Trade-Off Between Bleeding and Ischemic Events From Left Ventricular Assist Devices: A EUROMACS Registry Analysis.

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.

Objectives: The authors sought to characterize the opposing risk of ischemic and bleeding hemocompatibility-related adverse events (HRAEs) in LVAD carriers with contemporary practice.

Methods: We included 4,320 patients undergoing centrifugal-flow LVAD implantation (HeartWare [HVAD] cohort: 2,088, HM3 cohort: 2,232) in EUROMACS (European Registry for Patients with Mechanical Circulatory Support). First ischemic HRAEs (ischemic stroke, pump thrombosis, and arterial noncentral nervous system thromboembolism) and first major nonsurgical bleeding HRAEs (intracranial and non-intracranial) occurring between 2 weeks and 2 years from LVAD implantation were evaluated.

Results: A lower incidence in ischemic (2.9% vs 15.3% per 100 patient-years; 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 HRAEs. The results were consistent for all subtypes of events and by subperiods (15-90, 91-365, >365 days). Despite higher absolute risks in the HVAD cohort, the trade-off between ischemic and bleeding HRAEs was better matched in the HVAD as compared to the HM3 cohorts (bleeding events - ischemic events: 2.7% vs 8.9% per 100 patient-years; P < 0.001), with a persistently prevalent bleeding risk in HM3 carriers across subperiods. 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.