1. 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

2. Disclosures
Research Funding (FDP, KA, SM)
NHLBI
HeartWare
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3. 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)
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4. 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
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5. Methods
IRB approval
Retrospective review of prospectively collected database
Outcomes
Survival
Bleeding, TE events
Neurologic events
Infection
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6. 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
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7. Preop Clinical Characteristics
HMII HVAD p
Age at implant
INTERMACS
Creatinine
Male % % 0.002
HTN % % 0.013
BTT % % <0.001
Preop IABP 48% % 0.011
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8. Intraop Clinical Characteristics
HMII HVAD p
Redo sternotomy 33% 31% 0.51
TV surgery 38% 21% <0.001
AV surgery % % 0.22
Temporary RVAD 5% % 0.44
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9. Early Postop Outcome HMII HVAD p Early mortality 7.4% 7.5% 0.95
Dialysis % 10% 0.96
Postop inotropes 6 days 5 days 0.3
LOS days 16 days <0.001
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10. 1,120 patient-years of support
Follow-up
n = 680
Max., 10.4 yrs.
Median, 1 yrs.
1,120 patient-years of support
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11. Survival by Device Percent HeartMate II HeartWare HVAD p=0.96 Years

12. GI Bleeding by Device HeartMate II HeartWare HVAD Percent p=0.18
Follow-up time, years

13. Stroke by Device HeartMate II HeartWare HVAD Percent p=0.006
Follow-up time, years

14. Any Infection by Device
HeartMate II
HeartWare HVAD
Percent
p=0.039
Follow-up time, years

15. Driveline Infection by Device
HeartMate II
HeartWare HVAD
Percent
p=0.14
Follow-up time, years

16. Pump Thrombus by Device
HeartMate II
HeartWare HVAD
Percent
p=0.35
Follow-up time, years

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

18. AE Comparison (EPPY) HMII HVAD p DLI 0.12 0.06 0051
Stroke
Pump thrombus
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19. 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
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20. 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
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21. Perspective
Understanding differences enhances preop counseling and postop management
Need for more collaborative efforts
Ultimate result?
Guidelines, “best practices”
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22. MCSRN
Mechanical Circulatory Support Research Network