Hemocompatibility-Related Adverse Events in a Real-World Cohort Comparing Three Different LVADs, the HeartWare, HeartMate II, and HeartMate 3: A Multicenter Observational Study

Objectives: Hemocompatibility-related adverse events (HRAEs) remain the Achilles heel of left ventricular assist device (LVAD) treatment. Previous study showed Promising results of the HeartMate 3 (HM3) device with lower HRAEs than with the HeartMate II (HMII) LVAD. This study aims to compare HRAEs and long-term outcomes between HMII, HeartWare (HVAD) and HM3 in a real-life cohort.

Methods: We retrospectively analyzed all patients who received LVAD implantation between January 2014 and October 2019 in three mid-volume German centers. Long-term outcomes and HRAEs according to MONEMTUM3 trial's definitions were compared between HM3, HMII, and HVAD patients. We utilized competing risk regression to analyze survival free of HRAEs.

Result: A total of 327 patients, 84% male with a median age of 65 years (HM3 [n = 73], HMII [n = 142], HVAD [n = 112]) contributed to a total person-time at risk of 7,793 months. Median follow-up was 22 months (IQR: 37). Intention to treat as destination therapy did not differ among HM3, HMII, and HVAD patients (53 vs. 47 vs. 51%, p = 0.627, respectively). Distribution of INTERMACS levels I and II was similar between HM3, HMII, and HVAD patients (25 vs. 30 vs. 33%, p = 0.305, respectively). HVAD and HMII patients had significantly decreased HRAEs free survival compared with HM3 (sub-hazard ratio [SHR]: 2.89 [95% CI: 1.52–5.49], p = 0.001 and SHR 3.07 [95% CI: 1.63–5.78], p = 0.001, respectively).

Conclusion: HeartMate 3 showed the lowest HCS with significantly lower HRAEs compared with HVAD and HMII. HVAD patients had the highest pump thrombosis incidence. Distribution of bleeding events was similar between all three devices. HVAD and HMII patients had a clear increased hazard ratio for mortality because of HRAEs compared with HM3 patients.

No conflict of interest has been declared by the author(s).

Publication History

Article published online:
19 February 2021