Recent Trials With Durable LVADs: Is There a Superior Device?

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Natalie Oliver
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1 Recent Trials With Durable LVADs: Is There a Superior Device? Francis D. Pagani MD PhD Otto Gago MD Endowed Professor of Cardiac Surgery Michigan Medicine

2 Current Device Landscape 2018 HeartMate 3 HeartMate II HVAD Approved Short Term 2017 Approved BTT 2008 Approved BTT 2012 Approved DT 2010 Approved DT 2017

3 Recent IDE Clinical Trials in MCS HeartMate II Pivotal Trial for Bridge to Transplant (2008) and Destination Therapy (2010) ADVANCE - Pivotal Trial for HVAD for Bridge to Transplant Indication (2012) ENDURANCE I and ENDURANCE Supplemental Trial - Pivotal Trial for HVAD for Destination Therapy (2017) MOMENTUM 3 - Pivotal Trial for HeartMate 3 for Short Term and Long Term Use (2017)

4 HeartMate II versus HVAD

5 ENDURANCE TRIAL Primary endpoint: Survival free of disabling stroke (mrs < 4 at 24 weeks post stroke) on the originally implanted device or transplanted or explanted due to myocardial recovery 5

6 ENDURANCE TRIAL Primary Endpoint Overall Survival

8 Stroke Risk Factor Multivariable Analysis (HVAD) MAP (> 90 mmhg) Odds Ratio P-value 14.1 < INR ( 2) ASA ( 81 mg) Statistically significantly more HVAD patients (7.3%, 0.07 EPPY) had a sub-therapeutic INR <2.0 compared to control patients (2.2%, 0.02 EPPY), P=

9 Endurance Supplemental Trial The primary endpoint was the incidence of neurologic injury (defined as any stroke with an MRS >0 at 24- weeks post-stroke or any transient ischemic attack (TIA) or spinal cord infarct) at 12 months, including only time on the originally implanted LVAD. Strokes with MRS = 0 at 24 weeks (n=13 for HVAD, n=5 for control) were not included in the primary endpoint of neurological injury Intervention: BP Management for the HVAD arm versus B. Percent of Subjects 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 87% 76% 79% 83% 70% 72% 66% 53% 54% 54% HeartWare HVAD Control LVAD Milano et al. ISHLT April 2017 > <=85

10 Endurance Supplemental Trial. 90 p = p = p = Average MAP (mmhg) p = ENDURANCE HeartWare HVAD ENDURANCE Control LVAD 70 ENDURANCE Supplemental HeartWare HVAD ENDURANCE Supplemental Control LVAD 65 Baseline Discharge 3 Months 6 Months 12 Months versus Milano et al. ISHLT April 2017

11 Endurance Supplemental Trial Milano et al. ISHLT April 2017

12 Endurance Supplemental Trial Study Device N=308 Control Device N=157 Adverse Event Patients with event n (%) No. of events Patients with event n (%) No. of events P value Device Malfunction/Failure 74 (24.0%) (24.2%) 47 >0.99 Hemolysis 4 (1.3%) 5 9 (5.7%) Stroke Ischemic Cerebrovascular Event Hemorrhagic Cerebrovascular Event TIA Pump replacement Exchange for pump thrombosis 52 (16.9%) 40 (13.0%) 16 (5.2%) 13 (4.2%) 16 (5.2%) 14 (4.5%) NA 23 (14.6%) 12 (7.6%) 11 (7.0%) 1 (0.6%) 18 (11.5%) 16 (10.2%) NA Milano et al. ISHLT April 2017

13 Endurance Supplemental Trial Secondary Endpoint: (Stroke-free survival (Modified Rankin Score <4 at 24-weeks post-stroke) at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery) Milano et al. ISHLT April 2017

14 HeartMate II versus HeartMate 3

15 HeartMate 3 Engineering

16 MOMENTUM 3 TRIAL The primary end point was a composite of survival free of disabling stroke (Modified Rankin Score < 4) or survival free of reoperation to replace or remove the device (for reasons other than recovery or transplant) at 6 months after implantation.

17 PRIMARY OUTCOME

18 HeartMate 3: US MOMENTUM TRIAL Short Term Cohort: 6 Months Primary Endpoint Overall Survival

20 Circulation. 2017;135: DOI: /CIRCULATIONAHA

21 Circulation. 2017;135: DOI: /CIRCULATIONAHA

22 versus HeartMate 3 HVAD Approved Short Term 2017 Approved BTT 2012 Approved DT 2017

23 Important Challenges Stroke -Technology goal < 5% Device-related infection Device thrombosis

24 Summary 2017 was a progressive year for durable VAD therapy -Optimism stemming from continued improvements in technology -The importance of new technology significantly reducing pump thrombosis can not be understated -Important understanding of how management practices can influence outcomes (i.e., BP control) Centrifugal pumps will dominate clinical use Continued dissemination/diffusion of the therapy Stroke and device-related infections remain important barriers into the less ill population

27 Role: Speaker Date: Thursday, March 8, 2108 Session: Plenary Session: Hot Topics in Mechanical Circulatory Support for Heart and Lung Title: Recent Trials With Durable LVADs: Is There a Superior Device? Time: 8:10 a.m. - 8:30 a.m.

28 Dear Dr. Pagani, We look forward to your participation in the AATS Mechanical Circulatory Support Symposium: 21 st Century State of the Art Treatment of Heart and Lung Failure, taking place March 8-9, 2018 at the Marriott Marquis Houston in Houston, Texas. Attached is a copy of the program agenda listing your presentation(s) date(s), time(s) and title(s). Your role for each is listed below. Role: Speaker Date: Thursday, March 8, 2108 Session: Plenary Session: Hot Topics in Mechanical Circualtory Support for Heart and Lung Title: Recent Trials With Durable LVADs: Is There a Superior Device? Time: 8:10 a.m. - 8:30 a.m. Role: Moderator Date: Thursday, March 8, 2108 Session: Concurrent Session IIIa: Patient Selection and Optimization for Durable MCS Devices Time: 1:30 p.m. - 3:00 p.m. Role: Moderator Date: Friday, March 9, 2018 Session: Concurrent Session VIIa: Debates on Controversial Subjects Time: 9:45 a.m. - 10:45 a.m. As you prepare your presentation slides, please keep in mind the following: All Relevant Financial Relationships must be disclosed to learners prior to the start of the live activity. A Disclosure Statement slide must be included as the second slide for all presentations. AATS will be using 16:9 Wide Screens. Instructions for formatting slides wide screen are attached. You will NOT have access to speaker notes view in your session room please bring a hardcopy of your notes, if needed. Laptops are NOT allowed to be connected to the podium monitor- please bring a copy of your presentation on a USB drive.

Destination Therapy SO MUCH DATA IN SUCH A SMALL DEVICE. HeartWare HVAD System The ONLY intrapericardial VAD approved for DT.

DT Destination Therapy SO MUCH DATA IN SUCH A SMALL DEVICE. HeartWare HVAD System The ONLY intrapericardial VAD approved for DT. ONLY WE HAVE THIS BREADTH OF CLINICAL EVIDENCE TO SUPPORT DESTINATION THERAPY.