Status of Implantable VADs

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Clare Arnold
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1 Status of Implantable VADs John V. Conte, MD, Professor of Surgery Johns Hopkins University School of Medicine Division of Cardiac Surgery The Johns Hopkins Medical Institutions

2 Conflict of Interest Statement No Financial Interests Investigator Thoratec: Heartmate 2 LVAD Heartware: HVAD LVAD Abiomed : Abiocor TAH

3 Status of Implantable VADs Current approved devices Contemporary outcomes Survival Complications GI Bleeding Thrombosis Stroke Infection Future Considerations

4 Implantable VAD

5 Indications for Implantable LVADs Bridge to Transplant (BTT) Non-reversible left heart failure Imminent risk of death Candidate for cardiac transplantation Destination Therapy (DT) NYHA Class IIIB or IV heart failure Optimal medical therapy 45 of last 60 days Not candidate for cardiac transplantation

Worldwide Clinical Experience > 10,000 Patients Implanted Pilot Trial n=53 Pivotal Trial Commercial n=1315* Experience *as treated n>9000 (+114 XVEs) Bridge to Transplant n=490 BTT Approvals

6 Worldwide Clinical Experience > 10,000 Patients Implanted Pilot Trial n=53 Pivotal Trial Commercial n=1315* Experience *as treated n>9000 (+114 XVEs) Bridge to Transplant n=490 BTT Approvals CE Mark: Nov FDA: Apr Health Canada: May 2009 Destination Therapy n=825 DT Approvals CE Mark: Nov FDA: Jan Health Canada: Nov 2010 On file with Thoratec As of Apr 2012

7 Worldwide Clinical Experience* More than 10,000 patients worldwide have now been implanted with the HeartMate II LVAS. Patients supported 1 year: 3771 Patients supported 2 years: 1528 Patients supported 3 years: 552 Patients supported 4 years: 194 Patients supported 5 years: 62 Patients supported 6 years: 16 Patients supported 7 years: 1 On file with Thoratec As of Apr 2012 *Based on clinical trial and device tracking data

8 Heartmate 2: BTT Experience Survival Percent Implant dates n 30 d 6 Mo 12 mo 50 a Apr 08 - Oct % 89% 85% b Apr 08 - Aug % 90% 85% 40 c Mar 07 - Apr % 86% 80% d Mar 05 - Mar % 82% 73% e Mar 05 - May % 75% 68% a John et al STS 2011 b Starling et al JACC (in press) d Pagani et al JACC 2009 e Miller et al NEJM Months Post-Trial a Post-Approval Study b Late Trial c Early-mid Trial d Early Trial e

9 INTERMACS Profiles Starling, Naka, Boyle, et al. JACC. 2011;57:19.

10 Outcomes Based on INTERMACS Profile Length of Stay Post-VAD Actuarial Survival Post-VAD Less acutely ill, ambulatory patients in INTERMACS profiles 4 7 had better survival and reduced length of stay compared to patients who were more accurately ill in profiles 1 3. Group 1: INTERMACS 1 Group 2: INTERMACS 2 3 Group 3: INTERMACS 4 7 Boyle, Ascheim, Russo, et al. JHLT. 2011;30:4.

11 . End-Organ Function Data Renal Function BUN (mg/dl) Creatinine (mg/dl) VAD Day Baseline Values: Above Normal Baseline Values: Normal All Pts with abnormal renal function group demonstrated significant improvements (p<0.0001) over the period of support. Russell SD, Rogers JG, Milano CA, et al, Circulation, 2009;120:

12 End-Organ Function Data Hepatic Function Total Bilirubin (mg/dl) Baseline Values: Above Normal 1. 0 Baseline Values: Normal 0. 0 All AST (U/L) ALT (U/L) V A D D a y Pts with abnormal hepatic function group demonstrated significant improvements (p<0.001) over the period of support. Russell SD, Rogers JG, Milano CA, et al, Circulation, 2009;120:

13 500 HM2 DT Trial CAP: Functional Class Improvements 6-Minute Walk Test and NYHA Functional Class I & II 6MWD NYHA Class I or II 400 EarlyTrial (N=133) Distance (m meters) Mid Trial (N=281) P < over time P = between groups P = interaction Pts Tested Months Pts Tested: Park, S, et al Circ Heart Fail

14 HeartMate Functional II demonstrated Capacity and clinically Quality of meaningful Life Data improvements across each of the five measures assessed Clinically Meaningful during Measure the HeartMate II Pivotal Measure Focus Trial. HM II Data Change Change Six Minute Walk Test Functional Capacity 39-m m NYHA Functional Assessment Functional Capacity 1 NYHA Improvement 80% 2 NYHA Improvements Metabolic Equivalent Task Score (METs) Functional Capacity 1 MET Improvement 60% 1 MET Improvement Minnesota Living with Heart Failure Quality of Life 5 points points Kansas City Cardiomyopathy Questionnaire Quality of Life 5 points points 1 Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346: Rector TS, Cohn JN., Am Heart J 1992;124: Rector TS, Kubo SH, Cohn JN. Am J Cardiol 1993;71: Spertus J, Peterson E, Conard MW, et al. Am Heart J 2005;150: Majani G, Giardini A, Opasich C, et alj Card Fail 2005;11: Rogers JG, Aaronson KD, Boyle AJ et al, JACC, 2010;55:

15 Patients demonstrated neurocognitive improvement in each Neurocognitive of the five domains Function over Data the two year follow-up period with no decline seen during any interval. p-values Domain Test 3 mo 6 mo 12 mo 24 mo (1) Visual-Spatial Perception (2) Memory Auditory Clock Drawing WAIS-III Block Design < WMS-III LM <0.001 <0.001 <0.001 <0.001 WMS-III LM Delay <0.001 <0.001 <0.001 <0.001 (2) Memory Visual WMS-III VR <0.001 <0.001 < WMS VR Delay <0.001 <0.001 <0.001 <0.001 (3) Executive Function WAIS-III Digit Symbol <0.001 < Trail Making B < (4) Language Boston Naming (abbrev) <0.001 <0.001 (5) Processing Speed Trail Making A < Statistically Significant Improvement Petrucci R, Russell S, Gallagher C, et. al., ISHLT 2010.

HeartMateII Adverse Events Post-approval study pts experienced a reduced or similar rate of adverse events in a broader patient care environment compared to clinical trial patients.

16 HeartMateII Adverse Events Post-approval study pts experienced a reduced or similar rate of adverse events in a broader patient care environment compared to clinical trial patients. No pump replacements through the first 6 mos of support in the post-approval study group. Starling, Naka, Boyle, et al. JACC. 2011;57: PaganiFD, Miller LW, Russell SD.. J Am CollCardiol. 2009;54:

17 HM II Risk Score Study Cohorts Patients undergoing HeartMateII implant enrolled into the HeartMateII Bridge-to-Transplant (N=489) 1,2 and Destination Therapy (N=633) 3 trials were included (Total N=1,122). Multivariable analyses were performed to identify the risk factors of death following LVAD implantation. Patients were prospectively and randomly assigned to either the derivation cohort or to the validation cohort. Cowger J, Sundareswaran K, Rogers J, et al. ISHLT Miller L, Pagani F, et al. N Engl J Med. 2007;357: Pagani F, Miller L, et al. JACC. 2009;54: Slaughter M, Milano C, Rogers J, et al. N Engl J Med. 2009;361:

18 Risk Stratification in HeartMate II Patients Comparison of Derivation and Validation Cohorts Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.

19 Multivariate Predictors* of Death Post LVAD Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.

20 Bleeding, Stroke, Thrombosis HM2 Outpatients Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

21 Female Gender Only Independent Risk Factor for Stroke and Pump Thrombosis Females were twice as likely to experience a stroke or pump thrombosis event. Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

Impact of Infection on Stroke and Thrombosis During a ±14 day window around an infection event patients were: 4 times more likely to experience a hemorrhagic stroke

22 Impact of Infection on Stroke and Thrombosis During a ±14 day window around an infection event patients were: 4 times more likely to experience a hemorrhagic stroke event 8 times more likely to experience an ischemic stroke event 9 times more likely to experience a pump thrombosis event Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

23 Driveline Infections

24 Velour Versus Silicone Skin Interface Velour N=16 Silicone N=16 Mean Age (years) Gender (M/F) 14/2 13/3 Indication (BTT/BTC/DT) 11/1/4 13/1/2 Ledford ID, Miller DV, Mason NO, et al. ISHLT 2011.

25 Histology Velour exhibits more dermal inflammation and an irregular shaped stratum corneum. Silicone is smooth and regular, and shows less inflammation. Ledford ID, Miller DV, Mason NO, et al. ISHLT 2011.

26 Contemporary DT Results Park SJ. AHA Scientific Sessions, November Slaughter M, Milano C, Rogers J, et al. N EnglJ Med. 2009;361:

27 Contemporary DT Results Park SJ. AHA Scientific Sessions, November 2010.

28 Contemporary DT Results The CAP results show a decrease in major adverse events. Park SJ. AHA Scientific Sessions, November 2010.

29 Heartware HVAD BTT and CAP 241 ptsthru 1/15/11

30 European Assoc Cardiothoracic Surgery Oct 2011

31 HM2 64 % Intermacs1 & 2 European Assoc Cardiothoracic Surgery Oct 2011

32 HM with velour and 0.0 with silicone HM2 3% RVAD European Assoc Cardiothoracic Surgery Oct 2011

33 HM events HM events European Assoc Cardiothoracic Surgery Oct 2011

34 European Assoc Cardiothoracic Surgery Oct 2011

35 European Assoc Cardiothoracic Surgery Oct 2011

36 European Assoc Cardiothoracic Surgery Oct 2011

37 Future Considerations

38 Non Sternotomy LVAD Insertion

39 Non Sternotomy LVAD Insertion

40 Heartware

L/min 1-8 L/min 1 8 L/min 1-8 L/min Size

41 Heartware Miniaturization May Lead to Multiple VAD Configurations Flow 2-10 L/min 1-8 L/min 1 8 L/min 1-8 L/min Size 58 mm tall 46 mm tall 46 mm tall with 8cm cannula mm length Impeller wide blade centrifugal wide blade axial wide blade axial wide blade axial RPM 1,800 4,000 12,000 24,000 12,000 24,000 12,000 24,000

42 Heartmate

43 Circulite

44 44

45 2012 ISHLT Annual Meeting Prague Czech Republic B. Meyns, F. Rega, M. Strueber, A. Barbone, E. Vitaliand D. Burkhoff "A New Treatment Option for INTERMACS Profile 4, 5 and 6 Patients with the Circulite Synergy System 50 patients, 28 hemodynamic data Longest pt2.6 yrs, many over 1 yr Last 13 pa ents have significantly rate of overall SAE s (events per patient-years). No strokes or other episodes of neurologic dysfunction

46 MinVasc W Cohn, Texas Heart Inst.

48 Driveline Infections

49 Transcutaneous Energy Transmission Systems (TETS)

50 Magnetically Coupled Resonators Magnetic Resonance to wirelessly transfer energy Based on work of Nikola Tesla early 20 th century Presented STS 2012

51 New TAH = Creative VAD Adaptation

52 Thank you!

Mechanical assist patient selection, device selection, and outcomes

Mechanical assist patient selection, device selection, and outcomes Josef Stehlik, MD, MPH Associate Professor of Medicine Medical Director, Heart Transplant Program University of Utah School of Medicine