MCSRN Mechanical Circulatory Support Research Network A Multi-Institutional Comparison of Adverse Events in Contemporary Continuous Flow LVAD Significant Differences Exist? Stulak JM, Davis ME, Haglund N, Dunlay S, Cowger J, Shah P, Pagani FD, Aaronson KD, Maltais S

Disclosures Research Funding (FDP, KA, SM) NHLBI HeartWare MCSRN

Background INTERMACS 6th annual report 8 years, >10,000 pt, accrual 2,000pt/yr Very few comparisons of 2nd and 3rd generation LVADs Aaronson et al., 2012 (n=499 vs. 140) Lalonde, et al., 2013 (n=13 vs. 33) Pagani, et al., 2015 (n=148 vs. 297) MCSRN

Aim Evaluate outcomes in a large, multicenter cohort with an “all comers” approach Stratify outcomes according to contemporary 2nd and 3rd generation LVAD Report overall incidence and time-related cumulative risk of AE’s MCSRN

Methods IRB approval Retrospective review of prospectively collected database Outcomes Survival Bleeding, TE events Neurologic events Infection MCSRN

Patients May 2004 Sept 2014 n =734 Age 18 82 57 yr 577 157 560 HMII, 174 HVAD Age 18 82 57 yr 577 157 MCSRN

Preop Clinical Characteristics HMII HVAD p Age at implant 60 58 0.02 INTERMACS 2.8 2.9 0.045 Creatinine 1.4 1.3 0.004 Male 83% 72% 0.002 HTN 47% 58% 0.013 BTT 53% 81% <0.001 Preop IABP 48% 37% 0.011 MCSRN

Intraop Clinical Characteristics HMII HVAD p Redo sternotomy 33% 31% 0.51 TV surgery 38% 21% <0.001 AV surgery 9% 5% 0.22 Temporary RVAD 5% 4% 0.44 MCSRN

Early Postop Outcome HMII HVAD p Early mortality 7.4% 7.5% 0.95 Dialysis 10% 10% 0.96 Postop inotropes 6 days 5 days 0.3 LOS 20 days 16 days <0.001 MCSRN

1,120 patient-years of support Follow-up n = 680 Max., 10.4 yrs. Median, 1 yrs. 1,120 patient-years of support MCSRN

Survival by Device Percent HeartMate II HeartWare HVAD p=0.96 Years 560 299 164 94 59 31 174 65 25 13 1 1

GI Bleeding by Device HeartMate II HeartWare HVAD Percent p=0.18 Follow-up time, years 560 299 164 94 59 31 174 65 25 13 1 1

Stroke by Device HeartMate II HeartWare HVAD Percent p=0.006 Follow-up time, years 560 299 164 94 59 31 174 65 25 13 1 1

Any Infection by Device HeartMate II HeartWare HVAD Percent p=0.039 Follow-up time, years 560 299 164 94 59 31 174 65 25 13 1 1

Driveline Infection by Device HeartMate II HeartWare HVAD Percent p=0.14 Follow-up time, years 560 299 164 94 59 31 174 65 25 13 1 1

Pump Thrombus by Device HeartMate II HeartWare HVAD Percent p=0.35 Follow-up time, years 560 299 164 94 59 31 174 65 25 13 1 1

AE Risk Comparison Thrombus Survival Stroke Infection GI bleed Driveline Hazard ratio vs. HeartMate II

AE Comparison (EPPY) HMII HVAD p DLI 0.12 0.06 0051 Stroke 0.11 0.26 0.05 Pump thrombus 0.1 0.2 0.09 MCSRN

Multivariable Model Survival p=0.27 GI bleeding p=0.63 Any infection p=0.32 DLI p=0.1 Stroke p=0.003 (HVAD, H.R.:1.8) Pump thrombus p=0.64 MCSRN

Summary and Conclusions Large, multicenter collaborative analysis to stratify outcomes between devices with “all comers” strategy HeartWare HVAD ↑ stroke risk EPPY (trends) HeartMate II ↑ DLI HVAD ↑ stroke, pump thrombus MCSRN

Perspective Understanding differences enhances preop counseling and postop management Need for more collaborative efforts Ultimate result? Guidelines, “best practices” MCSRN

MCSRN Mechanical Circulatory Support Research Network