UMHS Center for Circulatory Support Program Overview

1. UMHS Center for Circulatory Support Program Overview

2. Ventricular Assist Device Innovation Continuous Flow Technology Centrifugal Design Continuous Flow Technology Axial Design 3rd Generation 2nd Generation Pulsatile Technology 1st Generation Investigational Bearingless with magnetic levitation FDA Approved BTT 2008 DT 2010 Bearings with stator FDA Approved BTT 1998 DT 2002 Bearings • Minaturization • Durability

3. Indications For VAD Implant • Bridge to Transplant (BTT) • NYHA Class III-IV end-stage left ventricular failure • Received optimal medical therapy for at least 60 of the last 90 days • Life expectancy of less than two years • Destination Therapy (DT) • All of the above • Not candidates for cardiac transplantation • Bridge to Recovery • Acute events ie. MI, viral • Bridge to Decision • Unknown eligibility for cardiac transplantation • Short term devices

4. Center for Circulatory Support Goals The Center for Circulatory Support will: • Be a leading program world-wide for the treatment of cardiogenic shock and advanced heart failure with MCS therapy • Provide best practice care that is integrated across disciplines offering optimal support of patients and their families • Be a world leader in research for MCS technologies. As new devices become available, both in clinical trials and after FDA approval, UM patients will be the first to benefit from their use • Refine our techniques and procedures as a leader in setting the standard for MCS technologies • Be recognized as the center that “trains the trainers” while training physicians and healthcare providers from around the world

5. Adult VAD Program C Cardiovascular Center Center for Circulatory Support Director Francis Pagani, MD, PhD Medical Director of Outpatient Mechanical Circulatory Support Jennifer Cowger, MD CV Surgeons Jonathan Haft, MD Matthew Romano, MD Supervisor VAD Program Maureen Daly-Myers RN, BSN VAD Research Sarah Fox, BA Lydia McGowan, MS Advanced Practice Professional Kevin Knott, MS, PA-C VAD Team Advance Heart Failure Program Ancillary Groups Support Nurse Manager Special Programs Janice Norville, RN MSN, MSBA, VAD Coordinators Deb Blissick, RN Teresa Colaianne, RN, BSN Rena Lucier, RN, MS Terry Mayville, RN, BSN Administrative Specialist Mark White, B.S.,MBA Administrative Assistant Lori Brenneman Pre & Post Transplant Nurses Heart Failure Nurses Pharmacy Angela Clark, PharmD Simona Butler, PharmD UjjainiKhgnderia, PharmD Physical & Occupational Therapy Dietary Social Work Ruth Halben, MSW Jennifer Reinstein- Campbell, LLMSW Erin Spangler. LLMSW Nursing Cardiac Perfusion Jan Aukerman, CCP Russell Butler, CCP Jackie Conliffe, CCP Kevin Griffith, CCP Financial Anne Maskill Biomedical David Marlow, CBET CVICU (CVC 4) Unit Manager Jole’ Mowry, RN, MSN 4C Unit Manager Bethany Lee-Lehner, RN Referring Physicians EMS Family Extended Care Facilities Home Health Cardiac Rehab

6. Program History • 1996: Program established under the direction of Dr. Pagani; First HeartMate IP implant • 1997: First patient to be discharged to home on LVAD support • 2000: Participated in REMATCH Trial (use of VADs for permanent therapy) • 2002: First 100 implanted patients • 2003: First patient to be discharged to an Extended Care Facility • 2004: First implant of the HeartMate II LVAD; Training center for Thoratec Inc • 2007: First implant of the DuraHeart LVAD; Training center for TerumoHeartInc • 2008: >300 long-term LVAD implants; Program achieves Advanced Certification from The Joint Commission • 2009: First implant of the HeatWare LVAD • 2010: Awarded $14.9 million dollar contract from the NHLBI to study the use of LVADs in less advanced stages of heart failure • 2011: 100+ ongoing patients at home; > 430 primary implants • 2012: Longest surviving patient in the world on continuous support with the HearMate II LVAD (8 years) was on the initial pump (7 years).

7. Total Long-term VAD Implants

8. Program Strengths • Highly skilled and experienced team • Longevity of staff in multiple disciplines • Internationally recognized faculty and staff • Multidisciplinary team approach • Participation and leader in clinical trials • Exceptional patient outcomes

9. Program Advancements & Improvements • Device Proficiency review bi-annually. • Outreach Program development in process. • Internal web page to share and disseminate program and device information. • New VAD Support Group (Meets 2x/month). • Enhanced Outpatient Ambulatory Services through a shared collaborative model with Heart Failure Cardiologist and Cardiac Surgeons.

10. INTERMACS • INTERMACS®(Interagency Registry for Mechanically Assisted Circulatory Support) • National registry for patients who are receiving FDA approved mechanical circulatory support device therapy to treat advanced heart failure.  • 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.

11. INTERMACS • Participation in INTERMACS is MANDATORY to receive CMS reimbursement for Destination Therapy (DT) • Participation as a center in good standing is required by The Joint Commission for Advanced Certification

12. The Joint Commission Advanced Certification • For the adult VAD DT population. • Requires strong infrastructure and support from program administration. • Must be an active continuous member of a national registry (INTERMACS). • Have a Board Certified Cardiac Surgeon who has implanted at least 10 devices over the last 36 months. • Certification requires on site survey every 2 years with an intra-cycle review during the off year. • Monthly data collection with quarterly data submission on four performance measures. • Show continuous improvement activities through regular clinician & DSC program staff meetings.

13. Performance Measures • Patient 1yr Survival Rate • Length of Stay (Post-op Index Hospitalization) • Major Bleeding • Major Device Infection

14. Rolling 1-yr Survival Rate 2010-2011

15. Survival Benchmark - Intermacs

16. 2008-2010 Index LOS

17. Hospital LOS 2010-2011 • Performance Measures • Length of Stay (Index Hospitalization) • 2010 (58 Patients) • LOS 26 days • 2011 (37 Patients) • LOS 29 days

18. Major Bleeding 2010-2011 • Performance Measures • Major Bleeding (Returned to OR for bleeding or received 4 units PRBC’s after original implant) • 2010 • 7/61 (11.5%) • 2011 • 4/39 (10.3%)

19. Major Device Infection 2010-2011 • Performance Measures • Major Device Infection • 2010 • 1/61(1.64%) Patients with major device infections • 2011 • 1/39 (2.56%)Patients with major device infection

20. INTERMACS: June, 2006 – June, 2011

21. Program Challenges • Dissemination of knowledge within institution • Hospital Policy Development (Transport, ACMS, MPU) • Maintaining competency/training • Education • Patient • Healthcare Providers • Referral Physicians • Community • Continual communication • Allowing team to optimize care • Maintaining operational and service management with increasing patient volume • 100+ patients at home.