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Review of Study Protocol - UAB

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					                     SUMMARY OF CHANGES TO THE
                  INTERMACS MANUAL OF OPERATIONS

PROTOCOL

Added Cover Page

Changes to, Header and Table of Contents
   Changed version from 2.3 to 3.0
   Changed version date from 10/30/2008 to 10/07/2011
   Section 4.7, Changed “Certification” to “Participation Fee”
   Section 6.5, Deleted “Blood and Tissue Samples”

Changes to 1.0, Executive Summary
   Changed Contract Number from “N01 HV58198” to “HHSN268201100025C”
   Deleted, “all located at UAB and hereafter referred to as the UAB:DCC.”
   Deleted, “and tissue samples”
   Deleted, “blood and tissue samples”
   Changed, “100” to “115”
   Changed, “5” to “9”
   Deleted, “and specimens”
   Deleted, “and tissue/blood samples”
   Deleted, “and biological specimens”
   Deleted, “by the UAB:DCC”
   Added, “In March, 2007 CMS mandated that one of the conditions for hospital
     certification as a destination therapy center is that the hospital be a member of
     INTERMACS. INTERMACS works with the hospitals to facilitate this
     requirement.”
   Changed, “UAB:DCC” to Data Coordinating Center
   Added, “(this committee consists of the INTERMACS co-PIs and representatives
     from the federal agencies and the data collection repository)”
   Added, “sample”
   Deleted, “model”
   Added, “University of Michigan”

Changes to 2.0, Study Description and Goals
   Changed “UAB:DCC” to “the University of Alabama at Birmingham”
   Changed “UAB: DCC” to “DCC”

Summary of Changes
10/7/2011                                                                       Page 1
Changes to 3.1, Patient Eligibility
   Changed Inclusion Criteria, “The Registry will include every consented patient
     who receives an eligible MCSD (as listed below) at a participating center,
     regardless of reason: bridge to recovery, bridge to alternative bridge, bridge to
     clinical improvement for transplant eligibility, bridge to transplant, or destination
     therapy” to “The Registry will include every patient who receives an eligible
     MCSD and is consented.”
   Deleted, “If a patient is part of a FDA Investigational Device Exemption (IDE)
     study, please contact the INTERMACS Data Coordinating Center at 205-934-
     1061 for instructions.”
   Deleted, Exclusion Patients, “Patients who fulfill the eligibility criteria but are part
     of an FDA pre-approval study (these patients will be entered into the clinical trial
     database that is maintained by the device manufacturer)
   Deleted, “immediately”

Changes to 3.4, Major End Points
   Replaced Table

                                                        Baseline Variables And Endpoints
                                                       Baseline Patient                      Device and                                       Heart Failure
                                                        Characteristics                    Implant Elements                                 Severity Variables


                                                                                      Patient-Device-Disease
                                                                                              Profiles
                                                                                                        Variables collected at implant and regular
                                                                                                        Intervals are entered into multivariable analysis

                                                                     Discrete
                                                                     Endpoints



                                                                     Death       Transplant        Explant for
                                                                                                    Recovery                     Complex
                                                                                                                                 Endpoints




                                                        Outcome           Adverse Events      Quality of Life           Costs             Hospitalizations
                                                        Indicators                                                   (Resource
                                                                                                                     utilization)

                                               with

      Deleted, “At the current stage of mechanical circulatory support technology,
       reported one year survival is in the range of 40-60% for the randomized trial
       experience of REMATCH destination therapy and for the initial analysis of the
       413 patients in the ISHLT MCSD database.”

Changes to 3.5, Observational Study Monitoring Board (OSMB)
   Added, “The NHLBI policy on Monitoring Boards for Data and Safety can be
     found at http://public.nhlbi.nih.gov/ocr/home/GetPolicy.aspx?id=8 .”


Summary of Changes
10/7/2011                                                                                                                                                   Page 2
      Deleted remainder of the section, “The OSMB is composed of a Chair and
       members with expertise in biostatistics, clinical trials, bioethics, heart failure,
       cardiac surgery, bioengineering and device complications. Consultants may be
       added to the OSMB when it may be helpful to have greater representation of
       expertise in the relevant scientific field. All standing members of an OSMB may
       vote. Consultants have the same voting rights as an official OSMB member
       when reviewing the protocol.

       Individuals are invited to serve on the OSMB by the NIH Director. Members are
       required to complete a Conflict of Interest Certification for review and acceptance
       by the institute prior to serving on the Board. At the beginning of all meetings the
       Chair or the Executive Secretary (ES) will verbally remind the members of the
       importance of avoiding conflicts of interest and that members must notify the ES
       promptly if any changes occur which may pose a potential conflict of interest.

       The ES is an NIH staff member, other than the Project Officer, appointed by the
       Division Director. The ES is responsible for working with the OSMB Chair to
       ensure the Board fully considers the data pertaining to the participants’ safety
       and study integrity; engages in full discussion of relevant issues; and addresses
       issues of protocol modifications and contraindications to participant enrollment.

       OSMB members will meet face-to-face or via teleconference on a regular basis.
       Interim meetings may be held and, when appropriate, may be conducted by
       conference call. Meeting attendees typically include OSMB members; the ES;
       NIH staff, including a biostatistician; Data Coordinating Center (UAB:DCC)
       representatives; Operations Committee Chair; and ad hoc consultants or other
       representatives invited to the meeting on an as needed basis.

       The ES will prepare the agenda for meetings after consultation with the OSMB
       Chair, NIH staff, and UAB:DCC staff. The agenda may include an Executive
       Session. Executive Sessions may exclude non-voting members, with the
       exception of the ES. NIH representatives will attend an Executive Session on an
       as needed basis.

       The ES will prepare minutes for all meetings. The minutes will include general
       recommendations, action items, any protocol changes or study UAB:DCC
       recommendations, the justifications for these recommendations, and the
       estimated time frame for the next meeting. Minutes will not typically include
       confidential trials outcome data.

       Draft minutes will be sent to the Chair for review and then signed by the Chair
       and the ES. The signed minutes will be distributed to OSMB members prior to
       the next meeting. The ES will communicate relevant recommendations and may
       send excerpts of the minutes to the federal partners and the UAB:DCC.


Summary of Changes
10/7/2011                                                                            Page 3
              OSMB Responsibility                              Possible Materials

     Completeness, quality, and analysis of       Plans/procedures for data collection and
     measurements that are made                   monitoring data quality

     Adequacy of data submission from             Plans/procedures to monitor performance –
     individual centers (including possible       e.g. participant accrual, data accuracy and
     recommendations on actions to be taken       timeliness, protocol compliance, compliance
     regarding any center that performs           with federal regulations, long-term patient
     unsatisfactorily)                            follow-up, and on-site data audits

     Interim results of study for evidence of     Plans/procedures for monitoring adverse
     safety or adverse events                     events and outcomes of interest

                                                  Draft Table of Contents for OSMB Report Book
                                                  to facilitate discussion on format and content.
     Possible protocol modifications              Procedures for amending protocols



      OSMB Meetings

      The agenda for the meetings of the OSMB will include an overview of the role
      and the responsibilities of the OSMB; a discussion on the format, including a
      distribution timeline for the presentation of ongoing data; and the process the
      Board will use to make recommendations on continuing a study.

      In addition, the OSMB will discuss the registry monitoring plans for data quality
      and subject safety. The table above presents possible materials that may be
      used to address the OSMB responsibilities in this area. Of note, the UAB:DCC,
      in consultation with the Operations Committee, will be responsible for
      determining the selection and organization of the materials. Questions
      regarding meeting materials may be sent to the ES.

      Meeting materials will be distributed by the UAB:DCC. The UAB:DCC will
      consult with the ES regarding distribution timelines. It is the responsibility of the
      ES to ensure OSMB members receive data reports with sufficient time for review.

      Review of Study Protocol

      The OSMB will review the study protocol and monitoring plans. The OSMB
      review will focus on data quality and safety assurance.

Summary of Changes
10/7/2011                                                                            Page 4
      For the initial protocol review, the following materials were provided to OSMB
      members:

           final protocol
           manual of operations
           informed consent document (prototype)
           data and safety monitoring plan
           study policies regarding COI, publications, and data sharing
           detailed recruitment goals

      Additional materials to address data quality and participant safety on the study
      should also be supplied. The UAB:DCC, in consultation with the Operations
      Committee, will be responsible for determining the selection and organization of
      the materials. Questions regarding meeting materials may be sent to the ES.

      At the end of each review the ES will ask the OSMB members to vote regarding
      acceptance of the study protocol. The OSMB recommendation will be directed to
      the Institute for implementation as appropriate.

      Data Oversight

      The UAB:DCC will prepare and distribute data reports. The basic format for the
      presentation of ongoing data and the need to provide these data within a certain
      time frame will be established at the initial OSMB meeting. Prior to each
      meeting, the ES and other program staff should review the data and materials
      and, if needed, communicate with the UAB:DCC. It is the responsibility of the ES
      to ensure OSMB members receive data reports with sufficient time for review.

      When important issues, such as breaches of the protocol, or other major issues
      impacting on the conduct of the study are discussed during a meeting, the ES will
      document the discussions and the outcome. The ES will work with the OSMB to
      discern and assess critical issues such as:

           failure to comply satisfactory with recruitment goals, including those
            related to the participation of women and minorities;
           trends of increased or decreased morbidity and/or mortality observed
            adverse events;
           the unsatisfactory performance of the UAB:DCC and/or study centers;
           suspicion of fraud; and
           any other issues that would lead to important protocol changes.

      If such issues arise, the ES will discuss the situation with the appropriate NIH
      staff, including grants management or contracts operations staff, and notify the
      NIH Director promptly. Some ways in which the NIH may respond to such issues
Summary of Changes
10/7/2011                                                                         Page 5
      include: expanding the number of enrolling centers, extending the period of
      recruitment, stopping recruitment because of inadequate rate of acquisition,
      modifying the protocol (in collaboration with the Investigators/ Operations
      Committee), or discontinuing a center with poor performance. It may also elect
      to establish an ad hoc committee to provide assistance in these matters. Such
      ad hoc committees may include representation from initial reviewers, OSMB
      members, and members of the relevant scientific community.”

Changes to 4.2, Registration
   Deleted, “Provide personnel and facilities to collect, preserve package and
     transport biological specimens (should the center elect to participate in the blood
     and tissue program)”
   Added, “online”
   Deleted, “Lab Coordinator (should the Center elect to participate in the blood and
     tissue program), responsible for oversight of the collection, preservation,
     packaging, transport and documentation regarding blood and tissue specimens”

Changes to 4.3, IRB Approval
   Added, “and current Clinical Laboratory Improvement Amendments (CLIA)
     documentation”
   Deleted, “Support Via fax (804-782-4809:Attn INTERMACS Coordinator) or Mail:
     INTERMACS Coordinator, UNOS Data Management Services, 700 North 4th
     Street, Richmond, VA 23219.”
   Changed, “Support@intermacs.org” to “INTERMACS”
   Added, “(Adult)”
   Deleted, “Patient Consent for Participation in Blood and Tissue Repository”
   Deleted, “Parent Consent for Child’s Participation in Blood and Tissue
     Repository”
   Deleted, “HIPAA Authorization for Release of Information in Blood and Tissue
     Repository (Adult)”
   Deleted, “HIPAA Authorization for Release of Information in Blood and Tissue
     Repository (Pediatric)”
   Deleted, “Revoke Authorization for Participation in Blood and Tissue Repository
     (Adult)”
   Deleted, “Revoke Authorization for Participation in Blood and Tissue Repository
     (Pediatric)”
   Added Informed Consent, “Patient Authorization for INTERMACS to Release
     Information (Adult)”
   Added Informed Consent, “Patient Authorization for INTERMACS to Release
     Information (Pediatric)”

Summary of Changes
10/7/2011                                                                         Page 6
Changes to 4.4, Participation Agreement
   Deleted, “Support Via fax (804-782-4809:Attn INTERMACS Coordinator) or Mail:
     INTERMACS Coordinator, UNOS Data Management Services, 700 North 4th
     Street, Richmond, VA 23219.”

Changes to 4.5, Financial Disclosure and Conflict of Interest
   Changed, “the personnel at each hospital who have a major role in
     INTERMACS”, to “Clinical site personnel who are involved in patient treatment
     and evaluation of INTERMACS consented participants”
   Deleted, “Support Via fax (804-782-4809:Attn INTERMACS Coordinator) or Mail:
     INTERMACS Coordinator, UNOS Data Management Services, 700 North 4th
     Street, Richmond, VA 23219.”

Changes to 4.6, Human Subjects Training
   Deleted, “Support Via fax (804-782-4809:Attn INTERMACS Coordinator) or Mail:
     INTERMACS Coordinator, UNOS Data Management Services, 700 North 4th
     Street, Richmond, VA 23219.”

Changes to 4.7, Certification
   Changed text, “Certification. Once steps 4.1 through 4.6 are completed and the
     necessary documentation has been submitted to INTERMACS Support then the
     site will be certified as a participating INTERMACS center. The site will be
     notified of the certification” to “Participation Fee, Each site must pay a required
     participation fee prior to activation. INTERMACS is structured to provide value to
     the hospitals for this fee. For example, INTERMACS completes and submits the
     FDA Medical Device Forms (MDR 3500A) for each hospital, INTERMACS
     provides quarterly quality assurance reports for each participating hospital,
     INTERMACS creates patient specific clinical summaries of the major events after
     implant, INTERMACS encourages local physicians and coordinators to
     participate in the administration and research within the registry.”

Changes to 4.8, Training
   Deleted, “A completed post-test must be submitted for review”
   Deleted, “For more information, please contact INTERMACS Support at
     support@intermacs.org or call 804-782-4072.”

Changes to 4.9, Activation
   Deleted, “For more information, please contact INTERMACS Support at
     support@intermacs.org or call 801-782-4072.”
Summary of Changes
10/7/2011                                                                         Page 7
Changes to 4.10, Annual Re-Certification
   Changed “Maintain annual IRB approval and Federal Wide Assurance Number”
     to “Maintain and provide INTERMACS with the annual IRB approval and current
     Federal Wide Assurance Number documentation”
   Added, “Provide current Clinical Laboratory Improvement Amendments (CLIA)
     documentation”
   Added, “Provide annual participation fee”

Changes to 5.1, Risk and Benefits
   Deleted, “and remnant surgical material”
   Added, “limited functional capacity data,”

Changes to 5.2, IRB Review and Approval
   Added, “INTERMACS”
   Deleted, “the UAB:DCC in cooperation with the Operations Committee”
   Changed, “the United Network for Organ Sharing Data Collection Repository,
     hereafter, referred to as UNOS:DCR. The UNOS DCR” to “INTERMACS”
   Added, “to the participating centers”

Changes to 5.3, Informed Consent Process
   Added, “except in the instance of patient transfer to another INTERMACS site”

Changes to 6.1, Web-based data entry and System Security
   Changed, “Microsoft’s SMS 2003 (Systems Management Server)” to “Microsoft
     System Center Configuration Manager 2007”
   Changed, “VLAN” to “Virtual Local Area Networks (VLAN)”

Changes to 6.2, Clinical Data
   Added, “Kansas City Cardiomyopathy Questionnaire (KCCQ),”

Changes to 6.3, Quality of Life
   Changed, “sixteen” to “twenty three”
   Added, “and the KCCQ”
   Changed, “this” to these”
   Added, “per instrument”
   Deleted, “When able, the patients will complete the instrument themselves. If
     unable, they can answer questions read aloud by the coordinator or by a family
     member. The method of completion will be recorded.”
Summary of Changes
10/7/2011                                                                      Page 8
      Added, “and KCCQ”

Changes to 6.4, Neuro-cognitive data
   Deleted, “Part B involves connecting, in alternating order, encircled numbers (1-
     12) and encircled letters (A-L) randomly arranged on a page. This test is scored
     by overall time required to complete the connection accurately. The examiner
     points out and corrects mistakes as they occur; the effect of mistakes, then, is to
     increase the time required to complete the test. This test usually takes 3-4
     minutes to administer. This score will be entered directly into the web-based
     data entry system.”

Changes to 6.5, Blood and Tissue Samples
   Deleted Section 6.5, “This is a prospective program to obtain and bank intra-
     operative myocardial tissue and blood samples in end-stage heart failure patients
     receiving a MCSD at the time of device implant, explant or device exchange.
     Whenever possible, tissue samples (i.e. apical core or explanted heart) will be
     collected for pathology, immunohistochemistry, and future molecular analyses.
     Venous blood samples will be collected to determine neurohumoral, DNA, and
     serum analyses. Specific studies relating to genomics, proteomics, and
     structural biology will be submitted by investigating institutions requesting tissue
     specimens. Investigating institutions are those which contribute blood and tissue
     to the INTERMACS® NHLBI repository. Blood and tissue will be banked for a
     year before any analyses are performed.

       Myocardial tissue samples and venous blood samples will be collected at time of
       device implant and device removal (i.e. explanted failing heart during transplant,
       MCSD exchange, or myocardial recovery). Please refer to the standard
       operating procedures (SOPs), Appendix H for Hospitals for explicit instructions
       for collection, on-site storage, and shipping procedures. Collected tissue and
       blood specimens will be stored onsite at -80 degrees Celsius or in liquid nitrogen
       tanks. Using pre-paid shipping labels, the site will ship the samples to the NHLBI
       designated repository every three patients, or every three months, whichever
       comes first.

       Instructions on methods and procedures will be provided by the NHLBI
       repository, including packing materials, coding labels and preaddressed shipping
       labels. Batched samples will be sent quarterly (or every 3 patients, whichever
       comes first) directly to the address provided below and in the Site User’s Guide.
       A shipping manifest will be emailed to the NHLBI repository and their 24-hour
       emergency contact at the time of shipment to facilitate tracking.

       NHLBI repository:
       SeraCare Life Sciences
       Ms. Linda Brunson
Summary of Changes
10/7/2011                                                                          Page 9
                217 Perry Parkway
                Gaithersburg, MD 20877
                Tel: 301.208.8100
                Fax: 301.208.8829
                http://www.nhlbi.nih.gov/resources/medres/reposit/reposit.htm
                NHLBI@seracare.com and bbibiotech@chemtelinc.com (24-hour emergency
                contact)”

Changes to 7.2, Purposes
   Added, “and rescue therapy”
   Deleted, “Estimate changes in biological markers (derived from blood and tissue
     samples) from pre to post MCSD implant and relate such changes to probability
     of improvement in or recovery of ventricular function.”
   Deleted, “Analyze biologic markers obtained from MCSD patients and indicators
     of severity of advance heart failure.”

Changes to 7.4, Primary Endpoints
   Replaced table

                  Sample* Endpoint Analyses
                                                                                                                                                  Sample Endpoint Analyses
          Discrete Endpoints
                                                                                                                                                         Discrete Endpoints



      Death                    Hospitalizations                  Transplant              Explant for Recovery                                        Death                  Transplant                  Explant for Recovery

    • Causes of Death         • Days Alive Out of Hospital      • Competing Outcomes   • Prediction of Recovery                                    • Causes of Death        • Competing Outcomes     • Prediction of Recovery
    • Risk Factor Analyses    • Risk Factors for Repeated          Analyses            • Post-Explant Survival                                     • Risk Factor Analyses      Analyses              • Post-Explant Survival
                                                                                                                                                                            • Post-transplant           Analyses
                                 Hospitalizations               • Post-transplant         Analyses                                                                             Survival Analyses
                                                                   Survival Analyses
                                                                                                                                                        Complex Endpoints
                         Complex Endpoints


                                                                                                                                    Improvement                Adverse Events            Quality of Life          Costs             Hospitalizations
                                                                                                                                      Indicators                                                                (resource
                                                                                                                                                             • Repeating Event           • Determinants of
     Improvement                Adverse Events               Quality of Life       Costs              Blood/Tissue                                                                                             utilization)         • Days Alive out of
                                                                                                                                • Patient/Device/Disease        Analyses                    post-MCSD QOL
                                                                                                                                                                                                                                        Hospital
       Indicators                                                                (resource             Parameters                  Predictors of Favorable   • Determination of Causes   • Comparison of QOL     • Predictors of
                                                                                                                                                                                                                                    • Risk Factors for
                              • Repeating Event         • Determinants of                                                                                       (Device-, Patient-,         With Other Therapies    Implant Costs
                                                                                utilization)                                       Outcome
                                                                                                                                                                                                                 • Cost
                                                                                                                                                                                                                                        Repeated
 • Patient/Device/Disease        Analyses                  post-MCSD QOL                         • Genomic Predictors           • Comparison of Outcome         Management-Related)
                                                                                                                                                                                                                                        Hospitalizations
    Predictors of Favorable   • Determination of Causes • Comparison of QOL                         of Recovery                    With Other Therapies                                                             Effectiveness
                                                                                • Predictors of                                                                                                                     Analyses
                                 (Device-, Patient-,       With Other Therapies
    Outcome                                                                        Implant Costs • Blood/Tissue
 • Comparison of Outcome         Management-Related)                                                Correlates of
                                                                                • Cost
    With Other Therapies                                                           Effectiveness    Myocardial Failure
                                                                                   Analyses         Severity




                                                                                                                         with


Changes to 7.5, Transfer of Data to UAB for Analyses
   Changed, “UNOS:DCR” to “the INTERMACS Data Collection Repository”
   Changed, “SAS version 9.1” to “SAS version 9”
   Deleted, “The UAB:DCC will receive a limited access data file.”

Changes to 7.7, Planned Analyses
   Deleted, “Analysis of Tissue and Blood Samples. Tissue and blood data will be
     analyzed to characterize patients who are receiving MCSDs and to examine
     changes in this data from pre-implant to explants. Standard statistical techniques
     for assessing changes across time will be employed. The pre-implant blood and
     tissue data will be part of the risk factor analyses to assess factors associated
     with the outcome endpoints.”
   Deleted, “tissue and blood variables”


Summary of Changes
10/7/2011                                                                                                                                                                                                                                                  Page 10
      Deleted, “Additional analyses at Participating Centers. In addition to the site-
       specific information provided routinely, qualified centers in good standing
       regarding data contribution may consider applying to receive a summary dataset
       with identifiers removed, for specific planned analysis as approved by the
       Operations Committee.”

Changes to 8.0, Periodic Statistical Summaries
   Changed, “The UAB:DCC” to “INTERMACS”

Changes to 8.1, Quarterly Progress Reports
   Changed, “Quarterly Progress” to “Semi-Annual”
   Changed, “quarter” to “semi-annual period”
   Deleted, “and specimens”
   Added, “Form completion rates”
   Added, “Current list of all contract staff including positions, titles, full time
     employment levels and status of individual information security training.”
   Changed, “Quarterly” to “Semi-Annual”

Changes to 8.2, Centers for Medicare and Medicaid Services (CMS)
   Deleted, “(no patient specific data will be given)”
   Added, “At the request of CMS, INTERMACS also works with the Joint
     Commission to identify hospitals that are no longer active members of
     INTERMACS and therefore are at risk for DT decertification by CMS.”

Changes to 8.3, Food and Drug Administration (FDA)
   Changed, “INTERMACS . can be used…” to “INTERMACS can be used…”

Changes to 8.5, Individual Sites
   Added, “identified”
   Changed “These reports will be similar to the industry reports except that they
     will describe a site’s experience instead of the experience with a specific MCSD”
     to “These reports have two components. The first component is a quality
     assurance report that summarizes and compares the results at the individual
     hospital with the entire INTERMACS registry. These benchmark comparisons
     allow the hospital to evaluate the patients and outcomes as compared to the
     aggregate data of the United States. The second component focuses on patient
     specific data and the quality of the site data. Clinical summaries for each patient
     are provided that contain a chronological history of the major implant related
     events. The Medical Device Reports that have been submitted to FDA on behalf
     of the site are also included in this report.”

Changes to 9.1, Quality Assurance
   Changed, “The United Network for Organ Sharing (UNOS) will act as the Data
     Collection Repository (UNOS:DCR) for INTERMACS. UNOS:DCR will


Summary of Changes
10/7/2011                                                                               Page 11
       continually evaluate data quality and completeness through consistency checks
       at data entry and audits. The UAB:DCC” to “INTERMACS”
      Changed, “the UAB:DCC will make no changes to the data” to “INTERMACS will
       not make changes to the data but will rely on the participating site to make
       necessary corrections.”
      Deleted, “prior to each analysis”
      Deleted, “;only UNOS:DCR will make corrections to the original data files”


Changes to 9.2, Data Monitoring and Checks for Inconsistencies
   Changed, “UNOS:DCR and UAB:DCC staff members” to “INTERMACS”
   Changed, “Operations” to “Executive”
   Changed “UNOS:DCR” to ”INTERMACS”

Changes to 9.3, Event Adjudication
   Changed, “Event Adjudication” to “Medical Event Review”
   Changed, “The Adjudication Committee will be comprised of the Adverse Event
     subcommittee. There will be a pediatric cardiovascular physician included.
     Industry representatives will not be included in the Adjudication Committee. The
     chair of the Adverse Events Committee will be the chair of the Adjudication
     Committee. The function of the Adjudication Committee is to review specified
     adverse events (i.e., infection, bleeding, neurological dysfunction, device
     malfunction and death). They will make final decisions regarding causes of
     death, device failure categories, validation of an adverse event, and any other
     relevant variables concerning death and adverse events. The UAB:DCC will
     facilitate the functions of the Adjudication Committee by scheduling meetings and
     providing the necessary data for the adjudication process.” to “The function of the
     Medical Event Review Committee is to review specified adverse events (i.e.,
     infection, bleeding, neurological dysfunction, device malfunction and death).
     They will make final decisions regarding causes of death, device failure
     categories, validation of an adverse event, and any other relevant variables
     concerning death and adverse events. The DCC will facilitate the functions of
     the Medical Event Review Committee by scheduling meetings and providing the
     necessary reports for the review process.”

Changes to 10.1, Requirements for Centers
   Deleted, “and”
   Added, “proof of federal Wide Assurance Number”
   Added, “and proof of Clinical Laboratory Improvement Amendments (CLIA)
     documentation”
   Added, (2) have at least one person complete training”
   Added, “baseline, implant and”
   Deleted, “by UNOS:DCR”

Changes to 10.2, Training for Centers
Summary of Changes
10/7/2011                                                                       Page 12
      Delete, “These meetings can be linked to conference calls and recorded for
       future use”
      Deleted, “This system will enable users to take online exams as well as enable
       UNOS:DCR to capture exam results, track and report certifications and help
       users identify areas of improvement.”

Changes to 10.3, Assistance to Centers
   Deleted, “proper protocol and”
   Deleted, “and specimen”
   Added, “collection”
   Deleted, “(located at the UNOS:DCR)

Changes to 10.4, Audit Process for Centers
   Changed, “The audit process for INTERMACS® will include visits to all
     participating centers. Annual audit visits will begin in year 2 and proceed each
     consecutive year, through and including year 5. For those registry participants
     that have accumulated up to and including 20 patients by their assigned audit
     year, all patient records will be audited. For those registry participants that have
     accumulated in excess of 20 patients by their assigned audit year, a random
     sample totaling 20 patients records will be audited. Sites will be notified 60 days
     prior to an audit visit. Audited data will include key data fields, as determined by
     the UAB:DCC in consultation with the Operations Committee. Audit visits will
     monitor data accuracy of web-based data submissions and information contained
     in source documents as well as participant performance and progress. “For
     Cause” audit visits will be made as indicated by the Operations Committee. All
     audit results will be reported to the Operations Committee.” to “The audit process
     for INTERMACS® will include visits to all participating centers. Sites will be
     notified 60 days prior to an audit visit. Audited data will include key data fields,
     as determined by INTERMACS. The INTERMACS nurse monitor contacts the
     site for a pre-visit phone audit approximately 2 weeks before the on-site audit.
     During the call the monitor reviews site specific summaries for duplicated events,
     unknown sources of bleeding, unknown causes of death, device explants
     inconsistencies and any other noted discrepancies. The sites are requested to
     make corrections prior to the on-site visit. Audit visits will monitor data accuracy
     of web-based data submissions and information contained in source documents
     as well as participant performance and progress. Per site, five percent of the total
     number of patients plus 12 patients for major events will be audited.
   Changed, “Operations” to “Hospital Standards”
   Changed, “Operations” to Executive”
   Changed, “The UNOS:DCR staff” to “INTERMACS”
   Deleted, “The UNOS:DCR staff will inform UAB:DCC of the audit findings an
     resolutions. The UAB:DCC staff will prepare summary reports for the Hospital
     Training and Standards Committee”



Summary of Changes
10/7/2011                                                                        Page 13
                      SUMMARY OF CHANGES TO THE
                     INFORMED CONSENT DOCUMENTS

INFORMED CONSENT DOCUMENTS (Appendix C)

Consent Form for Participation in Research (adult)

Changes to, Header
   Changed version from 2.3 to 3.0
   Changed date from 10/30/2008 to 10/07/2011

Changes to, Sponsor
   Changed, “Contract #HHSN268200548198C” to “Contract
     #HHSN268201100025C”
   Changed, “Principal Investigator: James K. Kirklin, M.D.” to “Principal
     Investigator: (Insert local Principal Investigator)”
   Changed, “Phone Number: 205-934-4201” to “Phone Number: (Insert local
     Principal Investigator phone number)”

Changes to, Informed Consent
   Changed from “80 hospitals” to “115 hospitals”
   Changed from “four years” to “nine years”

Changes to, Your Participation is Voluntary
   Changed, “study” to “registry”

Changes to, What is the Purpose of this Study?
   Changed, “study” to “registry”
   Changed, “twenty” to “twenty five”
   Changed, “adverse events”, to “side effects”


Changes to, What Do I Have to Do If I Am In this Study?
   Changed, “study” to “registry”
   Added, “complete a limited functional capacity test (how far you can walk in 6
     minutes and how fast you can walk 15 feet)”


Summary of Changes
10/7/2011                                                                      Page 14
Changes to, How Many People Will Take Part in This Study?
   Changed, “study” to “registry”
   Changed, “8,000” to “10,000”
   Changed, “2,000” to “Over 1,000”
   Changed, “4 years” to “9 years”
   Changed, “2000” to “more than 1,000”
   Changed, “80” to “115”

Changes to, How Long Will I be in this Study?
   Changed, “study” to “registry”
   Changed, “log” to “long”
   Changed, “study” to “registry”

Changes to, What are the Risks of the Registry?
   Added, “a limited functional capacity test (how far you can walk in 6 minutes and
     how fast you can walk 15 feet)”
   Changed, “20 minutes” to “30 minutes”

Changes to, What are the Benefits of the Registry?
   Changed, “study” to “registry”
   Added, “in the future”

Changes to, What About Confidentiality?
   Changed, “study” to “registry”
   Changed “…will be entered into the confidential database at UNOS” to “…will be
     entered into the confidential INTERMACS database”
   Changed, “UNOS employees” to “INTERMACS staff”
   Deleted, “They are fully compliant with the Health Insurance Portability and
     Accountability Act (HIPAA) and are certified by the Health Resources and
     services Administration (HRSA)”
   Changed, “UNOS” to “INTERMACS”
   Deleted, “They are audited annually by HRSA for compliance. Monitors and print
     outs are in areas that are badge-access only.”
   Added, “and registries”
   Deleted, “at United Network of Organ Sharing (UNOS), the Clinical Research
     Organization for this study,”

Changes to, What Are My Rights As A Research Subject?
   Changed, “study” to “registry”
Summary of Changes
10/7/2011                                                                     Page 15
Changes to, What do I do if I Have Questions or Problems?
   Changed, “study” to “registry”


Changes to, Statement of Consent
   Changed, “study” to “registry”

Changes to PI or Designee’s statement
   Changed, “study” to “registry”
   Authorization for the Use and Disclosure of Protected Health Information
     (HIPAA) (adult)

Changes to, Header
   Changed version from 2.3 to 3.0
   Changed date from 10/30/2008 to 10/07/2011

Changes to, Sponsor
   Changed, “Contract #HHSN268200548198C” to “Contract
     #HHSN268201100025C”
   Changed, “Principal Investigator: James K. Kirklin, M.D.” to “Principal
     Investigator: (Insert local Principal Investigator)”
   Changed, “Phone Number: 205-934-4201” to “Phone Number: (Insert local
     Principal Investigator phone number)”
   Changed, “study” to “registry”
   Changed, “WHY IS THIS STUDY BEING DONE?” to “WHAT IS THE PURPOSE
     OF THIS REGISTRY?”
   Changed, “study” to “registry”
   Changed, “United Network for Organ Sharing (UNOS), which maintains the
     database for the registry” to “INTERMACS database”
   Changed, “…but they will not know your name or social security number (partial)”
     to “…but they will not know your name entire social security number (Only the
     last 5 digits will be collected).”
   Changed, “earlier, see” to “in the”
   Added, “including the (name of institution’s) Institutional Review Board (IRB), the
     National Heart, Lung, and Blood Institute (NHLBI), INTERMACS study monitors”
   Changed, “study” to “registry”
   Changed, “research study” to “registry”
   Changed, “study” to “registry”

Changes to, Statement of Consent
Summary of Changes
10/7/2011                                                                      Page 16
      Changed, “study” to “registry”

Patient Authorization for INTERMACS to Release Information (adult)

Changes to, Header
   Changed version from 2.3 to 3.0
   Changed date from 10/30/2008 to 10/07/2011
   Deleted, “Amendment 1, 08/16/10”

Changes to, Sponsor
   Changed, “Contract #HHSN268200548198C” to “Contract
     #HHSN268201100025C”
   Changed, “Principal Investigator: xxxxxx” to “Principal Investigator: (Insert local
     Principal Investigator)”
   Changed, “Phone Number: xxxxxx” to “Phone Number: (Insert local Principal
     Investigator phone number)”
   Changed, “Hospital A” to “blank”
   Changed, “Hospital B” to “insert the name of your hospital”

Revoke Authorization for Participation in Researcher (adult)

Changes to, Header
   Changed version from 2.3 to 3.0
   Changed date from 10/30/2008 to 10/07/2011
   Changed title, “Revoke Authorization for Participation in Research” to “Revoke
     Authorization in Participation in INTERMACS”
   Deleted, “Re: REVOKE MY AUTHORIZATION FOR THE RESEARCHERS TO
     COLLECT AND USE MY INFORMATION”

Parent Consent (Child Assent) Form for Child’s Participation in Research

Changes to, Header
   Changed version from 2.3 to 3.0
   Changed date from 10/30/2008 to 10/07/2011

Changes to, Sponsor
   Changed, “Contract #HHSN268200548198C” to “Contract
     #HHSN268201100025C”



Summary of Changes
10/7/2011                                                                         Page 17
      Changed, “Principal Investigator: James K. Kirklin, M.D.” to “Principal
       Investigator: (Insert local Principal Investigator)”
      Changed, “Phone Number: 205-934-4201” to “Phone Number: (Insert local
       Principal Investigator phone number)”

Changes to, Informed Consent
   Changed from “70 hospitals” to “115 hospitals”
   Changed from “four years” to “nine years”

Changes to, Your Participation is Voluntary
   Changed, “study” to “registry”

Changes to, What is the Purpose of This Registry ?
   Changed, “twenty” to “twenty five”

Changes to, What Do I Have to Do if I am in This Study?
   Changed “STUDY” to “REGISTRY”

Changes to, How Many People Will Take Part in This Study?
   Changed “STUDY” to “REGISTRY”
   Changed, “8,000” to 10,000”
   Changed, “2,000” to “Over 1,000”
   Changed, “4 years” to “9 years”
   Changed, “2000” to “more than 1,000”
   Changed, “80” to “115”

Changes to, How Long Will I Be In This Study?
   Changed, “STUDY” to “REGISTRY”
   Changed, “log” to “long”
   Changed, “study” to “registry”

Changes to, What Are the Benefits of the Registry?
   Changed, “study” to “registry”

Changes to, What About Confidentiality?
   Changed, “study” to “registry”
   Changed “…will be entered into the confidential database at UNOS” to “…will be
     entered into the confidential INTERMACS database”
   Changed, “UNOS” to “INTERMACS”
Summary of Changes
10/7/2011                                                                    Page 18
      Deleted, “They are fully compliant with the Health Insurance Portability and
       Accountability Act (HIPAA) and are certified by the Health Resources and
       services Administration (HRSA)”
      Changed, “UNOS” to “INTERMACS”
      Deleted, “they are audited annually by HRSA for compliance. Monitors and print
       outs are in areas that are badge-access only.”
      Added, “and registries”
      Deleted, “at United Network of Organ Sharing (UNOS), the Clinical Research
       Organization for this study,”

Changes to, What are My Rights as a Research Subject?
   Changed, “study” to “registry”

Changes to, What Do I Do If I Have Questions or Problems?
   Changed, “study” to “registry”

Changes to, Statement of Consent
   Changed, “study” to “registry”

Changes to, PI or Designee’s statement
   Changed, “study” to “registry”


Authorization for the Use and Disclosure of Protected Health Information (HIPAA)
(child)

Changes to, Header
   Changed version from 2.3 to 3.0
   Changed date from 10/30/2008 to 10/07/2011

Changes to, Sponsor
   Changed, “Contract #HHSN268200548198C” to “Contract
     #HHSN268201100025C”
   Changed, “Principal Investigator: James K. Kirklin, M.D.” to “Principal
     Investigator: (Insert local Principal Investigator)”
   Changed, “Phone Number: 205-934-4201” to “Phone Number: (Insert local
     Principal Investigator phone number)”
   Changed, “study” to “registry”


Summary of Changes
10/7/2011                                                                     Page 19
      Changed, “WHY IS THIS STUDY BEING DONE?” to “WHAT IS THE
       PURPOSED OF THIS REGISTRY?”
      Added, “the persons who will collect and use your information for this registry:”
      Changed, “…but they will not know your child’s name or social security number
       (partial)” to “…but they will not know your child’s name or entire social security
       number (Only the last 5 digits will be collected).”
      Changed, “study” to “registry”
      Changed, “research study” to “registry”
      Changed, “study” to “registry”

Changes to, Statement of Consent
   Changed, “study” to “registry”

Patient Authorization for INTERMACS to Release Information Child Form

Changes to, Header
   Changed version from 2.3 to 3.0
   Changed date from 10/30/2008 to 10/07/2011

Changes to, Sponsor
   Changed, “Contract #HHSN268200548198C” to “Contract
     #HHSN268201100025C”
   Changed, “Principal Investigator: xxxxxx” to “Principal Investigator: (Insert local
     Principal Investigator)”
   Changed, “Phone Number: xxxxxx” to “Phone Number: (Insert local Principal
     Investigator phone number)”
   Changed, “Hospital A” to “blank”
   Changed, “Hospital B” to “insert the name of your hospital”
   Added, “If you agree to continued participation, (insert the name of your
     hospital)____would also like to obtain the registry information already entered
     into INTERMACS about you. This authorization gives INTERMACS permission to
     release all of the information entered into the registry about you to (insert the
     name of your hospital)”
   Changed, “Hospital B” to “insert the name of your hospital”

REVOKE MY AUTHORIZATION FOR THE RESEARCHERS TO COLLECT AND USE
MY CHILD’S INFORMATION

Changes to, Header
   Changed version from 2.3 to 3.0

Summary of Changes
10/7/2011                                                                          Page 20
      Changed date from 10/30/2008 to 10/07/2011

Changed title, “Revoke Authorization for Participation in Research” to “Revoke
      Authorization in Participation in INTERMACS” (child)




                         SUMMARY OF CHANGES TO THE
                                 Appendix F

EuroQol (EQ-5D/3L) (Appendix F)
Additions have been added to Appendix F. Quality of Life questions have been added to
the pre-implant and post-implant assessments.

PRE IMPLANT FORM

Please answer questions #1-7 below to provide some additional information.

1. Which one of the following best describes your “one” main activity? (select one)

                             Too sick to work (disabled)
                             Actively working
                             Keeping house
                             Student
                             Retired
                             Seeking work
                             Other                               please specify: ___________

       Is this “one” main activity considered: Full time         or      Part time

2. How many of your close friends or relatives do you see in person, speak to on the telephone
or contact via the internet at least once a month? __________ (please count each person 1
time)

3. Have you unintentionally lost more than 10 pounds in the last year?    Yes  No

4. Do you currently smoke cigarettes?  Yes            No
       If YES, how many cigarettes are you currently smoking, on average?
        Half a pack or less per day         1 to 2 packs per day
        More than half to 1 pack per day  2 or more packs per day
Summary of Changes
10/7/2011                                                                             Page 21
Please circle a number from 1 to 10, to respond to the questions below.

5. How much stress related to your health issues do you feel you’ve been under during the past
1 month?             1        2        3        4        5         6       7        8
9        10
   No stress                                                                       Very much
stress

6. How well do you feel you’ve been coping with or handling your stress related to your health
issues during the past 1 month?
        1        2        3      4        5        6        7        8         9        10
   Coping very poorly                                                       Coping very well

7. How confident are you that you can do the tasks and activities needed to manage your heart
failure so as to reduce how much having heart failure affects your everyday life?
        1         2       3       4       5         6         7        8         9        10
    Not at all confident                                                        Totally confident

8. How satisfied are you with the outcome of your therapy for heart failure during the past 3
months?
        1        2       3        4       5        6        7         8        9        10
   Not satisfied                                                                     Very
satisfied

POST IMPLANT FORM
Please answer questions #1-8 below to provide some additional information.

1. Which one of the following best describes your “one” main activity? (select one)
                             Too sick to work (disabled)
                             Actively working
                             Keeping house
                             Student
                             Retired
                             Seeking work
                             Other                               please specify: ___________

       Is this “one” main activity considered: Full time           or     Part time

2. How many of your close friends or relatives do you see in person, speak to on the telephone
or contact via the internet at least once a month? __________ (please count each person 1
time)


Summary of Changes
10/7/2011                                                                                Page 22
3. Have you unintentionally lost more than 10 pounds in the last year?      Yes  No

4. Do you currently smoke cigarettes?  Yes            No
       If YES, how many cigarettes are you currently smoking, on average?
        Half a pack or less per day         1 to 2 packs per day
        More than half to 1 pack per day  2 or more packs per day

Please circle a number, to respond to the questions below.
5. How much stress related to your health issues do you feel you’ve been under during the past
1 month?             1         2        3       4        5         6       7        8
9        10
   No stress                                                                       Very much
stress

6. How well do you feel you’ve been coping with or handling your stress related to your health
issues during the past 1 month?
        1        2        3      4        5        6        7        8         9        10
   Coping very poorly                                                        Coping very well

7. How confident are you that you can do the tasks and activities needed to manage your
ventricular assist device so as to reduce how much having a ventricular assist device affects
your everyday life?                                        1        2          3        4
5        6          7        8        9       10
   Not at all confident                                                          Totally
confident

8. How satisfied are you with the outcome of your ventricular assist device surgery, during the
past 3 months?        1        2       3        4        5         6         7        8
9         10
   Not satisfied                                                                       Very
satisfied

9. If you had to do it all over again, would you decide to have a ventricular assist device
knowing what you know now?
        1                       2                     3                     4
        5
    Definitely No           Probably No                   Not Sure              Probably Yes
Definitely Yes




Summary of Changes
10/7/2011                                                                                Page 23
                                             SUMMARY OF CHANGES TO THE
                                                    Appendix H

Kansas City Cardiomyopathy Questionnaire (Appendix H)
Appendix H (Blood and Tissue Collection) from protocol version 2.3 has been replaced
with Appendix H, Kansas City Cardiomyopathy Questionnaire (KCCQ)



THE KANSAS CITY CARDIOMYOPATHY QUESTIONNAIRE: (KCCQ)

The following questions refer to your heart failure and how it may affect your life. Please read and
complete the following questions. There are no right or wrong answers. Please mark the answer that
best applies to you.
1. Heart Failure affects different people in different ways. Some feel shortness of breath while others feel
   fatigue. Please indicate how much you are limited by heart failure (shortness of breath or fatigue) in
   your ability to do the following activities over the past 2 weeks.


                                                  Place an X in one box on each line
Activity                 Extremely                Quite a bit  Moderately          Slightly                                 Not at all    Limited for
other reasons
                         limited                  limited                 limited                   limited                  limited       or did not
do the activity
Dressing yourself                                                                                                                                 
Showering/Bathing                                                                                                             

Walking 1 block on
    level ground                                                                                                                                  
Doing yardwork,
  housework or
    carrying groceries                                                                                                        

Climbing a flight of
   stairs without
    stopping                                                                                                                                      
Hurrying or jogging
    (as if to catch a bus)                                                                                                                        

2. Compared with 2 weeks ago, have your symptoms of heart failure (shortness of breath, fatigue or ankle
swelling)
   changed? My symptoms of heart failure have become…

    Much worse         Slightly worse             Not changed                   Slightly better               Much better       I’ve had no symptoms
                                                                                                                               over the last 2 weeks

Summary of Changes
10/7/2011                                                                                                                                     Page 24
                                                                                                                       

3.  Over the past 2 weeks, how many times did you have swelling in your feet, ankles or legs when you woke
up in
    in the morning?

      Every        3 or more times                1-2 times a              Less than once      Never over the
      morning      a week, but not              week                    a week            past 2 weeks
                      every day

                                                                                              

4.    Over the past 2 weeks, how much has swelling in your feet, ankles or legs bothered you?
     In has been…


  Extremely Quite a bit            Moderately           Slightly                         Not at all              I’ve had no
swelling
  bothersome bothersome            bothersome          bothersome               bothersome

                                                                                                        
5. Over the past 2 weeks, on average, how many times has fatigue limited your ability to do what you want?

All of the time    Several times     At least once a       3 or more times               1-2 times per           Less than once a
  Never over
                      per day                   day         per week but not                  week                    week
the past 2
                                                                    every day
weeks
                                                                                                                   





THE KANSAS CITY CARDIOMYOPATHY QUESTIONNAIRE: (KCCQ)

6. Over the past 2 weeks, how much has your fatigue bothered you?
   It has been…

    Extremely      Quite a bit     Moderately          Slightly              Not at all               I’ve had no fatigue
    bothersome     bothersome      bothersome          bothersome            bothersome
                                                                                                                           

7. Over the past 2 weeks, on average, how many times has shortness of breath limited your ability to do
what you wanted?



Summary of Changes
10/7/2011                                                                                                               Page 25
All of the time          Several times    At least once a      3 or more times                               1-2 times per   Less than once a
  Never over
                            per day                  day        per week but not                                 week             week
the past 2
                                                                             every day
weeks
                                                                                                                               


8. Over the past 2 weeks, how much has your shortness of breath bothered you?

  Extremely  Quite a bit                 Moderately         Slightly                                         Not at all       I’ve had no
shortness
  bothersome bothersome                  bothersome         bothersome                   bothersome                          of breath

                                                                                                                                   

9. Over the past 2 weeks, on average, how many times have you been forced to sleep sitting up in a chair or
with at least 3
   pillows to prop you up because of shortness of breath?

      Every night        3 or more times 1-2 times a     Less than once Never over the
                           a week, but not          week            a week       past 2 weeks
                         every day

                                                                                                 

10. Heart Failure symptoms can worsen for a number of reasons. How sure are you that you know what to do,
or whom to
    call, if your heart failure gets worse?

       Not at all        Not very sure   Somewhat sure Mostly sure                   Completely sure
         sure
                                                                                             

11. How well do you understand what things you are able to do to keep your heart failure symptoms from
getting worse? (for example, weighing yourself, eating a low salt diet, etc.)

        Do not     Do not                Somewhat             Mostly                 Completely
      understand understand               understand        understand               understand
      at all     very well
                                                                                         

12. Over the past 2 weeks, how much has your heart failure limited your enjoyment of life?

    It has extremely          It has limited       It has          It has slightly It has not limited my
       limited my   my enjoyment moderately                limited my        enjoyment of life
     enjoyment of    of life quite      limited my        enjoyment of            at all

Summary of Changes
10/7/2011                                                                                                                           Page 26
      life                a bit                                  enjoyment of life                     life

                                                                                                                  

THE KANSAS CITY CARDIOMYOPATHY QUESTIONNAIRE: (KCCQ)

13. If you had to spend the rest of your life with your heart failure the way it is right now, how would you feel
about this?

     Not at all          Mostly                  Somewhat                  Mostly satisfied Completely
     satisfied        dissatisfied                satisfied                                  satisfied
                                                                                                              

14. Over the past 2 weeks, how often have you felt discouraged or down in the dumps because of your heart
failure?

     I felt that way I felt that                  way      I occasionally I rarely felt that I never felt that
     all of the      most of the                 felt that way           way              way
        time            time

                                                                                                              

15. How much does your heart failure affect your lifestyle? Please indicate how your heart failure may have
limited your
     participation in the following activities over the past 2 weeks?
                                     Please place an X in one box on each line

Activity                Severely                 Limited             Moderately Slightly                                    Did not                   Does
not apply or did
                         limited                 quite a bit               limited             limited                    limit at all       not do for other
reasons
Hobbies, recreational
      activities                                                                                                                                    
Working or doing
    household chores                                                                                                                 

Visiting family or friends
    out of your home                                                                                                                                
Intimate relationships
    with loved ones                                                                                                                                 


Developed by John Spertus et al., Mid America Heart Institute, Saint Luke’s Hospital, Kansas City, MO.




Summary of Changes
10/7/2011                                                                                                                                            Page 27
                      SUMMARY OF CHANGES TO THE
                           DATA ELEMENTS

DATA ELEMENTS

The following elements have been added to the INTERMACS data collection:

      Marital Status, Domestic Partners
      Chronic Renal Disease, Yes or No
      Unfavorable mediastinal anatomy, Yes or No
      Frequent ICD Shocks, Yes or No
      Sustained Ventricular Tachycardia episode or ICD shocks, Yes or No
      Tracheostomy, Yes or No
      Plastic Bronchitis, Yes or No
      GI Ulcers, Yes or No
      Anasarca, Yes or No
      BMT(bone marrow transplant), Yes or No
      HIV, Yes or No
      Genetic syndrome, Yes or No
      Frequent ICD Shocks, Yes or No
      Atrial arrhythmia, Yes or No
      Atrial pacing
      Ventricular pacing
      Atrial and ventricular pacing
      Use of allopurinol
      Aneursyomectomy (DOR)
      Endocarditis, native
      IV inotrope therapy, Other specify
      CRT (chronic resynchronization therapy), Yes, No or Unknown
      Use of Metalozone/Thiazide, Yes, No or Unknown
      Phosphodiesterase inhibitors, Yes, No or Unknown
      Insensitivity (C Reactive Protein)
      Uric Acid
      Lymphocyte Count
      LDH
      Lupus anticoagulant
      Hydralazine
      Antiplatelet therapy drug
      Syncope without known cause
      Fever without known cause
      Gait Speed, 15 foot walk in ____ seconds
      Pre-implant Quality of Life questions

Summary of Changes
10/7/2011                                                                   Page 28
      Post-implant Quality of Life questions
      KCCQ (Kansas City Cardiomyopathy Questionnaire)
      Doppler Opening Pressure: ____ mmHg, Unknown or Not Done
      CVP: ___mmHg, Unknown or Not Done
      Symptoms of TIA (Transient Ischemic Attack)
      Symptoms of Encephalopathy: Metabolic, Anoxic, Traumatic, Other
      Symptoms of Confusion
      Location of CNS event: Bilateral, Cerebellar, Thalamic
      Primary causes of death: Specify
      CNS Death
      Multi system organ system
      Reason for hospitalization: Specify
      Reason support withdrawn: Specify
      Neurological Dysfunction Categories: CVA: Ischemic, CVA: Hemorrhagic, CVA:
       Other, Seizure: Generalized, Seizure: Focal, Encephalopathy: Metabolic,
       Encephalopathy: Anoxic, Encephalopathy: Traumaticm, Encephalopathy: Other,
       Confusion
      Location of CNS event: Right hemisphere: frontal, Right hemisphere: temporal,
       Right hemisphere: occipital, Right hemisphere: parietal, Left hemisphere:
       frontal, Left hemisphere: temporal, Left hemisphere: occipital, Left hemisphere:
       parietal, Bilateral: frontal, Bilateral: temporal, Bilateral: occipital, Bilateral:
       parietal, Occipital, Brain stem, Cerebellar, Thalamic, Unknown, Other
      Source/cause/location of Bleeding: Mediastinal: chest wall, outflow-aorta
       anastomosis, outflow conduit, inflow conduit, aortic- venous cannulation site,
       coagulopathy with no surgical site, other surgical site, Pump Pocket, Pleural
       space, Intra-abdominal, Retroperitoneal, Pulmonary,Device anastamosis,Urinary
       tract, GI: Upper gastrointestinal (esophagus, stomach, duodenum, small bowel),
       Lower gastrointestinal (colon, rectum, and anus), unknown, but guaiac positive
       stools

The following elements have been added to the INTERMACS Pediatrics data
collection:

      Age Ranges: 0-1, 2-10, 11-21
      Body Surface Area and Body Mass Index
      Plastic Bronchitis, Yes or No
      Protein Losing Enteropathy, Yes or No
      Genetic Syndrome: Muscular Dystrophy, Down’s Syndrome, Noonan’s, Other
       specify
      Pyschosocial issues: Parental concerns
      Number of cardiac hospitalizations: 0-1, 2-3, >4
      Cardiac diagnosis: Cancer, Congenital Artery Disease, Single Ventricle,
       Hypoplastic Left Heart, Pulmomary Artesia with IVS, Heterotaxy/Complex CAVC,
Summary of Changes
10/7/2011                                                                          Page 29
       Congenitally Corrected Transposition (I-TGA), Ebstein’s Anomaly, Kawasaki
       Disease, Left Heart Valve/Structural Hypoplasia, TOF/TOF Variant, Transposition
       of the Great Arteries (d-TGA), Trancus Arteriosus
       Dialated - Adriamycin, Alcoholic, Familial, Idiopathic, Myocarditis, Post Partum,
       Viral, Ischemic, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy:
       Amyloidosis, Endocardial Fibrosis, Idiopathic, Sarcoidosis, Radiation/Chem,
       Valvular Heart Disease, Transplant, Unknown, Other specify
      Congenital cardiac surgery: Arterial switch, atrial switch (senning/mustard)
       Functional Capacity: Sedated, Paralyzed, Intubated, Ambulating, Primary
       Nutrition orally, Primary Nutrition per feeding tube, Primary Nutrition TPN
      Temporary support: Rotaflow
      Thrombus, ASD
      PVR
      Ventricular tachycardia
      Location of CNS event: Subdural, Spinal cord
      Method of Diangosis of CNS event: EEG, Ultrasound
      Wound Dehiscensce Location: Sternum, Driveline sites




Summary of Changes
10/7/2011                                                                       Page 30

				
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