Sixth Annual Meeting Coordinator Training Session March 11, :00pm to 9:00pm Arlington, VA 1 INTERMACS Coordinator Training March 2012

Conflict of Interest Presenters and panel members are members of Hospitals, National Heart, Lung and Blood Institute, Food and Drug Administration, United Network for Organ Sharing, and Device Manufacturers. Financial Disclosures from presenters and panel members include equity interests in the form of stocks and employment, and significant payments to individuals and institutions for consulting and clinical trials. Please contact INTERMACS for a full list of disclosures. Sixth Annual Meeting, March 11, 2012 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Welcome David C Naftel, PhD Co-PI INTERMACS Director of the DCC 3 INTERMACS Coordinator Training March 2012

We would like to welcome our new INTERMACS hospitals. We would also like to welcome any hospitals that are considering joining INTERMACS INTERMACS Coordinator Training March 2012

We would like to welcome our new INTERMACS hospitals in Canada INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Handouts  Agenda  Site Users’ Guide  Evaluation form  All slides from today’s meeting and tomorrow’s Annual Meeting will be on the INTERMACS website 6

What is INTERMACS ? INTERMACS is the United States national registry for patients who are receiving durable, FDA approved mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives. Sixth Annual Meeting, March 11, 2012 INTERMACS Coordinator Training March 2012

Facilitate the refinement of patient selection to maximize outcomes with current and new device options. Identify predictors of good outcomes as well as risk factors for adverse events after device implantation. Develop consensus “best practice” guidelines to improve clinical management by reducing short and long term complications of MCSD therapy. Guide clinical application and evolution of next generation devices. Utilize Registry information to guide improvements in technology, particularly as next generation devices evolve. Goals of the Registry INTERMACS Coordinator Training March 2012

“Perhaps the most successful example of a coordinated effort to study newly introduced devices has been the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), established to capture detailed clinical data on all patients receiving implantable ventricular assist pumps in the United States.” Postmarketing Surveillance of Medical Devices - Filling in the Gaps Frederic S. Resnic, M.D., and Sharon-Lise T. Normand, Ph.D. February 14 th, 2012 INTERMACS Coordinator Training March 2012

Original Contract May 31, 2005 – May 30, 2010 Contract Extension May 31, 2010 – November 30, 2010 Second Contract December 1, 2010 – November 30, 2015 Sixth Annual Meeting, March 11, 2012 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 COURSE OBJECTIVES  Obtain better understanding of WBDE System  Management of adverse event reporting  Review registry data compliance and data elements 11 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, 2012 Nurse Monitors 12 INTERMACS Coordinator Training March 2012

We Listened (Evaluation from last year’s Coordinator Training and Annual Meeting and everything we heard throughout the year)  Made changes to the Site Users’ Guide  Handouts  Online Training  Coordinator Training on a Separate Day and Keep the Presentations on Time  WBDE entry modifications  Expansions to the QA Site reports 13 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Status of INTERMACS Re-Launch 14  INTERMACSMyers  pediMACSNaftel  Local IRB Submission Clark and Hospital Enrollment INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 INTERMACS Susan L. Myers INTERMACS Database Administrator 15 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 INTERMACS Re-launch Status 16  Our Goals :  Reduce the number of elements and forms  Streamline the data entry process  Clarify elements that were confusing in the past  Examine the AE definitions for current clinical relevance INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 INTERMACS Re-launch Status 17  We (INTERMACS PIs, NIH, various committees, Site Coordinators, Site Administrators, etc.) have spent 1 year reviewing the WBDE in all aspects:  AE definitions and other definitions  Screens / Forms  Data Elements  Patient Flow through the WBDE INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 INTERMACS Re-launch Status 18  Live test site  Currently available (March 9, 2011)  Testing by INTERMACS Nurse Monitors  Testing by the DCC Data Managers  Testing by the INTERMACS Co-PIs  Testing by 3 Hospitals (Beta Sites)  Testing NOW during this live training session  Target Launch Date: April 4, 2012  Training will be available before launch date Live Test Site March 9, 2012 LAUNCH April 4, 2012 Mar 11 - Mar 30 “March Madness” INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 pediMACS David C. Naftel, PhD 19 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 INTERMACS Re-Launch Status  Our Goals :  Reduce the number of elements and forms  Streamline the data entry process  Clarify elements that were confusing in the past  Examine the AE definitions for current clinical relevance 20 It became clear that the pediatric VAD patients needed a different web-based data entry system. INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 pediMACS Launch Status  Pediatric Committee  Betsy Blume, MD- Chair  David Morales, MD  David Rosenthal, MD  Peter Wearden, MD  Christopher Almond, MD  Robert Jaquiss, MD  Jonathan Chen, MD  Dee Dee Epstein, RN  Heidi Moses, MEd, CCRA  David Naftel, PhD  Tim Baldwin, PhD 21 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 pediMACS Launch Status 22  We (Pediatric Committee, NIH, INTERMACS Co-PIs) have spent 1 year reviewing the WBDE in all aspects:  AE definitions and other definitions  Screens / Forms  Data Elements  Patient Flow through the WBDE INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 pediMACS Launch Status 23  pediMACS will follow the structure of INTERMACS  A few important changes from INTERMACS:  Pediatric patients (< 19 yrs. at time of implant)  Includes both durable and temporary support MCSDs  Modifications of AE definitions  Possible expansion of quality of life instruments INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 pediMACS Launch Status 24  Target Live test site: July 1, 2012  Testing by INTERMACS Nurse Monitors  Testing by the DCC Data Managers  Testing by the INTERMACS Co-PIs  Testing by 3 Hospitals (Beta Sites)  Testing by Pediatric Committee  Target Launch Date: August 1, 2012  Online training will be available  Training Session in September 2012 Target: Live Test Site July 1, 2012 Target: LAUNCH Date Aug 1, 2012 Jul 1 - Jul 31 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 pediMACS Launch Status 25  Training Session for pediMACS  “Mechanical Cardiac Support in Pediatric Heart Disease – State of the Art 2012”: September 20-22, 2012  The St. Louis Children’s and Washington University Heart Center INTERMACS Coordinator Training March 2012

Institutional Review Board or Ethics Board Submission Mary Lynne Clark Regulatory Manager INTERMACS INTERMACS Coordinator Training March 2012

Coordinator Training, March 11, 2012 If you want to make enemies, try to change something. ~Woodrow Wilson INTERMACS Coordinator Training March 2012

INTERMACS Changes Protocol 3.0 Consent Documents Users’ Guide Web Based Data Entry Wednesday, April 4, 2012 Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

INTERMACS Changes Protocol 3.0 Consent Documents Users’ Guide Web Based Data Entry Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

Protocol 3.0 Revised Contract Number Increased number of participating sites Increased number of contract years Revised site enrollment requirements Revised annual renewal requirements Clarified Inclusion Criteria Added Kansas Cardiomyopathy Questionnaire (KCCQ) Increased Quality of Life Questionnaire Removed Blood and Tissue Collection Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

INTERMACS Changes Protocol 3.0 Consent Documents Users’ Guide Web Based Data Entry Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

Consent Documents Increased number of sites Increased number of potential subjects Increased number of contract years KCCQ 6 minute walk and gait speed Increased time for QoL and functional tests Changed Study to Registry Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

INTERMACS Changes Protocol 3.0 Consent Documents Users’ Guide Web Based Data Entry Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

Users’ Guide Today’s discussion Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

INTERMACS Changes Protocol 3.0 Consent Documents Users’ Guide Web Based Data Entry Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

Web Based Data Entry Today’s discussion Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

First to provide IRB approval for the Protocol version 3.0 Univ. of Iowa Hospitals and Clinics Received on 2/3/2012 Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

I just submitted version 2.3 for approval. What do I do now? Enrolling Sites Oh no!! Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

Continue with the version 2.3 approval then follow up with the version 3.0 as an amendment. Retract the version 2.3 submission and replace it with the version 3.0 Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

Coordinator Training UNOS Jo SmithRochelle Taylor Susan GroffRuth Henson Kathryn Philibin DCC Kathryn HollifieldGail Mertz Jessica RobinsonMary Lynne Clark INTERMACS Coordinator Training March 2012

Busy: engaged in action; full of activity 3/9/2012 Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012

133 Activated Sites (currently 131) 1,705 INTERMACS Personnel 1,267 IRB Approvals since ,590 Informed Consent, HIPAA, Revoke Authorization, Transfer, Blood / Tissue documents 1,490 Human Subjects Training Certificates 1,805 Financial Disclosure / Conflict of Interest Coordinator Training, March 11, 2012 INTERMACS Coordinator Training March 2012