A. Spain, M.D.

                    Follicular and Hurthle Cell Carcinoma of the Thyroid Gland ............................. 44
                    R. Phitayakorn, MD, C.R. McHenry, MD

                    Home Based Ventilator Weaning in Tetraplegics: Results of the
                    Diaphragm Pacing Stimulation (DPS) System ..................................................... 45
                    Raymond P. Onders, M.D., Mary Jo Elmo, ACNP, Anthony R. Ignagni

                    Laparoscopic Mapping of the Motor Points in Partially Denervated
                    Diaphragms: Key Finding For Successful Placement of the Diaphragm
                    Pacing System ........................................................................................................ 46
                    Raymond Onders MD, anthony Ignagni MS, Mary Jo Elmo RN,
                    Bashar Katirji MD, Robert Schilz DO, PhD


        iv                                                                                                              Case Surgery
Long-Term Central Venous Catheters: Size and Location do Matter .................. 47




                                                                                                                              Table of Contents
R.P. Onders, T. A. Stellato

Natural Orifice Transvisceral Endoscopic Surgery in the Intensive Care
Unit (ICU) ............................................................................................................. 48
Raymond Onders MD, Michael McGee MD, Jeffrey Marks MD,
Anthony Ignagni MS

Optimizing Peritoneal Access for Natural Orifice Transvisceral
Endoscopic Surgery (NOTES) ...................................................... 49, 50, 51, 52, 53
MJ Rosen, M McGee, J Marks, A Chak, R Onders, A Faulx,
A Ignagni, S Schomisch, J Ponsky

Options for Ventilatory Assist in Amyotrophic Laterl Sclerosis (ALS):
The Possibility of Diaphragm Pacing Via Laparoscopically Placed
Intramuscular Electrodes ..................................................................................... 54
RP Onders, AR Ignagni, B Katirji, R Schilz, MJ Elmo

Parathyroidectomy: Overview of the Anatomic Basis and Surgical
Strategies for Parathyroid Operations ................................................................. 55
R. Phitayakorn, MD, C.R. McHenry, MD

Staged Repair of Massive Incisional Hernias with Loss of Abdominal
Domain: A Novel Approach ................................................................................. 56
Jeremy Lipman MD, Daniel Medalie MD, Michael J. Rosen MD

Successful Diaphragm Pacing in a Porcine Model With Natural Orifice
Transvisceral Endoscopic Surgery (NOTES): Increasing the Options
for Intensive Care Unit (ICU) Patients ................................................................. 57
Raymond Onders MD, Michael McGee MD, Jeffrey Marks MD,
Anthony Ignagni MS, Michael Rosen MD, Amitabh Chak MD,
Ashley Fauix MD, Robert Schilz DO, Steve Schomisch BS,
Mary Jo Elmo ACNP, Jeffrey Ponsky MD

The Hurricanes of 2005 and Ventilators: The Benefits of the
Diaphragm Pacing Stimulation (DPS) System ..................................................... 58
Raymond P. Onders M.D., Mary Jo Elmo ACNP, Anthony R. Ignagni

The Single Staged Approach to the Surgical Management of
Abdominal Wall Hernias In Contaminated Fields ............................................... 59
Diya Alaedeen, MD, Jonathan Belding MS, Jeremy Lipman MD,
Daniel Medalie MD, Michael J. Rosen, MD

Weaning Readiness and Fluid Balance in Older Critically Ill
Surgical Patients .................................................................................................... 60
Epstein CD, Peerless JR




2005-2006 Abstracts                                                                                                           v
Table of Contents
                    Section 4:
                    Pediatric Surgery
                    Appendiceal Fecalith is Associated With Early Perforation in
                    Pediatric Patients .................................................................................................. 63
                    Diya I. Alaedeen, MD, Marc Cook, MS, Walter J. Chwals, MD

                    C-Reactive Protein-Determined Injury Severity: Length of Stay
                    Predictor In Surgical Infants ................................................................................ 64
                    Alaedeen DI, Queen AL, Leung E, Liu D, Chwals WJ

                    Total Parenteral Nutrition-Associated Hyperglycemia Correlates With
                    Prolonged Mechanical Ventilation And Hospital Stay in Septic Infants .............. 65
                    Alaedeen DI, Walsh MC, Chwals WJ

                    TPN-Associated Hyperbilirubinemia Correlates With Length Of Stay
                    in Septic Premature Neonates ............................................................................... 66
                    Diya I. Alaedeen, Walter J. Chwals

                    Section 5:
                    Plastic and Reconstructive Surgery
                    Plastic and Reconstructive Surgery Calibrated Lateral Crus Stabilizer ............... 69
                    Bahman Guyuron, M.D., Brian Pinsky, B.A.

                    Components of the Short Nostril ......................................................................... 70
                    Bahman Guyuron, M.D., Ashkan Ghavami, M.D., Sarah M. Wishnek, B.A.

                    Comprehensive Surgical Treatment of Migraine Headaches ............................... 71
                    Bahman Guyuron, M.D., Jennifer S. Kriegler, M.D., Janine Davis, R.N.,
                    Saeid B. Amini, Ph.D., M.B.A., J.D.

                    Modified Temporal Incision for Facial Rhytidectomy:
                    An 18 Year Experience ........................................................................................... 72
                    Bahman Guyuron, M.D., Frederick Watkins, M.D., Ali Totonchi, M.D.

                    The Lesser and Third Occipital Nerves and Migraine Headaches ....................... 73
                    Krishna S. Dash, M.D., Jeffrey E. Janis, M.D., Bahman Guyuron, M.D.

                    The Zygomaticotemporal Branch of the Trigeminal Nerve:
                    An Anatomical Study ............................................................................................ 74
                    Ali Totonchi, M.D., Nazly Pashmini, M.D., Bahman Guyuron, M.D.

                    Section 6:
                    Transplantion and Hepatobiliary Surgery
                    A Consideration of “Critical Mass” in Living Donor Kidney
                    Exchange Programs ........................................................................................ 77, 78
                    E.S. Woodle, M. Rees, A. Bohnengle, M. Aeder, D. Goldfarb, M. Henry,
                    M.H. Alonso


        vi                                                                                                             Case Surgery
                                                                                                                               Table of Contents
An Internet-Based Living Donor Kidney Exchange Program with
Computer Matching of Donor/Recipient Pairs .................................................... 79
Michael Rees, E. Steve Woodle, Audrey Bohnengel, David Goldfarb,
Tanmay Lal, Annette Blair, Jonathan Kopke, Alan Rees, Mitchell Henry,
Mark Aeder, Ann Taylor, Marie Alonso

Barriers to Reaching the Potential of Consortium-Based Kidney
Exchange Programs: A Survey Of Program Directors and
Program Policies ................................................................................................... 80
E. Steve Woodle, Michael Rees, Amy Waterman, Audrey Bohnengle,
David Goldfarb, Mark Aeder, Mitchell Henry, Maria Alonso, Ann Taylor

Independent Benefit of African American Donor Ethnicity on Renal
Outcomes in a Cohort Of African American Kidney
Transplant Recipients ........................................................................................... 81
Mark I. Aeder, Joshua J. Augustine, David Siu, Donald E. Hricik,
James A. Schulak

O Blood Group (OBG) and Highly Sensitized Patients are Not
Disadvantaged With a Living Donor Kidney Exchange Program ....................... 82
Mark I. Aeder, E. Steve Woodle, Michael A. Rees, Audrey B. Bohnengel,
Jonathan Kopke, David Goldfarb, Maria H. Alonzo, Mitchell L. Henry,
Ann Taylor, Kidney Committee, Ohio Solid Organ

Transplantation Consortium, Columbus, OH; University of Cincinnati,
Cincinnati, OH OPO-Based Centralization of Donor Reimbursement
Costs Provides Advantages for Living Donor Kidney Exchange
Programs ............................................................................................................... 83
K. Holloway, A. Bohnengle, E.S. Woodle, M.A. Rees, D. Goldfarb,
M. Aeder, M.L. Henry, M.H. Alonso, A. Taylor

Pretransplant Frequencies of Donor-Stimulated, Interferon Gamma-
Producing LymphocytesMeasured by Elispot Predict Acute Rejection
and Renal Function in African American Kidney Transplant Recipients ............ 84
Joshua J. Augustine, David Siu, Michael Clemente, Mark Aeder,
James A. Schulak, Peter S. Heeger, Donald E. Hricik

Properties of UW Solution in Liver Grafts ........................................................... 85
Sanabria JR MDm, Alo M

Recipient and Donor Characteristics in a Computer-Based Living
Donor Kidney Exchange Program ........................................................................ 86
M. Rees, S. Woodle, J. Kopke, A. Bohnengel, D. Goldfarb, T. Lal, M. Henry,
M. Aeder, A. Taylor, M. Alonso

Suboptimal Long-Term Outcomes After Steroid Withdrawal in African
Americans Receiving Sirolumus and Tacrolimus ................................................. 87
Donald E, Hricik, Thomas C. Knauss, Kenneth A. Bodziak,
Joshua J. Augustine, Mark Aeder, Christopher Siegel, James A. Schulak




2005-2006 Abstracts                                                                                                           vii
Table of Contents
                    Variability in Patient Referral Rates Within a Multicenter Living Donor
                    Kidney Exchange Consortium and Estimation of Potential Volume ................... 88
                    E. Steve Woodle, Audrey Bohnengle, Amy Waterman, Michael Rees,
                    David Goldfarb, Mark Aeder, Mitchell Henry, Ann Taylor, Mari Alonso

                    Section 7:
                    Trauma
                    Characterizing the Need for Mechanical Ventilation Following Cervical
                    Spinal Cord Injury with Neurologic Deficit ......................................................... 91
                    John J. Como, MD, Erica RH Sutton, MD, Maureen McCunn, MD,
                    Richard P. Dutton, MD, Steven B. Johnson, MD, Bizhan Aarabi, MD,
                    Thomas M. Scalea, MD

                    Contemporary Management of Penetrating Colon Trauma ............................... 92
                    Joshua M. Braveman, MD, Mark A. Malangoni, MD

                    Hospital and Burn Center Internal Response to Burn Disaster .......................... 93
                    Lynne Yurko, RN, BSN, CAN, Tammy Coffee RN, ACNP, Charles J. Yowler,
                    MD,Christopher P. Brandt, MD

                    Hydrofluoric Acid Burns: Case Report ................................................................ 94
                    Nilam Patel, Pharm D. BCPS, Tammy Coffee, RN, ACNP,
                    Lynne Yurko, RN, BSN, Charles J. Yowler, MD, Christopher P. Brandt, MD

                    Life After 80 Hours: The Impact of Resident Work Hours Mandates on
                    Trauma and Emergency Experience and Work Effort for Senior
                    Residents and Faculty ........................................................................................... 95
                    Mark A. Malangoni, MD, John J. Como, MD, Charlene Mancuso, RN,
                    Charles J. Yowler, MD

                    Penetrating Trauma to a Persistent Sciatic Artery ............................................... 96
                    John J. Como, MD, Carnell Cooper, MD, Stuart E. Mirvis, MD,
                    Thomas M. Scalea, MD

                    Post-Traumatic Meningitis: Risk Factors, Clinical Features,
                    Bacteriology and Outcome ................................................................................... 97
                    Brian R. Plaisier, M.D., Charles J. Yowler, M.D., William F. Fallon, M.D.,
                    Matt J. Likavec, M.D., James S. Anderson, M.D., Mark A. Malangoni, M.D.

                    The Impact of Guided Imagery on Pain and Anxiety Levels of
                    Burn Patients ........................................................................................................ 98
                    Arthur A. Snedeker, M. Div., Charles J. Yowler, MD,
                    Richard B. Fratianne, MD

                    The Real Predictors of Disposition in Patients with Spinal
                    Cord Injuries ......................................................................................................... 99
                    Jeffrey A. Claridge, MD, Martin A. Croce, MD, Jordan a. Weinberg, MD,
                    Raquel M. Forsythe, MD, Christopher Miller, BS, Timothy C. Fabian, MD




  viii                                                                                                                   Case Surgery
                                                                                                                              Table of Contents
The Use of Vacuum Assisted Closure (V.A.C.) in Severe Frostbite of the
Hind Foot ............................................................................................................ 100
Tammy Coffee, RN, Christopher P. Brandt, MD, Charles J. Yowler, MD

Transport of Top Tier Pediatric Trauma to a Tertiary Trauma Center
Directly From the Scene Versus Transfer From Outside Hospitals:
Impact on Mortality and Length of Stay ............................................................. 101
Diya I. Alaedeen, Eric E. Marsh, Walter J. Chwals

Section 8:
Vascular Surgery
“Open Versus Endovascular Repair” .................................................................. 105
Jesse Jean-Claude MD, Gilles Pinault MD

Section 9:
Clinical Trials
Cardiothoracic Surgery ......................................................................... 109

Colorectal Surgery ................................................................................ 109

General Surgery ............................................................................ 109, 110

Plastic Surgery ...................................................................................... 110

Surgical Oncology ................................................... 110, 111, 112, 113, 114

Transplant ............................................................................................. 115

Trauma .................................................................................................. 115

Vascular Surgery ................................................................................... 115

Index of
Authors ....................................................................................... 117




2005-2006 Abstracts                                                                                                          ix
               Table of Contents




x
Case Surgery
Section 1
Cardiovascular and
Cardiothoracic
Surgery
Case Surgery
                                                                                                     Cardiovascular and Cardiothoracic Surgery
AORTIC COARCTATION WITH ANOMALOUS ORIGIN OF THE LEFT
MAIN CORONARY ARTERY FROM THE RIGHT PULMONARY ARTERY.
TWO STAGE REPAIR
Yakov Elgudin, M.D., Harpreet Singh M.D., Resai Bengur, M.D., Ernest Siwik, M.D.,
Ken Zahka, M.D.,and Hani Hennein, M.D.
Divisions of Pediatric Cardiology and Pediatric Cardiothoracic Surgery;
Rainbow Babies and Children’s Hospital, Case School of Medicine
INTRODUCTION: Anomalous origin of the left coronary artery from the main pulmonary artery
(ALCAPA) most commonly exists as an isolated defect. However, anomalous origin of the left
coronary artery from the right pulmonary artery (ALCARPA) appears to be associated with a
variety of defects such as coarctation of the aorta, VSD, aortopulmonary window, and
hypoplastic left heart syndrome. Presence of the dominant congenital defect makes
preoperative diagnosis of ALCARPA rather difficult. We present a case of a neonate with severe
coarctation and ALCARPA diagnosed by echocardiography and confirmed by cardiac
catheterization. Patient underwent staged repair of the coarctation followed by the coronary
artery transfer during same hospitalization. Novel technique of coronary transfer is also
described.
CASE SUMMARY: A five day old neonate in no distress was evaluated for a systolic murmur
and decreased peripheral pulses. ECHO showed severe coarctation of the aorta and possible
ALCARPA. Cardiac catheterization confirmed this diagnosis showing that left coronary artery
takes off from the mid-portion of the RPA directly posterior to the ascending aorta. As this
patient was only few days old and pulmonary vascular resistance remained high, there was an
antegrade flow seen from the RPA into the anomalous coronary artery. Both ECHO and
ventriculogram showed preserved left ventricular (LV) function without wall motion
abnormalities.
Patient had first undergone a repair of the aortic coarctation through the left thoracotomy
incision. A week later, patient underwent a repair of the ALCARPA by the direct transfer of the
left coronary button from the RPA into the back of the divided ascending aorta. Both aorta and
RPA were closed primarily. Patient went on to have an uncomplicated recovery with preserved
LV function.
COMMENT: Preoperative diagnosis of the ALCARPA is rare. Most of the patients undergo
repair of the associated congenital cardiac anomaly (coarctation, VSD, hypoplastic left heart
etc.), develop severe heart failure postoperatively that prompts further investigation and finally
leads to this obscured diagnosis. Such a delay often results in prolonged myocardial ischemia,
infarction, and profound and irreversible LV failure. Once the diagnosis is made, repair can be
done as combined or staged procedures with the main goal of preservation of the LV function.
Direct transfer of the coronary button from the RPA requires complete division of the ascending
aorta and inclusion of the button into the aortic closure. Pulmonary artery can be then
reconstructed primarily or with a pericardial patch.




                                                                                                     1




2005-2006 Abstracts                                                                                  1
Cardiovascular and Cardiothoracic Surgery
                                            DIAMINE EXTENSION OF GLUTARALDEHYDE CROSSLINKS
                                            ATTENUATES AORTIC WALL CALCIFICATION IN RAT
                                            SUBCUTANEOUS IMPLANT MODEL
                                            Steve J. Schomisch, Jamie M. Andrews, Hani A. Hennein, Alon S. Aharon, and Yakov
                                            L. Elgudin
                                            Calcification is the primary cause of dysfunction of glutaraldehyde (GA) -fixed bioprosthetic
                                            heart valves. Introduction of the donor amine groups into the fixation process may increase
                                            density of GA-induced collagen cross-linking and decrease calcification.

                                            In an attempt to increase cross-linking density and reduce calcification, we investigated an
                                            alternative way of tissue preservation for bioprosthetic heart valves. Porcine aortic wall was
                                            fixed with 0.625% GA (control) or with 0.625% GA+ 100 m M L-lysine (diamine). In Vitro
                                            assessment of cross-linking efficiency was based on shrinkage temperature, resistance to
                                            protease digestion, residual amine analysis and moisture content. Calcium levels, calcification
                                            patterns and inflammation were assessed after 5 weeks of subcutaneous implantation in rats.
                                            Compared to the control group (GA) the addition of diamine increased shrinkage temperature
                                            (86.5 ± 0.6 v. 93.3 ± 0.9oC, p<0.002), increased resistance to protease digestion (50.5 ± 2.1 v.
                                            74.0 ± 3.0 % mass remaining, p<0.001), decreased residual amines (31.4 ± 1.5 v. 28.6 ± 0.4
                                            nM/mg, p=0.121) and decreased the moisture content (69.6 ± 1.0 v. 64.7 ± 1.3 %, p=0.01).
                                            After 5 weeks of subcutaneous implantation the combined treatment of GA and diamine
                                            reduced the extent of aortic wall calcification (24.5 ± 2.4 v. 8.2 ± 0.6 ug/mg, p<0.001). The
                                            calcification pattern was visibly different in tissue pretreated with diamine.

                                            Our preliminary study demonstrates that the use of diamine improved cross-linking density and
                                            reduced calcification of the porcine aortic wall. This method may be considered as an alternative
                                            to a standard GA preservation of the bioprosthetic heart valves and conduits.

                                                                                              Shrinkage Temperature                                                                            Degradation Resistance
                                                                                                                                       *p<0.002                                                                                             n=4
                                                                                                                                       n=4                                                                                                  p<0.001
                                                                                   96                                                                                                  80.0
                                                                                                                                                                                                                                    *
                                                                                   94
                                                                                                                                  *                                                    70.0
                                                                                   92
                                                                                                                                                                  Mass Remaining (%)
                                                    Temperature (C)




                                                                                   90                                                                                                  60.0

                                                                                   88

                                                                                                                                                                                       50.0
                                                                                   86

                                                                                   84
                                                                                                                                                                                       40.0
                                                                                   82

                                                                                   80                                                                                                  30.0
                                                                                                                                                                                                     Glut                  Glut + Lysine
                                                                                              Glut                Glut + Lysine
                                                                                                         Treatm ent                                                                                           Treatment


                                                                                                     Residual Amines                                                                            Moisture Content
                                                                                                                                         n=4                                                                                               p=0.01
                                                                                                                                         p=.121                                                                                            n=8
                                                                                       42.0                                                                       72.0
                                                                                       40.0

                                                                                       38.0                                                                       70.0

                                                                                       36.0
                                                                                                                                                                  68.0
                                                                      Amines (nM/mg)




                                                                                       34.0
                                                                                                                                                  Mass lost (%)




                      1                                                                32.0

                                                                                       30.0
                                                                                                                                                                  66.0                                                             *
                                                                                       28.0                                                                       64.0
                                                                                       26.0

                                                                                       24.0                                                                       62.0

                                                                                       22.0
                                                                                                                                                                  60.0
                                                                                       20.0                                                                                                   Glut                       Glut + Lysine
                                                                                                Glut                   Glut + Lysine

                                                                                                                                                                                                            Treatm ent
                                                                                                          Treatm ent



                                                                Figure 1. Shrinkage Temperature, Degradation Resistance,
                                                                Residual Amines and Moisture Content of porcine aortic wall tissue
                                                                fixed in 0.625% Glutaraldehyde or 0.625% Glutaraldehyde + 100 mM
                                                                Lysine.




                              2                                                                                                                                                                                                                       Case Surgery
                                                                                                      Cardiovascular and Cardiothoracic Surgery
SUPRAVALVULAR AORTIC STENOSIS AND MULTILEVEL
PULMONARY ARTERY STENOSIS COMPLICATED BY THE LEFT MAIN
CORONARY ARTERY STENOSIS
Yakov Elgudin, Shivaprakash Seshadri, Ernest Siwik, and Hani Hennein

INTRODUCTION: Supravalvular aortic stenosis (SVAS) is a congenital anomaly that can occur
as a part of William’s syndrome, as a familial, or a sporadic anomaly. Diffuse elastin artetiopathy
is often implicated in patients having a combination of SVAS, localized or diffuse pulmonary
artery stenoses (PAS), and involvement of one or both main coronary arteries. Biventricular
outflow obstruction in patients with severe SVAS and PAS can cause severe pressure overload
and increase risk of ventricular ischemia and a sudden death. We report a case of a patient with
severe supravalvular aortic stenosis, multilevel pulmonary arterial stenoses and critical ostial
stenosis of the left main coronary artery.
CASE SUMMARY: A three month old girl had undergone an evaluation for an asymptomatic
heart murmur. Echocardiogram and cardiac catheterization showed multilevel (valvular,
supravalvular, and distal branches) stenoses of the pulmonary artery, severe supravalvular
aortic stenosis, and ostial stenoses of left main coronary artery. The patient underwent repair of
supravalvular aortic stenosis, repair of a critical stenosis of the left main coronary artery,
pulmonary valvuloplasty, and pulmonary patch arterioplasty as a first stage intervention.
Follow up catheterization showed resolution of a supravalvular aortic stenosis. Balloon
angioplasty was used to relieve left and right branched pulmonary arteries stenoses.
CONCLUSION: Patients with biventricular outflow obstruction complicated by the left main
coronary artery stenosis may require extensive staged interventions to relieve multilevel
pulmonary artery, coronary artery, and supravalvular aortic stenoses. Timing and sequence of
the procedures are dictated by severity of biventricular obstruction and the presence of a
coronary artery stenosis.




                                                                                                      1




2005-2006 Abstracts                                                                                   3
               1
                   Cardiovascular and Cardiothoracic Surgery




4
Case Surgery
Section 2
Colorectal Surgery
6   Case Surgery
                                                                                                     Colorectoral Surgery
A CRITICAL ANALYSIS OF LAPAROSCOPIC COLECTOMY AT A
SINGLE INSTITUTION: LESSONS LEARNED AFTER 1000 CASES
Anthony J. Senagore, MD, Conor P. Delaney, MD.

HYPOTHESIS: The acceptance of a laparoscopic colectomy has been slower than other
advanced laparoscopic procedures primarily due to the steep learning curve and lack of
confirmation of demonstrable benefits from a large data set. A critical outcome analysis of a
large, single institution experience provides a better frame of reference for an assessment of the
role of laparoscopic colectomy for colorectal pathology.
DESIGN: Review of a prospectively gathered database.
SETTING: Tertiary referral center

PATIENTS: A consecutive series of laparoscopic colectomy patients who were operated on by
two surgeons at a single institution using standardized operative techniques and postoperative
care plans.
MAIN OUTCOME MEASUREMENTS: Patients were assessed for operative indications, type of
resection, operative time, conversion, complications, duration of stay, and re-admission within
30 days.
RESULTS: 1000 consecutive patients undergoing laparoscopic colectomy from January 1999
thru December 2004 were analyzed. The types of resections were: right colectomy-314;
left/sigmoid colectomy/anterior resection-435; total colectomy-61; total proctocolectomy-14; and
other-176. The indications for surgery were: diverticular disease-285; colorectal neoplasia-285;
inflammatory bowel disease-172; rectal prolapse-81,; and other-177. The conversion rate was
11.4%. The mean operative time was 112 45 minutes for all resections. The mean duration of
hospitalization for all patients was 3.66 3.8. The mortality rate was 0.5%. The overall
complication rate was 9.9%, with the most frequent complications being: ileus-2.8%; pulmonary-
1.6%; cardiac-1.4%; and wound infection-2.6%. The 30-day re-admission rate was 9.1% and              2
the most frequent reasons for re-admission were ileus/small bowel obstruction, infection and
anastomotic leak.
CONCLUSIONS: These data represent the largest single institution experience with
laparoscopic colectomy and confirm the benefits of a standardized approach to the operative
techniques and perioperative care. Patients undergoing laparoscopic colectomy can be
managed without need for prolonged operative procedures while deriving benefits of shorter
hospital rehabilitation, a low incidence of cardiopulmonary and wound complications, and a
acceptable rate of 30 day re-admission. Efforts need to be directed towards improved access to
training in laparoscopic colectomy techniques to increase patient access to this new technology.




2005-2006 Abstracts                                                                                  7
Colorectoral Surgery
                       ADMINISTRATION OF ALVIMOPAN, A PERIPHERALLY ACTING
                       MU-OPIOID RECEPTOR (PAM-OR) ANTAGONIST, IS ASSOCIATED
                       WITH REDUCED RATES OF READMISSION, POSTOPERATIVE
                       PROCEDURES, HOSPITAL LENGTH OF STAY, AND COST AFTER
                       BOWEL RESECTION
                       Anthony Senagore, MD, MS, MBA;1 Conor Delaney, MD, PhD;2 Bruce Wolff, MD;3
                       Eugene Viscusi, MD;4 Timothy Bell, MHA;5 John Fort, MD, MBA6
                       PURPOSE: To examine hospital costs associated with patients undergoing large or small bowel
                       resection (BR) who received alvimopan 6 or 12 mg in phase III clinical trials. Alvimopan 12 mg
                       may produce a more pronounced treatment effect and was used in the analysis.
                       METHODS: Hospital length of stay (LOS) was assessed for BR patients enrolled in 3 alvimopan
                       randomized, phase III trials evaluating GI recovery after laparotomy. The average cost per
                       hospital day was US $1,290 in 2002 (2002 US Census data), or approximately $1,400 per day
                       when inflated to 2004 US Dollars. Currently, alvimopan cost has not been established. Unit
                       costs were applied to hospital LOS data to determine per-patient costs.
                       RESULTS: Patient characteristics, surgical procedures, and perioperative care were
                       comparable between groups. The average hospital LOS was 128.4 hours (5.35 days) for
                       patients receiving alvimopan 12 mg (n = 397) and 146.8 hours (6.12 days) for patients receiving
                       placebo (n = 383). When quantified into costs, patients receiving alvimopan 12 mg had mean
                       total hospitalization costs of $7,472 compared with $8,539 for patients receiving placebo.
                       CONCLUSION Bowel resection patients receiving alvimopan 12 mg are discharged from the
                       hospital more than 3/4 of a day sooner than patients receiving placebo. This decrease in LOS is
                       associated with a mean reduction of $1,067 in hospitalization costs. The alvimopan 12-mg
                       group also had a lower rate of rehospitalization (7.7% vs 11.7%) and less postoperative
                       nasogastric tube insertions (6.8% vs 12.2%) compared with placebo. These reductions in
          2            postoperative morbidity may lead to additional savings for the hospital.




              8                                                                                     Case Surgery
                                                                                                    Colorectoral Surgery
CHEMOTHERAPY AND RADIATION FOR SQUAMOUS CELL
CARCINOMA OF THE ANUS: OUTCOMES IN HIV AND NON-HIV
PATIENTS IN THE HAART ERA
Skitzki J, Reynolds HL, Chipman G, Merlino J, Delaney C, Remick S, Kinsella T
PURPOSE – The incidence of squamous cell carcinoma of the anus (SCCA) is increasing. Little
data exists on the use of chemotherapy and radiation (CR) in the treatment of SCCA in human
immunodeficiency patients (HIV) treated with highly active retroviral therapy (HAART). We
report outcomes of CR in HIV and non-HIV patients with SCCA in the HAART era.

METHODS – Retrospective review from 1999-2005 at a tertiary care center of 32 patients (15
HIV, 17 non-HIV). Data collected included demographics, response to CR, stage, survival, and
need for surgical intervention and/or stoma. Kaplan-Meier survival analysis, Fishers Exact Test,
and the Mann-Whitney Rank Sum Test were used as appropriate.

RESULTS – HIV patients were more often male ( 80% v.23.5%, p<.004) and younger at time of
diagnosis (median 45 y v. 59 y for non-HIV (p<.001)). Presenting stages were similar (median
stage II). HIV and non-HIV patients received similar radiation dosages (59.3 Gy vs. 62.1 Gy).
There was no significant difference in the number of complete responders (73.3%(11/15) HIV+
vs. 88.2% (15/17) non HIV, p=??). Survival was similar at 2 years (73.3% HIV+v.76.5% non-
HIV, p=0.944). There was no difference in need for diversion between HIV (33%) and non HIV
(12%) patients (p=0.209). 25% (8/32) of all patients requiring laparotomy and 21.9% (7/32),
requiring a permanent stoma, with no difference between groups???.

CONCLUSIONS –HAART era HIV patients are younger males that tolerate and respond to CR.
Tolerance to therapy, survival, and need for surgical diversion were similar in HIV and non-HIV
cases, although, with larger numbers the need for stoma creation or other surgical interventions
may be more prevalent in the HIV group. Despite primary medical therapy for SCCA, frequent
surgical intervention is necessary. The surgeon remains an integral part of the multidisciplinary
team managing these difficult patients.                                                             2




2005-2006 Abstracts                                                                                 9
Colorectoral Surgery
                       COLORECTAL CANCER: MANAGEMENT OF ASSOCIATED DISEASES
                       INTERFERES WITH APPROPRIATE SCREENING AND DIAGNOSIS
                       James I Merlino1, Conor P. Delaney2, Harry S. Reynolds2, Bridget Ermlich2, Mark A.
                       Malangoni1.
                       Department of Surgery MetroHealth Medical Center1 and University Hospitals of
                       Cleveland2; Case School of Medicine, Cleveland, Oh.
                       Despite directed efforts at increasing awareness and screening for colorectal cancer patients
                       with regular medical follow-up for other diseases are routinely diagnosed with advanced
                       colorectal malignancy.
                       37 consecutive patients (23 female, 62%) with advanced colorectal cancer were treated by
                       three colorectal surgeons over six months (July 2005 – January 2006). The mean age was 65.5
                       years. Pre-operative staging was available for 35 patients (II = 6, III = 12, IV = 17). Common
                       presenting complaints were bleeding (n=23), pain (n=19), and weight loss (n=10). Most patients
                       (n=20) presented to the emergency department with complaints of bleeding (n=14) or
                       obstruction (n=4). Mean presenting lab values were: CEA 41.0 ng/ml (range 0.5 – 436),
                       Hematocrit 33.0 % (range 22.0 – 50.6), and albumin 3.1 g/dl (range 0.9 – 4.6). Two-thirds had
                       insurance that would have covered cancer screening.
                       29 (78.4%) patients had operations. Five patients were inoperable and three are currently
                       receiving neoadjuvant therapy. Rectal cancers predominated (n=19) and were more common in
                       males (n=12). Most patients with rectal cancer required a colostomy (n=11) or were inoperable
                       (n=5). Seventeen (58.6%) patients developed post-operative complications; the most common
                       being post-operative ileus (24.1%). Average hospital stay was 10 days. 25 patients received
                       neo-adjuvant chemoradiation therapy, including 5 who received intra-operative radiation for
                       locally advanced disease.
                       Detailed computer medical records were available for 18 patients (48.6%). 14 (77.8%) had an
                       average of 4.64 physician visits in the six months preceding their cancer diagnosis for the
          2            treatment of unrelated co-morbidities. Four had not been seen because of lack of insurance.
                       Ten (71.4%) had fecal occult blood testing ordered (six not completed with no follow-up, three
                       were negative, one positive with no follow-up). Screening colonoscopy was ordered for two
                       patients; both refused.
                       CONCLUSION: These results suggest that co-morbid diseases may mask symptoms and signs
                       of colorectal cancer and cause appropriate screening to be ignored. Patients with advanced
                       colorectal malignancy present anemic, malnourished, have frequent post-operative
                       complications, long hospital stays, and require more radical operations. Modern use of
                       advanced multidisciplinary treatment and neoadjuvant therapy may offer patients with advanced
                       disease more options today then in the past.




      10                                                                                           Case Surgery
                                                                                             Colorectoral Surgery
  EFFECT OF ALVIMOPAN ON GASTROINTESTINAL (GI)
  RECOVERY FOLLOWING RESECTION (SBR) IN PATIENTS WITH
  AND WITHOUT CROHN’S DISEASE (CD): RESULTS OF A
  POOLED ANALYSIS OF 3 RANDOMIZED, PLACEBO-
  CONTROLLED TRIALS
  Bruce Wolff, MD1; Eugene Viscusi, MD2; Conor Delaney, MD, PhD3; Wei Du,
  PhD4; John G. Fort, MD4; Lee Techner, DPM4
  1
    Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN; 2Department
  of Anesthesiology, Jefferson Medical College, Thomas Jefferson University,
  Philadelphia, PA; 3Division of Colorectal Surgery, University Hospitals of
  Cleveland, Cleveland, OH; 4Adolor Corporation, Exton, PA
  Crohn’s disease is a common indication for bowel resection (BR), and the prevalence of
  surgery (strictureplasty or BR) in this setting ranges from 38% to 96%. Postoperative
  ileus (POI), a temporary impairment of GI function, occurs after abdominal surgery.
  Alvimopan, a novel, peripherally acting, mu-opioid receptor antagonist under
  investigation for the management of POI, accelerated GI recovery in patients undergoing
  laparotomy for BR or total abdominal hysterectomy in 3 multicenter phase III trials.
  Pooled data from these trials were analyzed for patients with and without CD who
  received SBR.
  Trials enrolled patients 18 years old who were scheduled for postoperative opioid IV
  patient-controlled analgesia. Alvimopan (6 or 12 mg) or placebo was administered 0.5 to
  5 hours before surgery and twice daily starting postoperative day (POD) 1 until hospital
  discharge for 7 PODs. Cox proportional hazard ratios were used to analyze treatment
  effects on time to events and to provide an estimate (in hours) of treatment effect. The
  primary endpoint was GI-3 recovery (time to first flatus or bowel movement [BM] and
  toleration of solid food). Secondary endpoints included time to first BM and time to
  hospital discharge order written.
                                                                                             2
  Of the patients who participated in the phase III alvimopan trials, 47 patients with CD
  and 54 patients without CD underwent SBR. Results are reported in Table 1.
  Although the number of patients in this analysis was small, patients who received
  alvimopan (regardless of their CD diagnosis) had reduced time to GI recovery and
  discharge compared with placebo. Moreover, efficacy was comparable for patients with
  and without CD.




2005-2006 Abstracts                                                                          11
Colorectoral Surgery
                       Table 1. Time to Recovery in Patients Undergoing SBR With and Without CD,
                       MITT Population
                                                   Patients With CD                       Patients Without CD
                                                    Alvimopan       Alvimopan               Alvimopan       Alvimopan
                                         Placebo       6 mg           12 mg       Placebo      6 mg           12 mg
                                          n = 11      n = 19          n = 17       n = 17     n = 20          n = 17
                       GI-3
                        HR (CI)              -    1.37 (0.6, 3.1) 2.88 (1.2, 6.8)     -   2.33 (1.2, 4.7) 2.79 (1.3, 6.0)
                        Time to event,     115          100             71           98         73              69
                        median hours
                       BM
                        HR (CI)              -    1.35 (0.6, 3.0) 1.84 (0.8, 4.2)     -   3.19 (1.5, 6.9) 3.12 (1.4, 7.0)
                        Time to event,      88           77             69           89         51              51
                        median hours
                       DCO written
                        HR (CI)              -    1.49 (0.7, 3.4) 2.43 (1.1, 5.6)     -   1.97 (1.0, 3.9) 2.62 (1.2, 5.5)
                        Time to event,     134          108             91          118         96              89
                        median hours
                       SBR = Small bowel resection; CD = Crohn’s disease; MITT = Modified intent to treat; GI-3 = Time to first flatus or BM and
                       toleration of solid food; HR = Hazard ratio; CI = Confidence interval; BM = Bowel movement; DCO = Discharge order.
                              Title character count = 213 (max = 255 including spaces)

                              Abstract character count = 2,254 (max = 2,700 including spaces and table; Table =

                              700 characters)




          2                      F:\Word\Adolor Corporation\ADO ENT 6104 DDW abstract crohns' disease - study 125\Abstract\Crohn's disease DDW

                                                                                                           abstract 12-1-05 SEDV.doc, 12/1/05




      12                                                                                                                           Case Surgery
                                                                                                  Colorectoral Surgery
EFFICACY OF ALVIMOPAN, A PERIPHERALLY ACTIVING
MU-OPIOID RECEPTOR (PAM-OR) ANTAGONIST, AND
TIMING OF PREOPERATIVE DOSING: PHARMACODYNAMIC
AND PHARMACOKINETIC CONSIDERATION IN PATIENTS
UNDERGOING OPEN LAPAROTOMY
Yehuda Kariv, MD, PhD;1 Eugene Viscusi, MD;2 Bruce Wolff, MD;3 Conor Delaney, MD,
PhD;4 Anthony Senagore, MD, MS, MBA;5 Wei Du, PhD;6 Lee Techner, DPM;6 Bruce
Wallin, MD;6 Alvimopan Postoperative Ileus Study Group

OBJECTIVE: To determine the timing range for alvimopan preoperative dosing based on
achieving and maintaining effective (free) concentrations of alvimopan at the receptor site
during the period of maximal opioid exposure (perioperatively). Free plasma concentration after
alvimopan (single dose) will achieve/exceed Ki for receptor antagonism for 6-10 hours of the
dosing interval in 50% of patients.
STUDY DESIGN: Analysis was completed using the pooled modified intent-to-treat population
from 3 phase III, randomized, placebo-controlled trials of alvimopan 6 mg (n=502) and 12 mg
(n=508) versus placebo (n=501). Time of induction of anesthesia was used as a surrogate for
start of surgery. Summary statistics were performed on elapsed time and number of patients
with preoperative dosing     or >2 hours (88% of patients dosed between 0.5-5.0 hours).
Covariate analysis was conducted to evaluate whether timing of the preoperative dose
influenced time to recovery of gastrointestinal (GI) function. A Cox proportional hazard model
with treatment effect and a covariate of time from preoperative dose to time of induction was
fitted to the data.
RESULTS: Mean elapsed time from preoperative dose to start of induction was 2.9±1.4
(placebo), 3.0±1.53 (alvimopan 6 mg), and 2.9±1.34 hours (alvimopan 12 mg). Overall, 22.6%
and 73.5% of patients received alvimopan 2 and >2 hours before surgery, respectively.
Analysis of the treatment effect revealed a significant difference between alvimopan 6 mg
versus placebo (hazard ratio [HR]=1.25; P=0.001) and alvimopan 12 mg versus placebo               2
(HR=1.29; P<0.001) in time to recovery of GI function. Covariate analysis demonstrated that
timing of the preoperative dose did not significantly influence time to recovery of GI function
(HR=1.03; P=0.185).
CONCLUSIONS: Patients dosed 2 hours before surgery had similar GI recovery compared
with patients dosed >2 hours before surgery. Dosing 0.5-5.0 hours before the scheduled start of
surgery should provide adequate mean levels of alvimopan.




2005-2006 Abstracts                                                                               13
Colorectoral Surgery
                       GI RECOVERY AFTER BOWEL RESECTION (BR): LITERATURE
                       REVIEW OF LAPAROSCOPIC (L) VS OPEN (O) BR AND COMPARISON
                       WITH ALVIMOPAN (ALV) PHASE III RESULTS
                       C Delaney MD, A Senagore MD, R Prasad, J Fort MD, W Du PhD, L Techner MD, Div
                       of Colorectal Surg, U Hosp Clev, Clev, OH, US; Med U of OH, Toledo, OH, US; Adolor
                       Corp, Exton, PA, US
                       INTRODUCTION: ALV significantly reduced time to GI recovery after BR by O laparotomy in
                       randomized, controlled studies. A review was performed to compare GI recovery and hospital
                       length of stay (LOS) from the pooled ALV phase III BR population with published literature for O
                       and LBR.
                       METHODS: A MEDLINE database search was performed from 1995-present using these terms:
                       LBR; laparoscopically assisted bowel surgery; L colectomy; bowel surgery L; intestinal
                       resection L. Descriptive statistics related to outcomes were pooled whenever possible.
                       Summary data was compared with pooled analysis of BR patients from 3 ALV trials.
                       RESULTS: Summary data were limited to 28 studies from 2000-2005. 11 studies (n=1545)
                       were conducted ex-US, and 17 studies (n=2950) were completed in the US. 93% of studies
                       were conducted at single centers, 36% were randomized, and 64% were retrospective.




          2            Study endpoints from pooled analysis of ALV US trials are reported in Table 1, and are comparable with
                       results in LBR.

                       CONCLUSIONS: Mean LOS after BR varied from 5.9-9.7 days for all studies and was shorter in
                       US studies compared with non-US studies. Mean time to first BM and LOS in ALV trials with
                       OBR compared favorably with overall LBR results. Reductions in time to first BM and LOS can
                       be achieved using various approaches including LBR and ALV treatment. Further studies
                       investigating pharmacologic intervention in LBR are warranted.




      14                                                                                                  Case Surgery
                                                                                                 Colorectoral Surgery
 IF I HAVE SURGERY, WILL I BE ABLE TO GO HOME?
 AND WILL I NEED A BAG? – PREDICTORS OF SURGICAL
 OUTCOME IN MALIGNANT BOWEL OBSTRUCTION
 W Wang, Y Kariv, J Hammel, JM Church, CP Delaney
 BACKGROUND: Malignant bowel obstruction (MBO) is a common, yet difficult problem.
 Few data exist to guide appropriate management strategies. Patients often wish to avoid
 a stoma and discharge to a nursing facility as a result of a surgical intervention. This
 study defines a predictive instrument that will assist in preoperative patient counseling
 and decision-making.
 PATIENTS AND METHODS: Consecutive patients who underwent surgery between
 May 1998 and March 2002 for MBO were identified from coded hospital records, and
 data were retrospectively collected. Outcome measures included creation of stoma and
 discharge destination. Covariate adjustment analysis and multivariable tree models were
 used to identify preoperative predictors of outcomes.

 RESULTS: 149 patients (age 63.3 12.7 years, 40% male) with intra-abdominal cancer
 (77 colorectal, 25 other gastrointestinal, 37 gynecological, 10 urological) underwent
 laparotomy (67 bowel resection, 56 lysis of adhesions, 52 stoma, 21 bypass, 4
 gastrostomy) for bowel obstruction during the study period. Perioperative morbidity and
 mortality rates were 32% and 6.0%, respectively. 127 patients (85.2%) were discharged
 from hospital. XX patients (YY%) had a new ileostomy and ZZ (YY%) had a new
 colostomy. Statistically significant (p<0.05) associations of preoperative factors with
 stoma creation are listed.

Preoperative variable               Univariable         Multivariable    p   Adjusted
                                    p value             value                OR (95% CI)
Large bowel obstruction             <0.001              <0.001               18.07 (6.57,49.7)
Known metastatic spread             0.001               0.001                4.10 (1.83,9.18)
Gynecologic cancer                  0.031               NS                   NS                  2
Gastrointestinal cancer             0.019               0.025                0.18 (0.04,0.81)
Preoperative chemotherapy           0.003               0.005                3.39 (1.46,7.87)

 Age was a single predictor of discharge to home (adjusted OR (95% CI) 0.64
 (0.48,0.83).
 Tree analyses have demonstrated similar predictors of outcomes. Leave-one-out cross
 validation of these models has demonstrated 73% and 86% agreement for stoma and
 discharge destination, respectively.
 CONCLUSIONS: This predictive model permits validated pre-operative counseling of
 patients undergoing surgery for MBO, and establishes baseline outcomes for this little-
 studied subject.




2005-2006 Abstracts                                                                              15
Colorectoral Surgery
                       INCIDENCE OF POSTOPERATIVE NAUSEA, VOMITING,
                       NASOGASTRIC TUBE (NGT) INSERTION AND GASTROINTESTINAL
                       RECOVERY (GI-2) IN PATIENTS UNDERGOING BOWEL RESECTION
                       (BR): RESULTS OF THE PLACEBO GROUP IN THE ALVIMOPAN
                       PHASE III TRIALS
                       CP Delaney, MD, PhD2, BG Wolff, MD1, ER Viscusi, MD3, W Du, PhD4, L Techner,
                       DPM4, B Wallin, MD4, Alvimopan Postoperative Ileus Study Group
                       OBJECTIVE: To assess the incidence and relationship of nausea, vomiting, NGT insertion and
                       upper and lower gastrointestinal (GI) recovery in patients undergoing open laparotomy.
                       METHODS: Pooled analysis of placebo patients undergoing open laparotomy (partial BR with
                       primary anastomosis) enrolled in 3 alvimopan phase III efficacy trials investigating management
                       of post-operative ileus (POI). Trials enrolled patients 18 years scheduled for postoperative
                       pain management with PCA with opioids. The incidence of nausea (only) and vomiting (only)
                       were reported based on investigator reports and coded using standard MeDRA dictionary. NGT
                       insertion data was collected separately. Recovery of upper and lower GI recovery was assessed
                       by GI-2 (2 component measure consisting of maximum time to lower [BM] and upper GI [solid
                       food intake] recovery).
                       RESULTS: The MITT BR population contained 383 patients who received placebo.

                                    25


                                    20

                                                                                        Nausea
                                    15
                          Percent




                                                                                        Vomiting
                                                                                        NGT
          2                         10
                                                                                        GI2

                                     5


                                     0
                                         0   1   2   3   4   5   6    7   8   9   10
                                                     Post-Operative Day



                       Nausea was the most frequent GI symptom. The incidence of nausea was highest on post-
                       operative day 0 (21%) and quickly decreased thereafter. The incidence of vomiting was low on
                       day 0 (1%) but increased to 2-3%on post-operative days 1-6. The incidence of NGT insertion
                       was highest on days 2 (12%) and remained high through day 5 (8%). GI recovery began on
                       postoperative day 2 and occurred more frequently on postoperative day 5. Thirty-six patients
                       (9.4%) remained hospitalized beyond postoperative day 10.
                       CONCLUSIONS: Recovery of intestinal function takes longer than appreciated by many
                       surgeons. Persistent postoperative nausea and vomiting are associated with delayed recovery
                       of bowel function that takes > 7 days in 10% of patients.




      16                                                                                            Case Surgery
                                                                                             Colorectoral Surgery
MULTIVARIATE ANALYSIS OF FACTORS ASSOCIATED WITH
READMISSION TO HOSPITAL AFTER INTESTINAL SURGERY
Y Kariv1, W Wang1, AJ Senagore1, J Hammel2, VW Fazio1, CP Delaney1
BACKGROUND: Readmission (RD) rates after major abdominal surgery are 5-15 %
and have a significant impact on cost of care and the impression of quality. Few data
exist to determine predictors of readmission. Recognition of these factors may improve
postoperative clinical care and discharge plans.
STUDY DESIGN: 150 consecutive patients, readmitted within 30 days of discharge
after intestinal surgery (September 2003 to June 2004) were compared to matched
(DRG code 146-149) non-readmitted (NRD) patients from the same time period. ‘Patient
related’ (demographic, co-morbidity, medications) and ‘disease related’ (diagnosis, type
of surgery, perioperative course) variables were collected retrospectively. Logistic
regression analysis identified predictors of RD.
RESULTS: Groups did not differ in age, gender, diagnosis, type of bowel resection (BR)
or frequency or type of stoma. RD was associated with chronic obstructive pulmonary
disease (COPD; adjusted odds ratio(OR): 5.8, 95% confidence interval (CI): 1.3-26.5),
prior anticoagulant therapy (PAT: OR:4.1, CI:1.1-15.4), and steroid treatment (prior to
admission, preoperatively, or at discharge; all significant). In patients operated for
intestinal perforation, RD rate was reduced (OR:0.3, CI:0.1-0.9), but this was associated
with longer primary hospital stay (8.8 vs 6.2 days, p= ??). Age, gender, co-morbidities,
postoperative minor or major complications, length of stay, hemoglobin level, white
blood cell count, serum creatinine and albumin level at discharge did not affect
readmission.
RD causes included septic complications (23%), small bowel obstruction/ileus (26%),
wound infection (17%), dehydration (13%) or medical complications (15%) within a
mean±SD of 10.2±8.2 days from discharge. RD generally lasted 6.6±6.4 days. Variables         2
including cancer, stoma at discharge, abscess found during surgery, re-operation during
the first admission, postoperative fever or major complication, albumin level and
discharge destination were associated with specific causes of RD.
CONCLUSIONS: COPD, PAT and steroids were the only variables associated with
increased RD rates. Although ‘disease related’ factors and perioperative course have
minor impact on RD rates, they may help predict specific causes of readmission. Means
of reducing the adverse impact of steroids, or stratifying perioperative anticoagulant use
may reduce unexpected readmissions in this patient population.




2005-2006 Abstracts                                                                          17
Colorectoral Surgery
                       POST-OPERATIVE MORBIDITY ASSOCIATED WITH
                       LAPAROTOMY: RESULTS FROM A POOLED ANALYSIS OF
                       THREE RANDOMIZED CONTROLLED TRIALS OF ALVIMOPAN
                       IN THE MANAGEMENT OF POI
                       Conor Delaney MD, PhD, Bruce Wolff MD, Eugene Viscusi MD, Anthony
                       Senagore MD, MBA, Wei Du PhD, Lee Techner DPM, Bruce Wallin MD
                       OBJECTIVE: Pooled analysis of 3 phase III studies on the efficacy of alvimopan in
                       accelerating recovery of gastrointestinal (GI) function after open laparotomy.


                       METHODS: A pre-specified pooled analysis was performed of patients undergoing
                       open laparotomy (partial bowel resection with primary anastomosis (n=???) and
                       hysterectomy (n=???)) enrolled in three alvimopan phase III efficacy trials for the
                       management of POI. Trials enrolled patients 18 years undergoing open laparotomy
                       and scheduled for postoperative pain management with opioid patient controlled
                       analgesia. Analysis included all treated patients who had surgery. Pre-specified
                       postoperative morbidity variables included nasogastric (NG) tube insertion, POI as a
                       serious adverse event (SAE), prolonged hospital stay 7 days, early postoperative
                       small bowel obstruction (EPSBO), and hospital readmission. Post hoc analysis of
                       anastomotic leak and time to hospital discharge order written (DOW) > 7 days
                       following surgery was also performed. Summary statistics were performed. 95%
                       confidence intervals were calculated using normal approximation.

                       RESULTS:
                            Event             Placebo       Alvimopan 6     Alvimopan 12
                                              N= 534            mg               mg
                                                               N=530            N=534
                         Post-surgery NG           9.6%        5.5%*            5.6%*
          2                   insertion
                            POI as SAE             5.4%          1.9%*           1.5%*
                              Hospital            11.0%          6.6%*           7.1%*
                           re-admission
                         Hospital DOW >7          29.3%         18.8%**         15.7%**
                                days
                       *P values calculated by Fischer’s Exact test; indicates statistical significance after
                       adjustment for multiplicity according to Hochberg’s method.
                       **P values calculated from logistic regression model; indicates statistical significance
                       after adjustment for multiplicity according to Hochberg’s method.

                       CONCLUSIONS: Alvimopan 6 and 12 mg was associated with a significant reduction
                       in common postoperative morbidities following laparotomy as compared with placebo.
                       Alvimopan 12 mg was associated with significantly lower rate of Hospital DOW > 7
                       days compared to alvimopan 6 mg. The use of alvimopan and the subsequent
                       acceleration in GI recovery did not increase the likelihood of an anastomotic leak.




      18                                                                                             Case Surgery
                                                                                                    Colorectoral Surgery
RANDOMIZED PLACEBO-CONTROLLED STUDY OF ALVIMOPAN IN
PARTIAL BOWEL RESECTION (BR): PRE-OP DOSE TIMING,
ACCELERATION OF GI RECOVERY, AND REDUCTION IN LENGTH OF
HOSPITAL STAY
Kirk Ludwig, Warren Enker, Conor Delaney, Bruce Wolff, Wei Du, Lee Techner
OBJECTIVE: To study the efficacy of alvimopan 12-mg administered 30-90 minutes prior to and
bid until hospital discharge (or 7 days) after laparotomy for small/large BR surgery with primary
anastomosis.
METHODS: This was a randomized, double-blind, placebo-controlled phase IIIb study of
alvimopan. Adult patients scheduled for postoperative IV opioid-based patient-controlled
analgesia were enrolled June-04 through November-05. Treatment effects on time-to-events in
the modified intent-to-treat (MITT) population were analyzed using a Cox proportional hazards
model. Magnitude of treatment effect was expressed using the difference in Kaplan-Meier
means for time-to-event endpoints. The primary endpoint was GI2, a 2-component composite
measure=maximum of time to lower (bowel movement) and upper GI (solid food) recovery.
Other endpoints included uncensored length of hospital stay (LOS; defined by distribution of
discharge order written [DOW] by postoperative day [POD]). The incidence of POI-related
postoperative morbidity (POM; defined as NGT insertion or complications of POI [POI resulting
in prolonged stay/readmission]) was evaluated using Fischer’s exact test. Patients were
monitored for adverse events (AEs).
RESULTS: A total of 654 patients were randomized. The MITT population included 629 patients
with a mean age of 60 years, 51% of whom were women. The most common primary reasons
for BR were colon cancer (36%) and diverticulitis (16%).

                                            Placebo      Alvimopan        P value
Endpoint                                     N=313         N=317
GI2 (Hazard ratio)
LOS (DOW by POD)
                                               —
                                              6.2
                                                            1.53
                                                             5.2
                                                                           <0.001
                                                                           <0.001
                                                                                                    2
Incidence of POI-related POM (%)              14.4            6.9           0.003

The 3 most commonly reported AEs were nausea (alvimopan, 57.8%; placebo, 66.2%;
P=0.030), vomiting (alvimopan, 14.0%; placebo, 24.6%; P<0.001), and abdominal distension
(alvimopan, 17.6%; placebo, 20.3%; P=0.425).
CONCLUSIONS: Alvimopan 12-mg administered 30-90 minutes before surgery and bid
following surgery accelerated upper and lower GI recovery, reduced hospital LOS and reduced
POI-related POM. This new study provides further data on the efficacy, dose, and optimal dose
timing of alvimopan.




2005-2006 Abstracts                                                                                 19
               2
                   Colorectoral Surgery




20
Case Surgery
Section 3
General Surgery
3




22   Case Surgery
                                                                                                   General Surgery
A NOVEL REPORT CARD SYSTEM TO MEASURE PROGRAM
WELLNESS
Jerry M Shuck, M.D., D.Sc., Roy Phitayakorn, M.D.
DESCRIPTION: Our institutions have 57 residency and fellowship programs under the
supervision of the DIO. We have developed a program evaluation instrument for formative
feedback as well as to permit programmatic comparison utilizing metrics. This session will
discuss the creation, validation, and implementation of our Report Card system. We encourage
audience feedback and suggestions for further polishing our ideas.

LEARNING OBJECTIVES:
    a. to describe and share a new program assessment instrument called the Report Card
    b. to elucidate our efforts to validate this instrument
    c. to consider the strengths and weaknesses of this new instrument

PRESENTATION: Dr. Shuck will first present the Report Card and how it has now evolved. (15-
20 minutes) Dr. Phitayakorn will discuss our metrics and validation efforts. (15-20 minutes) The
final 20 to 30 minutes will be devoted to audience interaction, brainstorming and helping our
ideas to further evolve.

                                                                                                   3




2005-2006 Abstracts                                                                                23
General Surgery
                  A NOVEL TECHNIQUE FOR MANAGEMENT OF ENDOSCOPIC
                  GASTROTOMY FOLLOWING NATURAL ORIFICE TRANSVISCERAL
                  ENDOSCOPIC SURGERY
                  Jeffrey Marks M.D., Michael McGee M.D., Michael Rosen M.D., Raymond Onders M.D.,
                  Amitabh Chak M.D., Ashley Faulx, M.D., Anthony Ignagni, Steve Schomisch, Jeffrey
                  Ponsky M.D.
                  BACKGROUND: Natural Orifice Transvisceral Endoscopic Surgery (NOTES) has been
                  recently heralded as the next possible generation in minimally invasive approaches to the
                  abdominal cavity. There are numerous limitations to this conceptual technique, foremost being
                  the management of the endoscopically created gastrotomy. Endoscopic suturing tools are still
                  cumbersome and other presently available tissue approximating devices provide only superficial
                  mucosal closure. Creation of a temporary gastrocutaneous fistula with a PEG is a safe and
                  reliable alternative until a reproducible and dependable full thickness endoscopic closure is
                  available.
                  METHODS:        Pigs were anesthetized and following endotracheal intubation, standard
                  endoscopy with a diagnostic gastroscope was performed. Using a seldinger technique a
                  guidewire was placed into the gastric lumen at a standard site on the abdominal wall for a PEG .
                  The endoscope and guidewire were then brought out through the mouth, and the endoscope
         3        was reinserted along side the guidewire. A gastrotomy was performed with a combination of
                  needle knife cautery followed by endoscopic balloon dilation. The endoscope was advanced into
                  the peritoneal cavity and all four quadrants of the peritoneum were inspected and the scope was
                  then removed. A standard Pull PEG tube (BARD, Billerica, Ma) was attached to the wire exiting
                  the mouth and the PEG was withdrawn back through the gastrotomy, leaving the internal
                  mushroom bumper in the gastric lumen. The lumen of the stomach was then filled with diluted
                  betadine solution and the animals were sacrificed and analyzed.
                  RESULTS: Six pigs were studied and all showed complete sealing of the gastrotomy site with
                  the PEG bumper in appropriate position. There was no evidence of extravasation of the diluted
                  betadine solution in any of the animals.
                  CONCLUSION:       This study supports the use of this novel technique for gastrotomy
                  management following NOTES until a safe and reliable closure technique has been developed.
                  Corollary studies with longer term evaluation of the durability of this closure technique in
                  animals are necessary prior to proceeding to clinical trials.




      24                                                                                        Case Surgery
                                                                                                  General Surgery
A RELIABLE METHOD FOR INTRA-ABDOMINAL PRESSURE
MONITORING DURING NATURAL ORIFICE TRANSVISCERAL
ENDOSCOPIC SURGERY (NOTES)
Michael F. McGee MD, Michael J. rosen MD, Jeffrey Marks MD, Amitabh Chak MD,
Raymond Onders MD, Ashley Faulx MD, Anthony Ignagni, Steve Schomisch, Jeffrey
Ponsky MD
BACKGROUND: Natural Orifice Transvisceral Endoscopic Surgery (NOTES) provides access
to the peritoneal cavity to perform abdominal surgical procedures without skin incisions. NOTES
requires pneumoperitoneum to visualize and manipulate abdominal organs, akin to laparoscopy.
A reliable method to monitor pneumoperitoneum pressures during NOTES has not been
identified. Accurate measurement of pneumoperitoneum is essential to avoid potentially
deleterious effects of intraabdominal compartment syndrome. This study evaluated several
methods of monitoring intraabdominal pressures with a standard gastroscope during NOTES.
METHODS: Four female pigs (25kg) were sedated and a single channel gastroscope was
passed trans-gastrically into the peritoneal cavity. Pneumoperitoneum was achieved via a
pressure insufflator through a percutaneous, intraperitoneal 14- guage catheter. Three other
pressures were recorded via separate catheters. First, a 14-gauge percutaneous catheter
passed intraperitoneally measured true intraabdominal pressure. The second tranducer was a
14-gauge tube attached to the endoscope used to measure endoscope tip pressure. The third
pressure transducer was connected to the biopsy channel port of the endoscope. The abdomen
                                                                                                  3
was insufflated to a range (10-30 mmHg) of pressures, and simultaneous pressures were
recorded from all pressure sensors.
RESULTS:        Pressure correlation curves were developed for all animals across all
intraperitoneal pressures (mean error -4.25 to -1 mmHg). Endoscope tip pressures correlated
with biopsy channel pressures (R2=0.99). Biopsy channel and endoscope tip pressures fit a
least-squares linear model to predict actual intraabdominal pressure (R=0.99 for both). Both
scope tip and biopsy channel port pressures were strongly correlative with true intraabdominal
pressures (R2=0.98, R2-0.99 respectively).

CONCLUSION: This study demonstrates that monitoring pressure through an endoscope is
reliable and predictive of true intraabdominal pressure. Gastroscope pressure monitoring is a
useful adjunct to NOTES. Future NOTES procedures should incorporate continuous
intraabdominal pressure monitoring to avoid the potentially deleterious effects of
pneumoperitoneum during NOTES. Future gastroscopes should integrate pressure monitoring
abilities.




2005-2006 Abstracts                                                                               25
General Surgery
                  AN AGGRESSIVE SURGICAL APPROACH IS WARRANTED IN THE
                  MANAGEMENT OF CYSTIC PANCREATIC NEOPLASMS
                  J.M. Hardacre, M.F. McGee, T.A.Stellato, and J.A. Schulak
                  University Hospitals of Cleveland, Case Western Reserve University School of Medicine
                  BACKGROUND: Cystic pancreatic neoplasms encompass a range of benign to malignant
                  disease. This study assesses the incidence of malignancy in these neoplasms and establishes
                  a strategy for their surgical management.
                  METHODS: The pathology database at our institution was queried for the spectrum of cystic
                  pancreatic neoplasms from January 1996 through December 2005. Hospital and physician
                  charts were retrospectively reviewed. Neoplasms were grouped into Serous Cystic Neoplasms
                  (SCN), Mucinous Cystic Neoplasms (MCN) Adenoma/Borderline, MCN Invasive, Intraductal
                  Papillary Mucinous Neoplasms (IPMN) Adenoma/Borderline, IPMN Carcinoma-in-Situ (CIS),
                  and IPMN Invasive.
                  RESULTS: During the study period 60 resections were performed for 16 SCNs, seven MCNs,
                  and 37 IPMNs. The mean age of the patients was 65 years, and 63% were female. Thirty-
                  seven percent (22/60) of the lesions were found incidentally. Forty-five percent (10/22) of
                  incidental lesions were mucinous.              Twenty-nine distal pancreatectomies, 23
                  pancreaticoduodenectomies, five total pancreatectomies, two enucleations, and one central
         3        pancreatectomy were performed. There were two peri-operative deaths (3.3%). The overall
                  median length of stay was 8 days. Fifty-eight percent (33/57) of patients suffered at least one
                  complication. Endoscopic ultrasound-guided fine-needle aspiration biopsy failed to diagnose
                  invasive cancer in the three patients with cancer that had this procedure performed. Twenty-
                  five percent (15/60) of all neoplasms contained invasive cancer, 34% (15/44) of mucinous
                  neoplasms contained invasive cancer, and 4.5% (1/22) of incidental neoplasms contained
                  invasive cancer. Sixty percent (9/15) of patients with invasive cancer had lymph node
                  metastases. Sixty-seven percent (10/15) of patients with invasive cancer had invasive cancer
                  within one mm of a final surgical margin. Fifty-three percent (8/15) of patients with invasive
                  cancer developed a recurrence. No patients with SCN or MCN Adenoma/Borderline died during
                  the study period. Patients with MCN or IPMN Invasive neoplasms experienced significantly
                  diminished overall five-year survival compared to patients with IPMN CIS neoplasms and to
                  patients with MCN or IPMN Adenoma/Borderline neoplasms (22% vs 73% vs 94%, p=0.004).
                  CONCLUSION: Given the poor long-term survival of patients with cystic pancreatic neoplasms
                  containing invasive cancer and the current inability to pre-operatively distinguish among the
                  various types of lesions in a reliable manner, our data support an aggressive surgical approach
                  to the management of cystic pancreatic neoplasms.




      26                                                                                       Case Surgery
                                                                                                   General Surgery
ANALYSIS OF LARGE VS. SMALL PHEOCHROMOCYTOMAS:
OPERATIVE APPROACHES AND PATIENT OUTCOMES

SM Wilhelm, RA Prinz, AM Barbu, RP Onders, CC Solorzano
PURPOSE: Laparoscopic adrenalectomy for small pheochromocytomas, although challenging,
is widely accepted. However, its application to pheochromocytomas larger than 6 cm is
questioned due to concerns of malignancy and case complexity. Our aim was to examine the
impact of pheochromocytoma tumor size ( 6 cm vs. <6 cm) on operative approach and post-
operative patient outcomes.
METHODS: A retrospective review of adrenalectomies performed at three university hospitals
over one decade was analyzed. All pheochromocytomas were identified and then divided
based on size into large ( 6cm) and small (<6cm) groups. We examined patient and tumor
demographics, pathologic diagnosis, operative approach (laparoscopic vs. open), postoperative
complications, and biochemical cure rates. Data was analyzed using student’s t-tests and a
Fisher’s Exact test with a p value <0.05 considered significant.
RESULTS: From 1995-2005, sixty-five pheochromocytomas were resected. 38% of tumors
(n=25) were 6cm and 62% (n=40) were <6cm. For the large tumors, 1 out of 25 (4%) was
malignant, while no small tumors were malignant. There was no statistically significant
increased risk of malignancy in tumors 6cm in size (p=0.31). Initial operative approach was
based on surgeon preference. 88% of all adrenalectomies were performed laparoscopically,           3
with 3 of 25 (12%) large tumors requiring conversion from laparoscopic to open for intra-
operative bleeding. None of the small tumors required conversion. No major postoperative
complications (i.e. stroke, myocardial infarction) occurred in either group. Minor complications
(wound infections and hematomas) were noted in 16% of large tumors and 12.5% for small
tumors (p=0.45). 96% (24 of 25) of patients with large tumors and 100% with small tumors
showed postoperative biochemical cure. Tumor recurrence was noted in one patient with a
tumor < 6cm.
CONCLUSIONS: Pheochromocytomas 6cm pose a challenge for laparoscopic resection, and
concerns have been raised as to the validity of this operative approach. This study
demonstrates that there is no significant difference in the rate of malignancy for
pheochromocytomas 6cm vs. <6cm. There were also no significant differences identified in
complication rates, postoperative biochemical cure, or tumor recurrence rates between these
two groups. Laparoscopic resection of pheochromocytomas can be safely accomplished
regardless of size in experienced centers.




2005-2006 Abstracts                                                                                27
General Surgery
                  CONTRIBUTIONS TO THE MANAGEMENT OF INTRAABDOMINAL
                  INFECTIONS
                  Mark A. Malangoni, M.D

                  Intra-abdominal infection represents a spectrum of diseases with a common pathogenesis.
                  Establishing a prompt diagnosis and avoiding treatment delays are keys to achieving the best
                  outcomes. Mortality depends upon initiating early appropriate treatment to restore fluid and
                  electrolyte imbalances, supporting the function of vital organs, provide appropriate broad-
                  spectrum antimicrobial therapy and achieving adequate source control. Faculty from the
                  Department of Surgery at the University of Louisville have made significant contributions to the
                  understanding and management of intra-abdominal infections that have affected clinical practice
                  and patient outcomes.




         3




      28                                                                                        Case Surgery
                                                                                                         General Surgery
CURRENT STATUS OF MINIMALLY INVASIVE DIAPHRAGM PACING:
SPINAL CORD INJURED PATIENTS AND ALS (LOU GEHRIG’S
DISEASE)
Raymond P. Onders, M.D., FACS, Mary Jo Elmo, ACNP, Robert Schilz, PhD,
D.O., Bashar Katirji M.D., Anthony R. Ignagni
BACKGROUND: ALS(Lou Gehrig’s Disease) is a progressive neurodegenerative disease that
affects around 5,000 individuals annually. The cause of death for most patients is respiratory
failure unless the only available option of long-term positive pressure ventilation is used.
Therapeutic electrical stimulation has been shown to maintain the strength of other peripheral
muscles in ALS by maintaining physiologic activity, contractile properties and calcium levels.
Motor units can be compensated for by collateral axon sprouting and the rate of sprouting
increases with electrical stimulation. For high spinal cord injured patients with chronic
respiratory insufficiency, electrically induced diaphragm pacing is a clinically useful alternative to
long-term positive pressure ventilation. We have shown in spinal cord injured patients that the
laparoscopic diaphragm pacing system is a low-risk, cost-effective outpatient system that will
support the respiratory needs of patients.
METHOD: Following FDA and IRB approval, patients underwent laparoscopic mapping of their
diaphragm to locate the phrenic nerve motor points. Two electrodes were implanted in each
hemidiaphragm. Two weeks after surgery, stimulus/output characteristics of each electrode
were determined and diaphragm conditioning was initiated on an out-patient basis with patient
                                                                                                         3
caregiver monitoring.
RESULTS: Sixteen patients spinal cord injured patient (13 male, three female) have undergone
diaphragm pacing by this method. Length of time from injury to implantation ranged from one to
25 years. All procedures were performed on an outpatient observational basis with no
intraoperative complications. One patient had a false positive preoperative phrenic nerve
conduction study and therefore pacing was unsuccessful. All of the remaining 15 patients were
able to achieve greater than their predicted tidal volume. Diaphragm conditioning required 1.3 -
28 weeks (n=11) to achieve at least 12 consecutive hours of pacing, without the need for
mechanical ventilation. Four patients are still conditioning their diaphragms. Eleven patients
use the pacing device as their primary mode of ventilatory support, with the longest patient
using the device for 54 consecutive months. One patient expired secondary to an unrelated
event. Each patient has noted substantial advantages of ventilatory support by diaphragm
pacing compared to mechanical ventilation. Four patients have been enrolled in the Phase 1
FDA trial and the success of strengthening their diaphragm is being followed.
CONCLUSION: For spinal cord injured patients, the laparoscopic diaphragm pacing system to
be a low-risk, cost-effective outpatient system that will support the respiratory needs of patients.
Therapeutic electrical stimulation has been used for patients with ALS in the past but it could
never help the end result of the respiratory decline. We now have an easy way to stimulate the
diaphragm and this study will show whether this will help the quality of patients’ respiration with
ALS.




2005-2006 Abstracts                                                                                      29
General Surgery
                  CURRENT STATUS OF PHRENIC NERVE PACING VIA
                  LAPAROSCOPICALLY PLACED INTRAMUSCULAR ELECTRODES IN
                  TETRAPLEGICS
                  RP Onders, AR Ignagni, AF DiMarco, MJ Elmo, J Road*
                  University Hospitals of Cleveland, Case Western Reserve University
                  *Vancouver General Hospital, University of British Columbia
                  BACKGROUND: For high spinal cord injured patients with chronic respiratory insufficiency,
                  electrically induced diaphragm pacing is a clinically useful alternative to long-term positive
                  pressure ventilation. Presently the only available phrenic nerve pacing systems require phrenic
                  nerve dissection and placement of electrodes placed in direct contact with the nerve via
                  thoracotomy. The goal of the present study was to demonstrate the feasibility of diaphragm
                  pacing with intramuscular electrodes implanted into the diaphragm via laparoscopy, a less
                  invasive procedure usually performed on an out-patient basis.
                  METHOD: Following FDA and IRB approval, patients underwent laparoscopic mapping of their
                  diaphragm to locate the phrenic nerve motor points. Two electrodes were implanted in each
                  hemidiaphragm. Two weeks after surgery, stimulus/output characteristics of each electrode
                  were determined and diaphragm conditioning was initiated on an out-patient basis with patient
                  caregiver monitoring.
         3        RESULTS: Fourteen patients (11 male, three female) have undergone diaphragm pacing by
                  this method. Length of time from injury to implantation ranged from one to 25 years. All
                  procedures were performed on an outpatient observational basis. There were no intraoperative
                  complications. One patient had a false positive preoperative phrenic nerve conduction study
                  and therefore pacing was unsuccessful. All of the remaining 13 patients were able to achieve
                  greater than their predicted tidal volume 8-10 ml/kg for females (n=3) and 7-11 ml/kg for males
                  (n=10) during stimulation. Diaphragm conditioning required 1.3 - 28 weeks (n=10) to achieve at
                  least 12 consecutive hours of pacing, without the need for mechanical ventilation. Eleven
                  patients use the pacing device as their primary mode of ventilatory support, with the longest
                  patient using the device for 54 consecutive months. Each patient has noted substantial
                  advantages of ventilatory support by diaphragm pacing compared to mechanical ventilation.
                  CONCLUSION: The results show the laparoscopic diaphragm pacing system to be a low-risk,
                  cost-effective outpatient system that will support the respiratory needs of patients.




      30                                                                                        Case Surgery
                                                                                              General Surgery
 DIAPHRAGM PACING IN AMYOTROPHIC LATERAL SCLEROSIS:
 EARLY RESULTS PROMISING
 Raymond P. Onders, M.D., FACS, Mary Jo Elmo, ACNP, Robert Schilz, PhD,
 D.O., Bashar Katirji M.D., Anthony R. Ignagni
 BACKGROUND: Respiratory failure is responsible for the majority of deaths in patients
 with amyotrophic lateral sclerosis (ALS). Therapeutic electrical stimulation has been
 shown to maintain the strength and activity of peripheral muscles in ALS and promote
 collateral axon sprouting. We have shown in 20 spinal cord injured patients that a
 laparoscopic diaphragm pacing system is a low-risk, cost-effective outpatient system for
 ventilation.
 OBJECTIVE: To evaluate the safety of implanting the diaphragm pacing system for use
 in conditioning the diaphragm of ALS patients. Our secondary objectives are to assess
 the system in slowing the respiratory decline and improving quality of life.
 METHODS: The principle inclusion requirements are a forced vital capacity above 50%.
 Each patient is followed for two months pre-implantation and then post implantation with
 a series of tests including: pulmonary function tests, speech phonation times, ultrasound
 analysis of diaphragm thickness, and quality of life tests. Patients undergo an outpatient
 laparoscopic mapping of their diaphragm to locate the phrenic nerve motor points with
 two electrodes implanted in each hemidiaphragm. The patients then condition their            3
 diaphragm at home with five 30 minute sessions of therapeutic electrical stimulation per
 day.
 RESULTS: Five patients have been successfully implanted. The diaphragms at surgery
 presented with significant weakness in two patients. One patient had a radial banding
 appearance of her intact motor units. All have been able to tolerate training with the
 system. Initial results show the patients’ FVC has reached a plateau or decreased
 slightly. Phonation times, muscle thickness and movement of diaphragm with stimulation
 under fluoroscopy have improved.
 CONCLUSION: The diaphragm pacing system can be safely implanted and utilized in
 patients with ALS. The early results look promising for a long term improvement in
 survival and quality of life.




2005-2006 Abstracts                                                                           31
General Surgery
                  DIAPHRAGM PACING IN THE VENTILATOR DEPENDANT SPINAL
                  CORD INJURED PATIENT
                  Mary Jo Elmo, ACNP, Raymond P. Onders, MD., Anthony R. Ignagni
                  BACKGROUND: Cervical spine injuries usually result in life long requirement of mechanical
                  ventilation. Chronic mechanical ventilation is associated with decrease in mobility, alterations is
                  speech patterns, increase in infections and tracheal injuries. The ventilator has psychosocial
                  implications of increase in caregiver burden and feelings of isolation. In the SCI population, the
                  need for mechanical ventilation decreases life expectancy. Diaphragm pacing has been utilized
                  for over 30 years to assist ventilation in lieu of the mechanical ventilator. An electrical stimulus
                  is delivered to the phrenic nerve producing diaphragm contraction resulting in respiration.
                  Benefits of diaphragm pacing include improved speech patterns, increased mobility and ease of
                  care. There are reports of improved quality of life and decrease in mortality. Despite benefits of
                  diaphragm pacing, it is a rarely utilized therapy. This is likely due to the high risk nature of the
                  surgical procedure.

                  METHODOLOGY:           A new technique implanting diaphragm pacers is currently under
                  investigation at University Hospitals of Cleveland. A retrospective review of eighteen patients
                  laparoscopically implanted with diaphragm pacers from 03/06/00 to 07/08/05 was analyzed.
                  Gender, age at the time of injury, years on mechanical ventilation, OR time, in hospital training
                  time, conditioning time, pacing status and patient satisfaction were documented.
         3
                  RESULTS: 15 pts were males, 12 with C1-2 level injury, 3 with C3-4 level injury. Three pts
                  were females all with C1-2 level injury. Age at the time of injury ranged from 2 to 70 years with
                  the average being 26 years. Average OR time 3.1 hours. At present, 9 pts are full time pacing,
                  three part time and four undergoing conditioning. One patient died of unrelated causes, 1 1/2
                  years post surgery and one patient had a false positive and never was paced.

                  IMPLICATIONS: Diaphragm pacing performed by a laparoscopic surgeon specifically trained in
                  this technique is a low risk outpatient surgical procedure. A home-based conditioning protocol
                  has been employed, thus decreasing hospital stay even further. Diaphragm pacing has the
                  potential to ameliorate the adverse outcomes associated with the mechanical ventilator.




      32                                                                                            Case Surgery
                                                                                                        General Surgery
DIAPHRAGM PACING WITH NATURAL ORIFICE TRANSVISCERAL
ENDOSCOPIC SURGERY (NOTES): POTENTIAL FOR DIFFICULT TO
WEAN INTENSIVE CARE UNIT (ICU) PATIENTS
Raymond Onders MD, Jeffrey Marks MD, Anthony Ignagni MS, Michael McGee MD,
Michael Rosen MD, Amitabh Chak MD, Ashley Faulx MD, Robert Schilz DO, Steve
Schomisch BS, Jeffrey Ponsky MD
BACKGROUND: Up to 50% of ICU patients require mechanical ventilation with 20% on a
ventilator for over 7 days. Over 40% of time is spent weaning a patient from mechanical
ventilation. Failure to wean from mechanical ventilation can in part be due to rapid onset of
diaphragm atrophy, barotrauma, posterior lobe atelectasis, and impaired hemodynamics which
are normally improved by maintaining a more natural negative chest pressure. We have shown
that laparoscopic implantation of a diaphragm pacing system successfully provides adequate
ventilation in spinal cord injured patients. Our preliminary data also suggests that DPS may
benefit amyotrophic lateral sclerosis (ALS) patients with partial diaphragmatic atrophy. With the
knowledge we have gained from these patients, we propose that acute ventilator assist with
interventional neurostimulation of the diaphragm in the ICU is feasible and could facilitate
weaning from mechanical ventilation. Current DPS implantation is carried out electively in the
operating room but transfer of critically ill patients for procedures is not always possible or safe.
NOTES has the potential to expand the benefits of DPS to this acute patient population by
allowing it to be done at the bedside like the common gastrostomy tube. This study evaluates            3
the feasibility of this approach in a porcine model.
METHODS: Pigs were anesthetized and peritoneal access with the flexible endoscope was
obtained using a guidewire, needle knife cautery and balloon dilatation. The diaphragm was
mapped to locate the motor point (where stimulation provides complete contraction of the
diaphragm) with a novel endoscopic electrostimulation catheter. An intramuscular electrode was
then placed at the motor point with a percutaneous needle. This was then attached to the
diaphragm pacing system. The gastrotomy was managed with a gastrostomy tube.
RESULTS: Four pigs were studied and the diaphragm could be mapped with the endoscopic
mapping instrument to identify the motor point. In one animal, under transgastric endoscopic
visualization a percutaneous electrode was placed into the motor point and the diaphragm could
be paced in conjunction with mechanical ventilation.
CONCLUSIONS: These animal studies support the concept that trans-gastric mapping of the
diaphragm and implantation of a percutaneous electrode for therapeutic diaphragmatic
stimulation is feasible. These encouraging results warrant a prospective human trial to assess
safety and efficacy.




2005-2006 Abstracts                                                                                     33
General Surgery
                  DOES THE ADDITION OF GLUTAMINE TO ENTERAL
                  FEEDS AFFECT PATIENT MORTALITY?
                  Alison Saalwachter Schulman, MD; Kate F. Willcutts, MS, RD, CNSD; Jeffrey A.
                  Claridge, MD; Heather L. Evans, MD, MS; Amy E. Radigan, RD, CNSD; Kelly B.
                  O’Donnell, MS, RD, CNSD; Jeremy R . Camden, BA; Tae W. Chong, MD; Shannon T.
                  McElearney, MD; Robert L. Smith, MD; Leo M. Gazoni, MD; Heidi-Marie A. Farinholt,
                  MD; Cara C. Heuser, MD; Stuart M. Lowson, MD; Bruce D. Schirmer, MD, FACS;
                  Robert G. Sawyer, MD, FACS
                  OBJECTIVE: Studies have failed to consistently demonstrate improved survival in intensive
                  care unit (ICU) patients receiving immune-modulating nutrient-enhanced enteral feeds when
                  compared with standard enternal feeds. The objective was to study in a prospective fashion the
                  effects of adding glutamine to standard or immune-modulated (supplemented with omega-3
                  fatty acids, B-carotene, and amino acids such as glutamine and arginine) tube feeds.
                  DESIGN: Prospective, unblinded study using sequential allocation.
                  Setting: A university surgical trauma ICU.
                  Patients: All surgical and trauma patients admitted to the surgical trauma ICU at a university
                  hospital over a 3-yr period who were t receive enteral feeds (n=185).
                  INTERVENTIONS: Sequential assignment to three isocaloric, isonitrogenous diets was
         3        performed as follows: standard 1-kcal/mL feeds with added protein (group 1), standard feeds
                  with the addition of 20-40 g/day (0.6 g/kg/day) glutamine (group2), or an immune-modulated
                  formula with similar addition of glutamine (group 3). The goal for all patients was 25-30
                  kcal/kg/day and 2 g/kg/day protein.
                  MEASUREMENTS AND MAIN RESULTS: Patients were followed until discharge form the
                  hospital. The primary end point was in-hospital mortality, and multiple secondary end points
                  were recorded. In-hospital mortality for group 1 was 6.3% (four of 64) vs. 16.9% (ten of 59, p =
                  .09) for group 2 and 16.1% (ten of 62, p = .09) for group 3. After controlling for age and severity
                  of illness, the difference in mortality between patients receiving glutamine was not significant (p
                  < or = .11). There were no statistically significant differences between the groups for secondary
                  end points.
                  CONCLUSIONS:         The addition of glutamine to standard enteral feeds or to an
                  immunomodulatroy formula did not improve outcomes. These findings suggest that enteral
                  glutamine should not be routinely administered to patients with surgical critical illness.




      34                                                                                           Case Surgery
                                                                                              General Surgery
 EARLY RESULTS OF LAPAROSCOPIC MOTOR POINT
 DIAPHRAGM PACING IN AMYOTROPHIC LATERAL SCLEROSIS:
 CAN EXOGENOUS ELECTRICAL STIMULATION IMPACT
 RESPIRATORY FAILURE?
 RP Onders, AR Ignagni, B Katirji, R Schilz, MJ Elmo
 BACKGROUND: Respiratory failure is responsible for the majority of deaths in patients
 with amyotrophic lateral sclerosis (ALS). Therapeutic electrical stimulation has been
 shown to maintain the strength of other peripheral muscles in ALS. Electrical stimulation
 may also maintain physiologic activity, contractile properties, calcium levels and promote
 collateral axon sprouting. We have shown that a laparoscopic diaphragm pacing system
 in spinal cord injured patients is a low-risk, cost-effective outpatient system that will
 support the full-time respiratory needs of patients. We are currently studying the use of
 this technology in patients with ALS and respiratory insufficiency.
 OBJECTIVE: To evaluate, in this Phase I trial, the safety of implanting the diaphragm
 pacing system for use in conditioning the diaphragm of classic ALS patients. Our
 secondary objectives are to assess the system in slowing the respiratory decline and
 improve quality of life for implanted patients.
 METHODS: The principle inclusion requirements are a forced vital capacity above 50%          3
 at the start of the study and above 45% at the time of surgical implantation. Each patient
 is followed for three months pre-implantation with a series of tests including: pulmonary
 function tests, speech phonation times, ultrasound analysis of diaphragm thickness,
 phrenic nerve conduction tests and quality of life tests. Patients undergo a one to two
 hour outpatient laparoscopic mapping of their diaphragm to locate the phrenic nerve
 motor points with two electrodes implanted in each hemidiaphragm. Two weeks after
 surgery, the stimulus output characteristics of each electrode are determined and
 stimulus parameters are selected for conditioning. The patients then condition their
 diaphragm at home with five 30-minute sessions of therapeutic electrical stimulation per
 day. The conditioning sessions may be performed while they are doing their ordinary
 activities of daily living. Patients are assessed post-operatively on a monthly basis with
 the same tests performed pre-operatively to compare pre- & post-implant trends.
 RESULTS: Three patients were successfully implanted. All three had an FVC of 53% or
 less at the time of surgery. The diaphragms at surgery presented with significant
 weakness in two patients. One patient had a radial banding appearance of her intact
 motor units. All have been able to tolerate training with the system. At early follow-up
 the patients’ FVC (without stimulation) has decreased but at the two-month follow-up the
 first two patient’s FVC had increased to above the one-month follow-up. In all patients
 the phonation times, muscle thickness and movement of diaphragm with stimulation
 under fluoroscopy have improved. All three patients have, anecdotally, reported feeling
 better.
 CONCLUSION: The diaphragm pacing system can be safely implanted and utilized in
 patients with ALS. Whether there will be a long-term improvement in ventilation leading
 to an increased survival or quality of life requires further follow-up.




2005-2006 Abstracts                                                                           35
General Surgery
                  ENDOLUMINAL SURGERY: PAST, PRESENT AND FUTURE
                  JL Ponsky, MD

                  Flexible endoscopy has evolved from a diagnostic tool practiced predominantly by
                  gastroenterologists to a minimally invasive surgical tool. Therapeutic endoluminal procedures
                  have become the standard of care for many gastric, biliary, pancreatic and colonic maladies.
                  New technologies are under investigation for endoscopic treatment of gastroesophageal reflux,
                  morbid obesity, and ablation of premalignant tissue. In the future, flexible endoscopes may play
                  a role in “natural orifice” surgery, performing operations through the mouth or rectum without the
                  need for external incisions.




         3




      36                                                                                          Case Surgery
                                                                                                   General Surgery
ENDOSCOPIC PLACEMENT AND FIXATION OF A TEMPORARY SELF-
EXPANDING PLASTIC STENT FOR AN ANASTOMOTIC DEHISCENCE
AND STRICTURE
Jeffrey Marks, Amitabh Chak, Victor Chen, Jeffrey Ponsky
The management of postoperative anastomotic complications frequently requires a
multimodality approach including radiologic, endoscopic, and surgical techniques. We report on
the technique for placement of a recently developed self-expanding plastic esophageal stent, as
well as a modification to minimize migration.

A 72 year old male was referred following surgery for recurrent gastric cancer. He had
undergone completion gastrectomy and esophagojejunostomy with Roux-en-Y reconstruction.
Post-operatively, the patient complained of severe dysphagia. Contrast studies identified an
anastomotic stricture and contained dehiscence.

Endoscopic evaluation confirmed these findings and a 120 mm x 20 mm removable plastic stent
was placed utilizing fluoroscopic guidance. Proximal and distal points 6cm above and below the
anastomosis were marked with submucosal injections of contrast. Due to the concern for stent
migration, 2-0 silk sutures were placed on the proximal edge of the stent and secured, following
deployment, by endoscopic clips. Post-procedure barium swallow showed flow of contrast into
the small bowel and absence of the dehiscence. Serial KUBs every two weeks to identify any
migration of the stent are performed and the stent is then removed at six weeks. This novel
                                                                                                   3
endoscopic tool may avoid the need for major surgical intervention for this complex
postoperative problem.




2005-2006 Abstracts                                                                                37
General Surgery
                  EVALUATION AND MANAGEMENT OF INCIDENTAL THYROID
                  NODULES IN PATIENTS WITH ANOTHER PRIMARY MALIGNANCY

                  Scott M. Wilhelm, MD, Ann V. Robinson, Smitha A. Krishnamurthi, MD, and Harry L.
                  Reynolds, MD. University Hospitals of Cleveland, Case Surgery, Cleveland, OH.

                  BACKGROUND: Some studies indicate that incidental thyroid nodules may have a higher rate
                  of malignancy (7-12%) than traditionally discovered nodules (5%). Biopsy of incidental
                  nodules >1cm is indicated, but measurement accuracy of imaging modalities is not clear. We
                  sought: 1) to determine rates of malignancy in incidental thyroid nodules in patients with other
                  malignancies, and 2) to examine the accuracy of ultrasound (U/S) vs. CT scan in determining
                  nodule size.

                  METHODS: We did a retrospective review of 21 pts with history of another known malignancy
                  (Gastrointestinal-10, breast- 4, others- 7) referred for evaluation of an incidental thyroid nodule
                  found on various imaging modalities (CT, U/S, and others). Pts underwent office based U/S
                  and FNABx of nodules > 1cm. Surgical intervention was based on biopsy results. Pearson
                  correlation test was done to compare nodule size at pathology to size seen on CT or U/S. R2
                  and P values were calculated.

         3        RESULTS: 19 pts met criteria for FNABx. 14/19 (74%) pts had atypical findings warranting
                  resection. 11/14 underwent surgery. Pathology yielded 3 pts with papillary thyroid cancer
                  (PTC), 2 pts (microPTC),        1 metastatic cancer, and 5 benign lesions. Ultrasound
                  measurement of nodules compared to size measured at pathology had an R2 correlation value
                  of 0.97 with P value <0.0001. CT scan had an R2 value of 0.63 and P value of 0.11.

                  CONCLUSIONS: Incidental thyroid nodules found in pts with another malignancy warranted
                  resection in 74% of pts. Well differentiated thyroid CA was found in 27% of pts and micro PTC
                  in 18%. Metastatic lesions (1 patient) were uncommon. Incidental lesions found on CT scan
                  were often inaccurately measured. U/S had a near-perfect correlation with nodule size at
                  pathology. Thyroid U/S is essential in these pts to determine accurate lesion size if we are to
                  use size as a criteria for which lesions warrant biopsy and thus surgical resection. All
                  incidental thyroid nodules > 1cm seen in pts with another malignancy warrant further
                  evaluation.




      38                                                                                           Case Surgery
                                                                                                          General Surgery
EXPERT WITNESS TESTIMONY: THE PROBLEM AND
RECOMMENDATIONS FOR OVERSIGHT AND REFORM
Christopher R. McHenry, M.D.1, Walter L. Biffl, M.D.2, William C. Chapman, M.D.3
and David A. Spain, M.D.4, Department of Surgery, MetroHealth Medical Center,
Case Western Reserve University, School of Medicine, Cleveland, Ohio1,
Department of Surgery, Division of Trauma and Surgical Critical Care, Rhode Island
Hospital/Brown Medical School, Providence, Rhode Island2,
Department of Surgery, Section of Transplantation, Washington University, School of Medicine,
St. Louis, Missouri3,
Department of Surgery, Division of Trauma/Surgical Critical Care, Stanford University, Stanford,
California4

ABSTRACT:
A lack of regulation and oversight of expert medical witness testimony is a significant factor
contributing to frivolous lawsuits and erroneous conclusions in medical liability litigation. This is
a position paper based on interpretation of precedent and practice that represents a desired end
that was formulated by the members of the Committee on Social and Legislative Issues of the
Society of University Surgeons (SUS), posted on the SUS website for review and comments by
its membership and approved by its Executive Council (1). It summarizes the role of the expert            3
medical witness and what constitutes expert medical witness testimony. The problems that
exist with expert witnesses and their testimony and efforts to reform the expert witness process
are reviewed. Suggestions to help improve the credibility of the expert medical witness and
recommendations for oversight and reform of the expert medical witness process are presented.


INTRODUCTION

The increase in medical liability litigation and the increase in cost of medical liability insurance is
forcing many physicians to move to states where insurance costs are less and others to give up
their practices entirely. It has lead some specialists to limit their practices to avoid the potential
for medical liability suits such as orthopedic surgeons and neurosurgeons who are withdrawing
from coverage of emergency departments and doctors trained in family practice and obstetrics
and gynecology who are no longer delivering babies (2,3). It is also deterring highly qualified
individuals from choosing specialties that are at high-risk for medical liability litigation and others
from choosing careers in medicine altogether (4,5). Trauma and maternity units are closing and
patients are losing timely access to life-saving specialists (2,3). Given the negative impact that
medical liability litigation is having on health care, physicians should have a major interest in
trying to improve the litigation process. One area that physicians are in a unique position to
help change is the credibility of the expert witness.
The results of medical liability litigation in the United States are affected by the testimony of
expert witnesses. Existing tort law in many states requires a physician expert’s statement of
negligence and deviation from the standard of care in order to initiate a lawsuit (6). The
traditional process in the American system has been for lawyers, both for the plaintiff and the
defendant, to retain expert witnesses who offer their opinions about the standard of care and the
specific care rendered by another physician. Lawyers from opposite sides are given the
opportunity to cross-examine expert witnesses and a jury determines the validity of their
testimony. No other country routinely relies on a jury of lay people to determine the outcome of
a potentially complex medical liability lawsuit. Elsewhere, magistrates preside over and
determine the outcome of medical liability cases and advice and opinions are obtained from
medical experts who may be questioned by counsel for the plaintiff or the defendant (7).


In the United States there are over 18 million lawsuits per year (6). This large volume of
lawsuits has created a lucrative business for the “expert witness for hire”. Physicians and other
medical personnel make up the largest proportion of expert witnesses testifying in over half of
all federal civil trials (6). There is a significant concern about the lack of regulation and
oversight of expert medical witness testimony in depositions and at trial.




2005-2006 Abstracts                                                                                       39
General Surgery
                  WHAT CONSTITUTES AN EXPERT WITNESS AND EXPERT WITNESS TESTIMONY
                  An expert medical witness is defined as someone who is qualified to offer an opinion to a judge
                  and jury about clinical findings and the standard of care, whereas a non-expert witness is only
                  permitted to testify about what he or she has observed. The Federal Rules of Evidence (FRE),
                  the Frye test, and the Daubert guidelines form the basis for determining the admissibility of
                  expert medical or scientific testimony (6, 8-12). The FRE formally apply to federal courts,
                  however, they have been adopted by many state courts as a guide for dealing with expert
                  witness testimony (Table). Under FRE 702, a witness may be classified as an expert on the
                  basis of “knowledge, skill, experience, training or education” (8,11). The rule provides the court
                  with considerable latitude for determining who constitutes an expert witness and whether or not
                  the testimony will help the jury to understand the evidence.

                  The “Frye test” establishes expert testimony as reliable only if it is based on information that is
                  generally accepted in the scientific community. The court case, Frye v. the United States in
                  1923 involved testimony about the reliability of the precursor of the modern day lie detector (9).
                  The court decided that for a technique to be used it must be “generally accepted within the
                  scientific community before expert opinion about data gained from use of the technique is
                  admissible into evidence”. The Frye test provides the legal basis for judges to exclude expert
                  testimony that is based on information, principles or opinion not generally accepted by the
                  scientific community.
                  In 1993, the United States Supreme Court provided guidelines for expert witnesses in the
         3        federal court case of Daubert v. Merrel Dow Pharmaceuticals (10). In this case, plaintiffs
                  claimed that the children born to mothers who received Bendectin, an anti-nausea medication,
                  developed birth defects. However, scientific evidence failed to establish any association
                  between Bendectin and birth defects. The Supreme Court affirmed that expert testimony should
                  be based on information that has been subjected to the scientific method rather than
                  unsupported speculation. The Supreme Court also directed trial judges to determine whether
                  expert testimony was relevant and based on valid scientific evidence. It gave its support to the
                  FRE 706 (Table) which permits judges to appoint their own independent expert witnesses and
                  encouraged trial judges to do so.

                  THE ROLE OF THE EXPERT WITNESS
                  The primary purpose of the expert witness is to assist the trier of facts in understanding the
                  specific medical issues in a given case. An expert witness must be able to: determine the
                  relevant facts of a case, define the standard of care for management of a specific problem,
                  determine whether a physician’s action conformed or deviated from the standard of care and
                  assess the relationship between the alleged substandard care and the patient’s outcome
                  (13,14). As a result, an expert witness must have qualifications that relate specifically to the
                  medical problem of the case. The expert should be actively involved in the clinical or scientific
                  practice that deals with the subject matter of the case. An expert opinion should be based on
                  the scientific knowledge and accepted scientific principles that were relevant at the time of the
                  occurrence or incident that is being litigated.




      40                                                                                          Case Surgery
                                                                                                       General Surgery
THE PROBLEM WITH EXPERT WITNESSES AND EXPERT WITNESS TESTIMONY
In many states, any licensed physician is presumed to be an expert solely on the basis of his or
her medical degree. Testimony by an “expert” is often allowed by judges even though other
physicians or scientists do not regard the individuals’ credentials as those of an expert in a
particular field. Expert testimony has become increasingly subjective and based on speculation
and opinion rather than sound scientific principles. Very little constraint is applied to the
testimony of an expert, often giving them inordinate latitude to comment on things that are
outside their area of expertise. The perception exists that an expert can be found to support any
point of view as long as the financial compensation is right. Some medical-legal firms have
made sizable earnings by supplying attorneys with experts until they find an opinion that is
satisfactory.
The laxity of judges in allowing unqualified individuals to give “expert” testimony increases the
likelihood of scientifically untenable outcomes. Review of expert witness testimony involving
neurologists in Massachusetts revealed that, in 64 closed claims from 1980 to 1990, 37% of all
cases were determined to have errors of fact or interpretation, incorrect statements and
erroneous conclusions regarding medical malpractice (15).

Another issue of concern is the competence of courts to determine: the credibility of an expert
witness, the scientific validity of expert testimony and the medical certainty of the conclusions.
Rarely do courts insist on having expert witnesses detail what his or her conclusions are based
on. There is no peer-review of expert witness testimony to insure its merit or validity. As a
result, expert witnesses have not been held to the standards of scientific practice. This became       3
increasingly apparent in the litigation dealing with the alleged relationship of silicone breast
implants and latent connective tissue disorders (16). A United States District Court order
established a National Science Panel to clarify the scientific evidence for such an association.
The panel found no evidence to support the expert testimony suggesting an association
between silicone breast implants and connective tissue disorders.

Many state jurisdictions adhere solely to the FRE as the basis for expert witness testimony. As
a result of the FRE, judges have allowed the opinions of “experts” that lack scientific validity and
have left the responsibility of determining the scientific validity and relevance of medical
testimony to a lay jury (17,18). This has resulted in the acceptance of scientific misconceptions
and legal decisions that are in contradiction to scientific knowledge.      Many legal experts
believe that the FRE are too liberal and, as a result, have led to a general deterioration in the
judicial process with testimony that is improper, inaccurate, pseudoscientific, and at times,
dishonest (17,18).
PRIOR EFFORTS TO REFORM THE EXPERT WITNESS PROCESS
In 1987, the American College of Obstetricians and Gynecologists took steps to educate
physicians regarding the difference between taking a side and becoming an advocate in a
malpractice trial, versus acting as an impartial observer who presents an objective interpretation
of data (5). The American Academy of Pediatrics published guidelines for expert witness
testimony in a medical liability case (14,19). The American Academy of Neurologic Surgeons,
the American Academy of Orthopedic Surgeons, and the American Academy of Neurology
recommended that expert witnesses should be in active practice and familiar with the specific
medical issues of the case, and should derive not more than 20% of their income from expert
witness testimony (6, 20-22). The American Academy of Neurologic Surgeons has maintained
a file of depositions and trial testimony given by neurosurgical expert witnesses and has
censured and sanctioned numerous neurosurgeons for improper testimony. The American
Academy of Neurology created a Grievance Committee for review of faulty medical witness
testimony, and created a mechanism for ensuring due process and for administering sanctions
(6). In 1998, The American Medical Association passed a resolution that expert witness
testimony should be considered a scholarly endeavor that is part of the practice of medicine and
subject to peer review (6). The American Medical Association also agreed to help specialty
societies with disciplinary actions against physicians.




2005-2006 Abstracts                                                                                    41
General Surgery
                  In 2004, the American College of Surgeons issued a “Statement on the physician acting as an
                  expert witness” (Statement 8, http://www.facs.org/fellows_info/statements/statement.html),
                  which includes recommended qualifications and guidelines for behavior of the physician who
                  acts as an expert witness (23). The American College of Surgeons, as well as the American
                  Academy of Orthopedic Surgeons and the American College of Obstetricians and
                  Gynecologists, recommended that members who serve as expert witnesses in medical liability
                  litigation voluntarily sign an expert witness affirmation that they will adhere to certain principles
                  guiding expert witness testimony (23). The American College of Surgeons has asked its
                  members to send information about faulty expert witness testimony to the Collaborative Defense
                  Network for Expert Witness Research, an organization which collects information on and
                  researches the background of an expert witnesses (www.idex.com). They have also created a
                  mechanism for dealing with the irresponsible expert witness. A professional liability library has
                  been established for storage of depositions and court testimonies of individuals for whom
                  complaints have been received. A Central Judiciary Committee reviews the complaints,
                  determines whether the bylaws have been violated, and makes recommendations to the Board
                  of Reagents regarding whether disciplinary action should be taken and the severity of the
                  penalty. During the year 2004, punitive action was taken against two Fellows of the American
                  College of Surgeons and a number of others are under investigation for acting as an
                  irresponsible expert witness. The American College of Surgeons has also developed model
                  state legislation that is available on its website (www.facs.org).

         3        RECOMMENDATIONS FOR OVERSIGHT AND REFORM OF EXPERT MEDICAL WITNESS
                  TESTIMONY
                  Laws, such as the one in New York State, which prevent the identity of an expert witness and
                  his or her testimony from becoming public record unless the case goes to trial, need to be
                  eliminated (24). Expert testimony should be treated as a scholarly activity that is subject to peer
                  review. Selected transcripts of testimony (with identifying characteristics of the defendant
                  removed) should be published in specialty-specific peer reviewed journals, with invited
                  commentaries from one or more experts in the same field identified by the editorial boards of the
                  journal. Such invited experts would provide a conclusion regarding the accuracy of the
                  testimony, and the expert witness would be given a chance to respond. The possibility of
                  having transcripts of testimony published with a written commentary from a peer in the same
                  field would be a deterrent for inauthentic testimony.
                  At the state level, action should be taken to define expert witness activity as part of the practice
                  of medicine. It should be recognized that an expert witness who reviews data and renders an
                  opinion in a medical-liability case applies the same scientific principles that he or she uses to
                  give a second opinion regarding the diagnosis and treatment of a medical problem. State
                  medical licensing boards should have the authority to discipline physicians who render improper
                  testimony or violate professional standards, including the revocation of medical licensure. It
                  should be clearly understood that improper testimony by an expert for either the plaintiff or
                  defendant are equally egregious and warrant the same disciplinary action. Recently, federal
                  courts have upheld the concept that doctors may be disciplined for giving false testimony (25).




      42                                                                                            Case Surgery
                                                                                                       General Surgery
State medical licensing boards should also establish guidelines for expert witness testimony and
reaffirm standards of professionalism. This should include a clear statement that a physician
who is retained to testify regarding the standard of care must have qualifications that relate
directly to the medical problem being reviewed. The expert witness should be board certified in
the specialty in which the person purports to be an expert witness and be actively practicing in
the specialty. The expert witness should be advised about the importance of not becoming a
partisan advocate for the viewpoint of the plaintiff or defense in a legal proceeding. The receipt
of contingency fees by a physician or medical-legal firm based on a percentage of the
settlement or judgment for expert witness testimony, which are provided as incentives to testify,
should be explicitly denounced as unethical. Testimony should be impartial, objective, and
based on scientific data. Medical experts should be routinely expected to document the
foundations on which their conclusions are made and their testimony should be subject to peer
review and monitoring by specialty societies and medical licensing boards.
State and federal judicial systems need to make the standard for reliability of expert witness
testimony more stringent. The FRE afford the judge and lawyers too much latitude in
determining who qualifies as an expert witness and what constitutes expert testimony.
According to FRE 702 (Table), an individual may be considered an expert witness based only
on their education or training. This is a disservice to the judicial system. More weight should be
given to the Daubert guidelines which specify that the trial judge should insure that an expert’s
opinion is relevant and scientifically valid. Rather than leaving the responsibility for determining
the validity of expert witness testimony to a lay jury, judges should screen proposed expert
witnesses to insure their credibility. They should exclude testimony when it is based on               3
information that is not accepted by the mainstream of individuals within the relevant scientific
community. Ultimately, it would be optimal for judges to appoint an independent panel of
experts based on the recommendation of a nationally recognized specialty-specific professional
organization (such as the American College of Surgeons) and the plaintiff and defendant would
share the cost of compensating the expert or expert panel.
Professional organizations could maintain listings of expert witnesses for specific specialty
areas that judges and defense and plaintiff attorneys could use. A physician identified as an
expert should avail themself to judges and plaintiff and defense attorneys to help validate their
role as an independent, nonpartisan authority which may have implications for eliminating
frivolous lawsuits. Professional organizations could also provide judges with a source to help
screen “expert” witnesses. This would promote increased judicial effort to scrutinize the
qualifications of experts as specified by FRE 706 (Table). In addition, professional associations
could provide a source for independent, unbiased third-party experts to assure that expert
testimony is relevant and scientifically valid. They could also make recommendations for
individuals to be part of independent scientific panels when the courts need clarification
regarding the scientific evidence in a legal proceeding. Furthermore, specialty societies could
form oversight committees that would be responsible for investigation of allegations of improper
testimony and would refer offenders to medical licensing boards for disciplinary action.

ACKNOWLEDGEMENT
The authors would like to acknowledge the critical review of this manuscript by Mary L.
Legerski, Esq., The MetroHealth System, James L. Malone, Esq., Reminger & Reminger and
William West, Esq., The MetroHealth System. Their input regarding the accuracy of specific
legal issues was very much appreciated.




2005-2006 Abstracts                                                                                    43
General Surgery
                  FOLLICULAR AND HÜRTHLE CELL CARCINOMA OF THE THYROID
                  GLAND
                  R. Phitayakorn, MD and C.R. McHenry, MD.



                  SYNOPSIS:
                          Follicular and Hürthle cell carcinoma of the thyroid gland are uncommon tumors that are
                  genotypically similar. Current and future diagnostic adjuncts, treatment, and post-operative
                  follow-up for patients with follicular and Hürthle cell cancer are outlined. Risk factors for
                  recurrence and mortality and the reported outcomes of treatment of follicular and Hürthle cell
                  carcinoma are reviewed.




         3




      44                                                                                        Case Surgery
                                                                                              General Surgery
HOME BASED VENTILATOR WEANING IN TETRAPLEGICS:
RESULTS OF THE DIAPHRAGM PACING STIMULATION (DPS)
SYSTEM
Raymond P. Onders M.D.; Mary Jo Elmo ACNP; Anthony R. Ignagni
OBJECTIVE: For high spinal cord injured patients with chronic respiratory insufficiency,
electrically induced diaphragm pacing is an alternative to long-term positive pressure
ventilation. The goal of this study was to demonstrate the effectiveness of a home-based
ventilator weaning program after outpatient laparoscopic implantation of the DPS
system.
DESIGN: Prospective FDA trial of the NeuRx RA/4 DPS System for electrical activation
of the diaphragm for ventilatory assist in spinal cord injured patients with intact phrenic
nerves.
PARTICIPANTS/METHODS: Patients underwent laparoscopic mapping of their
diaphragm to locate the phrenic nerve motor points for electrode implantation. Two
weeks after surgery, stimulus/output characteristics of each electrode were determined
for optimal settings. Caregivers were trained to use the DPS system and a Wright
Spirometer. Progressively lengthening conditioning (weaning) sessions would involve
turning off the ventilator and turning on the DPS system with documentation of time
used, oxygen saturation, tidal volumes and a modified Borg scale of respiratory difficulty.   3
Weekly electronic communication with investigators allowed for input and changes of
stimulation parameters by exchange of devices.
RESULTS: Eighteen patients have been implanted with the DPS system. All procedures
were performed on an outpatient basis with no intra-operative complications. One patient
had a false positive preoperative phrenic nerve conduction study and therefore was
never able to pace. The remaining 17 patients (94%) achieved greater than their
predicted tidal volume during stimulation with fifteen patients undergoing weaning from
the ventilator at home. Ten patients use the device full time, 6 use it 12-24 hours a day
resulting in over 25 years of cumulative active implantation time. The home-based
weaning protocol allows patients to maintain caregiver support, work, and significantly
lower expenses.

CONCLUSION: The results show the laparoscopic DPS system to be a low-risk, cost-
effective outpatient system for ventilatory support with home-based weaning from the
ventilator.




2005-2006 Abstracts                                                                           45
General Surgery
                  LAPAROSCOPIC MAPPING OF THE MOTOR POINTS IN PARTIALLY
                  DENERVATED DIAPHRAMS: KEY FINDING FOR SUCCESSFUL
                  PLACEMENT OF THE DIAPHRAGM PACING SYSTEM
                  Raymond Onders MD, Anthony Ignagni MS, Mary Jo Elmo RN, Bashar Katirji MD,
                  Robert Schilz DO, PhD
                  BACKGROUND: The laparoscopic diaphragm pacing stimulation (DPS) system (Synapse
                  Biomedical) is successful in providing adequate ventilation in spinal cord injured patients who
                  have intact phrenic nerves but its efficacy in patients with partial denervation is unknown.
                  Progressive denervation is the hallmark of amyotrophic lateral sclerosis(ALS or Lou Gehrig’s
                  disease) which leads to progressive diaphragm weakness and subsequent respiratory failure.
                  Patients with spinal cord injuries(SCI) from C3 to C5 can also have injuries to the motor neurons
                  that comprise the phrenic nerve. We undertook a Phase I trial of DPS in patients with ALS to
                  assess if diaphragm function can be maintained in the setting of progressive motor neuron
                  degeneration and have successfully implanted DPS in a SCI patient with partial diaphragmatic
                  denervation. This report outlines the ability to identify the motor point of the diaphragm in a
                  partially denervated diaphragm either from ALS or SCI to facilitate successful diaphragm
                  pacing.
                  METHODS: Patients underwent outpatient laparoscopic mapping of their diaphragm to locate
         3        the phrenic nerve motor points and two electrodes were implanted into each hemidiaphragm.
                  The technique of mapping and identifying the motor point were compared to patients that had
                  normal phrenic nerve and non-denervated diaphragms with successful implantation of the DPS
                  system.
                  RESULTS: Four ALS patients and one C4 level SCI patient who had a partially denervated left
                  diaphragm were implanted. The key finding of mapping a partially denervated diaphragm are:
                  1)The denervation is easily visualized laparoscopically, 2) Patients with ALS have multiple
                  patterns of movement and atrophy. We have observed both diffuse atrophy and radial banding
                  of the diaphragm with better diaphragmatic function. 3) Mapping using a “burst’ stimulation as
                  opposed to “twitch” stimulation provides better qualitative assessment to locate the phrenic
                  nerve                                       motor                                        point.
                  CONCLUSION: The use of burst stimulation and qualitative assessment of diaphragmatic
                  function allowed the successful implantation in these five patients with heterogenous
                  diaphragmatic atrophy. The long term success in ALS will be determined with further follow-up.
                  The success of the SCI patient in this study suggests that SCI patients with inconclusive phrenic
                  nerve studies may be successfully paced after laparoscopic assessment of the diaphragm.




      46                                                                                        Case Surgery
                                                                                                         General Surgery
LONG-TERM CENTRAL VENOUS CATHETERS: SIZE AND LOCATION
DO MATTER
R.P. Onders and T. A. Stellato
INTRODUCTION: Placement of long-term silicone rubber central venous catheters is one of the
most common surgical procedures performed at large teaching hospitals. There has been an
increase in the usage of large bore triple lumen catheters. Factors related to operative technical
difficulty and complications associated with the size and location of insertion have not been
determined.

METHODS: The operative records, office charts and hospital charts of 251 consecutive long-
term externally tunneled catheters placed over a one year time period were reviewed for patient
demographics, indications, complications, operative time and technical problems. Technical
difficulties in placing the catheters were defined as arterial puncture, guidewire in wrong
position, catheter in wrong position, need to switch site of access, sheath difficulty, and inability
to place the catheter.

RESULTS Three complications were identified (1%). Technical difficulties during insertion of
the catheter occurred in 17% of the patients. There was no increased difficulty or operative
complications in placing these catheters in patients based on the indication for insertion. Only
size of catheter and site of placement increased technical difficulties with statistical significance.
The triple lumen catheter had more difficulty with insertion than the double lumen catheter or the
                                                                                                         3
single lumen catheter (28.9% versus 12.8% and 11.3% respectively; p<0.02). Right subclavian
placement was associated with a 24.4% technical difficulty rate versus 10.4% rate for left
subclavian placement. (p<0.01)

CONCLUSION Since an increased technical difficulty rate may lead to an increased
complication rate, we recommend using the smallest catheter possible and to initially attempt
placement via the left subclavian vein.




2005-2006 Abstracts                                                                                      47
General Surgery
                  NATURAL ORIFICE TRANSVISCERAL ENDOSCOPIC SURGERY IN
                  THE INTENSIVE CARE UNIT (ICU)
                  Raymond Onders MD, Jeffrey Marks MD, Michael Rosen MD, Michael McGee MD,
                  Amitabh Chak MD, Ashley Faulx MD, Anthony Ignagni BS, Steve Schomisch BS,
                  Jeffrey Ponsky MD
                  BACKGROUND: Autopsy studies confirm that many ICU patients die from unrecognized
                  sources of abdominal sepsis or ischemia. CT scans can be of limited utility for these diagnoses
                  and difficult to obtain in critically ill patients who require significant support for transport.
                  Bedside laparoscopy has been described but still is cumbersome to perform. Bedside flexible
                  endoscopy as a diagnostic tool or for placement of gastrostomy tubes is a standard ICU
                  procedure. Natural orifice transvisceral endoscopic surgery (NOTES) can provide access to the
                  peritoneal cavity as a bedside procedure and decrease the amount of patients with
                  unrecognized intraabdominal catastrophic events.
                  METHODS: Pigs were anesthetized and standard endoscopy was performed. Using a
                  Seldinger technique a guidewire was placed into the gastric lumen at a standard site fro a PEG
                  and brought out through the mouth. The guidewire was maintained as an access point through
                  the mouth, stomach, peritoneal cavity and skin throughout the procedure. Different methods of
                  accessing the peritoneal cavity through the gastric wall were then attempted. The trans-gastric
                  endoscope was used to explore all quadrants of the abdominal cavity. The small bowel was run
         3        to complete the exploration. The transgastric access location was then closed with the use of a
                  gastrostomy tube. The animals were euthanized and analyzed.
                  RESULTS: Eight pigs were studied and complete abdominal exploration including diaphragm
                  visualization was possible in all cases. Endoscopic guided biopsies were performed, adhesions
                  lysed, and the gallbladder was successfully drained percutaneously. Different methods of
                  transgastric access were evaluated. A needle knife cautery along the guidewire and subsequent
                  balloon dilation was determined to be the most consistent way to access the peritoneal cavity.
                  CONCLUSIONS: These animal studies support the concept that NOTES with closure of the
                  gastric opening with a gastrostomy tube may be another approach for finding unrecognized
                  sources of abdominal sepsis or mesenteric ischemia in difficult ICU patients. These encouraging
                  results warrant a prospective human trial to assess safety and efficacy.




      48                                                                                        Case Surgery
                                                                                                      General Surgery
OPTIMIZING PERITONEAL ACCESS FOR NATURAL ORIFICE
TRANSVISCERAL ENDOSCOPIC SURGERY (NOTES)
MJ Rosen, M McGee, J Marks, A Chak, R Onders, A Faulx, A Ignagni, S Schmoisch, J
Ponsky. Case Advanced Surgical Endoscopy Team (CASE-T), Case Western Reserve
University, School of Medicine, Department of Surgery, Cleveland, Ohio
BACKGROUND: Natural orifice surgery involves novel techniques to access the peritoneal
cavity without creating abdominal scars. Identifying a reliable technique to access the peritoneal
cavity through the gastric wall is an important step in developing this procedure. This study
evaluates three techniques to gain peritoneal access.
METHODS: 4 pigs underwent NOTES having 3 separate access techniques performed at
separate sites in the stomach. In all pigs, a percutaneous guidewire was placed using the
seldinger technique through the gastric wall and brought out transorally to maintain transgastric
peritoneal access. The endoscope was reinserted alongside the wire. In technique 1, a needle
knife cautery was used to make a 3mm free cut along the wire. An endoscopic balloon was
passed alongside the wire and the gastrotomy was dilated and peritoneal cavity entered. In
technique 2, a 3mm free hand cut was placed next to the percutaneous wire, and a double
channel sphincterotome was used to create a gastrotomy. In technique 3, a 10mm free hand full
thickness cut was made using a needle knife cautery and the scope was passed directly into the
abdominal cavity. After accessing the peritoneal cavity the stomach exit site was inspected at
laparotomy for the size of the defect created, surrounding tissue injury, or adjacent visceral/       3
organ injury and then sutured closed. Time from intubation of the esophagus to successful
identification of the peritoneal cavity was recorded. If peritoneal access was not achieved within
20 minutes the technique was aborted and deemed a failure.
RESULTS: Technique 1 was aborted when a balloon size less than 20mm was used. The
20mm balloon provided a reliable access and was typically achieved in <10 min. Technique 2
was aborted in 3 of 4 cases secondary to false passage or inability to accurately direct the tip of
the catheter. Technique 3 provided the fastest access to the peritoneal cavity in typically < 8
minutes but tended to result in a larger gastrotomy. No thermal injuries to surrounding structures
occurred.
CONCLUSIONS: NOTES is technically feasible. This study demonstrates that a 20mm
endoscopic balloon dilatation system or a free transmural cut provide the most reliable
techniques to enter the peritoneal cavity. Further study in a chronic animal model is necessary
to identify the implications of these techniques on eventual gastrotomy closure.




2005-2006 Abstracts                                                                                   49
General Surgery
                  A NOVEL TECHNIQUE FOR MANAGEMENT OF
                  ENDOSCOPIC GASTROTOMY FOLLOWING NATURAL ORIFICE
                  TRANSVISCERAL ENDOSCOPIC SURGERY
                  J Marks, MJ Rosen, M McGee, A Chak, R Onders, A Faulx, A Ignagni, S Schmoisch, J
                  Ponsky. Case Advanced Surgical Endoscopy Team (CASE-T), Case Western Reserve
                  University, School of Medicine, Department of Surgery, Cleveland, Ohio
                  BACKGROUND: Natural Orifice Transvisceral Endoscopic Surgery (NOTES) ) is the most
                  novel minimally invasive approach to the abdominal cavity. There are numerous limitations to
                  this conceptual technique, foremost being safe management of the endoscopically created
                  gastrotomy. Endoscopic suturing tools are still cumbersome and other presently available tissue
                  approximating devices provide only superficial mucosal closure. Creation of a temporary
                  gastrocutaneous fistula with a Percutaneous Endoscopic Gastrostomy (PEG) is a safe and
                  reliable alternative until a reproducible and dependable full thickness endoscopic closure
                  technique is available.
                  METHODS: Pigs were anesthetized and following endotracheal intubation, standard endoscopy
                  with a diagnostic gastroscope was performed. Using a seldinger technique a guidewire was
                  placed into the gastric lumen at a standard site on the abdominal wall for a PEG . The
                  endoscope and guidewire were then brought out through the mouth, and the endoscope was
         3        reinserted along side the guidewire. A gastrotomy was performed with a combination of needle
                  knife cautery followed by endoscopic balloon dilation. The endoscope was advanced into the
                  peritoneal cavity and all four quadrants of the peritoneum were inspected and the scope was
                  then removed. A standard Pull PEG tube was attached to the wire exiting the mouth and the
                  PEG was withdrawn back through the gastrotomy, leaving the internal mushroom bumper in the
                  gastric lumen. The lumen of the stomach was then filled with 500 cc diluted India ink solution
                  and the animals were sacrificed and analyzed.
                  RESULTS: Four pigs were studied and all showed complete sealing of the gastrotomy site with
                  the PEG bumper in appropriate position. There was no evidence of extravasation of the diluted
                  India ink solution in any of the animals.
                  CONCLUSION: This study supports the use of this novel technique for gastrotomy
                  management following NOTES until a safe and reliable closure technique has been developed.
                  Corollary studies with longer term evaluation in animals are necessary prior to proceeding to
                  clinical trials.




      50                                                                                       Case Surgery
                                                                                                  General Surgery
A RELIABLE METHOD FOR INTRA-ABDOMINAL PRESSURE
MONITORING DURING NATURAL ORIFICE TRANSVISCERAL
ENDOSCOPIC SURGERY (NOTES)

Michael F. McGee MD, Michael J. Rosen MD, Jeffrey Marks MD, Amitabh Chak MD,
Raymond Onders MD, Ashley Faulx MD, Anthony Ignagni, Steve Schomisch, Jeffrey
Ponsky MD. Case Advanced Surgical Endoscopy Team (CASE-T), Case Western
Reserve University, School of Medicine, Department of Surgery, Cleveland, Ohio
BACKGROUND: Natural Orifice Transvisceral Endoscopic Surgery (NOTES) provides access
to the peritoneal cavity to perform abdominal surgical procedures without skin incisions. NOTES
requires pneumoperitoneum to visualize and manipulate abdominal organs, akin to laparoscopy.
A reliable method to monitor pneumoperitoneum pressures during NOTES has not been
identified. Accurate measurement of pneumoperitoneum is essential to avoid potentially
deleterious effects of intraabdominal compartment syndrome. This study evaluated several
methods of monitoring intra-abdominal pressures with a standard gastroscope during NOTES.
METHODS: Four female pigs (25kg) were sedated and a single channel gastroscope was
passed trans-gastrically into the peritoneal cavity. Pneumoperitoneum was achieved via a
pressure insufflator through a percutaneous, intraperitoneal 14-gauge catheter. Three other
pressures were recorded via separate catheters. First, a 14-gauge percutaneous catheter
passed intraperitoneally measured true intra-abdominal pressure. The second transducer was a      3
14-gauge tube attached to the endoscope used to measure endoscope tip pressure. The third
pressure transducer was connected to the biopsy channel port of the endoscope. The abdomen
was insufflated to a range (10- 30 mmHg) of pressures, and simultaneous pressures were
recorded from all pressure sensors.
RESULTS: Pressure correlation curves were developed for all animals across all intraperitoneal
pressures (mean error -4.25 to -1 mmHg). Endoscope tip pressures correlated with biopsy
channel pressures (R2=0.99). Biopsy channel and endoscope tip pressures fit a least-squares
linear model to predict actual intra-abdominal pressure (R=0.99 for both). Both scope tip and
biopsy channel port pressures were strongly correlative with true intra-abdominal pressures (R2
= 0.98, R2=0.99 respectively).
CONCLUSION: This study demonstrates that monitoring pressure through an endoscope is
reliable and predictive of true intra-abdominal pressure. Gastroscope pressure monitoring is a
useful adjunct to NOTES. Future NOTES procedures should incorporate continuous intra-
abdominal pressure monitoring to avoid the potentially deleterious effects of pneumoperitoneum
during NOTES. Future gastroscopes should integrate pressure monitoring abilities.




2005-2006 Abstracts                                                                               51
General Surgery
                  DIAPHRAGM PACING WITH NATURAL ORIFICE TRANSVISCERAL
                  ENDOSCOPIC SURGERY (NOTES): POTENTIAL FOR DIFFICULT TO
                  WEAN INTENSIVE CARE UNIT(ICU) PATIENTS
                  Raymond Onders MD, Jeffrey Marks MD, Anthony Ignagni MS, Michael McGee MD,
                  Michael Rosen MD, Amitabh Chak MD, Ashley Faulx MD, Robert Schilz DO, Steve
                  Schomisch BS, Jeffrey Ponsky MD. University Hospitals of Cleveland and Case
                  Western Reserve University, School of Medicine, Cleveland, Ohio
                  BACKGROUND: Up to 50% of ICU patients require mechanical ventilation with 20% on
                  a ventilator for over 7 days. Over 40% of time is spent weaning a patient from mechanical
                  ventilation. Failure to wean from mechanical ventilation can in part be due to rapid onset of
                  diaphragm atrophy, barotrauma, posterior lobe atelectasis, and impaired hemodynamics which
                  are normally improved by maintaining a more natural negative chest pressure. We have shown
                  that laparoscopic implantation of a diaphragm pacing system successfully provides adequate
                  ventilation in spinal cord injured patients. Our preliminary data also suggests that DPS may
                  benefit amyotrophic lateral sclerosis (ALS) patients with partial diaphragmatic atrophy. With the
                  knowledge we have gained from these patients, we propose that acute ventilator assist with
                  interventional neurostimulation of the diaphragm in the ICU is feasible and could facilitate
                  weaning from mechanical ventilation. Current DPS implantation is carried out electively in the
                  operating room but transfer of critically ill patients for procedures is not always possible or safe.
         3        NOTES has the potential to expand the benefits of DPS to this acute patient population by
                  allowing it to be done at the bedside like the common gastrostomy tube. This study evaluates
                  the feasibility of this approach in a porcine model.
                  METHODS: Pigs were anesthetized and peritoneal access with the flexible endoscope was
                  obtained using a guidewire, needle knife cautery and balloon dilatation. The diaphragm was
                  mapped to locate the motor point (where stimulation provides complete contraction of the
                  diaphragm) with a novel endoscopic electrostimulation catheter. An intramuscular electrode was
                  then placed at the motor point with a percutaneous needle. This was then attached to the
                  diaphragm pacing system. The gastrotomy was managed with a gastrostomy tube.
                  RESULTS: Four pigs were studied and the diaphragm could be mapped with the endoscopic
                  mapping instrument to identify the motor point. In one animal, under transgastric endoscopic
                  visualization a percutaneous electrode was placed into the motor point and the diaphragm could
                  be paced in conjunction with mechanical ventilation.

                  CONCLUSIONS: These animal studies support the concept that trans-gastric mapping of the
                  diaphragm and implantation of a percutaneous electrode for therapeutic diaphragmatic
                  stimulation is feasible. These encouraging results warrant a prospective human trial to assess
                  safety and efficacy.




      52                                                                                            Case Surgery
                                                                                                            General Surgery
NATURAL ORIFICE TRANSVISCERAL ENDOSCOPIC SURGERY IN
THE INTENSIVE CARE UNIT (ICU)
Raymond Onders M.D., Jeffrey Marks M.D., Michael Rosen M.D., Michael McGee M.D.,
Amitabh Chak M.D., Ashley Faulx M.D. , Anthony Ignagni, B.S., Steve Schomisch, B.S.
Jeffrey Ponsky M.D. Case Advanced Surgical Endoscopy Team (CASE-T), Case
Western Reserve University, School of Medicine, Department of Surgery, Cleveland,
Ohio
BACKGROUND: Autopsy studies confirm that many ICU patients die from unrecognized
sources of abdominal sepsis or ischemia. CT scans can be of limited utility for these diagnoses
and difficult to obtain in critically ill patients who require significant support for transport. Bedside
laparoscopy has been described but still is cumbersome to perform. Bedside flexible endoscopy
as a diagnostic tool or for placement of gastrostomy tubes is a standard ICU procedure. Natural
orifice transvisceral endoscopic surgery (NOTES) can provide access to the peritoneal cavity as
a bedside procedure and decrease the amount of patients with unrecognized intraabdominal
catastrophic events.
METHODS: Pigs were anesthetized and standard endoscopy was performed. Using a Seldinger
technique a guidewire was placed into the gastric lumen at a standard site for a PEG and
brought out through the mouth. The guidewire was maintained as an access point through the
mouth, stomach, peritoneal cavity and skin throughout the procedure. Different methods of                   3
accessing the peritoneal cavity through the gastric wall were then attempted. The trans-gastric
endoscope was used to explore all quadrants of the abdominal cavity. The small bowel was run
to complete the exploration. The transgastric access location was then closed with the use of a
gastrostomy tube. The animals were euthanized and analyzed.
RESULTS: Eight pigs were studied and complete abdominal exploration including diaphragm
visualization was possible in all cases. Endoscopic guided biopsies were performed, adhesions
lysed, and the gallbladder was successfully drained percutaneously. Different methods of trans-
gastric access were evaluated. A needle knife cautery along the guidewire and subsequent
balloon dilation was determined to be the most consistent way to access the peritoneal cavity.
CONCLUSIONS: These animal studies support the concept that NOTES with closure of the
gastric opening with a gastrostomy tube may be another approach for finding unrecognized
sources of abdominal sepsis or mesenteric ischemia in difficult ICU patients. These encouraging
results warrant a prospective human trial to assess safety and efficacy.




2005-2006 Abstracts                                                                                         53
General Surgery
                  OPTIONS FOR VENTILATORY ASSIST IN AMYOTROPHIC LATERAL
                  SCLEROSIS(ALS): THE POSSIBILITY OF DIAPHRAGM PACING VIA
                  LAPAROSCOPICALLY PLACED INTRAMUSCULAR ELECTRODES
                  RP Onders, AR Ignagni, B Katirji, R Schilz, MJ Elmo
                  BACKGROUND: ALS(Charcot’s or Lou Gehrig’s Disease) is a progressive neurodegenerative
                  disease that affects around 1.4/100,000 individuals annually. The cause of death for most
                  patients is respiratory failure unless the only available option of long-term positive pressure
                  ventilation is used. Therapeutic electrical stimulation has been shown to maintain the strength
                  of other peripheral muscles in ALS by maintaining physiologic activity, contractile properties and
                  calcium levels. Motor units can be compensated for by collateral axon sprouting and the rate of
                  sprouting increases with electrical stimulation. We have shown in spinal cord injured patients
                  that the laparoscopic diaphragm pacing system is a low-risk, cost-effective outpatient system
                  that will support the respiratory needs of patients. The objective of the present study is to
                  assess the use of this system to slow or temporarily arrest the rate of respiratory decline of
                  patients with ALS.
                  METHOD: With FDA and IRB approval a phase one study of ten patients with ALS and FVC
                  greater than 50% has begun. Each patient will be followed for three months pre-implantation
                  with a series of tests including: pulmonary function tests, ultrasound analysis of diaphragm
         3        thickness and phrenic nerve conduction tests. Patients will undergo outpatient laparoscopic
                  mapping of their diaphragm to locate the phrenic nerve motor points and two electrodes will be
                  implanted in each hemidiaphragm. Two weeks after surgery, stimulus/output characteristics of
                  each electrode will be determined. The patients will then condition the diaphragm with three to
                  five 30 minute sessions of therapeutic electrical stimulation per day. Success will be measured
                  by stopping or reversing the rate of progression of the decreasing pulmonary reserve.
                  CONCLUSION: Therapeutic electrical stimulation has been used for patients with ALS in the
                  past but it could never help the end result of the respiratory decline. We now have an easy way
                  to stimulate the diaphragm and this study will show whether this will help the quality of patients’
                  respiration with ALS.




      54                                                                                          Case Surgery
                                                                                                      General Surgery
PARATHYROIDECTOMY: OVERVIEW OF THE ANATOMIC BASIS AND
SURGICAL STRATEGIES FOR PARATHYROID OPERATIONS
R. Phitayakorn, MD and C.R. McHenry, MD.

It is imperative for the surgeon who performs parathyroidectomy to have a thorough
understanding of the anatomy and embryology of the parathyroid glands in order to optimize the
cure rate for patients with hyperparathyroidism. Furthermore, all clinicians caring for patients
with hyperparathyroidism should be aware of the advancements in: preoperative parathyroid
localization, intraoperative PTH monitoring and surgical strategies for treatment of
hyperparathyroidism. In this chapter, the anatomy and embryology of the parathyroid glands
will be reviewed.        The available surgical options for treatment of patients with
hyperparathyroidism will be addressed including: “focused” parathyroidectomy, bilateral neck
exploration, radioguided parathyroidectomy, and endoscopic and video-assisted
parathyroidectomy. The unique challenge associated with reoperative parathyroidectomy for
persistent or recurrent hyperparathyroidism will be outlined. Finally, insight into how to locate a
qualified surgeon will be provided and recommendations will be made on what constitutes an
appropriate choice of operation for specific patients with primary hyperparathyroidism.



                                                                                                      3




2005-2006 Abstracts                                                                                   55
General Surgery
                  STAGED REPAIR OF MASSIVE INCISIONAL HERNIAS WITH LOSS OF
                  ABDOMINAL DOMAIN: A NOVEL APPROACH
                  Jeremy Lipman MD, Daniel Medalie MD, Michael J. Rosen MD.
                  Case Comprehensive Hernia Institute, University Hospitals of Cleveland, Case Western
                  Reserve University School of Medicine.
                  BACKGROUND: The management of massive ventral hernias with loss of intra-abdominal
                  domain is a challenging surgical dilemma. We report a novel approach for repairing these
                  extremely complicated hernias.
                  METHODS: We retrospectively reviewed our experience with the staged resection of ePTFE
                  Dual mesh in the setting of massive abdominal wall defects. The initial stage involves reduction
                  of the hernia and placement of a large sheet of ePTFE Dual mesh secured to the fascial edges.
                  Subsequent stages involve serial excision of the mesh until the fascia can be approximated in
                  the midline without tension. Finally, the mesh is excised, and the fascia is reapproximated with
                  component separation, and alloderm onlay.
                  RESULTS: We have performed this procedure on 3 women, with a mean age of 60 yrs (52-67).
                  All patients had multiply recurrent ventral hernias with an average of 6 prior laparotomies (4-9).
                  The fascial defect averaged 645 cm2 (600-884) and on average 8 serial operations were
                  necessary to achieve fascial closure. Reduction mammoplasty and paniculectomy were
         3        performed in 2 patients to protect skin closure from excessive tension from overhanging skin.
                  One patient developed a partial fascial dehiscence during a coughing episode, necessitating
                  placement of another sheet of GoreTex mesh during serial excision. Average length of stay was
                  22 days (19-27). In our first patient alloderm overlay was not performed initially and this patient
                  developed an early recurrence. Subsequently, alloderm was placed as an overlay and in our
                  remaining patients no recurrences have been identified during routine follow up.
                  CONCLUSIONS: Serial Gore-Tex extraction to facilitate primary fascial closure with AlloDerm
                  overlay is an effective treatment for massive, incisional hernias with loss of abdominal domain
                  and avoids the risks associated with long-term prosthetic fascial closures.




      56                                                                                           Case Surgery
                                                                                                     General Surgery
SUCCESSFUL DIAPHRAGM PACING IN A PORCINE MODEL WITH
NATURAL ORIFICE TRANSVISCERAL ENDOSCOPIC SURGERY
(NOTES): INCREASING THE OPTIONS FOR INTENSIVE CARE
UNIT(ICU) PATIENTS
Raymond Onders MD, Michael McGee MD, , Jeffrey Marks MD, Anthony Ignagni MS, , Michael
Rosen MD, Amitabh Chak MD, Ashley Faulx MD, Robert Schilz DO, Steve Schomisch BS, Mary
Jo Elmo ACNP Jeffrey Ponsky MD, University Hospitals of Cleveland and CASE School of
Medicine
BACKGROUND: Patients requiring prolonged mechanical ventilation in ICUs spend up to 40%
of the time weaning from the ventilator. Failure to wean from mechanical ventilation can in part
be due to rapid onset of diaphragm atrophy, barotrauma, posterior lobe atelectasis, and
impaired hemodynamics which all would be improved by maintaining a more natural negative
chest pressure with diaphragm pacing. We have shown that laparoscopic implantation of a
diaphragm pacing stimulation (DPS) system successfully provides adequate ventilation in spinal
cord injured patients and decreases respiratory decline in patients with amyotrophic lateral
sclerosis (ALS) patients who have progressive diaphragmatic atrophy. We propose that acute
ventilator assist with interventional neurostimulation of the diaphragm in the ICU is feasible and
could facilitate weaning from mechanical ventilation. NOTES has the potential to expand the
benefits of DPS to this acute patient population by allowing it to be done at the bedside like the
common gastrostomy tube as opposed to our present laparoscopic operating room implantation.          3
This study expands our previous feasibility evaluations in a porcine model.

METHODS: Pigs were anesthetized and peritoneal access with the flexible endoscope was
obtained using a guidewire, needle knife cautery and balloon dilatation. The diaphragm was
mapped to locate the motor point (where stimulation provides complete contraction of the
diaphragm) with a novel endoscopic electrostimulation catheter. Intramuscular electrodes were
placed at the motor point with a percutaneous needle into both diaphragms. This was then
attached to the DPS system for pacing. The gastrotomy was managed with a gastrostomy tube.
RESULTS: Three pigs were studied and the diaphragm could be mapped with the endoscopic
mapping instrument to identify the motor point. Under trans-gastric endoscopic visualization
bilateral percutaneous pacing electrodes were successfully placed in all animals in less than 15
minutes. With the DPS system, ventilation was then performed with tidal volumes measured
with Wright Spirometer. The animals were sacrificed and examined. There were no trans-
diaphragmatic injuries from percutaneous needle placement, the gastrostomy tube adequately
closed the gastric opening and the pacing wires could be completely removed with less tensile
force than standard temporary cardiac pacing wires.
CONCLUSION: These animal studies confirm that trans-gastric mapping of the diaphragm and
implantation of a percutaneous electrode for therapeutic diaphragmatic stimulation is feasible.
This NOTES method of implanting temporary pacing wires will be assessed as a continuation of
an IRB approved trial of laparoscopic implantation of temporary pacing wires for patients on
prolonged mechanical ventilation requiring feeding tube placement.




2005-2006 Abstracts                                                                                  57
General Surgery
                  THE HURRICANES OF 2005 AND VENTILATORS: THE BENEFITS OF
                  THE DIAPHRAGM PACING STIMULATION (DPS) SYSTEM
                  Raymond P. Onders M.D.; Mary Jo Elmo ACNP; Anthony R. Ignagni
                  OBJECTIVE: During hurricanes the wide spread loss of electricity can cause significant
                  problems for high spinal cord injured patients dependent on ventilators. This study
                  demonstrates the difficulty these patients have during natural disasters associated with
                  power loss and the benefits of the DPS system.
                  DESIGN: Retrospective analysis of patients who live in hurricane ravaged areas involved or
                  evaluated in an FDA trial of the DPS System for electrical activation of the diaphragm for
                  ventilatory assist.
                  PARTICIPANTS/METHODS: Patients in effected areas were interviewed concerning their
                  responses to hurricanes Dennis(7/05), Katrina(8/05) and Rita(9/05). Ventilator batteries last
                  from only 1-8 hours before requiring electricity for recharging while the DPS system uses a
                  standard disposable external battery that lasts 500 hours and patients have a stock of
                  batteries.
                  RESULTS: In summary, all patients experienced loss of electricity during the hurricanes.
                  The problems of being on a ventilator during hurricanes included: risks and fuel shortage with
         3        external generators to power ventilators, evacuation centers not equipped for quadriplegics
                  (a special need shelter refused entry of one patient as being too “sick”), hospitals not willing
                  to accept patients just for ventilator power, and traveling with ventilator to areas out of the
                  threat of loss of power is difficult, expensive and time consuming. In three patients with the
                  DPS system the benefits included: loss of electricity alone no longer a concern, evacuation
                  easier(less packing) and transportation simplified; less need for space or additional
                  personnel. One patient with the DPS system who lost her home to Rita states the lack of
                  noise and space from a ventilator simplifies living in a crowded temporary facility.
                  CONCLUSION: Hurricanes are devastating and a significant cause of anxiety in ventilator
                  dependent quadriplegics. The DPS system improves the quality of life during these events by
                  decreasing anxiety, easing evacuation, and simplifying temporary housing.




      58                                                                                         Case Surgery
                                                                                                       General Surgery
THE SINGLE STAGED APPROACH TO THE SURGICAL
MANAGEMENT OF ABDOMINAL WALL HERNIAS IN
CONTAMINATED FIELDS
Diya Alaedeen MD, Jonathan Belding MS, Jeremy Lipman MD, Daniel Medalie MD,
Michael J. Rosen MD.
Case Comprehensive Hernia Institute, University Hospitals of Cleveland, Case Western
Reserve University School of Medicine
INTRODUCTION: The surgical treatment of large ventral hernias with accompanying
contamination is challenging. We have reviewed our institutions experience with a single
staged repair of complex ventral hernias in the setting of contamination.
METHODS: We retrospectively reviewed the medical records of all patients who underwent
ventral hernia repairs in the setting of a contaminated field. Pertinent details included baseline
demographics, reason for contamination, operative technique and details, postoperative
morbidity, mortality and recurrence rates.
RESULTS: Between December 1999 and January 2006, 19 patients were identified with large
ventral hernia repairs performed in contaminated fields. There were 5 males and 14 females
with a mean age of 60 years (40-82), ASA 3.3 (2-4), and BMI of 36 kg/m2 (20-50). 13 patients
had prior intraperitoneal mesh placed: alloderm (1), prolene (8), Goretex (1), and Composix (3).
Reasons for contamination included: enterocutaneous fistula (7), mesh infection (8),
                                                                                                       3
concomitant bowel resection (2), chronic non-healing wound (1), and necrotizing fasciitis (1).
Operative approaches included primary repair (3), component separation without reinforcement
(2), and with prosthetic reinforcement (11). In three patients the fascia could not be
reapproximated in the midline and the defect was bridged with vicryl mesh (1), Surgisis (1), and
light weight polypropylene (1) placed in the retrorectus space. Mean operative time was 258
min (90-600). Thirteen postoperative complications occurred in 8 (42%) patients and included
wound infection (6), respiratory failure (2), ileus (2), postoperative hemorrhage (1), renal failure
(1), and recurrent fistula (1). There was no mortality in this series. During routine follow up one
recurrence was identified by physical exam.
CONCLUSIONS: This study shows that single stage treatment of ventral hernias in
contaminated fields can be accomplished with a low recurrence rate and acceptable morbidity in
these extremely challenging patients.




2005-2006 Abstracts                                                                                    59
General Surgery
                  WEANING READINESS AND FLUID BALANCE IN OLDER CRITICALLY
                  ILL SURGICAL PATIENTS
                  Epstein CD, Peerless JR.
                  BACKGROUND: Few studies address predictors for successful weaning of older adults from
                  mechanical ventilation. OBJECTIVE: To develop a clinical profile of older patients who are
                  successfully weaned from long term mechanical ventilation. METHODS: Forty patients in the
                  trauma and surgical intensive care unit who were at least 60 years old were enrolled in the
                  study after 3 days of active weaning and were monitored daily until successfully weaned or until
                  the end of the 14-day study. Hemodynamic and gas exchange variables, fluid balance, oxygen
                  cost of breathing, and scores on the Burns Weaning Assessment Program were analyzed.

                  RESULTS: Compared with patients who were not weaned, successfully weaned patients
                  required mechanical ventilation for 5.3 days, started active weaning earlier (mean 10.7 vs. 14.5
                  days, P=.04), had lower mean negative daily fluid balances in the beginning (-0.394 vs. 1.107L,
                  P=.004), and had lower mean net cumulative fluid balances (6.856 vs. 16.212 L) at the time of
                  enrollment. They also maintained both a lower mean net cumulative fluid balance (10.753 vs.
                  25.049L, P=.02) and a negative daily fluid balance (-03.89 vs. 1.904L, P=.03) throughout. Their
                  mean central venous pressure decreased over time and was significantly lower (P<.001).

                  CONCLUSION: Persistent positive fluid balance in older surgical patients is associated with
         3        prolonged mechanical ventilation. Estimates of fluid balance might be useful in weaning older
                  patients from long term mechanical ventilation.




      60                                                                                        Case Surgery
Section 4
Pediatric Surgery
62   Case Surgery
                                                                                                   Pediatric Surgery
APPENDICEAL FECALITH IS ASSOCIATED WITH EARLY
PERFORATION IN PEDIATRIC PATIENTS
Diya I. Alaedeen, MD, Marc Cook, MS, and Walter J. Chwals, MD


OBJECTIVE: A fecalith (appendicalith) is a fecal concretion that can obstruct the appendix
leading to acute appendicitis. The presence of a fecalith may predict a more rapid progression
of appendiceal inflammation and perforation. We studied the incidence of appendiceal rupture
with a finding of a fecalith.

METHODS: Between January 2001 and December 2005 the charts of all pediatric patients
(younger than 18 years old) treated for appendicitis at our institution were reviewed. Age,
gender, presenting symptoms, radiological and laboratory studies, operative and pathological
findings, duration of symptoms and timing between presentation and operation were reviewed.
RESULTS: There were 418 patients who met the study criteria. A fecalith was present on
radiological study, intraoperative finding, or pathological review in 28.7% of patients (N=120).
The appendix was perforated in 57.5% of patients who had a fecalith versus 31.8% in patients
without a fecalith (p<0.001). Patients with fecalith and appendiceal perforation had a
significantly higher presenting serum C-reactive protein (CRP) levels than those without
perforation (13.9 vs. 4.2 mg/dL, P<0.0001). The overall rate of interval appendectomies was
11%. A fecalith was present on the initial radiological studies of 35% of the patients who had
interval appendectomies, and the appendix was perforated significantly sooner (shorter interval
between onset of symptoms and presentation) in these patients when compared to those
without a fecalith (91 vs. 150 hours, P= 0.036).
CONCLUSION: This study demonstrates that appendiceal fecalith is associated with early and
high-rate of perforation in pediatric patients. Elevated inflammatory


                                                                                                   4




2005-2006 Abstracts                                                                                63
Pediatric Surgery
                    C-REACTIVE PROTEIN-DETERMINED INJURY SEVERITY:
                    LENGTH OF STAY PREDICTOR IN SURGICAL INFANTS
                    Alaedeen DI, Queen AL, Leung E, Liu D, Chwals WJ

                    BACKGROUND/PURPOSE: Serum C-reactive protein (CRP) levels reflect the severity
                    of the metabolic response to injury in critically ill children. During this period, caloric
                    overfeeding can increase complications and delay recovery. The authors hypothesized
                    that by avoiding excessive caloric delivery, the effect of injury severity would be the
                    major factor determining clinical outcome.
                    METHODS: Twenty-eight surgical infants who had indirect calorimetry measurements
                    while in the Neonatal Intensive Care Unit between August 2000 and January 2002 were
                    studied. Serum CRP concentrations, mean energy expenditure (MEE), respiratory
                    quotient (RQ), length of hospital stay (LOS), and caloric intake (I) at the time of indirect
                    calorimetry were recorded. Data were analyzed using the Pearson product-moment
                    correlation.
                    RESULTS: Peak serum CRP was significantly correlated to LOS in all patients (r = 0.79,
                    P < .0001). When net caloric balance (I-MEE) did not exceed 5 kcal/kg/d (n = 9), peak
                    serum CRP was correlated positively with RQ (r = 0.66, P = .05). When I-MEE exceeded
                    5 kcal/kg/d (n = 19), the positive correlation of serum CRP with RQ was diminished (r =
                    0.23, P = .33).
                    CONCLUSIONS: CRP-measured injury severity is a major determinant of clinical
                    outcome in surgical infants. In addition, overfeeding causes additional RQ elevation.




          4




     64                                                                                           Case Surgery
                                                                                                    Pediatric Surgery
TOTAL PARENTERAL NUTRITION-ASSOCIATED HYPERGLYCEMIA
CORRELATES WITH PROLONGED MECHANICAL VENTILATION AND
HOSPITAL STAY IN SEPTIC INFANTS
Alaedeen DI, Walsh MC, Chwals WJ

PURPOSE: We studied the effects of total parenteral nutrition (TPN)-associated hyperglycemia
on the clinical outcome in premature septic infants in the neonatal intensive care unit.
METHODS: The charts of all premature infants weighing less than 1500 g upon admission to
the neonatal intensive care unit between January 1, 2002, and December 31, 2002, with sepsis,
ventilator dependence, and feeding intolerance were studied. Maximum serum glucose
concentrations were compared with duration of TPN, mechanical ventilation, hospital length of
stay, and survival using Pearson regression analysis and Student's t test.
RESULTS: Thirty-seven patients met the search criteria. The average caloric intake for all
infants at the time of blood culture-proven sepsis was 83 +/- 19 kcal/kg per day. The maximum
serum glucose concentration (milligrams per deciliter) after having positive blood cultures
(sepsis) was positively correlated with the duration of TPN (r = 0.45, P = .005), length of
dependence on mechanical ventilation (r = 0.45, P = .006), and hospital length of stay (r = 0.36,
P = .03). The average maximum serum glucose level was significantly higher in the
nonsurviving infants (241 +/- 46 vs 141 +/- 48, P < .0001).
CONCLUSION: Hyperglycemia correlated with prolonged ventilator dependency and increased
hospital length of stay in premature septic infants. Avoidance of excessive nutrient delivery and
tight glycemic control during periods of acute metabolic stress may improve outcome in this
patient population.




                                                                                                    4




2005-2006 Abstracts                                                                                 65
Pediatric Surgery
                    TPN-ASSOCIATED HYPERBILIRUBINEMIA CORRELATES WITH
                    LENGTH OF STAY IN SEPTIC PREMATURE NEONATES
                    Diya I. Alaedeen and Walter J Chwals

                    PURPOSE: We studied the effects of TPN-associated hyperbilirubinemia on the clinical
                    outcome in premature, septic infants in the neonatal intensive care unit (NICU).
                    METHODS: The charts of all premature infants weighing <1500 grams upon admission to the
                    NICU between 1/1/2002 –12/31/2002 with sepsis, ventilator dependence, and feeding
                    intolerance were studied. Maximum total bilirubin levels were compared to duration of TPN, and
                    hospital length of stay using Pearson regression analysis.
                    RESULTS: 37 patients met the search criteria. The average caloric intake for all infants at the
                    time of blood culture-proven sepsis was 83 ± 19 kcal/kg/D. The maximum total bilirubin levels
                    (mg/dL) following positive blood cultures (sepsis) was positively correlated with the duration of
                    TPN (r=0.45, p=0.006), land hospital length of stay (r= 0.5, p= 0.006).
                    CONCLUSION: Hyperbilirubinemia correlated with increased hospital length of stay in
                    premature septic infants. Avoidance of excessive nutrient delivery, especially during periods of
                    acute metabolic stress, may improve outcome in this patient population.




          4




      66                                                                                           Case Surgery
Section 5
Plastic and
Reconstructive
Surgery
68   Case Surgery
                                                                                                                       Cardiovascular
                                                                                                   Plastic and Reconstructive Surgery
  CALIBRATED LATERAL CRUS STABILIZER
  Bahman Guyuron, M.D., and Brian Pinsky, B.A.
  BACKGROUND: Fundamental shortcomings of the currently available instrumentation
  prompted the need for a device that facilitates stabilization of the lateral crus while at the
  same time allowing for precise measurement of the retained cartilage fragment along the
  anatomic axis of the lateral crus.
  METHODS: This article presents a new instrument, the calibrated lateral crus stabilizer,
  and highlights its unique features, which facilitate the precise and symmetric excision of
  the lateral crural cartilage.
  RESULTS: A lateral crus stabilizer with a calibration mechanism is introduced that
  provides the means for precise removal of the excess portion of the lower lateral
  cartilage during rhinoplasty.

  CONCLUSIONS: There was a need for improved instrumentation to stabilize the alar
  cartilage than what is currently available. New instrumentation is presented that answers
  that need.




                                                                                                   5




2005-2006 Abstracts                                                                                69
Plastic and Reconstructive Surgery
                                     COMPONENTS OF THE SHORT NOSTRIL
                                     Bahman Guyuron, M.D., Ashkan Ghavami, M.D., and Sarah M. Wishnek, B.A.

                                     BACKGROUND: The short nostril, best visualized on the basilar view, is a
                                     multifaceted dysmorphology that requires evaluation beyond that of
                                     alar/columellar deformities. While the soft triangle is the key component in short
                                     nostril disharmony, the alar rim and cartilaginous structures that border the
                                     nostrils play a salient role as well.
                                     METHODS: A retrospective review of 200 consecutive rhinoplasties (primary and
                                     secondary) examined the specific role of soft triangle excision and other components in
                                     the short nostril deformity. Twenty-seven patients underwent soft triangle excision with
                                     or without alteration of the other structures influential on nostril length. Of these 27
                                     patients, only three patients required soft triangle excision alone.

                                     RESULTS: The distance from the nostril apex to the caudal border of the alar
                                     dome was found to be the crucial element in defining the treatment approach for
                                     creating nostril length. When this distance was long, excision of the soft triangle
                                     lining and approximation of the alar rim to the lining under the dome elevated the
                                     nostril apex and elongated the nostril. When the distance between the nostril
                                     apex and overlying dome was ideal or short, soft triangle lining removal was not
                                     required, and an optimal nostril length was established by repositioning the other
                                     components. Raising the dome using transdomal sutures redirected the wide
                                     domal arch vertically, narrowing and lengthening the nostril, provided there was
                                     no redundancy in the soft triangle. In a similar fashion, interdomal sutures
                                     improved both nostril length and inclination. Placement of a columellar strut also
                                     elongated the nostril. An alar rim graft, used primarily to correct alar rim retraction
                                     and concavity, also elongated the short nostril.
                                     CONCLUSION: The most important factor in analysis and treatment of the short nostril
                                     is the extent of the soft triangle tissue present. Soft triangle lining removal is indicated
                                     when the distance from the nostril apex to the caudal dome is excessive. This allows the
                                     nostril apex to be pulled anteriorly, thus elongating the nostril. The short nostril often
                                     coexists with multiple other abnormalities of the nasal base and tip, mandating a
                                     comprehensive approach to address all the deformities encountered. Correction of alar
                                     retraction also effectively increases nostril length. Further improvement of asymmetric
                                     tips and nostrils can be achieved through unilateral soft triangle lining excision with
                                     dome equalization through tip suturing and a subdomal graft.
                    5




         70                                                                                                       Case Surgery
                                                                                                                Cardiovascular
                                                                                            Plastic and Reconstructive Surgery
COMPREHENSIVE SURGICAL TREATMENT OF MIGRAINE
HEADACHES
Bahman Guyuron, M.D., Jennifer S. Kriegler, M.D., Janine Davis, R.N., and
Saeid B. Amini, Ph.D., M.B.A., J.D.
The purpose of this study was to investigate the efficacy of surgical deactivation of
migraine headache trigger sites. Of 125 patients diagnosed with migraine headaches,
100 were randomly assigned to the treatment group and 25 served as controls, with 4:1
allocation. Patients in the treatment group were injected with botulinum toxin A for
identification of trigger sites. Eighty nine patients who noted improvement in their
migraine headaches for 4 weeks underwent surgery. Eighty-two of the 89 patients (92
percent) in the treatment group who completed the study demonstrated at least 50
percent reduction in migraine headache frequency, duration, or intensity compared with
the baseline data; 31 (35 percent) reported elimination and 51 (57 percent) experienced
improvement over a mean follow-up period of 396 days. In comparison, three of 19
control patients (15.8 percent) recorded reduction in migraine headaches during the 1-
year follow-up (p< 0.001), and no patients observed elimination. All variables for the
treatment group improved significantly when compared with the baseline data and the
control group, including the Migraine-Specific Questionnaire, the Migraine Disability
Assessment score, and the Short Form-36 Health Survey. The mean annualized cost of
migraine care for the treatment group ($925) was reduced significantly compared with
the baseline expense ($7612) and the control group ($5530) (p < 0.001). The mean
monthly number of days lost from work for the treatment group (1.2) was reduced
significantly compared with the baseline data (4.41) and the control group (4.4) (p <
0.003). The common adverse effects related to injection of botulinum toxin A included
discomfort at the injection site in 27 patients after 227 injections (12 percent), temple
hollowing in 19 of 82 patients (23 percent), neck weakness in 15 of 55 patients (27
percent), and eyelid ptosis in nine patients (10 percent). The common complications of
surgical treatment were temporary dryness of the nose in 12 of 62 patients who
underwent septum and turbinate surgery (19.4 percent), rhinorrhea in 11 (17.7 percent),
intense scalp itching in seven of 80 patients who underwent forehead surgery (8.8
percent), and minor hair loss in five (6.3 percent). Surgical deactivation of migraine
trigger sites can eliminate or significantly reduce migraine symptoms. Additional studies
are necessary to clarify the mechanism of action and to determine the long-term results.

                                                                                            5




2005-2006 Abstracts                                                                         71
Plastic and Reconstructive Surgery
                                     MODIFIED TEMPORAL INCISION FOR FACIAL
                                     RHYTIDECTOMY: AN 18-YEAR EXPERIENCE
                                     Bahman Guyuron, M.D., Frederick Watkins, M.D., and Ali Totonchi, M.D.

                                     An 18-year experience with the senior author’s temporal incision is expounded.
                                     First, the existing sideburn is outlined with a marking pen. A sideburn is designed
                                     approximately 2 cm wide and 2 cm long, regardless of the extent of the existing
                                     sideburn providing the minimum sideburn. The posterocaudal portions of the
                                     newly designed sideburn will correspond to that of the existing dense portion of
                                     the sideburn.
                                     After dissection and removal of excess skin, the entire vertical portion of the scar
                                     will remain within the hair-bearing skin, eliminating the potential for visibility
                                     unless preoperatively the sideburn is less that 2 cm wide. There are several
                                     advantages to this approach. First, the configuration of the sideburn remains
                                     essentially unaltered.

                                     Second, the length of distribution for the redundant redraped facial skin is
                                     increased in comparison with most other incisions, thus avoiding a dog-ear
                                     regardless of the extent of the excess facial skin. Rhytidectomy is more effective
                                     because the distance from the incision to the nasolabial crease and the oral
                                     commissure is reduced, thereby effectively transmitting the traction forces to
                                     these sites compared with the conventional
                                     temporal incision that is placed above the ear. In addition, exposure of the
                                     surgical field is significantly enhanced by the added ability to rotate the skin flap
                                     medially. The potential disadvantage is that the operative time is increased to
                                     accommodate meticulous repair of the temporal incision. A slight modification of
                                     this incision has been implemented over the past 18 years, placing the anterior
                                     vertical incision farther posterior compared with the original report. The horizontal
                                     and posterior vertical portions of the incision are positioned at the hairline,
                                     resulting in an inconspicuous scar. None of the 125 patients in this latter group
                                     required a scar revision compared with 37 (4.28 percent) of 865 patients before
                                     this modification. This technique effectively achieves the goal of facial
                                     rhytidectomy and maintains a natural appearance without discernible scars for
                                     most patients. Patient and surgeon satisfaction with this method has been very
                                     high, and consequently, it has been used for almost all patients in the senior
                                     author’s (Guyuron’s) practice.
                    5




            72                                                                                             Case Surgery
                                                                                                         Cardiovascular
                                                                                     Plastic and Reconstructive Surgery
THE LESSER AND THIRD OCCIPITAL NERVES AND MIGRAINE
HEADACHES
Krishna S. Dash, M.D., Jeffrey E. Janis, M.D., and Bahman Guyuron, M.D.
BACKGROUND: Reports of a correlation between relief of migraine headaches
and
resection of corrugator muscles or injection of botulinum A toxin have renewed
interest in finding the cause of migraine headaches and identifying the trigger
sites. Four trigger sites have been described. One of these is along the course
of the greater occipital nerve. Recent anatomical studies of this nerve have
defined its location with respect to external landmarks, leading to new studies
with gratifying results. There is a subset of patients who undergo
chemodenervation or surgical release of the greater occipital nerve and note
improvement or elimination of the symptoms along the greater occipital nerve
course but who experience an emergence of migraine headache symptoms
laterally. The authors propose the lesser occipital nerve as the source of pain in
those who experience headaches laterally and involvement of the third occipital
nerve in those who notice residual symptoms in the midportion of the occipital
region.

METHODS: To test this hypothesis anatomically, 20 cadaver heads were
dissected to trace the course of the lesser occipital nerve and third occipital
nerve and define the location of these nerves with respect to external landmarks.
The midline and a line drawn between the inferiormost points of the external
auditory canals were used to obtain standardized measurements of these
nerves.
RESULTS: The location of emergence of the lesser occipital nerve was
determined to be an area centered 65.4 ± 11.6 mm from midline and 53.3 ± 15.6
mm below the line between the external auditory canals. The third occipital nerve
was found 13.2 ± 5.3 mm from midline and 62.0 ±_20.0 mm down from the line
between the two external auditory canals.
CONCLUSION: This information can be used to conduct clinical trials of
chemodenervation of these nerves in an attempt to eliminate migraine symptoms
in the subset of patients who continue to experience residual symptoms after
surgical release of the greater occipital nerve.                                     5




2005-2006 Abstracts                                                                  73
Plastic and Reconstructive Surgery
                                     THE ZYGOMATICOTEMPORAL BRANCH OF THE TRIGEMINAL
                                     NERVE: AN ANATOMICAL STUDY
                                     Ali Totonchi, M.D., Nazly Pashmini, M.D., and Bahman Guyuron, M.D.
                                     This study was conducted to determine the site of emergence of the
                                     zygomaticotemporal branch of the trigeminal nerve from the temporalis muscle
                                     and to identify the number of its accessory branches and their locations. A pilot
                                     study, conducted on the same number of patients, concluded that the main
                                     zygomaticotemporal branch emerges from the deep temporal fascia at a point on
                                     average 17 mm lateral and 6 mm cephalad to the lateral palpebral commissure,
                                     commonly referred to as the lateral canthus. These measurements, however,
                                     were obtained after dissection of the temporal area, rendering the findings less
                                     reliable. The current study included 20 consecutive patients, 19 women and one
                                     man, between the ages of 26 and 85 years, with an average age of 47.6 years.
                                     Those who had a history of previous trauma or surgery in the temple area were
                                     excluded. Before the start of the endoscopic forehead procedure, the likely
                                     topographic site of the zygomaticotemporal branch was marked 17 mm lateral
                                     and 6 mm cephalad to the lateral orbital commissure on the basis of the
                                     information extrapolated from the pilot study. The surface mark was then
                                     transferred to the deeper layers using a 25-gauge needle stained with brilliant
                                     green. After endoscopic exposure of the marked site, the distance between the
                                     main branch of the trigeminal nerve or its accessory branches and the tattoo
                                     mark was measured in posterolateral and cephalocaudal directions. In addition,
                                     the number and locations of the accessory branches of the trigeminal nerve were
                                     recorded. On the left side, the average distance of the emergence site of the
                                     main zygomaticotemporal branch of the trigeminal nerve from the palpebral
                                     fissure was 16.8 mm (range, 12 to 31 mm) in the posterolateral direction and an
                                     average of 6.4 mm (range, 4 to 11 mm) in the cephalad direction. On the right
                                     side, the average measurements for the main branch were 17.1 mm (range, 15
                                     to 21 mm) in the lateral direction and 6.65 mm (range, 5 to 11 mm) in the
                                     cephalic direction. Three types of accessory branches were found in relation to
                                     the main branch: (1) accessory branch cephalad, (2) accessory branch lateral,
                                     and (3) accessory branches in the immediate vicinity of the main branch. This
                                     anatomical information has proven colossally helpful in injection of botulinum
                                     toxin A in the temporalis muscle to eliminate the trigger sites in the
                                     parietotemporal region and surgical management of migraine headaches
                    5                triggered from this zone.




         74                                                                                                Case Surgery
Section 6
Transplant Surgery
76   Case Surgery
                                                                                             Cardiovascular
  A CONSIDERATION OF "CRITICAL MASS" IN LIVING DONOR




                                                                                         Transplant Surgery
  KIDNEY EXCHANGE PROGRAMS


  E. S. Woodle, M. Rees, A. Bohnengle, M. Aeder, D. Goldfarb, M. Henry, M. H.
  Alonso.. Ohio Solid Organ Transplant Consortium, OH

  Three theoretical constructs for kidney exchange programs (KEPs) exist:
  1) living donor/living donor (LD/LD, 2) LD/deceased donor (LD/DD) and 3)
  hierarchical KEPs (LD/LD KE is first attempted, then LD/DD KE allowed). Hierarchical
  KEPs have yielded a predominance of LD/DD KEs, however. To maximize the # of
  LD/LD KEs, a sufficient # of D/R pairs (ie, a "critical mass") must be available.

  PURPOSE: Determine the "critical mass" of D/R pairs for maximizing LD/LD KEs.

  METHODS: An exclusive LD/LD KEP was established with a consortium of 8 transplant
  (Tx) programs. LD/DD KEs were not allowed for 2 yrs to allow accumulation of D/R
  pairs. Matches were determined by monthly computer match runs (match variables:
  ABO, HLA Ab specifities, D/R age, wait time, PRA). RESULTS: Theoretical # of matches
  based on D/R pair# is presented in the figure.




  The figure demonstrates an exponential increase in matches once 20 D/R pairs are
  available. The results of 8 match runs is presented in the table.


                                                                                         6




2005-2006 Abstracts                                                                      77
Transplant Surgery
                                                 Match Run Results
                           #D/R
                                                         #ABO      #Histo-
                     Match Pairs  #Potential  Excluded                     #Feasible          #Completed
                                                        Incomp     incomp
                      Run   in   Combinations Matches                      Matches            Exchanges
                                                        Matches Matches
                           KEP
                     April
                              7          21        19 (95%)      18         1          2*           0
                     2004
                     May                              28
                              8          28                      27         1          0            0
                     2004                           (100%)
                     June                             28
                              8          28                      27         1          0            0
                     2004                           (100%)
                     July                             66
                              12         66                      56         9          0            0
                     2004                           (100%)
                     Aug                             103
                              15        105                      77        24         2**           1
                     2004                           (98%)
                     Sept                            151
                              18        153                     115        33         2***          1
                     2004                          (98.7%)
                      Oct                             120
                              16        120                      91        26          0            0
                     2004                           (100%)
                     Nov                             103
                              15        105                      76        25         2***     1 pending
                     2004                           (98%)
                                                  618        487       120                     2+1
                     Totals             626                                          8
                                                (98.7%) (78.8%) (19.4%)                      pending
                     *Both abandoned (1+XM;1 DD Tx: **1 had +XM;*** Mutually exclusive matches

                     Observed feasible match rate was 1.7%, indicating that a substantial # of potential
                     matches are needed to achieve substantial # of KEs. These data indicate that the
                     "critical mass" for LD/LD KEs approximates 20 D/R pairs.
                     Keywords: Donors, unrelated; Kidney transplantation




          6




       78                                                                                    Case Surgery
                                                                                                          Cardiovascular
                                                                                                      Transplant Surgery
AN INTERNET-BASED LIVING DONOR KIDNEY EXCHANGE
PROGRAM WITH COMPUTER MATCHING OF
DONOR/RECIPIENT PAIRS
Michael Rees, E. Steve Woodle, Audrey Bohnengel, David Goldfarb, Tanmay Lal,
Annette Blair, Jonathan Kopke, Alan Rees, Mitchell Henry, Mark Aeder, Ann Taylor,
Marie Alonso.. Kidney Committee, Ohio Solid Organ Transplantation Consortium,
Columbus, OH; Tissue Typing Laboratory, Medical College of Ohio, Toledo, OH;
Institute for Health Policy and Health Services Research, University of Cincinnati,
Cincinnati, OH; Anchor Enterprises, Atlanta, GA.
BACKGROUND: ABO/cross-match incompatibility limit living kidney donation. Approaches to
overcome this barrier include desensitization, living donor (LD)/deceased donor (DD) kidney
exchanges and LD/LD kidney exchanges. For LD/LD kidney exchange programs (LDKEP) to be
effective, a large number of willing but incompatible donor/recipient (D/R) pairs must be pooled
to generate sufficient matches. To this end, a consortium of ten renal transplant programs
created a common registry with computer-based matching of potential pairs.
METHODS: A computer program was designed to rank potential pair matches. Points are
allocated for the following parameters: wait time, distance between D/R hospitals, age disparity
of proposed D/R and donors, pediatric bonus, A to B/B to A exchanges, HLA mismatch, PRA,
and CMV/EBV mismatch. Pairs are excluded based on ABO incompatibilities or HLA
incompatibilities in sensitized recipients. Cross-matching is performed only after potential pairs
are identified, approved by consortium review and both pairs have accepted the proposed
match. Donor evaluations take place once cross-matches are negative. Financial arrangements
to fund the program have been approved by Medicare. Donors travel to the recipient hospital for
evaluation and nephrectomy. Both donor operations are performed simultaneously.
RESULTS: The first computerized LDKEP match run was performed in April 2004 and monthly
thereafter. A total of 25 donor/recipient pairs have been entered into the program and 8 potential
paired exchanges have been identified. Two successful exchanges or four renal transplants
have now been completed. Two additional exchanges are being further evaluated. Serving a
population of 11 million patients, the estimated potential is for 100 pairs to be enrolled per year
with 4-8 transplants resulting per month.

CONCLUSIONS: This LD/LD KEP presents the first large scale trial of 1) a KEP restricted to LD
exchanges with 2) computer-based matching of immunologically incompatible but willing D/R
pairs. This system is being established in several US and international consortia.
Keywords:     Donation;  Highly-sensitized;  Kidney    transplantation;     Public     policy




                                                                                                      6




2005-2006 Abstracts                                                                                   79
Transplant Surgery
                     BARRIERS TO REACHING THE POTENTIAL OF CONSORTIUM-BASED
                     KIDNEY EXCHANGE PROGRAMS: A SURVEY OF PROGRAM
                     DIRECTORS AND PROGRAM POLICIES

                     E. Steve Woodle, Michael Rees, Amy Waterman, Audrey Bohnengle, David Goldfarb,
                     Mark Aeder, Mitchell Henry, Maria Alonso, Ann Taylor. Ohio Solid Organ Transplant
                     Consortium, OH; Washington University, St. Louis, MO.

                     A living donor kidney exchange program (LDKEP) was established by a consortium of 8 kidney
                     transplant (KTx) programs performing over 650 KTx (340 live donor (LD) and 327 deceased
                     donor (DD) annually. The combined KTx waiting lists from these programs exceeds 1700
                     patients, yet the mean current referral rates of ABO or cross-match (XM ) incompatible
                     donor/recipient (D/R) pairs to the LDKEP average 3.9 D/R pairs per 100 wait listed patients and
                     14.9 per 100 LD transplants. To date, over 25 D/R pairs have been referred, however. The
                     purpose of this study was to examine policies for managing ABO and XM incompatible patients
                     (ie, LDKEP, DD wait listing, or desensitization (DES)) amongst KTx programs, and also to
                     survey program directors for their perceptions of barriers to D/R identification and referral to
                     LDKEP.
                     METHODS: Surveys were sent to medical directors of each KTx program. Where appropriate,
                     questions were answered using a Likert score (LS) (1 = no barrier, 5= strong barrier).
                     RESULTS: ABO incompatible D/R pairs were referred to LDKEP and DD wait listed at each
                     institution. In addition, one program considered DES approaches for ABO incompatible D/R
                     pairs. All programs referred to LDKEP and DD wait list both for serologic XM incompatible D/R
                     pairs. For ABO and serologic XM compatible, but flow XM incompatible pairs, 2 programs did
                     not perform flow XM, two programs considered LDKEP and DD wait listing, and 2 programs
                     considered LDKEP or transplantation on a case by case basis, and 1 program considered
                     LDKEP, DD wait listing, and DES. The strongest perceived barriers to D/R identification and
                     LDKEP referral were (results expressed as mean LS): donor reluctance to travel (2.57 + 1.38),
                     MD time (2.57 + 1.13), coordinator time (2.57 +0.98), donor refusal to participate (2.29 + 1.11),
                     and donor finances (2.14 + 1.07). Minimal barriers to LDKEP included: IRB problems (1.43 +
                     1.27, MD agreement on ABO and XM incompatibility treatment options (1.14 +0.38), ethical
                     concerns of MDs (1.0 + 0.00) and programmatic personnel ethical concerns (1.14 + 0.38).
                     CONCLUSIONS: These studies indicate that desensitization programs may not represent a
                     significant barrier to LDKEP participation. However, time requirements by physicians and
                     coordinators, and donor reluctance to travel do appear to represent significant barriers.

                     Keywords: Donors, unrelated; Kidney transplantation




          6




       80                                                                                           Case Surgery
                                                                                             Cardiovascular
                                                                                         Transplant Surgery
INDEPENDENT BENEFIT OF AFRICAN AMERICAN DONOR ETHNICITY
ON RENAL OUTCOMES IN A COHORT OF AFRICAN AMERICAN
KIDNEY TRANSPLANT RECIPIENTS

Mark I. Aeder, Joshua J. Augustine, David Siu, Donald E. Hricik, James A. Schulak..
Surgery, Case Western University Hospital, Cleveland, OH; Nephrology and
Hypertension, Case Western University Hospital, Cleveland, OH.

Previous studies in kidney transplant (ktx) have demonstrated reduced long-term graft
survival in African American (AA) vs. white recipients, and a recent analysis of USRDS
data showed worse outcomes in recipients of AA deceased donor organs. We analyzed
outcomes based on donor ethnicity in 94 consecutive AA ktx recipients receiving
tacrolimus, sirolimus and steroid immunotherapy between January 2001 and December
2003, 40 of whom received an AA donor kidney (group 1) and 54 a non-AA donor
kidney (group 2). Donor age and gender were similar between groups, but only 22% of
deceased donors were AA vs 93% of living donors (p<0.001). HLA matching was better
in group 1 vs. group 2 (2.8±1.7 vs 1.3±1.2, p<0.001). Incidence of rejection at three
months post transplant was 5% for group 1 vs. 20% for group 2 (p=0.033). Creatinine
clearance at 12 months (MDRD formula) was 57±15 ml/min in group 1 vs 45±17 ml/min
in group 2 (p=0.001). By multivariate linear regression, AA donor status remained a
significant correlate of higher MDRD clearance (p=0.05) along with younger donor age
(p=0.014) and no rejection (p=0.022), and was independent of donor source (living vs.
deceased), HLA matching, panel reactive antibody (PRA), and delayed graft function
(DGF). A sub-analysis of 66 recipients of deceased donor organs identified 14
AA donors and 52 non-AA donors. HLA matching was not different between these
groups, and early rejection rates were similar. Donor age was younger in AA donors
(30±16 vs. 40±16 years, p=0.031). MDRD clearance at 12 months was 57±16
ml/min with AA donors vs. 45±18 ml/min with non-AA donors (p=0.024). By linear
regression, higher MDRD clearance correlated with younger donor age (p=0.019)
and lack of rejection (p=0.043), with a trend for AA donor status (p=0.082). There
was no correlation with HLA matching, PRA or DGF.

CONCLUSION: AA donor status appeared to be beneficial at one year in this cohort
of AA      ktx recipients, independent of donor source, HLA matching, and
acute rejection. This benefit approached significance in recipients of deceased
donor organs. We believe that an increase in the availability of both living and
deceased AA donors may improve outcomes in AA recipients.




                                                                                         6




2005-2006 Abstracts                                                                      81
                     O BLOOD GROUP (OBG) AND HIGHLY SENSITIZED PATIENTS ARE
Transplant Surgery
                     NOT DISADVANTAGED WITH A LIVING DONOR KIDNEY EXCHANGE
                     PROGRAM

                     Mark I. Aeder, E. Steve Woodle, Michael A. Rees, Audrey B. Bohnengel, Jonathan Kopke,
                     David Goldfarb, Maria H. Alonzo, Mitchell L. Henry, Ann Taylor.. Kidney Committee, Ohio
                     Solid Organ Transplantation Consortium, Columbus, OH; University of Cincinnati,
                     Cincinnati, OH

                     A significant issue in the controversy between direct (living donor/living donor) versus indirect
                     (living donor/deceased donor), or hierarchical (direct followed by indirect) kidney exchange
                     programs (KEPs) is the ability to transplant OBG and high PRA patients. The inability to achieve a
                     direct exchange may result in prolonged wait times, whereas indirect exchanges may
                     negatively impact the O blood group waiting list. Moreover, high PRA patients are unlikely to
                     benefit from indirect exchanges as they are often already at the top of the deceased donor wait list.
                     Our KEP consortium was originally designed to maximize the probability of direct KEs by 1)
                     maximizing evaluation of all potential KEs using a complementary computer-matching program
                     and 2) by excluding indirect exchanges for two years. In this manner, a substantial pool of
                     donor/recipient (D/R) pairs would be created and a critical mass effect achieved to optimize the
                     exponential increase in matched pairs observed with increasing pool size. The purpose of the
                     present study was to determine the ability of our KEP to facilitate direct exchanges amongst
                     OBG and high PRA recipients.

                     METHODS: Patients were deemed eligible if they were ABO or cross-match incompatible. To
                     date, 25 D/R pairs have been registered with 8 matches, 4 transplants performed and
                     another 2 pairs being prepared for exchange. Of the 25 pairs registered to date, 15/25 (60%)
                     recipients and 9/25 (36%) donors are OBG and one OBG has participated in an exchange.
                     Recipient blood group and PRA data is shown in the table below:

                     Recipient Blood        # Pairs            # Placed in Medically Feasible         # Pairs
                     Group                  Registered         Matches                                Transplanted
                     A                      8                  5 (62%)                                2 (25%)
                     B                      2                  2 (100%)                               1 (50%)
                     AB                     0                  0                                      0
                     O                      15                 6 (40%)                                1 (7%)
                     Recipient PRA
                     0-10%                  10                 4 (40%)                                3 (30%)
                     11-49%                 6                  4 (67%)                                0 (0%)
                     >50%                   9                  5 (55%)                                1 (11%)

                     CONCLUSION: This initial experience indicates that OBG and highly sensitized recipients can
                     achieve matches within a LDKEP. This experience also indicates that a substantial proportion of
                     donors may be OBG, thereby facilitating transplantation of OBG recipients. Theoretically,
          6          expansion beyond our 25 pairs in the registry will exponentially increase the likelihood of achieving
                     matches, thereby further enhancing the direct exchanges.




       82                                                                                                 Case Surgery
                                                                                                         Cardiovascular
OPO-BASED CENTRALIZATION OF DONOR REIMBURSEMENT




                                                                                                     Transplant Surgery
COSTS PROVIDES ADVANTAGES FOR LIVING DONOR KIDNEY
EXCHANGE PROGRAMS

K. Holloway, A. Bohnengle, E. S. Woodle, M. A. Rees, D. Goldfarb, M. Aeder, M. L.
Henry, M. H. Alonso, A. Taylor.. Lifeline of Ohio Organ Procurement, Inc, Columbus,
OH; Kidney Committee, Ohio Solid Organ Transplant Consortium, OH
An important, but overlooked and confusing aspect of establishing consortium-based living
donor kidney exchange programs (LDKEP) is financial reimbursements for donor workup. To
ensure consistency in reimbursement for workup costs and to provide equitable cost distribution
to transplant (Tx) centers, a multi-center LKDEP arranged for a local organ procurement
organization (OPO) to serve as financial coordinator (FC) for living donor (LD) reimbursement.
Since OPO procurement activity is regulated by Medicare and is cost reimbursed, financial risk
is minimized when an OPO functions as FC. Unlike Tx centers, OPO's do not have to be
concerned about payor mix. Costs for provider reimbursement during donor workup are
relatively predictable. Since the OPO is a Medicare agency, donor costs are reimbursed at the
Medicare approved rate. This report describes our initial experience with an OPO as FC in a
consortium-based LDKEP.
METHODS: First, the FC sought approval from the Medicare Intermediary (MI) to create a lLD
Standard Acquisition Charge (SAC). This SAC is billed to the Tx center the same as for a
deceased donor SAC. The SAC estimate was based on 3 assumptions: 1) 100 pairs listed in the
first yr, 2)20 Tx (10 exchanges) in the first yr, 3) the only costs coordinated by the FC would be
donor workup costs outlined in the LDKEP policy and procedure manual. Program overhead
allocation was based on Medicare Cost Report rules. To assure that unnecessary overhead and
administrative costs would not apply, the MI agreed to a ratio method of cost allocation. The
ratio was determined by dividing all LD costs by remaining OPO renal procurement costs. Initial
estimates provided a cost allocation ratio of 4.49%.

RESULTS: Initial estimates yielded total program expense in the first yr of $138,739; for
20 Tx an initial SAC fee of $7,000 was proposed and approved by the MI. To date, 4 pts
have been transplanted (four donors in two exchanges). To date, SAC fees have been
submitted for 4 donors. Based on submitted charges, it appears costs for 4 donors will
average $7,250, and therefore appear to be close to the approved SAC. We anticipate
having complete cost data on approximately 12 donors at the time of the meeting.
CONCLUSIONS: OPO centralization of donor reimbursement costs has proven useful in
establishment of the LDKEP.




                                                                                                     6




2005-2006 Abstracts                                                                                  83
Transplant Surgery
                     PRETRANSPLANT FREQUENCIES OF DONOR-STIMULATED,
                     INTERFERON GAMMA-PRODUCING LYMPHOCYTES MEASURED BY
                     ELISPOT PREDICT ACUTE REJECTION AND RENAL FUNCTION IN
                     AFRICAN AMERICAN KIDNEY TRANSPLANT RECIPIENTS

                     Joshua J. Augustine, David Siu, Michael Clemente, Mark Aeder, James A. Schulak,
                     Peter S. Heeger, Donald E. Hricik.. Medicine, University Hospitals of Cleveland,
                     Cleveland, OH; Immunology, Cleveland Clinic Foundation, Cleveland, OH; Surgery,
                     University Hospitals of Cleveland, Cleveland, OH
                     We have shown that ELISPOT measurements of early posttransplant frequencies of interferon-
                     gamma-producing lymphocytes (IFN-ELISPOTS), predict long-term renal function in an
                     ethnically heterogeneous population of kidney transplant recipients treated with varied
                     immunosuppressive regimens. In this study, we determined the ability of pretransplant, donor-
                     specific IFN-ELISPOTS to predict posttransplant outcomes in African American kidney
                     recipients (AAs) treated homogeneously with sirolimus/tacrolimus-based immunosuppression.
                     IFN-ELISPOTS were measured pretransplant after recipient lymphocyte stimulation by T-cell
                     depleted donor splenocytes or PBLs in 50 AAs. Clinical characteristics: mean age 47+13 years,
                     living-donor source–28%, female–42%, delayed graft function-24%, induction antibody therapy–
                     12%. A positive IFN-ELISPOT (> 25 spots/300K cells) was detected in 14 of 50 patients. The
                     incidence of biopsy-proven acute rejection (BPAR) during the first 12 months posttransplant was
                     50% in IFN-ELISPOT positive patients and 11% in IFN-ELISPOT negative patients (p=0.002).
                     Calculated GFR (MDRD method) at 12 months was 37+16 ml/min in IFN-ELISPOT positive
                     patients and 57+17 ml/min in IFN-ELISPOT negative patients (p=0.001). Logistic regression
                     showed that a positive pretransplant IFN-ELISPOT (p=0.012) and delayed graft function
                     (p=0.014) were significant independent correlates of BPAR, while HLA match and current PRA
                     (measured by flow-PRA) had no significant correlation. Linear regression showed that a positive
                     pretransplant ELISPOT (p=0.001), delayed graft function (p=0.004) and donor age (p=0.021)
                     were significant independent correlates of GFR at 12 months, while donor source and BPAR
                     had no significant correlation. Our results suggest that pretransplant measurement of donor-
                     specific IFN-ELISPOTS independently predict early acute rejection in AAs receiving
                     sirolimus/tacrolimus-based immunosuppression. In addition, pretransplant donor-specific IFN-
                     ELISPOTS predict renal function 12 months posttransplant, independent of BPAR episodes.
                     Whether pretransplant IFN-ELISPOT measurements can be used to individualize posttransplant
                     immunosuppression in AAs or other transplant recipients requires further study.




          6




       84                                                                                          Case Surgery
                                                                                                 Cardiovascular
 PROPERTIES OF UW SOLUTION IN LIVER GRAFTS




                                                                                             Transplant Surgery
 Sanabria JR MD, Alo M
 Liver grafts preserved in cold undergo changes mainly manifested by morphological
 changes of the sinusoidal endothelium. Swollen and fragmented cytoplasm translates
 into poor portal blood flow, increase release of liver enzymes and low bile production
 upon liver reperfusion. Studies were performed to determine if the addition of higher
 molecular weight polyethylene glycol modified albumin to the University of Wisconsin
 (UW) preservation solution ameliorates the cold preservation injury of liver grafts.
 Mehtoxypolyethylene glycol 5000 activated with cyanuric chloride was covalently
 coupled to human albumin (Peg-Alb) at multiple sites. The Isolated Perfused Rat Liver
 model was used (IPRL).

 Table 1. IPRL results of grafts preserved with UW solution and UW solution plus Peg-
 Alb. Values are given after 60minutes of perfusion with a sanguineous perfusate.

 Group (n=4)                     Portal Blood flow    AST          Bile production
 *(preservation time in hours)   ml/g            of   Units/g   of  l/g of liver
                                 liver/minute         liver
 Control    neg   UW       *(1h) 0.93+0.033**         2.1+1.08*    10.5+5.97
 Mean+SD
 Control pos UW *(30h)           0.19+0.010           14.4+0.34     0+0
 PEG-Alb & UW *(30h)             0.98+0.005**         28.4+1.03     3.5+7.54
 Alb & UW *(30h)                 0.05+0.007           26.9+2.45     0+0
 ** p<0.05 by ANOVA

 CONCLUSION: The addition of high molecular albumin to UW preservation solution
 appears to ameliorate endothelial injury of cold preserved liver grafts as judged by both
 better portal vein blood flow and bile production. However, further morphological and
 molecular studies are needed to define its role.




                                                                                             6




2005-2006 Abstracts                                                                          85
Transplant Surgery
                     RECIPIENT AND DONOR CHARACTERISTICS IN A COMPUTER-
                     BASED LIVING DONOR KIDNEY EXCHANGE PROGRAM

                     M. Rees, S. Woodle, J. Kopke, A. Bohnengel, D. Goldfarb, T. Lal, M. Henry, M. Aeder,
                     A. Taylor, M. Alonso.. Ohio Solid Organ Transplantation Consortium, Columbus, OH;
                     University of Cincinnati, Cincinnati, OH

                     BACKGROUND: A consortium of ten renal transplant programs developed a living donor
                     kidney paired exchange program (LDKEP) utilizing computer-based matching. No data are
                     available characterizing patients that might populate such a registry and factors that
                     influence matching.
                     METHODS: We analyzed the prospectively collected data from the first 8 months of a
                     consortium-based computerized LDKEP in terms of recipient (R)/donor (D) sex, race, blood
                     type, age, and PRA. Data was evaluated to determine the factors impacting generation of a
                     potential paired exchange.
                     RESULTS: Computerized match runs were performed monthly. Seven to 18 pairs have been
                     available at any one time leading to 21 to 153 possible combinations per match run. Using 25
                     total pairs, 626 combinations have been generated in 8 match runs. Eight medically feasible
                     potential paired exchanges (1.3% of all possible matches) have been identified of which 2 (4
                     transplants) have progressed to successful transplantation and 2 are undergoing further
                     evaluation. Of the 11 male recipients, 5 have been placed in medically feasible matches (MFM)
                     and two have been transplanted. Of the 14 female recipients, 8 have been placed in MFM and
                     two have been transplanted. There have been 15 recipients with blood type (BT) O, 8 with BT A,
                     2 with BT B and none with BT AB. MFM have been arranged for 6 recipients with BT O, 5 with
                     BT A, and 2 with BT B. Transplants have occurred for 1 recipient with BT O, 2 with BT A, and 1
                     with BT B. The age of all four recipients that were transplanted was between 50-59. There have
                     been 3 recipients aged 19-39, 4 aged 40-49, 10 aged 50-59, and 8 aged 60-69. There have
                     been 10 recipients entered with a PRA of 0-10% of which 4 were placed in MFM and 3 were
                     transplanted. Ten recipients had a PRA of 11-49% of which 4 were placed in MFM and none
                     were transplanted. Nine recipients had a PRA of >50% of which 5 were placed in MFM and
                     1 was transplanted. Potential donors include 10 males and 15 females of which 9 had BT O, 10
                     BT A and 6 BT B. Of the four actual donors, 2 had BT O, 1 BT A and 1 BT B. Two donors were
                     aged 40 to 49 and 2 were aged 50-59.
                     CONCLUSIONS: These data demonstrate that a large pool of potential R/D pairs are required
                     to maximize a LDKEP and that a computerized matching system is required to handle that large
                     number of mathematically possible combinations.




          6




       86                                                                                        Case Surgery
                                                                                                        Cardiovascular
                                                                                                    Transplant Surgery
SUBOPTIMAL LONG-TERM OUTCOMES AFTER STEROID
WITHDRAWAL IN AFRICAN AMERICANS RECEIVING
SIROLIMUS AND TACROLIMUS

Donald E. Hricik, Thomas C. Knauss, Kenneth A. Bodziak, Joshua J. Augustine, Mark
Aeder, Christopher Siegel, James A. Schulak..

We previously reported excellent s hort-term outcomes in 30 primary African American (AA)
kidney transplant recipients withdrawn from prednisone between 3 and 5 months following
transplantation and maintained on concentration-controlled doses of sirolimus (target trough
concentrations, 10-15 ng/ml) and tacrolimus (target trough concentrations, 5-8 ng/ml). No
patient in this series received antibody induction therapy. After a mean follow-up of 14 months,
only 2 of 30 patients (6.7%) had experienced acute rejection and 90% of patients remained
steroid-free. This cohort of patients has now been followed for 24 to 57 months (mean 46+8
months). Clinical characteristics: age 46+13 years, 50% female, 40% living donor source, 23%
delayed graft function. At last follow-up, 17 of 30 patients (57%) have required renewal of
steroid therapy for hemolytic uremic syndrome (n=1), recurrent focal sclerosis (n=1), acute
rejection (n=11, 37%), or chronic allograft nephropathy (n=4). Steroids were renewed between 1
and 47 months (mean 26.4 months) after the initial withdrawal. There have been 6 graft losses,
including one death with a functioning graft. Actuarial 5-year graft survival is 73%. Gross
noncompliance has been reported by 7 patients, 6 of whom required renewal of steroids, and 3
of whom have lost their grafts. For the cohort of 24 patients with functioning grafts, serum
creatinine concentration increased from 1.5+0.5 prior to steroid withdrawal to 2.2+1.3 mg/dl at
last follow-up (p=0.004). For the 12 patients who renewed steroid therapy and have functioning
grafts, serum creatinine increased from 1.6+0.5 to 2.8+1.5 mg/dl (p=0.015). For the 12 patients
who remain off steroids and have functioning grafts, serum creatinine increased from 1.3+0.4 to
1.6+.0.5 mg/dl (p=0.074). Results of this uncontrolled study suggest that, beyond 2 years, only a
minority of AA kidney transplant recipients treated with sirolimus and tacrolimus can be
maintained off of steroids. Late episodes of acute rejection and noncompliance in AAs
withdrawn from steroids have a dramatically negative impact on graft function and survival.
Whether induction antibody therapy can improve the saftey of steroid withdrawal in AAs remains
to be determined.




                                                                                                    6




2005-2006 Abstracts                                                                                 87
Transplant Surgery
                     VARIABILITY IN PATIENT REFERRAL RATES WITHIN A MULTICENTER
                     LIVING DONOR KIDNEY EXCHANGE CONSORTIUM AND ESTIMATION
                     OF POTENTIAL VOLUME

                     E. Steve Woodle, Audrey Bohnengle, Amy Waterman, Michael Rees, David Goldfarb,
                     Mark Aeder, Mitchell Henry, Ann Taylor, Mari Alonso.. Kidney Committee, Ohio Solid
                     Organ Transplant Consortium, OH; Washington Univ, St. Louis, MO

                     Although at least 5 consortium-based kidney exchange programs (KEPs) have been established in
                     the international transplant (Tx) community, none have approached their theoretical potential. An
                     approach toward evaluating reasons for failure to reach this potential is evaluation of referral rates
                     (RR) of living donor/recipient (D/R) candidates by individual centers. Such studies, however, have
                     not been conducted. This study was conducted to define center-specific RR and to define the
                     potential volume of kidney exchanges.

                     METHODS: An 8 center living donor (LD) KEP was established with a complementary
                     computer-based matching program to optimize matching of D/R pairs. Computer matching was
                     performed monthly and match run data collected prospectively. Center volume data is derived
                     from 2003-2004. RESULTS: Kidney Tx volume and RR data are presented in the table:

                                                    Transplant Volume and Referral Rates
                              Total      LD      Wait       #D/R KEP      #D/R Reg in       #KEP                #KEP
                     Center
                              Tx/Yr     Tx/Yr    List#      Candidates        KEP        Reg/Listed Pt        Reg/LD Tx
                       A       146       85       583            2                2             0.0034          0.0250
                       B        61       34       320            1                1             0.0031          0.0290
                       C        13       10        5             1                1             0.2000          0.1000
                       D        70       30       80             10               4             0.0500          0.1420
                       E        70       30       65             5                1             0.0150          0.0333
                       F        66       18       115            14               14            0.1250          0.7777
                       G        30        8       80             2                0             0.0000          0.0000
                       H       216       115      482            0                0             0.0000          0.0000
                     Total     677       340     1730            35               23
                     Mean      84.6     42.5      216           4.38             2.88           0.0133          0.0676
                      SD     65.9      38.1      217          3.5              3.8              0.0543          0.2513
                     Reg= KEP registrations; Listed pt= deceased donor wait listed patient

                     These data indicate a 30-40 fold intercenter variability in D/R RR to KEP. Differences did not
                     appear to be related to wait list size, total TX volume, or LD Tx volume. RR (in terms of #D/R pair
                     KEP registrations per each non-KEP LD Tx in each program (from last column of Table) could be
                     generally classified into 3 groups: Low (RR = 0), Moderate (RR=0.025-0.0333), and High
                     (RR=0.10-0.777). If one accepts an average RR of 0.100 D/R pair per LD Tx at each center (and
          6          assuming that all D/R pairs get transplanted eventually), the potential for KPEs for increasing LD
                     Tx volume in the US approximates 10%.




       88                                                                                                Case Surgery
Section 7
Trauma
90   Case Surgery
                                                                                                   Cardiovascular
                                                                                                         Trauma
CHARACTERIZING THE NEED FOR MECHANICAL VENTILATION
FOLLOWING CERVICAL SPINAL CORD INJURY WITH NEUROLOGIC
DEFICIT
John J. Como, MD, Erica RH Sutton, MD, Maureen McCunn, MD Richard P. Dutton, MD,
Steven B. Johnson, MD, Bizhan Aarabi, MD, and Thomas M. Scalea, MD
BACKGROUND: Patients who sustain cervical spinal cord injury (C-SCI) with neurologic deficit
may require a definite airway and/or prolonged mechanical ventilation. The purpose of this
study was to characterize factors associated with a high risk for respiratory failure and/or the
need for mechanical ventilation in C-SCI patients.
METHODS: Patients with C-SCI and neurologic deficit admitted to a Level I Trauma Center
between July 1, 2000 and June 30, 2002 were retrospectively reviewed for demographics, level
and completeness of neurologic deficit, need for definitive airway, need for tracheostomy, need
for mechanical ventilation at hospital discharge (MVDC), and outcomes.            The level and
completeness of injury were defined by American Spinal Injury Association standards.
RESULTS: One hundred nineteen patients with C-SCI and neurologic deficit were identified
over this period. Of these, 45 were identified as complete C-SCI:12 (27%) patients had levels of
C1 to C4; 19 (42%) had a level of C5; and 14 (31%) had levels of C6 and below. There were 37
males and 8 females. There were 36 blunt and 9 penetrating injuries. The average age of
these patients was 40+/-21, and the average ISS was 45+/-22. Eight of the patients with
complete C-SCI died, for a mortality of 18%. Of the 37 survivors, 92% received a definitive
airway, 81% received tracheostomy, and 51% required MVDC. All patients with complete
injuries at the C5 level and above required a definitive airway and tracheostomy, and 71% of
survivors required MVDC. Of the patients with compete injuries of C6 and below, 79% received
a definitive airway, and only 7% required tracheostomy.
CONCLUSIONS: The need for definitive airway control, tracheostomy, and ventilator
dependence is significant, especially for patients with high complete C-SCI. Based on these
results we recommend consideration of early intubations and tracheostomy for patients with
complete C-SCI, especially for those with levels of C5 and above.
Key Words:     Airway, Cervical spine, Cricothyroidotomy, Intubation, Neurologic deficit,
Tracheostomy.




                                                                                                   7




2005-2006 Abstracts                                                                                91
Trauma
         CONTEMPORARY MANAGEMENT OF PENETRATING COLON
         TRAUMA
         Joshua M. Braveman, MD, Mark A. Malangoni, M.D., Cleveland, Ohio

         The management of penetrating colon injuries has evolved over the past decades.
         There has been a trend away from mandatory fecal diversion toward primary repair and
         anastomosis, even for destructive colon injuries. Recent prospective randomized trials
         have found that colostomy formation is associated with increased morbidity and has a
         limited role in the management of these injuries. This article reviews many aspects of
         the management of penetrating colon injuries including injury classification, etiology,
         operative management, results antibiotic use and wound management.




   7




 92                                                                             Case Surgery
                                                                                                     Cardiovascular
HOSPITAL AND BURN CENTER INTERNAL RESPONSE TO BURN




                                                                                                           Trauma
DISASTER
Lynne Yurko, RN, BSN, CAN, Tammy Coffee, RN, ACNP, Charles J. Yowler, MD,
Christopher P. Brandt, MD, MetroHealth Medical Center\Case Western Reserve
University, Cleveland, Ohio
Preparing for a disaster that would create large numbers of burn casualties challenges each
burn center’s readiness and response. Each burn center needs to develop policies and
procedures for such events. Decisions have to be made concerning the number of patients the
burn center can admit, the number that will require transfer to nearby burn centers and
coordination with both regional and American Burn Association national disaster plans. The
goal is to develop a program by which a large number of burn patients may be evaluated and
resuscitated in timely and organized fashion.

The internal disaster plan needs to identify a basic vital supply list, which is maintained on the
burn center. Access to additional supplies and equipment must be included in the plan. The
identification of staffing requirements is key to being prepared for the receipt of multiple
casualties. Our unit has developed a disaster phone call tree, which is maintained to allow for
proper initiation of calls to staff. We also maintain a list of all nurses and other burn team
members with burn care experience who still work within the hospital, but outside the burn
center. They will be called upon to assist, since they are already well-trained in the
management of burns. Designated staff responsibilities include a charge person who can
implement patient assignment and management of staff from other intensive care units
immediately. Staff rotating from other floors, who lack burn experience, can manage basic
assignments, vital signs, IV fluids and medications. This staff can also assist more experienced
nurses in initial debridement and application of dressings to burned areas.

Each burn center will, by necessity, have to develop a unique disaster plan based on its staffing
and institution. Preparation preplanning, however, allows the burn multidisciplinary team to
identify deficiencies and streamline procedures to continually assess readiness for potential
burn disaster.




                                                                                                     7




2005-2006 Abstracts                                                                                  93
Trauma
         HYDROFLUORIC ACID BURNS: CASE REPORT
         Nilam Patel, Pharm D. BCPS, Tammy Coffee, RN, ACNP, Lynne Yurko, RN, BSN,
         Charles J. Yowler, MD, Christopher P. Brandt, MD, MetroHealth Medical Center, Case
         Western Reserve University, Cleveland, Ohio
         Hydrofluoric Acid (HFA) has very unique properties. Even seemingly minor exposure to HFA can cause
         devastating complications. Most exposures to HFA are to the hands, mainly the fingertips. While
         certainly not fatal, these burns are quite painful. The pain is often resistant to traditional pain
         medications. The mainstay of therapy in these exposures is either the topical, intra-dermal or in more
         severe exposures the intra-arterial use of calcium. Intra-arterial calcium is not a very common therapy
         outside of the burn unit and therefore have been a few cases at out institution where therapy was
         delayed. To insure this did not happen again, we implemented a protocol based on existing literature and
         case reports. Attached is our protocol.

         Intra-arterial Calcium Infusion for Hydrofluoric Acid Burns
         Guidelines for Administration

         CALL ATTENDING IMMEDIATELY PRIOR TO ORDERING INTRA-ARTERIAL CALCIUM
         INFUSION

         Obtain baseline serum calcium, magnesium, phosphorus, prothrombin time (PT), and partial
                thromboplastin time (PTT).

         Patient must be admitted to the critical side for arterial pressure wave monitoring. The catheter
                 must be appropriately placed intravascularly as tissue necrosis and digit loss have
                 occurred following extravasation of calcium salts.

         Insert the catheter proximally several centimeters into the radial artery for burns to the thumb,
                 index, or middle fingers. Alternatively, the catheter is advanced proximally into the
                 brachial artery allowing access to the ulnar circulation for burns involving the ring and
                 the small finger.

         The appropriate artery is cannulated with a 20-gauge, 4 French or 5 French arterial catheter.

         Continuous EKG monitoring must also be done.

         Calcium infusion: 10ml of 10% calcium chloride diluted with 40ml of normal saline to be infused
                over 4 hours. May repeat every 4 to 8 hours based on symptom relief. May add 500
                units of heparin to reduce catheter clotting.

                 Alternative 50ml of 4% solution over 4 hr and repeated at q12hr

         Check arterial wave form every hour.

         After infusion of calcium chloride, flush with 10ml of normal saline over a 15 minute period.
                 Monitor waveform continuously and flush line with saline every hour as needed.

         After pain or discomfort from hydrofluoric acid burn has resolved, remove catheter. Observe for
                 24hr before discharging.

         Obtain serum calcium, magnesium, phosphorus, PT and PTT 1 hour after completion of
         infusion.

         Supplement electrolytes as per MetroHealth Medical Center electrolyte replacement guidelines.


   7




 94                                                                                           Case Surgery
                                                                                                  Cardiovascular
LIFE AFTER 80 HOURS: THE IMPACT OF RESIDENT WORK HOURS




                                                                                                        Trauma
MANDATES ON TRAUMA AND EMERGENCY EXPERIENCE AND
WORK EFFORT FOR SENIOR RESIDENTS AND FACULTY
Mark A. Malangoni, MD, John J. Como, MD, Charlene Mancuso, RN
Charles J. Yowler, MD
BACKGROUND: To evaluate the impact of work hours mandates on: 1) senior resident patient
exposure and operating experience in Trauma and Emergency Surgery; and 2) faculty work
effort.
METHODS: We measured resident and faculty work on the Trauma and Emergency Surgery
services at our Level I Trauma Center during two comparable six-month periods. Period 1
(7/01-12/31/2002) had no call restrictions, separate Trauma and Emergency service resident
call and some overlap of faculty call responsibilities. Period 2 (7/01-12/31/2003) had resident
work hours compliance and complete integration of resident and faculty Trauma and Emergency
call. Work hours were measured by surveys for faculty and residents. All data were collected
prospectively.
RESIULTS: Resident exposure to Trauma patients was similar during both time periods.
Emergency surgery admissions declined during Period 2, however intensive care unit
admissions increased. The number of operations done by senior residents did not change
however there was a shift in the median number of Emergency Surgery cases to more senior
residents. Faculty work hours increased slightly despite a decrease in faculty call.
CONCLUSIONS: Work hours compliance resulted in a 50% reduction in senior resident call
and a 19% decrease in their work hours with no significant change in Trauma/Emergency
patient care exposure or operative case load. Service call amalgamation reduced faculty call by
21% but did not result in a corresponding change in work hours or productivity.




                                                                                                  7




2005-2006 Abstracts                                                                               95
Trauma
         PENETRATING TRAUMA TO A PERSISTENT SCIATIC ARTERY
         John J. Como, MD, Carnell Cooper, MD, Stuart E. Mirvis, MD,
         and Thomas M. Scalea, MD
         Persistent sciatic artery (PSA) is a rare congenital anomaly, with few cases reported in the world
         literature. We describe a patient who sustained penetrating trauma to this vessel that required
         operative bypass. To our knowledge, this is the only case to date of an injury to this vessel due
         to penetrating trauma requiring immediate operative intervention.

         Case Report:
         A 24 year old male without prior medical history presented to the R Adams Shock Trauma
         Center after sustaining a gunshot wound to the right lower extremity. He was hemodynamically
         normal. Exterior wounds were located just above the knee anteriorly and at the posteromedial
         left thigh. The thigh was swollen. The patient had a palpable posterior tibial pulse and weak
         Doppler signal at the dorsalis pedis. Plain radiographs revealed a midshaft femur fracture. The
         patient had neurologic deficits in the tibial and peroneal distributions of the sciatic nerve. He
         had poor motor function on both plantar flexion and dorsiflexion. Angiogram was performed
         because of the difference between the vascular examinations of the two lower extremities, and it
         revealed bilateral PSAs (Fig. 1). The superficial femoral artery was found to by hypoplastic, and
         it ended in small muscular branches in the thigh (Fig. 2). The distal PSA filled retrograde from
         these small branches (Fig. 3). At the level of the fractured femur, there was an occlusion of the
         right PSA (Fig. 4). The patient arrived in the operating room four hours after his admission. A
         retrograde intramedullary nail was placed in the femur before the vessel was explored because
         perfusion of the leg was present. Exploration was found, and blast effect to the sciatic nerve
         was recognized. The nerve injury did not require repair. The artery was first debrided back to
         healthy tissue. A reversed great saphenous vein was used as an interposition graft to perform a
         bypass from the PSA to the popliteal artery. Completion angiogram revealed good blood flow to
         the foot. There were no postoperative complications, and the patient was discharged home on
         postoperative day four. On follow-up one month later, the patient had improving neurologic
         function in the distribution of the sciatic nerve along with a significant amount of neurogenic
         pain, but he had a normal pulse examination at the foot.
         Discussion:
         PSA is an uncommon anomaly of the vascular system that was first described by Green in
         1832. PSA is a result of persistence of the fetal circulation in which the sciatic artery connects
         the internal iliac artery to the popliteal artery. The incidence of PSA is estimated to be between
         0.01% and 0.05%, with no sexual prevalence. Twenty two percent of cases are bilateral. It may
         be associated with other congenital anomalies, such as lower limb hypertrophy, persistent
         sciatic vein, prominent extremity varicose veins, and abdominal wall capillary hemangioma.
         During early embryologic development , the axial artery is the dominant artery that supplies
         blood flow to the lower extremity. As the femoral artery develops, the axial artery involutes.
         The sciatic artery is the persistence of the embryologic axial artery. Failure of the femoral artery
         to develop or the axial artery involute will result in a PSA, which connects the internal iliac artery
         to the popliteal artery. The sciatic artery, as a continuation of a hyperplastic internal iliac artery,
         gives off the superior gluteal and pudendal arteries within the pelvis. It then enters the thigh
         through the greater sciatic foramen, at which pint it gives off an inferior gluteal branch. In the
         thigh, it maintains a relationship with the sciatic nerve, occasionally lying within the nerve
         sheath. The sciatic artery runs deep to the gluteus maximus and the hamstring muscles of the
         thigh. It passes laterally to adductor magnus and enters the popliteal fossa. After the femoral
         artery is fully developed, remnants of the sciatic artery persist as portions of the inferior and
         superior gluteal arteries and as the popliteal, anterior tibial, and digital vessels.


   7




 96                                                                                          Case Surgery
                                                                                                Cardiovascular
                                                                                                      Trauma
POST-TRAUMATIC MENINGITIS: RISK FACTORS,
CLINICAL FEATURES, BACTERIOLOGY AND OUTCOME
Brian R. Plaisier, M.D.*, Charles J. Yowler, M.D.†, William F. Fallon, M.D.†, Matt J.
Likavec, M.D.†, James S. Anderson, M.D.†, Mark A. Malangoni, M.D.† Trauma Program,
Bronson Methodist Hospital, Kalamazoo, Michigan*, Department of Surgery,
MetroHealth Medical Center, Cleveland, Ohio†
Patients with post-traumatic meningitis (PTM) at two trauma centers from January 1992-
December 1999 were retrospectively analyzed. Twenty-seven of 4,788 (0.56%) patients with
head injury developed meningitis. Twenty-one (78%) patients were male. Mean age was 31.3
years. Twenty-three (85%) patients sustained blunt trauma and four (15%) had penetrating
injuries. Median initial Glasgow coma scale (GCS) was 6. Twenty-one (78%) patients had
pneumocephalus. Twelve (44%) patients had a cerebrospinal fluid (CSF() leak. Fever was
seen in all patients and 23 (85%) displayed a decrease (greater than 2 points) in GCS. Twelve
(44%) patients had an intracranial pressure (ICP) monitor, eight (30%) a ventriculostomy, and
12 (44%) underwent craniotomy prior to developing meningitis. Median interval between injury
and diagnosis was 10 days. Pathogens were isolated from the CSF in 15 patients and brain
tissue in one. Treatment in the remainder was based on elevated CSF white blood cell count,
elevated CSF protein concentration, and low CSF glucose concentration. Measured functional
outcome was good in 10 (37%) patients while 8 (30%) had a residual disability requiring
dependent care and 5 (19%) remained in a vegetative state. Four (15%) patients died.
Admission GCS was predictive of a good functional outcome (p<0.01), but did not predict death
from infection.




                                                                                                7




2005-2006 Abstracts                                                                             97
Trauma
         THE IMPACT OF GUIDED IMAGERY ON PAIN AND
         ANXIETY LEVELS OF BURN PATIENTS
         Arthur A. Snedeker, M. Div., Charles J. Yowler, MD, Richard B. Fratianne, MD
         MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio
         We have used guided imagery in our Burn Unit for the past five years as an adjunctive therapy
         to assist in controlling pain and anxiety levels of patients before, during and after dressing
         changes, during periods of breakthrough pain and whenever high levels of anxiety develop
         during their recovery process.

         Guided imagery uses various relaxation techniques. This includes using rhythmic breathing,
         along with helping patients visualize a calm, relaxing image of a safe place or pleasurable
         experience. This process helps divert the attention of the patients away from their pain and
         helps to improve the mood and/or physical, psychological and spiritual well-being of the
         individual. We have observed that, through guided imagery, the patients can learn to control
         their heart rate, blood pressure an respiratory rate.

         Our studies have shown that guided imagery has helped patients create a sense of
         empowerment, allowing them to assume an important part in their physical recovery and
         support their emotional and spiritual process of healing. Furthermore, our studies have
         demonstrated that guided imagery can dramatically counteract a burn patient’s feelings of loss
         of control, fear, panic, helplessness and uncertainty, as well as reduce pain and anxiety levels.
         This more relaxed attitude encourages cooperation between patients and nurses during all
         phases of the recovery process.




   7




 98                                                                                     Case Surgery
                                                                                                       Cardiovascular
                                                                                                             Trauma
THE REAL PREDICTORS OF DISPOSITION
IN PATIENTS WITH SPINAL CORD INJURIES
Jeffrey A. Claridge, MD; Martin A. Croce, MD, Jordan A. Weinberg, MD,
Raquel M. Forsythe, MD, Christopher Miller, BS, and Timothy C. Fabian, MD
OBJECTIVES: A primary goal of health care providers for managing patients with spinal cord
injury (SCI) is to discharge them to a rehabilitation facility (RF) to allow for maximum functional
recover. This study was undertaken to analyze hospital mortality and disposition of patients
with SCI with a specific focus on evaluating the effect of payor source on discharge to a RF.
Our hypotheses was that commercial insurance (CI) would be the greatest influence of hosp9tal
disposition.
METHODS: All patients under 60 years of age with SCI over a 7-year period were identified
from the trauma registry; and grouped according to payor source: No insurance (NI),
Government insurance (GI), No Commercial insurance (NCI) (NCI = NI + GI), and CI.
RESULTS: A total of 492; patients with SCI were identified with a mean age f 33, an ISS of 29,
and a hospital mortality of 7.7%. Independent predictors of mortality were cervical SCI and
blood transfusions. Patients who were discharged to a RF had higher ISS and %CI with lower
functional independent measurement scores compared with patients who were not discharged
to a RF. Logistic regression analysis demonstrated that the predictors of disposition to a RF
were CI (P< 0.001) and ISS (P=0.002).
CONCLUSION: The presence of CI was an independent predictor of disposition to a RF for
patients with SCI.       Lack of commercial insurance clearly compromises recovery and
rehabilitation of patients with SCI and predicts outcome more clearly than any other parameter.
Additional funding for patients with out CI is necessary to afford all with an equal opportunity for
maximal functional recovery.




                                                                                                       7




2005-2006 Abstracts                                                                                    99
Trauma
         THE USE OF VACUUM ASSISTED CLOSURE (V.A.C.)
         IN SEVERE FROSTBITE OF THE HIND FOOT
         Tammy Coffee, RN, Christopher P. Brandt, MD, Charles J. Yowler, MD
         MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio
         The use of Vacuum Assisted Closure (V.A.C.) has increased in burn centers across the country.
         Our burn center has utilized it to improve the vascularity of wound beds prior to grafting, and as
         a stent over grafts in areas where graft take is problematic. We recently treated a patient whose
         tissue loss following frostbite injury would have traditionally required a bilateral below-knee
         amputation. Use of the V.A.C. technique assisted in eventual bilateral limb salvage.

         Case Report:
         A 37-yearold male was referred to our burn center 48 hours after receiving frostbite injuries to
         both feet. The patient’s injuries consisted of deep tissue necrosis of h is right great toe and
         adjacent two toes, and severe tissue loss of both heels. These injuries were treated
         conservatively and eventually debrided. At this time, the injuries to both hind feet were found to
         extend to the calcanei. Following soft-tissue debridement, 2-3 cm of each calcaneus was
         exposed. Nonviable bone was removed and both feet were placed in V.A.C. dressing. After
         one month of serial VAC dressings, both wounds were grafted. The patient is currently
         ambulating with no evidence of ulceration of infection.

         This case will be discussed in detail, including details of our V.A.C. management technique.




   7




100                                                                                      Case Surgery
                                                                                                   Cardiovascular
                                                                                                         Trauma
TRANSPORT OF TOP TIER PEDIATRIC TRAUMA TO A TERTIARY
TRAUMA CENTER DIRECTLY FROM THE SCENE VERSUS
TRANSFER FROM OUTSIDE HOSPITALS: IMPACT ON MORTALITY
AND LENGTH OF STAY
Diya I. Alaedeen (1), Eric E. Marsh (2), Walter J Chwals (1)
Departments of Surgery, Division of Pediatric Surgery, Rainbow Babies and Children’s Hospital,
Case Western Reserve University School of Medicine 2 Department of Emergency Medicine,
University of Pittsburgh Medical Center

OBJECTIVE: To study the mortality and length of stay of top tier pediatric trauma patients who
are transported directly from the scene versus those transferred from outside hospitals.
METHODS: The records of all top tier pediatric trauma patients admitted to our trauma center
between 1/1998 and 12/2002 were retrospectively reviewed. Patients transported from the
scene were designated as Group I, and those referred from outside hospitals as Group II. The
age, Injury Severity Score (ISS), Length of Hospital Stay (LOS), Length of Intensive Care Unit
stay (LOS-ICU), and mortality rates were analyzed between the two groups.
RESULTS: Of all 101 patients studied 52% were in Group I, and 48% were in Group II. The
average age of the patients was 6 years in both groups. Patients in Group I had a higher ISS
(22.8 16 vs. 15.3 12; p=0.01,) with an overall higher mortality rate (38% vs. 6%; p=0.001). In a
subgroup analysis for alive-upon-discharge with an ISS > 20, the average LOS-ICU for Group I
was significantly longer than for Group II (14 10 days vs. 5 6days; p=0.01). The average LOS
for the same subgroup was also higher in Group I vs. Group II (19 10days vs. 8 4 days;
p=0.003).
CONCLUSION: There is a survival and morbidity advantage in pediatric trauma patients
transferred from outside hospitals. This trend may support a modification in resource
mobilization for stable trauma patients transferred from outside hospitals.




                                                                                                   7




2005-2006 Abstracts                                                                                101
Trauma




   7




102      Case Surgery
Section 8
Vascular Surgery
104   Case Surgery
                                                                                                Cardiovascular
                                                                                              Vascular Surgery
VA Cooperative Study #498



OVER                        Jesse Jean-Claude,M.D., Gilles Pinault, M.D.

                            This VA Cooperative Study will determine which surgical
                            procedure (open or EVR) has a lower risk., fewer
                            complications, shorter hospital stays, quicker recovery
                            period and higher patient satisfaction when repairing
                            abdominal aortic aneurysms (AAA). It will be conducted at
                            40 VA Medical Centers around the country and will enroll
                            1,260 participants. The Louis Stokes Cleveland VAMC plans
                            to enroll about 32 subjects. Participants will last for as long
                            as 8 years.

Patients determined to be eligible
for participation in this study will
have their aneurysm repaired by–

STANDARD OPEN SURGERY which
involves opening the abdomen and
sewing a graft, which looks much like the
aorta but is made of a special fabric, into
the aorta, bypassing the aneurysm. This
takes 3 to 6 hours.
OR ENDOVASCULAR OPEN
SURGERY (EVR) which involves
making an incision in one or both sides of
the groin and inserting a graft through the
femoral (groin) artery up to the AAA. X-
ray viewing is used to properly place the
graft.




                                                      Healthy          Aneurysmal
                                                       Aorta             Aorta

                                              An aneurysm is a bulge or balloon that
                                              forms in the wall of a blood vessel. If an
                                              aneurysm forms in the part of the aorta
                                              (one of the body’s main blood vessels) that
                                              extends through the abdomen, it is called
   Endovascular                               an abdominal aortic aneurysm
    repair (EVR)                              (AAA).
      of a AAA

For more information regarding the OVER Study contact: Mathew Eiseman, R.N.                   8
Study Coordinator/Research Nurse • Phone: (216) 231-3464


2005-2006 Abstracts                                                                           105
Vascular Surgery




         8


106                Case Surgery
Section 9
Clinical Trials
108   Case Surgery
                                                                                                             Cardiovascular
                                                                                                              Clinical Trials
CARDIOTHORACIC SURGERY

“RELIANT Trial: Multicenter trial evaluating the use of the Novacor assist device for destination therapy”
Arie Blitz, MD

“Jarvik Trial: Multicenter trial evaluating the use of the Jarvik 2000 pump as a bridge to transplant”
Arie Blitz, MD



COLORECTAL SURGERY

CWRU 1201 – Serum Markers of Colon Cancer
Conor Delaney, MD, Sanford Markowitz, MD

CWRU 4201 – Response of Chemo and Radiation in Rectal Cancer
Conor Delaney, MD, Joseph Willis, MD

“Laparoscopic Hernia Pain Pump Study”
Michael Rosen, MD

“Quality of Life / Post-Op Ileus Discharge Criteria Study”
Conor Delaney, MD

“Confluent – Spray Gel Study”
Conor Delaney, MD

“Ethicon/STARR Procedure – Obstructive Defecation Syndrome”
Conor Delaney, MD



GENERAL SURGERY

“Stimulation of the Diaphragm in Amyotrophic Lateral Sclerosis”
Raymond Onders, MD, Bashar Katirji, MD, Robert Schilz, PhD, DO, Mary Jo Elmo, ACNP,
Jane E. Prasse, MA, CCC-SLP, Robert Gilkerson, MD

“Electrical Activation of the Diaphragm for Ventilatory Assist”
Raymond P. Onders, MD, Mary Jo Elmo, RN, ACNP, Robert Schilz, PhD, DO,
Subhalakashmi Sivashankara, MD, Bashar Katirji

“Electrical Activation of the Diaphragm for Ventilatory Assist in Spinal Cord
Injured Who Have a Cardiac Pacemaker”
Raymond Onders, MD, Mary Joe Elmo, RN, ACNP, Robert Schilz, PhD, DO,
Subhalakashmi Sivashankara, MD, Bruce S. Stambler, MD, Judith A. Mackall

“Ongoing Study of GISTs”
Jeffrey M. Hardacre, MD, Julian Kim, MD, Judy Jin, MD, Robert Shenk, MD, Thomas Stellato, MD,
Joseph Willis, MD

“Initial Experience with IORT for Pancreatic Cancer”
Jeffrey M. Hardacre, MD, Timothy Kinsella, MD, Christoher Siegel, MD, PhD, Juan Sanabria, MD,
Julian Kim, MD, James Schulak, MD, Charles Kunos, MD, Melanie Lynch, MD, Michael McGee, MD

“Intensive Sampling of Pancreaticoduodenectomy Specimens”
Jeffrey M. Hardacre, MD, Joseph Willis, MD, Thomas Stellato, MD, Keri Simo, MD

“The UHC Experience with Pancreatic Cancer in the New Millenium”
Jeffrey M. Hardacre, MD, Michael McGee, MD, Christopher Siegel, MD, PhD, Juan Sanabria, MD,
Julian Kim, MD, James Schulak, MD, Thomas Stellato, MD, Joseph Willis, MD, Joanna Brell, MD,
Timothy Kinsella, MD




                                                                                                             9

2005-2006 Abstracts                                                                                          109
Clinical Trials
                  “Hyperthyroidism Crisis Revisited”
                  Roy Phitayakorn, MD, Christopher McHenry, MD

                  “The Rate Of Conversion From a Laparoscopic to an Open Approach and Selective Open
                  Resection for Adrenal and Extraadrenal Neuroendocrine Tumors”
                  Roy Phitayakorn, MD, Christopher McHenry, MD

                  “Community-Acquired vs. Nosocomial Intra-abdominal Infection: a Retrospective Examination of Outcome”
                  Mark Malangoni

                  “Serum Thyroglobulin Monitoring in Thyroid Cancer Follow-Up”
                  Roy Phitayakorn, MD

                  “Incidence and Location of Ectopic Parathryoid Glands”
                  Roy Phitayakorn, MD, Christopher McHenry, MD

                  “A Prospective, Randomized, Controlled, Multi-Center Clinical Trial of MedLogic Surgical Skin Sealant and
                  the Prevention of Surgical Wound Contamination”
                  Mark Malangoni, MD, Christopher McHenry, MD




                  PLASTIC SURGERY

                  “Migraine Trigger Points and Surgical Treatment”
                  Bahman Guyuron, MD, Deborah Reed, MD, Jennifer Kriegler, MD

                  “Surgical Treatment for Elimination of Migraine Headache Trigger Sites”
                  Bahman Guyuron, MD, Deborah Reed, MD, Jennifer Kriegler, MD


                  SURGICAL ONCOLOGY
                  “NCIC MA27: A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women With
                  Receptor Positive Primary Breast Cancer”
                  Bruce Averbook, MD

                  “E5204: Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs
                  Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-
                  Oerative Chemoradiation (Version 12-22-05)”
                  Bruce Averbook, MD

                  “Interferon Alpha (NSC#377 523) Plus 13-Cis-Retinoic Acid Modulation of BCL-2 Plus Paclitaxel for Recurrent Small
                  Cell Lung Cancer (SCLC)”
                  Bruce Averbook, MD

                  “A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer:
                  Docetaxel / Doxorubicin / Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin / Cyclophosphamide Followed by
                  DD Paclitaxel (DD AC-->P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC -->PG)”
                  Bruce Averbook, MD

                  “C80405: A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or
                  Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic
                  Adenocarcinoma of the Colon or Rectum (Protocol dated 9/15/05, NCI Version 7/12/05)”
                  Bruce Averbook, MD

                  “E1Z03: Quality of Life Companion Study for NCIC MA27: A Randomized Phase III Trial of Exemestane Versus
                  Anastrozole in Postmenopausal Women With Receptor Positive Primary Breast Cancer”
                  Bruce Averbook, MD




        9

110                                                                                                               Case Surgery
                                                                                                                        Cardiovascular
“E4A03: A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose




                                                                                                                         Clinical Trials
Dexamethasone in Multiple Myeloma with Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders”
Bruce Averbook, MD

“E2204: An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in
Combination with Gemcitabine and in Combination with Chemoradiation (Capecitabine and Radiation) in Patients with
Completely-Resected Pancreatic Carcinoma (Protocol Version 02/07/06, includes Addendum #1)”
Bruce Averbook, MD

“E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin,
Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine
Prospectively the Prognostic Value of Molecular Markers”
Bruce Averbook, MD

“Community Breast Screening Database”
Jean Stevenson, MD

“E2603: A Double-blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006
versus Carboplatin, Paclitaxel and placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma
(Protocol version 10/17/05)”
Bruce Averbook

“E2903 A Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H For
Previously Treated Relapsed or Refractory Patients with Chronic Lymphocytic Leukemia(protocol version 3/28/06)”
Bruce Averbook, MD

“E5803: Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA (Incl. A 1-3
and U1)”
Bruce Averbook

“E2100, A Randomized Phase III Trial of Paclitaxel vs.Ppaclitaxel + Bevacizumab (rhuMAb VEGF) as First Line Therapy
for Locally Recurrent or Metastatic Breast Cancer”
Bruce Averbook, MD

“Cervical Spine Injuries in the Elderly Population”
Joel Peerless, MD

“IBCSG 24-02: A Phase III trial evaluating the role of ovarian function suppression and the role of exemestane as
adjuvant therapies for premenopausal women with endocrine responsive breast cancer (SOFT)”
Bruce Averbook, MD

“S9313 Phase III comparison of adjuvant chemotherapy with high-dose cyclophosphamide plus doxorubicin (AC)
versus sequential doxorubicin followed by cyclophosphamide (A>C) in high-risk node-negative breast cancer patients
(intergroup)”
Bruce Averbook, MD

“CTSU/CALGB49907: A randomized trial of adjuvant chemotherapy with standard regimens, cyclophosphamide,
methotrexate and fluorouracil-CMF or doxorubicin and cyclophosphamide-AC, versus capecitabine in women 65 years
and older with node positive or high risk”
Roy Phitayakorn, MD

“E1199 Phase III study of doxorubicin-cyclophosphamide therapy followed by paclitaxel, docetaxel, and tamoxifen,
given weekly or every 3 weeks in patients with axillary node-positive breast cancer”
Bruce Averbook, MD

“E1695 An evaluation of the immunologic mechanism of GM2-KLH/QS-21 vaccination in the context of ECOG trial
E1694: A phase III comparison of GM2-KLH/QS-21 vaccination and high-dose interferon alfa-2b therapy for high-risk
lymph node-metastatic cutaneous”
Bruce Averbook, MD

“Randomized phase III study in low grade lymphoma comparing maintenance anti-CD20 vs. observation following
induction therapy (E1496)”
Bruce Averbook, MD




                                                                                                                        9

2005-2006 Abstracts                                                                                                     111
Clinical Trials
                  “E1C99, A Phase II study of carboplatin + paclitaxel treatment of advanced thymoma or thymic carcinoma”
                  Bruce Averbook, MD

                  “Oral antibiotic prophylaxis of early infection in multiple myeloma (URCC U 10994)”
                  Bruce Averbook, MD

                  “Developing a quality monitoring system for cancer patients”
                  Jean Stevenson, MD

                  “CTSU/R9804, A Phase III trial of observation +/- Tamoxifen vs. RT +/- Tamoxifen for good risk duct carcinoma in situ
                  (DCIS) of the female breast”
                  Bruce Averbook, MD

                  “A Phase II Trial of STI-571 / Imatinib (Gleevec) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell
                  Carcinoma)”
                  Bruce Averbook, MD

                  “E4402, Randomized Phase III trial comparing two different rituximab dosing regimens for patients with low tumor
                  burden indolent non-Hodgkin's Lymphoma”
                  Bruce Averbook, MD

                  “N9831 A Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without
                  Trastuzumab as Adjuvant Treatment for Women With HER-2 Over-Expressing or Amplified Node Positive or High Risk
                  Node Negative Breast Cancer”
                  Bruce Averbook, MD

                  “CTSU/NCIC-BR.19, A Phase III prospective randomized, double blind, placebo controlled trial of the epidermal growth
                  factor receptor antagonist, ZD1839 (IRESSA) in completely resected primary Stage 1B, II and IIIA non small cell lung
                  cancer”
                  Bruce Averbook, MD

                  “Epidemiological Variables Associated with Large Goiters versus Small Goiters”
                  Christopher McHenry, MD

                  “E2496 A Randomized phase III trial of ABVD versus standard radiation therapy in locally extensive and advanced
                  stage Hodgkin's disease with 0-2 risk factors”
                  Bruce Averbook, MD

                  “Z9001, A Phase III randomized double blind study of adjuvant ST1571 (Gleevec) vs. placebo in patients following the
                  resection of primary gastrointestinal stromal tumor (GIST)”
                  Bruce Averbook, MD

                  “E1497 Phase II study of DAB389IL-2, an interleukin-2fusion toxin, for previously treated follicular low-grade non-
                  Hodgkin's lymphoma”
                  Bruce Averbook, MD

                  “ E1697 - A Randomized Study of Four Weeks of High Dose IFN- Alpha 2B In Stage T3-T4 or N1 (Microscopic)
                  Melanoma”
                  Bruce Averbook, MD

                  “ E1694/S9512 A phase III study of adjuvant ganglioside vaccination GM2-KLH/QS-21 therapy vs. high-dose interferon
                  alfa-2b (IntronA) for high risk melanoma (T4>4mm) primary or regional lymph node metastasis”
                  Bruce Averbook, MD
                  “Z0011, A Phase III randomized study of axillary lymph node dissection in women with stage 1 or 11A breast cancer
                  who have a positive sentinel node”
                  Bruce Averbook, MD

                  “E3598, Phase III Randomized study of carboplatin, paclitaxel, and radiotherapy with or without thalidomide in patients
                  with stage III non-small cell lung cancer”
                  Bruce Averbook, MD

                  Breast Cancer Database
                  Bruce Averbook, MD




        9

112                                                                                                                Case Surgery
                                                                                                                       Cardiovascular
“E2602, Phase II study of low dose Peginterferon Alfa-2b in patients with metastatic melanoma over-expressing basic




                                                                                                                        Clinical Trials
fibroblast growth factor”
Bruce Averbook, MD

“E4697 A randomized, placebo-controlled phase III trial of yeast derived GM-CSF vs. peptide vaccination vs. GM-CSF
plus peptide vaccination vs. placebo in patients with "no evidence of disease" after complete surgical resection of
"locally advanced" and/o”
Bruce Averbook, MD

“Eastern Cooperative Oncology Group ProtocolsEastern Cooperative Oncology Group Outreach Program”
Bruce Averbook, MD

“Z0010 A Phase III prognostic study of sentinel node and bone marrow micrometastases in women with clinical T1 or
T2 NO MO breast cancer”
Bruce Averbook, MD

C9343 Evaluation of lumpectomy, tamoxifen, and irradiation of the breast compared with lumpectomy plus tamoxifen in
women 70 years of age or older who have carcinoma of the breast that is less than or equal to 2 cm and
clinically negative axillary nodes:
Bruce Averbook, MD

“Melanoma Database”
Bruce Averbook, MD

“Sunbelt melanoma trial (SMT): A multicenter trial of adjuvant interferon Alfa-2b for melanoma patients with early
lymph node metastasis detected by lymphatic mapping and sentinel lymph node biopsy”
Bruce Averbook, MD

“E2993 Phase III randomized trial of autologous and allegenic bone marrow transplantation vs. intensive conventional
chemotherapy in acute lymphoblastic leukemia in first remission”
Bruce Averbook, MD

“E1A00, A randomized Phase III trial of thalidomide (NSC#66847) plus dexamethasone vs. dexamethasone in newly
diagnosed multiple myeloma”
Bruce Averbook, MD

“89803, A phase III intergroup trial of irinotecan (CPT-11) [nsc# 616348] plus fluorouracil/leucovorin (5-FU/LV) vs.
fluorouracil/leucovorin alone after curative resection for patients with stage III colon cancer”
Bruce Averbook, MD

“A Phase II trial of trastuzumab plus weekly ixabepilone (BMS-247550) and carboplatin in patients with HER2/Neu
positive metastatic breast cancer”
Bruce Averbook, MD

“E5194 Local excision alone for selected patients with DCIS of the breast”
Bruce Averbook, MD

“NSABP-B35, A clinical trial comparing anastrozole with tamoxifen in postmenopausal patients with ductal carcinoma
in situ (DCIS) undergoing lumpectomy with radiation therapy”
Bruce Averbook, MD

“Novel molecular markers in breast cancer: A cooperative pilot study”
Bruce Averbook, MD

“IBCSG 2502: A Phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for
premenopausal women with endocrine responsive breast cancer (TEXT)”
Bruce Averbook, MD

“Outcome of bowel anastomoses in damage control laparotomy and the use of primary gastrointestinal tract repair and
anastomosis”
John Como, MD

“JMA.17, A Phase III randomized double-blind study of Letrozole Vs. placebo in women with primary breast cancer
completing five or more years of adjuvant Tamoxifen”
Bruce Averbook, MD




                                                                                                                       9

 2005-2006 Abstracts                                                                                                   113
Clinical Trials
                  “Family conflict and decision making in advanced cancer”
                  Laura Siminoff, MD

                  “CTSU/CALGB40101: Cyclophosphamide and doxorubicin (CA) (4 vs. 6 cycles) vs. paclitaxel (12 weeks vs.
                  18 weeks) as adjuvant therapy for breast cancer in women with 0-3 positive axillary lymph nodes: A 2x2
                  factorial Phase III randomized study”
                  Bruce Averbook, MD

                  “N0147, A randomized phase III trial of oxaliplatin (OXAL) plus 5-fluorouracil (5-FU)/leucovorin (CF) with or without
                  cetuximab (C225) after curative resection for patients with Stage III colon cancer”
                  Bruce Averbook, MD

                  “E3999, A randomized, placebo-controlled, double blind, trial of the administration of the MDR modulator, Zosuquidar
                  Trihydrochloride (LY335979), during conventional induction and post-remission therapy in patients greater than 60
                  years of age with newly d”
                  Bruce Averbook, MD

                  “E4101, , A randomized Phase II trial of combination Anastrozole (NSC #719344) plus ZD1839 (Iressa, NSC #715055, IND
                  #61187) and of combination Fulvestrant (NSC 719276) plus ZD1839 in the treatment of postmenopausal women”
                  Bruce Averbook, MD

                  “E2197, Phase III study of adriamycin/taxotere vs. adriamycin/cytoxan for the adjuvant treatment of node
                  positive or high risk node negative breast cancer”
                  Bruce Averbook, MD

                  “E3903, Ancillary laboratory protocol for collecting diagnostic material on patients considered for ECOG treatment
                  trials for leukemia or related hematologic disorders”
                  Bruce Averbook, MD

                  “S0124, Randomized Phase III trial of cisplatin and irinotecan (NSC-616348) vs. cisplatin and etoposide in patients with
                  extensive stage small cell lung cancer (E-SCLC)(CTSU)”
                  Bruce Averbook, MD

                  “C9581 Phase III randomized study of adjuvant immunotherapy with monoclonal antibody 17-1A versus no adjuvant
                  therapy following resection for stage II (modified Astler-Coller B2) adenocarcinoma of the colon”
                  Bruce Averbook, MD

                  “NSAPBP-1.EXT - Breast cancer prevention trial (BCPT)- Extension of follow-up to access the long term outcome of the
                  participants of the BCPT”
                  Bruce Averbook, MD

                  “A Double Blind Phase II Study of BAY 43-9006 in Patients with Non-Small Cell Lung Cancer who have failed at least
                  Two Prior Chemotherapy Regimens”
                  Bruce Averbook, MD

                  “ECOG R9811, A Phase III randomized study of 5-fluorouracil, cisplatin, and radiotherapy vs. 5 fluorouracil, mitomycin-
                  C and radiotherapy in carcinoma of the anal canal”
                  Bruce Averbook, MD




        9

114                                                                                                                Case Surgery
                                                                                                                              Cardiovascular
                                                                                                                               Clinical Trials
TRANSPLANT
“Comparison of the Efficacy of The Rita Device vs The Cool Tip switching controller Device for the
Ablation of Primary and Secondary Liver Neoplasm’s in the Porcine Model”
Juan Sanabria MD MSc, Chris Siegel MD PhD, Jim Schulack MD

“Islet Cell Transplant Initiative”
Juan Sanabria MD MSc*, Christopher Siegel MD PhD*, James Schulak MD*, Donald Hricik MD **,
Faramarz Ismaeli-Beigi MD PhD***, Kathy Horowits MD***, Henry Brunengraber MD PhD ¶,
Michael Weiss MD PhD §
*Department of Surgery – Division of Transplant and Hepatobiliary Surgery **Department of Medicine – Division of Nephrology
*** Department of Medicine, Division of Endocrinology, ¶Department of Nutrition and Metabolism
§Department of Biochemistry

“Cost- effective Analysis of the Determination of the Intravascular Volume Status in
Patients with End Stage Renal Disease by the BVA-100 System”
Juan Sanabria MD MSc, Chris Siegel MD PhD, Mark Aeder MD, Joshua Agustine MD,
Ken Boziak MD, Jim O’Donell MD, Don Hrisick MD, Jim Schulak MD

“Metabolomics & Isotopomer Analysis in Normal and Diseased Human Livers”
              2                                 2                         2                       2
Juan Sanabria MD MSc, P.I, . Christopher Siegel MD PhD, Jeffrey Ponsky MD, Achilles Demetriou MD PhD,
                2                      2                2                8                   8
James Schulak MD, Thomas Stellato MD, Peter Holloway MD, Anthony Post MD, Pierre Gholam MD,
Jackson Wright8 MD, Anthony Tavill7,8 MD
1                          2         5              6              8                                             3
  Departments of Nutrition, Surgery, Biochemistry, Pharmacology and Medicine at Case Western Reserve University. The
                                                          4                                         6
Center for Proteomics at Case Western Reserve University. Department of Chemical Engineering at MIT. Consultants from
University of Southern California and Cleveland Clinic.

“Determinants of Access to Liver Transplantation in Ohio”
Juan Sanabra MD, Robert S. O’Shea MD, MSCE, Gregory Olds MD

TRAUMA

“The relationship of fever workup and blood cultures of Trauma patients in the ICU”
Jeffrey Claridge, William Phipps, Joel Peerless, Mark Malangoni, Charles Yowler, MD


“A Prospective Study of Outpatient Burns to Determine Risk Factors for Infection”
Charles Yowler, MD

“A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety
of Activated Recombinant Factor Vll (rFVLLa/Novo Seven Niastase) in the Treatment of Refractory Bleeding in Severely
Injured Trauma Patients”
Charles Yowler, MD, Jeffrey Claridge, MD

“Long-term Outcomes After Severe Traumatic Injury”
Jeffrey Claridge, MD, Charles Yowler, MD

“Management of Splenic Injury”
Charles Yowler, MD

“The Impact of Trauma on Survival Time in Cancer Patients”
Douglas Delahaunty

“Phase III, randomized, open label, parallel group study designed too evaluate the safety and efficacy of PolyHeme
when used to treat patients in hemorrhagic shock following traumatic injuries, beginning in the pre-hospital setting”
Mark Malangoni, MD

“Evaluating the need for magnetic resonance imaging of the cervical spine in obtunded trauma patients”
John Como, MD


“The effectiveness of music therapy protocols during the debridement process”
Richard Fratianne, MD


VASCULAR SURGERY

“The incidence of Deep Venous Thrombosis in Patients with Thermal Injury”
Jeffrey Alexander, MD, Charles Yowler, MD
                                                                                                                              9

2005-2006 Abstracts                                                                                                           115
Clinical Trials




        9

116               Case Surgery
Index of Authors




                   117
118   Case Surgery
                                                                                                                                            Cardiovascular
A




                                                                                                                                         Index of Authors
Aarabi, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
Aeder, M . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77, 78,79, 80, 81, 82, 83, 84, 86, 88, 115
Aharon, AS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Alaedeen, D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59, 63, 64, 65, 66, 101
Alexander, J. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Alonso, MH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77, 78, 79, 80, 82, 83, 85, 86
Anderson, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Andrews, JM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Augustine, JJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81, 84, 87, 115
Averbook, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110, 111, 112, 113, 114


B
Barbu, AM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Belding, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Bell, T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Bengur, R . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Biffl, WL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39, 40, 41, 42, 43
Blair, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Blitz, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Bodziak, KA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87, 115
Bohnengle, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77, 78, 79, 80, 82, 83
Brandt, CP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93, 94, 100
Braveman, JM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
Brell, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Brunengraber, H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115


C
Camden, JR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Chak, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24, 25, 33, 37, 49, 50, 51, 52, 53, 57
Chapman, WC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39, 40, 41, 42, 43
Chen, V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Chipman, G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Chong, TW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Church, JM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Chwals, WJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63, 64, 65, 66, 101
Claridge, JR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34, 99, 115
Clemente, M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Coffee, T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93, 94, 100
Como, JJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91, 95, 96, 115
Cook, M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Cooper, C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
Croce, MA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99




2005-2006 Abstracts                                                                                                                      119
Index of Authors
                   D
                   Dash, KS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
                   Davis, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
                   Delahaunty, D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
                   Delaney, CP . . . . . . . . . . . . . . . . . . .7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 109
                   Demetriou, A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
                   DiMarco, AF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
                   Dutton, RP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
                   Du, W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 13, 14, 16, 18, 19


                   E
                   Elgudin, Y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 2, 3
                   Elmo, MJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29, 30, 31, 32, 35, 45, 46, 57, 58, 109
                   Enker, W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
                   Epstein, CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
                   Ermlich, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
                   Evans, HL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34


                   F
                   Fabian, TC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
                   Fallon, WF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
                   Farinholt, H-MA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
                   Faulx, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24, 25, 33, 49, 50, 51, 52, 53, 57
                   Fazio, VW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
                   Forsythe, RM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
                   Fort, JG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 11, 12, 14
                   Fratianne, RB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98, 115

                   G
                   Gazoni, LM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
                   Ghavami, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
                   Gholam, P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
                   Gilkerson, R . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
                   Goldfarb, D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77, 78, 79, 80, 82, 83, 86, 88
                   Guyuron, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69, 70, 71, 72, 73, 74, 110

                   H
                   Hammel, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15, 17
                   Hardacre, JM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24, 109
                   Heeger, PS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
                   Hennein, H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 2, 3
                   Henry, ML . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77, 78, 79, 80, 82
                   Heuser, C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
                   Holloway, K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
                   Horowits, K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
                   Hricik, DE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81, 84, 87, 115



120                                                                                                                            Case Surgery
                                                                                                                                            Cardiovascular
I




                                                                                                                                         Index of Authors
Ignagni, AR . .24, 25, 29, 30, 31, 32, 33, 35, 45, 46, 48, 49, 50, 51, 52, 53, 54, 57, 58
Ismaeli-Beigi, F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115

J
Janis, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Jean-Claude, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
Jin, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Johnson, SB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91


K
Kariv, Y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13, 15, 17
Katirji, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29, 31, 35, 46, 54, 109
Kim, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Kinsella, T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 109
Knauss, TC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Kopke, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79, 82, 86
Kriegler, JS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71, 110
Krishnamurthi, SA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Kunos, C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109

L
Lal, T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79, 86
Leung, E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Likavec, MJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Lipman, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56, 59
Liu, D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Lowson, SM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Ludwig, K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Lynch, M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109

M
Mackall, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Malangoni, MA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 28, 92, 95, 97, 110, 115
Mancuso, C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Markowitz, S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Marks, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24, 25, 33, 37, 48, 49, 50, 51, 52, 53
Marsh, EE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101
McCunn, M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
McElearney, ST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
McGee, MF . . . . . . . . . . . . . . . . . . . . . . .24, 25, 26, 33, 48, 49, 50, 51, 52, 53, 57, 109
McHenry, CR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39, 40, 41, 42, 43, 44, 110
Medalie, D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56, 59
Merlino, JI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
Miller, C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
Mirvis, SE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96



2005-2006 Abstracts                                                                                                                      121
Index of Authors
                   O
                   O’Donnell, KB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34, 115
                   Olds, G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
                   Onders, RP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24, 25, 27, 29, 31, 32, 33, 35, 43,
                    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 57, 109
                   O’Shea, RS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115

                   P
                   Pashmini, N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
                   Patel, N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
                   Peerless, JR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60, 111, 115
                   Phipps, W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
                   Phitayakorn, R . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23, 44, 55, 110, 111
                   Pinault, G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
                   Pinsky, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
                   Plaisier, BR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
                   Ponsky, J . . . . . . . . . . . . . . . . . . . . . . . . .24, 25, 33, 36, 37, 49, 50, 51, 52, 53, 57, 115
                   Prasad, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
                   Prasse, JE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
                   Prinz, RA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

                   Q
                   Queen, AL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64

                   R
                   Radigan, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
                   Reed, D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
                   Rees, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
                   Rees, MA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77, 78, 79, 80, 82, 83, 86, 88
                   Remick, S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
                   Reynolds, HL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 38
                   Reynolds, HS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
                   Road, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
                   Robinson, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
                   Rosen, MJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24, 25, 33, 56, 57, 59, 109

                   S
                   Saalwachter-Schulman, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
                   Sanabria, JR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85, 109, 115
                   Sawyer, RG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
                   Scalea, TM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91, 96
                   Schilz, R . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29, 31, 33, 35, 54, 57
                   Schirmer, BD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
                   Schomisch, SJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2, 24, 25, 33, 49, 50, 51, 52, 53, 57
                   Schulak, JA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26, 81, 84, 87, 109, 115
                   Senagore, AJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 8, 14, 17, 18
                   Seshadri, S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
                   Shenk, R . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
                   Shuck, JM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

122                                                                                                                            Case Surgery
                                                                                                                                           Cardiovascular
Siegel, C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87, 109, 115




                                                                                                                                        Index of Authors
Siminoff, L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
Simo, K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Singh, H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Siu, D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81, 84
Sivashankara, S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Siwik, E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 3
Skitzki, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Smith, RL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Snedeker, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Solorzano, CC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Spain, DA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39, 40, 41, 42, 43
Stambler, BS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Stellato, TA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26, 47, 109, 115
Stevenson, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111, 112
Sutton, E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

T
Tavill, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Taylor, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79, 82, 83, 86, 88
Techner, L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 ,13, 14, 16, 18, 19
Totonchi, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72, 74

V
Viscusi, E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 11, 12, 13, 16, 18

W
Wallin, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13, 16, 18
Walsh, MC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Wang, W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15, 17
Waterman, A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80, 88
Watkins, F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Weinberg, JA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
Weiss, M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Wilhelm, SM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27, 38
Willcutts, K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Willis, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Wishnek, SM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Wolff, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 11, 12, 13, 16, 18, 19
Woodle, ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77, 78, 79, 80, 82, 86, 88
Wright, J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115

Y
Yowler, CJ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93, 94, 95, 97, 100, 115
Yurko, L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93, 94


Z
Zahka, K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1


2005-2006 Abstracts                                                                                                                     123
Case Surgery
        Department of Surgery
Case Western Reserve University
            School of Medicine
           11100 Euclid Avenue
         Cleveland, Ohio 44106
       Telephone: 216.844.3209
       Facsimile: 216.844.1350
          www.casesurgery.com




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