CRF_Appropriateness

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					PCI Appropriateness
     Evaluation
  Cardiovascular Research
     Foundation (CRF)
        New York, NY
  CRF is an independent, academically focused nonprofit
 dedicated to improving the survival and quality of life for
   people with cardiovascular disease through research
 and education. CRF is affiliated with Columbia University
          College of Physicians and Surgeons.
       Percutaneous Coronary
          Intervention (PCI)
Commonly known as coronary angioplasty or
simply angioplasty, PCI is a therapeutic
procedure used to treat the stenotic (narrowed)
coronary arteries of the heart, as found in
coronary heart disease.
These stenotic segments are caused by the
build up of cholesterol-laden plaques that form
due to atherosclerosis. PCI is usually performed
by an interventional cardiologist.
         PCI Appropriateness
• Given the widespread use of PCI, the
  appropriateness of these procedures in
  certain indications is being questioned
• Good clinical practice requires continuing
  examination of appropriateness of care
• Establishment of a proactive quality
  assessment review process will protect
  hospitals and their practitioners
• In the future, payers will likely request
  documentation of appropriateness criteria
  as condition of payment
  PCI Appropriateness Guidelines
American College of Cardiology Foundation (ACCF), Society for
Cardiac Angiography and Interventions (SCAI), American
Association for Thoracic Surgery (AATS), American Heart
Association (AHA), and American Society of Nuclear Cardiology
(ASNC) have published: PCI Appropriate Use Criteria (AUC). J Am
Coll Cardiol. 2009;53:530-53.
         How CRF Can Help (i)
• Quantification of lesion severity: Does the
  lesion meet the minimum standard criteria
  for stent implantation?
• Assessment of lesion morphology: Does the
  lesion have unstable features (eg, presence
  of thrombus)?
• Assessment of the overall complexity of
  coronary artery disease (ie, Syntax Score): Is
  the overall severity of the disease such that
  CABG surgery would have been a better
  option than PCI?
         How CRF Can Help (ii)
• Assessment of the quality of the PCI procedure:
  Quantification of acute angiographic results and
  assessment of angiographically documented
  complications
• CRF can also perform independent case assessment
  and review using NYC area practicing interventional
  and noninterventional cardiologists as well as other
  specialists as required. These panels are
  experienced in assessing procedural indications,
  complications, patient outcomes, and whether
  adverse outcomes are related to specific
  cardiovascular procedures.
Analyses can be customized to fit each client's needs
    1. Quantification of Lesion Severity:
  Does the lesion meet the minimum standard criteria for stent implantation?



Appropriate for PCI                     Not Appropriate for PCI




DS % = 83.33                             DS % = 19.94
    2. Assessment of Lesion Morphology:
         Does the lesion have unstable features (eg, presence of thrombus)?


Acute Total Occlusion                                  Globular Thrombus




 Two examples of angiographic evidence of thrombus (clot) in the RCA (left) and LAD (right).
An acute thrombus is a typical finding in patients presenting with an acute myocardial infarction.
                    3. Assessment of the Overall Complexity of
                    Coronary Artery Disease (ie, Syntax Score):
                Is the overall severity of the disease such that CABG surgery would have been a better option than PCI?



                 Triple Vessel Disease, Syntax Score = 53.5
                Based solely on coronary anatomy, most such cases are suitable for CABG
Strzep^Anna
                               rather than PCI, if revascularization is indicated
F 1940-06-30                                            Strzep^Anna
584/08                                                  F 1940-06-30
                                                        584/08                               Strzep^Anna
XA 2008-08-08                                                                                F 1940-06-30
                                                        XA 2008-08-08
                                                                                             584/08
                                                                                             XA 2008-08-08




                                                                                                                          NOT CALIBRATED
                                                                                   NOT CALIBRATED




                                           NOT CALIBRATED
                    3. Assessment of the Overall Complexity of
                    Coronary Artery Disease (ie, Syntax Score):
                                                           235-016
                Is the overall severity of the disease such that CABG surgery would have been a better option than PCI?
                                                           XA 2008-11-11
                                                           CATH POSS PCI



235-016
                    Triple Vessel Disease, Syntax Score = 13
XA 2008-11-11      Based solely on coronary anatomy, most such cases are suitable for PCI
CATH POSS PCI
                               rather than CABG, if revascularization is indicated
        4. Assessment of the Quality of the
                 PCI Procedure:
 Quantification of acute angiographic results and assessment of angiographically documented complications


  Dissection Type D                                      Dissection Type E




A dissection is a tear in the vessel wall that occurs during balloon inflation or stent implantation.
       Scoring systems allow grading of dissection severity that correlate with outcomes.
       4. Assessment of the Quality of the
                PCI Procedure:
Quantification of acute angiographic results and assessment of angiographically documented complications

                                 Distal Embolization
                                 Occluding the RCA




        Distal embolization is a migration of a thrombus (clot) to occlude a distal vessel.
             This can occur while performing PCI on a patient having a heart attack.
        4. Assessment of the Quality of the
                 PCI Procedure:
      Quantification of acute angiographic results and assessment of angiographically documented complications


                               Examples of Perforation
I                                       II                                      III




     A perforation is a break or rupture of the vessel wall that occurs during balloon inflation or stent
    implantation. Scoring systems allow grading of perforation severity that correlates with outcomes.
5. CRF Can Also Perform Independent
    Case Assessment and Review
• In addition to the ACL evaluation, independent
  physician review can take into consideration the
  following clinical criteria when evaluating an
  individual procedure:
      Symptoms and physical examination
      ECG and laboratory values
      Noninvasive stress testing
      Serial studies
      Procedural IVUS and FFR
      Other factors
            Not every case is black or white!
                CRFiCOR
    Comprehensive Cardiovascular
       Imaging Laboratories

Physician Direction
             Gary Mintz, MD
             Jeff Popma, MD
             Gregg Stone, MD

Providing Experience, Leadership and Vision
               CRFiCOR
      Imaging Experience Includes
• Angiography Core Lab (ACL)
     Coronary
     Peripheral
     Structural
     Physiology (vasoreactivity)
• Intravascular imaging
• Noninvasive
• Electrocardiography
            About CRFiCOR ACL (i)
• Founded in 1991, CRF’s ACL performs
  independent angiographic analysis and
  interpretations.
• Specializes in the analysis of:
     Coronary angiograms: Vascular intervention, complication
      assessment, AMI and ACS therapies (TIMI, frame counts,
      blush, LV function), risk scores (Syntax, etc), jeopardy scores,
      extent of revascularization
     Peripheral angiograms: Carotid and intracerebral, renal
      stenting and denervation, lower extremity (including stent
      fracture assessment)
     Structural heart disease: LV function and valve assessment,
      transcatheter valve integrity, LAA closure
        About CRFiCOR ACL (ii)
• CRF’s ACL developed and validated a broad
 range of quantitative and qualitative tools and
 methods, assessing and benchmarking device
 effectiveness, developing models to better
 understand short- and long-term outcomes,
 and evaluating mechanistic insights into
 treatment outcomes for a wide range of
 interventional devices and pharmacologic
 trials
  CRFiCOR ACL Accomplishments
• Completed over 550 trials, including first-in-
  human (FIH), pre-market approval (PMA), and
  post-marketing surveillance and support, from 10
  patient pilot studies to 11,000 patient, pivotal,
  randomized trials
• Performed analysis of over 100,000 patient
  angiograms from global sites
• Completed over 50 Investigational Device
  Exemption (IDE) trials, including new devices,
  first to fourth generation stents, primary
  angioplasty, vascular brachytherapy, and drug-
  eluting stents
         CRFiCOR ACL Staff

• Ecaterina       • 2 physician
 Cristea, MD        directors
 Director,        • 16 technicians
 NYC Campus
                  • 2 managers
• Alexandra
 Almonacid, MD    • Administrative,
 Director,          QA, and project
 Boston Campus      management
                    support
Contact Us for More Information
 Sarah Luijpers, PMP CLSSBB
 Director, Business Operations
 +1 646-434-4136
 sluijpers@crf.org


 Cardiovascular Research Foundation
 111 E 59th St
 New York, NY 10022

				
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