1. Sixth Annual Meeting March 12, 2012 8:00am to 4:00pm Crowne Plaza National Airport Arlington, VA INTERMACS Annual Meeting March 2012

2. Welcome James Young, MD INTERMACS Study Chair Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012

3. We would like to welcome our new INTERMACS hospitals in Canada INTERMACS Annual Meeting March 2012

4. 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 12, 2012 INTERMACS Annual Meeting March 2012

5. Folder Contents Agenda Slide Handouts ? ISHLT 2012 Abstracts and itinerary Publication, J. Kirklin List of all INTERMACS Publications, Abstracts and Authors Evaluation Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012

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 12, 2012 INTERMACS Annual Meeting March 2012

7. 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 Annual Meeting March 2012

8. INTERMACS Annual Meetings 133 178 150 176 Registered 170 Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012

9. 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 12, 2012 INTERMACS Annual Meeting March 2012

10. Impact of INTERMACS > 700 publications refer to INTERMACS Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012

11. “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 Annual Meeting March 2012

12. INTERMACS 2012: Past, Present and Future Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012

13. Overview of INTERMACS INTERMACS Re-Launch INTERMACS PediMACS INTERMACS Website: A New Look Business Plan Update Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012

14. What is on the horizon? –Revisit Adverse Event Definitions –New Data Elements –Revamped Auditing –Quality Assurance Reports including benchmarking –Expand and Augment Collection of Functional Capacity, Quality of Life and Neurocognitive Assessments –Revisit Process for Submitting Research Requests –Standardized Data Sets INTERMACS RENEWAL: April 2011 INTERMACS Annual Meeting March 2012

15. DONE INTERMACS RENEWAL: April 2011 What is on the horizon? –Revisit Adverse Event Definitions –New Data Elements –Revamped Auditing –Quality Assurance Reports including benchmarking –Expand and Augment Collection of Functional Capacity, Quality of Life and Neurocognitive Assessments –Revisit Process for Submitting Research Requests –Standardized Data Sets INTERMACS Annual Meeting March 2012

16. Overview of INTERMACS INTERMACS Re-LaunchNaftel INTERMACS PediMACS Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012

17. Coordinator Training Session: March 11, 2012 Status of INTERMACS Re-Launch 17  INTERMACSNaftel  pediMACSNaftel INTERMACS Annual Meeting March 2012

18. Coordinator Training Session: March 11, 2012 INTERMACS Re-launch Status 18  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 Annual Meeting March 2012

19. Coordinator Training Session: March 11, 2012 INTERMACS Re-launch Status 19  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 Annual Meeting March 2012

20. Coordinator Training Session: March 11, 2012 INTERMACS Re-launch Status 20  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 Annual Meeting March 2012

21. Coordinator Training Session: March 11, 2012 pediMACS Will be discussed later today David C. Naftel, PhD 21 INTERMACS Annual Meeting March 2012

22. INTERMACS Website: A New Look Mary Lynne Clark INTERMACS Annual Meeting March 2012

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29. Sixth Annual Meeting, March 12, 2012 Investigators INTERMACS Annual Meeting March 2012

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34. Sixth Annual Meeting, March 12, 2012 Enrolled Sites INTERMACS Annual Meeting March 2012

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