Mechanical assist patient selection, device selection, and outcomes

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1 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 Director, ISHLT Transplant Registry

2 Epidemiology of HF 5,000,000 individuals with HF 300,000 deaths /550,000 new diagnoses annualy Most frequent cause of hospitalization in >65 yrs Advanced/ refractory / stage D approx. 5% of HF population How to identify patients who should be evaluated for advanced HF therapies? How to decide which of the stage D patients should receive advanced HF therapies?

appropriate therapies Low risk / good prognosis Medical therapy Tx / LVAD

3 Higher-risk resource intensive therapies Aldosterone antagonists Beta-blockers ACE/ARB Low-risk cost-effective therapies Selection of appropriate therapies Low risk / good prognosis Medical therapy Tx / LVAD Appropriate candidate Medical therapy Tx / LVAD High risk / comorbidities Medical therapy Tx / LVAD

4 Survival (%) Survival after heart transplant PROMISE Class III-IV Half-life = 10 years Conditional half-life = 13 years 50 PRAISE Class III-IV Heart transplant 25 0 CONSENSUS Class IV Years Lund L, Stehlik J et al. JHLT Oct 2013

5 DT LVAD - Survival in HF stage D Percent Survival Months LVAD Destination Therapy (HMII Post Approval Study) Medical Management (REMATCH, NEJM 2001) Figure courtesy Ulrich Jorde, MD

6 HF patients in trouble not tolerating optimal medical therapy multiple admissions cardiorenal syndrome persistent poor exertional tolerance major lifestyle adjustments poor quality of life rapidly remodeling LV worsening pulmonary hypertension

7 Strategies for advanced HF patients Heart transplant LVAD bridge to transplant/transplant eligibility LVAD permanent (destination) therapy LVAD bridge to recovery

8 Bridge to transplantation HeartMate II - HeartMate II patients - no control group Primary outcome: transplantation, recovery or ongoing mechanical support while remaining eligible for transplantation, at 180 days Miller LW et al. NEJM, 2007 Aug 30;357(9)

9 HeartMate II BTT trial, primary outcome 75% 68% Miller LW et al. NEJM, 2007 Aug 30;357(9)

10 Six-minute walk test (meters) Functional status after LVAD implant Baseline 1 mo 3 mo 6 mo Time since LVAD implant Miller LW et al. NEJM, 2007 Aug 30;357(9)

11 HeartWare BTT trial, primary outcome Aaronson KD, Circulation, 2012

12 HeartWare H-VAD BTT trial Aaronson KD, Circulation, 2012

13 LVAD evolving clinical indications Acute cardiogenic shock Deterioration in a patient awaiting heart transplantation Poor quality of life in a patient awaiting heart transplantation

14 % of patients Patients bridged to transplant with MCS Year 2014 JHLT Oct 2014 Lund L, Stehlik J et al. JHLT Oct 2014

15 % of patients BTT MCS in patients of different ages TAH LVAD+RVAD RVAD LVAD JHLT Oct ECMO is excluded. Lund, Stehlik. JHLT Oct 2013

16 Destination therapy

Destination therapy: REMATCH Trial 1.00 0.90 VE LVAS (n=71) Percent Survival 0.80 0.70 0.60 0.50 0.40 0.30 P = 0.

17 Destination therapy: REMATCH Trial VE LVAS (n=71) Percent Survival P = P = OMM (n=61) Months Post Enrollment Rose, et al NEJM Nov, 2001

18 HeartMate II DT Trial Slaughter MS et al, NEJM Dec 2009;361(23)

19 Destination LVAD - survival Percent Survival Months HM II DT Jorde ISHLT 2013 HM II DT Park CIRC HF 2012 HM II DT Slaughter NEJM 2009 VE DT LVAD REMATCH Rose NEJM 2001 XVE DT LVAD Slaughter NEJM 2009 Novacor DT LVAD INTrEPID Rogers JACC 2007 OMM REMATCH Rose NEJM 2001 OMM INTrEPID Rogers JACC 2007 Jorde U, JACC 2013

21 Patient selection and post-vad survival

22 Patient acuity (INTERMACS Profile)

23 Patient acuity (INTERMACS Profile) Implants Kirklin JK et al, JHLT th Intermacs Report

24 Age CF LVAD and BiVAD implants Kirklin JK et al, JHLT th Intermacs Report

25 Quality of life after LVAD implant Grady et al, ISHLT 2014

26 Right heart failure risk CF LVAD and BiVAD implants Kirklin JK et al, JHLT th Intermacs Report

27 Renal failure CF LVAD and BiVAD implants Kirklin JK et al, JHLT th Intermacs Report

28 Device replacement Kirklin JK et al, JHLT th Intermacs Report

29 Future?

30 Drakos SG, JACC 2014

31 Engineered pulsatility of VAD flow HeartMateIII, in clinical trials

32 Fully implantable systems Mobile Tethered Free Wireless energy transfer HeartMate fully implantable system, in development

33 Further reduction in VAD size Role for partial support? HeartMate X, in development

34 Better biocompatibility? Reduced need for: - anticoagulation - antiplatelet therapy

35 Conclusions - VAD therapy outcomes have dramatically improved in the past decade - VAD therapy provides a favorable therapeutic option for a wide range of patients with advanced HF - Risk factors for poor outcome should be recognized - Future technology improvements are likely to further enhance survival and patient satisfaction after VAD implant

36 Transplant Registry

38 HMII adverse events Jorde et al. JACC 2014

39 HVAD adverse events

40 Rehospitalization after LVAD implant Takeda et al., JTCS 2014

42 Jarvik 2000 Implant: thoracotomy (no sternotomy) Postauricular configuration

Mechanical Circulatory Support in the Management of Heart Failure

Mechanical Circulatory Support in the Management of Heart Failure Feras Bader, MD, MS, FACC Associate Professor of Medicine Director, Heart Failure and Transplant Cleveland Clinic Abu Dhabi Chairman, Heart