Key result
HeartMate 3 is linked to ~81% fewer ischemic events than HVAD in LVAD patients.
Why the study?
Does the HeartMate 3 LVAD reduce ischemic and bleeding events compared to the Heartware LVAD in patients requiring mechanical circulatory support?
Cohort (n=4,320)
Yes
Does the HeartMate 3 LVAD reduce ischemic and bleeding events compared to the Heartware LVAD in patients requiring mechanical circulatory support?
Absolute Event Rate: 2.9% vs 15.3%
p-value: p=<0.001
The HeartMate 3 LVAD significantly reduces both ischemic and bleeding events compared to the HVAD, though a prevalent bleeding risk remains, suggesting a need for optimized antithrombotic strategies.
Background A fully magnetically levitated centrifugal-flow pump (HeartMate 3, HM3) has significantly reduced thromboembolic events in left ventricular assist device (LVAD) patients, potentially modifying the trade-off of ischemic and bleeding events with current management strategies. Purpose We sought to characterize the opposing risk of ischemic and bleeding hemocompatibility-related adverse events (HRAE) in LVAD carriers with contemporary practice. Methods 4320 patients undergoing centrifugal-flow LVAD implantation (Heartware, HVAD cohort: 2088, HM3 cohort: 2232) in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) were included. First ischemic HRAE (ischemic stroke, pump thrombosis and arterial non-central nervous system thromboembolism) and first major non-surgical bleeding HRAE (intracranial and non-intracranial) occurring between 2 weeks and 2 years from LVAD implant were evaluated. Results A lower incidence in ischemic (2.9% vs. 15.3% per 100 patient-year, p<0.001) and bleeding (11.8% vs. 18%, p<0.001) HRAEs was observed in the HM3 cohort as compared to the HVAD cohort, with the decrease being particularly pronounced for ischemic HRAE. The results were consistent for all sub-types of events, and by sub-periods (15-90, 91-365, >365 days). Despite higher absolute risks in the HVAD cohort, the trade-off between ischemic and bleeding HRAE was better matched in the HVAD as compared to the HM3 cohorts (bleeding events – ischemic events: 2.7% vs. 8.9% per 100 patient-year, p<0.001), with a persistently prevalent bleeding risk in HM3 carriers across sub-periods. Ischemic and bleeding HRAEs were associated with all-cause death in both cohorts. Conclusions Advances in pump technology have significantly reduced HRAEs in real-world LVAD carriers and have reshaped the balance between ischemic and bleeding risks under current management. The ongoing exceeding bleeding risk observed in contemporary practice underscores the urgent need for novel antithrombotic strategies that better align with the residual ischemic and bleeding profiles of LVAD patients.
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Gallone et al. (2025) conducted a cohort in Left ventricular assist device (LVAD) carriers (n=4,320). HeartMate 3 (HM3) LVAD vs. Heartware (HVAD) LVAD was evaluated on First ischemic hemocompatibility-related adverse events (HRAE) (p=<0.001). The HeartMate 3 LVAD was associated with a lower incidence of ischemic (2.9% vs 15.3% per 100 patient-years, P<0.001) and bleeding (11.8% vs 18%, P<0.001) events compared to the HVAD.
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