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

Sixth Annual Meeting March 12, 2012 8:00am to 4:00pm Crowne Plaza National Airport Arlington, VA. Research Symposium. INTERMACS Annual Meeting March 2012. Sixth Annual Meeting, March 12, 2012. What are the outstanding issues with VADs? Which of these can be answered by INTERMACS?

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

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

  2. Sixth Annual Meeting, March 12, 2012 What are the outstanding issues with VADs? Which of these can be answered by INTERMACS? Robert Kormos, MD INTERMACS Annual Meeting March 2012

  3. How can INTERMACS help shape the Future of MCS? • Where is the field today? • Recap the role of INTERMACS • Destination Therapy: Evolving • Heart Transplantation: Also Dynamic • Major Challenges to MCSD Therapy • Upcoming Initiatives to Help Answer the Questions INTERMACS Annual Meeting March 2012

  4. How can INTERMACS help shape the Future of MCS? • Where is the field today? • Recap the role of INTERMACS • Destination Therapy: Evolving • Heart Transplantation: Also Dynamic • Major Challenges to MCSD Therapy • Upcoming Initiatives to Help Answer the Questions INTERMACS Annual Meeting March 2012

  5. How can INTERMACS help shape the Future of MCS? INTERMACS Annual Meeting March 2012 Dr. Marvin Slepian, University of Arizona

  6. Changing the Life Cycle of New Technology Tornado Paradigm Shift 2 Value Added Adjuvant functions Controls Changeable parts R and L components Wear indicators Forgettable Bowling Alley Tornado Paradigm Shift 1 INTERMACS Annual Meeting March 2012 Bowling Alley ISHLT 2004

  7. How can INTERMACS help shape the Future of MCS? INTERMACS Annual Meeting March 2012 Dr. Marvin Slepian, University of Arizona

  8. How can INTERMACS help shape the Future of MCS? Temporary Devices (include only in conjunction LVAD, BIVAD, TAH with a durable device listed above) HeartMate II LVAS Abiomed AB5000 HeartMate IP Abiomed BVS 5000 HeartMate VE Levitronix Centrimag HeartMate XVE TandemHeart Micromed DeBakey VAD – Child Novacor PC Novacor PCq Thoratec IVAD Thoratec PVAD Abiocor TAH Syncardia Cardiowest INTERMACS Annual Meeting March 2012

  9. How can INTERMACS help shape the Future of MCS? Later this afternoon, Dr. Tim Baldwin will show the (miniature) pediatric devices that will be part of the PumpKiN Trial INTERMACS Annual Meeting March 2012

  10. How can INTERMACS help shape the Future of MCS? • Where is the field today? • Recap the role of INTERMACS • Destination Therapy : Evolving • Heart Transplantation: Also Dynamic • Major Challenges to MCSD Therapy • Upcoming Initiatives to Help Answer the Questions INTERMACS Annual Meeting March 2012

  11. INTERMACS Hospital Enrollment INTERMACS Annual Meeting March 2012

  12. : June 2006 – December 2011 Primary Implant Enrollment: n=5407 Continuous Flow Intracorporeal LVAD Pump Pulsatile Flow Intracorporeal TAH Pulsatile Flow Intracorporeal LVAD Pump Pulsatile Flow Paracorporeal LVAD Pump Implants per year INTERMACS Annual Meeting March 2012 Cont Intra Pump 1 1 464 843 1526 1548 Puls Intra TAH 2 22 22 24 27 15 Puls Intra Pump 82 263 183 55 12 2 Puls Para Pump 18 61 74 71 36 55

  13. INTERMACS: Survival After LVAD Implant Implants: June 2006 – March 2010 Continuous Flow Intracorporeal Device n=896, deaths=112 Pulsatile Flow Intracorporeal Device, n=470, deaths=140 Pulsatile Flow Paracorporeal Device, n=74, deaths=28 % Survival p (overall) < 0.0001 Event: Death (censored at transplant or recovery) INTERMACS Annual Meeting March 2012 Months after Device Implant

  14. How can INTERMACS help shape the Future of MCS? • Where is the field today? • Recap the role of INTERMACS • Destination Therapy : Evolving • Heart Transplantation: Also Dynamic • Major Challenges to MCSD Therapy • Upcoming Initiatives to Help Answer the Questions INTERMACS Annual Meeting March 2012

  15. How can INTERMACS help shape the Future of MCS? Destination Therapy Evolution from “Transplant Ineligible” to “Transplant Alternative” INTERMACS Annual Meeting March 2012

  16. How can INTERMACS help shape the Future of MCS? . INTERMACS Annual Meeting March 2012 Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure (for the REMATCH Study Group). N Engl J Med 2001; 345:1435-1443; Nov 15, 2001 .

  17. How can INTERMACS help shape the Future of MCS? . INTERMACS Annual Meeting March 2012 Long-Term Destination Therapy With the HeartMate XVE Left Ventricular Assist Device: Improved Outcomes Since the REMATCH Study. Congestive Heart Failure, 11: 133–138.

  18. Overall Survival : June 2006 – June 2011 Primary Continuous Flow LVADs (+/- RVADs): n= 3405* Bridge to Transplant Listed, n=1221, deaths=153 Destination Therapy, n=740, deaths=132 Bridge to Candidacy, n=1391, deaths=247 % Survival By initial Device Strategy p < .0001 Event: Death (censored at transplant or explant recovery) INTERMACS Annual Meeting March 2012 Months after Device Implant *An additional 53 pts had initial device strategy of rescue therapy (n=11), recovery (n=21) and other (n=21). These patients are not included in the figure. Figure 10 12/14/2011

  19. : June 2006 – December 2011 Primary Implant Enrollment: n=5407 Other* BTC BTT DT Implants per year INTERMACS Annual Meeting March 2012 Other 6 20 27 22 29 30 BTC 36 132 302 433 598 600 BTT 45 148 367 491 463 370 DT 16 47 47 47 511 620 * Other includes bridge to recovery, rescue therapy and miscellaneous.

  20. : June 2006 – December 2011 Primary Implant Enrollment, Destination Therapy: n=1286 Continuous Flow Intracorporeal Pump Pulsatile Flow Intracorporeal Pump Implants per year INTERMACS Annual Meeting March 2012 Cont Intra Pump 1 0 6 26 508 619 Puls Intra Pump 15 47 41 20 3 0

  21. How can INTERMACS help shape the Future of MCS? • Where is the field today? • Recap the role of INTERMACS • Destination Therapy : Evolving • Heart Transplantation: Also Dynamic • Major Challenges to MCSD Therapy • Upcoming Initiatives to Help Answer the Questions INTERMACS Annual Meeting March 2012

  22. Survival to 1 Year After Transplant for Adult Heart Transplants Performed Between January 1982 and June 2009, Stratified by Era of Transplant. INTERMACS Annual Meeting March 2012 The Registry of the International Society for Heart and Lung Transplantation-Twenty-eighth Adult Heart Transplant Report-2011. JHLT. 2011 Oct;30(10):1078-1094.

  23. Status II Patient CTRD: 1990 - 2001 100 Predicted Survival of a Status II Patient 90 No comorbid conditions 80 70 60 Smoker Percent Survival 50 40 30 20 10 INTERMACS Annual Meeting March 2012 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Years After Transplant

  24. Status II Patient CTRD: 1990 - 2001 100 Predicted Survival of a Status II Patient 90 No comorbid conditions 80 70 60 Smoker Percent Survival 50 40 30 20 Smoker, Diabetic 10 INTERMACS Annual Meeting March 2012 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Years After Transplant

  25. Status II Patient CTRD: 1990 - 2001 100 Predicted Survival of a Status II Patient 90 No comorbid conditions 80 70 60 Smoker Percent Survival 50 40 Smoker, Diabetic, Hx of Pulmonary Vascular Disease 30 20 Smoker, Diabetic 10 INTERMACS Annual Meeting March 2012 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Years After Transplant

  26. How can INTERMACS help shape the Future of MCS? • Where is the field today? • Recap the role of INTERMACS • Destination Therapy: Evolving • Heart Transplantation: Also Dynamic • Major Challenges to MCSD Therapy • Upcoming Initiatives to Help Answer the Questions INTERMACS Annual Meeting March 2012

  27. How can INTERMACS help shape the Future of MCS? • Major Challenges • Accurate contemporary risk-adjusted depictions of survival after cardiac transplantation • Risk-adjusted contemporary survival after mechanical circulatory support • Effective analyses that unveil the shortcomings of MCS therapy INTERMACS Annual Meeting March 2012

  28. How can INTERMACS help shape the Future of MCS? • Major Challenges • 4. Find “common ground” between Cardiac Transplantation and MCS analyses that accommodate the differing patient populations in Cardiac Transplantation, Destination Therapy – Transplant Ineligible, and Destination Therapy – Transplant Alternative INTERMACS Annual Meeting March 2012

  29. How can INTERMACS help shape the Future of MCS? • Major Challenges • 5. Develop analyses that are sensitive • to the evolution of individual devices and device categories as we allocate device therapies. INTERMACS Annual Meeting March 2012

  30. How can INTERMACS help shape the Future of MCS? • Specific Adverse Events that challenge the long-term implementation of MCS: • Early mortality and its causes • Infection of driveline and pump pockets • Right Ventricular Failure • Pump and Outflow Graft Thrombosis • Renal Dysfunction • Plus Quality of Life and Functional Capacity INTERMACS Annual Meeting March 2012

  31. Coordinator Training Session, March 11, 2012 DEVICE MALFUNCTION • Device Malfunction • Device malfunction denotes a failure of one or more of the components of the MCSD system which either directly causes or could potentially induce a state of inadequate circulatory support (low cardiac output state) or death. The manufacturer must confirm device failure. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure. • Device failure should be classified according to which components fails as follows: • ) Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components). In the special situation of pump thrombosis, thrombus is documented to be present within the device or its conduits that result in or could potentially induce circulatory failure. • 2) Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber) The Adverse Event: Device Malfunction Form is to be collected at time of event. FDA has set forth regulations regarding these events. For the purposes of submitting adverse event device malfunction information to the FDA, you must enter any device malfunction event that occurs within 72 hours of the event. INTERMACS Annual Meeting March 2012 INTERMACS Protocol 3.0 - Mar 5, 2012

  32. Coordinator Training Session, March 11, 2012 DEVICE MALFUNCTION INTERMACS Annual Meeting March 2012

  33. Coordinator Training Session, March 11, 2012 DEVICE MALFUNCTION INTERMACS Annual Meeting March 2012

  34. Coordinator Training Session, March 11, 2012 MAJOR INFECTION • Major Infection • A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). A positive culture from the infected site or organ should be present unless strong clinical evidence indicates the need for treatment despite negative cultures. The general categories of infection are listed below: • Localized Non-Device Infection • Infection localized to any organ system or region (e.g. mediastinitis) without evidence of systemic involvement (See sepsis definition), ascertained by standard clinical methods and either associated with evidence of bacterial, viral, fungal or protozoal infection, and/or requiring empirical treatment. • Percutaneous Site and/or Pocket Infection • A positive culture from the skin and/or tissue surrounding the drive line or from the tissue surrounding the external housing of a pump implanted within the body, coupled with the need to treat with antimicrobial therapy when there is clinical evidence of infection such as pain, fever, drainage, or leukocytosis. • Internal Pump Component, Inflow or Outflow Tract Infection • Infection of blood-contacting surfaces of the LVAD documented by positive site culture. (There should be a separate data field for paracorporeal pump that describes infection at the percutaneous cannula site, e.g. Thoratec PVAD). • Sepsis • Evidence of systemic involvement by infection, manifested by positive blood cultures and/or hypotension. INTERMACS Annual Meeting March 2012 INTERMACS Protocol 3.0 - Mar 5, 2012

  35. INTERMACS: June 2006 – September 2009: Infection Study Adult Primary intracorporeal LVADs: 1366 % Free of Infection Months Continuous Pulsatile/Intra Post Implant (n=896) (n=470) 1 81% 72% 3 74% 59% 6 67% 51% 12 61% 42% 24 58% 37% Continuous Intracorporeal pump, n=896, infections=265 % Freedom from Infection Pulsatile Intracorporeal pump, n=470, infections=190 P < .0001 Event: FirstInfection INTERMACS Annual Meeting March 2012 Months after Device Implant

  36. INTERMACS: June 2006 – September 2009: Infection Study Adult Primary intracorporeal LVADs: 1366 Continuous intracorporeal pump, n=896, infections=77 % Free of Pump pocket or Drive line Infection Pulsatile intracorporeal pump, n=470, infections=105 % Freedom from Pump pocket or Drive line Infection Months Continuous Pulsatile/Intra Post Implant (n=896) (n=470) 1 99% 96% 3 96% 87% 6 91% 77% 12 85% 64% 24 80% 62% P < .0001 Event: Firstpump pocket or drive line infection INTERMACS Annual Meeting March 2012 Months after Device Implant

  37. Freedom from Driveline Infection Continuous Flow Pump, n=2006, first DL infections=197 p < .0001 % Freedom from Driveline Infection Pulsatile Flow Pump, n=484, first DL infections=81 Months % Freedom 1 99% 6 93% 12 81% 24 74% INTERMACS Annual Meeting March 2012 Months after Implant

  38. Coordinator Training Session, March 11, 2012 NEUROLOGICAL DYSFUNCTION • Neurological Dysfunction • Any new, temporary or permanent, focal or global neurological deficit ascertained by a standard neurological examination (administered by a neurologist or other qualified physician and documented with appropriate diagnostic tests and consultation note). The examining physician will distinguish between a transient ischemic attack (TIA), which is fully reversible within 24 hours (and without evidence of infarction), and a stroke, which lasts longer than 24 hours (or less than 24 hours if there is evidence of infarction). The NIH Stroke Scale (for patients > 5 years old)must be re-administered at 30 and 60 days following the event to document the presence and severity of neurological deficits. Each neurological event must be subcategorized as: • Transient Ischemic Attack (acute event that resolves completely within 24 hours with no evidence of infarction) • Ischemic or Hemorrhagic Cardiovascular Accident/CVA (event that persists beyond 24 hours or less • than 24 hours associated with infarction on an imaging study.) INTERMACS Annual Meeting March 2012 INTERMACS Protocol 3.0 - Mar 5, 2012

  39. INTERMACS: June 2006 – September 2009: Neurological Dysfunction Adult Primary Continuous Intracorporeal LVADs: 896 By INTERMACS Patient Profile Levels IMACS 2, n=396, neuro events=28 IMACS 3, n=172, neuro events=12 IMACS 1, n=172, neuro events=23 IMACS 4-7, n=156, neuro events=15 % Free from Neurological Events p = .08 Event: First Neurological Event INTERMACS Annual Meeting March 2012 Months after Device Implant

  40. INTERMACS: June 2006 – September 2009: Neurological Dysfunction Adult Primary Pulsatile Intracorporeal LVADs: 470 By INTERMACS Patient Profile Levels IMACS 3, n=49, neuro events=8 IMACS 2, n=197, neuro events=33 IMACS 1, n=160, neuro events=41 % Free from Neurological Events IMACS 4-7, n=64, neuro events=11 p = .02 Event: First Neurological Event INTERMACS Annual Meeting March 2012 Months after Device Implant

  41. Coordinator Training Session, March 11, 2012 MAJOR BLEEDING AN EPISODE OF SUSPECTED INTERNAL OR EXTERNAL BLEEDINGTHAT RESULTS IN ONE OR MORE OF THE FOLLOWING: 1. Death, 2. Re-operation, 3. Hospitalization, 4. Transfusion of red blood cells If TRANSFUSION IS SELECTED, then apply the following rules: During first 7 days post implant: Adults (≥ 50 kg):≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant. After 7 days post implant Any transfusion of packed red blood cells (PRBC) after 7 days following implant with the investigator recording the number of units given. Note: Hemorrhagic stroke is considered a neurological event and not as a separate bleeding event. BLEEDING INTERMACS Annual Meeting March 2012 INTERMACS Protocol 3.0 - Mar 5, 2012

  42. Right Heart Failure Symptoms and signs of persistent right ventricular dysfunction [central venous pressure (CVP) > 18 mmHg with a cardiac index <2.0 L/min/m2 in the absence of elevated left atrial/pulmonary capillary wedge pressure (greater than 18 mmhg), tamponade, ventricular arrhythmias or pneumothorax] requiring RVAD implantation; or requiring inhaled nitric oxide or inotropic therapy for a duration of more than 1 week at any time after LVAD implantation. INTERMACS Protocol 2.3 - Oct 30, 2008 INTERMACS Annual Meeting March 2012

  43. Coordinator Training Session, March 11, 2012 RIGHT HEART FAILURE • Right Heart Failure • Symptoms and signs of persistent right ventricular dysfunction [central venous pressure (CVP) > 18 mmHg with a cardiac index <2.3 L/min/m2 in the absence of elevated left atrial/pulmonary capillary wedge pressure (greater than 18 mmhg), tamponade, ventricular arrhythmias or pneumothorax] requiring RVAD implantation; or requiring inhaled nitric oxide or inotropic therapy for a duration of more than 1 week at any time after LVAD implantation.” • LEVEL OF RIGHT HEART FAILURE • Severe RHF: RVAD • Moderate RHF: Inotrope or intravenous or inhaled pulmonary • vasodilator(e.g. prostaglandin E or inhaled nitric oxide) • Mild RHF: Meets 2 of the 4 clinical criteria listed below • CVP > 18 mmHg or mean RA pressure > 18 mmHg • CI < 2.3 L/min/M2 (by Swan) • Ascites or evidence of moderate to worse peripheraledema • Evidence of elevated CVP by echo (dilated VC, IVS with collapse), physical exam • (signs of increased jugular venous pressure) INTERMACS Annual Meeting March 2012 INTERMACS Protocol 3.0 - Mar 5, 2012

  44. Kaplan-Meier Survival: Device Type INTERMACS Annual Meeting March 2012

  45. INTERMACS: June 2006 – September 2009: Bi-VAD Study Adult Primary Implants, n=1706 Pre-Implant Patient Profile LVAD (n=1440) Bi-VAD (n=206) 1 Critical Cardiogenic Shock 380 (26%) 112 (54% 2 Progressive Decline 612 (43%) 78 (38%) 3 Stable but Inotrope dependent 226 (16%) 9 (4%) 4 Recurrent Advanced HF 150 (10%) 4 (2%) 5 Exertion Intolerant 27 (2%) 1 (1%) 6 Exertion Limited 22 (1%) 2 (1%) 7 Advanced NYHA Class III 23 (2%) 0 (0%) Total 1440 (100%) 216 (100%) p < .0001 * Total Artificial Heart devices (TAH) are excluded from this table INTERMACS Annual Meeting March 2012

  46. Implant dates: June 2006 – September 2009: Bi-VAD Study All Adult Primary LVADs and BIVADs: n=1646 RA Pressure LVAD (n=1440) Bi-VAD (n=206) < 10 277 (33%) 18(13%) 10-19 398 (47%) 72 (53%) 20-29 139 (17%) 44 (32%) 30+ 27 ( 3%) 3 (2%) Total 841 (100%) 137 (100%) Missing 599/1440 (42%) 69/206 (33%) INTERMACS Annual Meeting March 2012

  47. Coordinator Training Session, March 11, 2012 HEMOLYSIS Hemolysis A plasma-free hemoglobin value that is greater than 40 mg/dl, in association with clinical signs associated with hemolysis (e.g., anemia, low hematocrit, hyperbilirubinemia) occurring after the first 72 hours post-implant. Hemolysis related to documented non-device-related causes (e.g. transfusion or drug) is excluded from this definition. INTERMACS Annual Meeting March 2012 INTERMACS Protocol 3.0 - Mar 5, 2012

  48. How can INTERMACS help shape the Future of MCS? • Where is the field today? • Recap the role of INTERMACS • Destination Therapy: Evolving • Heart Transplantation: Also Dynamic • Major Challenges to MCSD Therapy • Upcoming Initiatives to Help Answer the Questions INTERMACS Annual Meeting March 2012

  49. MedaMACS • To provide parallel information about medical outcomes for survival, function, and quality of life • within INTERMACS profiles 4-7 • to help refine patient selection in the crucial range of ambulatory HF • where the greatest benefit of VAD is anticipated. INTERMACS Annual Meeting March 2012

  50. INTERMACS Annual Meeting March 2012

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