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

Gallone G. Baldetti L. Veen K.M. Bernhardt A.M. Caliskan K. Fiane A. Najjar E. Netuka I. Özbaran M. Pya Y. Scandroglio A.M. Spitaleri A. Sangiorgi D. Zimpfer D. Färber G. Gummert J. Meyns B. de By T.M.M.H. Schoenrath F. De Ferrari G.M. Rinaldi M. Potapov E. Loforte A.
14 October 2025 Elsevier Inc.

Journal of the American College of Cardiology
2025 #86 Issue 15 1111 - 1123 pp.

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.

advanced heart failure , bleeding , hemocompatibility-related adverse events , ischemic , left ventricular assist device

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Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
Department of Medical Sciences, University of Turin, Turin, Italy
Cardiac Intensive Care Unit, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Milan, Italy
Thorax Center, Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, Netherlands
University Heart and Vascular Center Hamburg, Department of Cardiovascular Surgery, Hamburg, Germany
Thorax Center, Department of Cardiology, Cardiovascular Institute, Erasmus MC University Medical Center, Rotterdam, Netherlands
Department of Cardiothoracic Surgery, Oslo University Hospital and Faculty of Medicine, Oslo, Norway
Karolinska University Hospital, Stockholm, Sweden
Department of Medicine, Karolinska Institutet, Stockholm, Sweden
Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Ege University Hospital, Izmir, Turkey
Heart Center, Corporate Fund University Medical Center, Astana, Kazakhstan
Department of Surgical Sciences, University of Turin, Turin, Italy
PhD Programme in Bioengineering and Medical-Surgical Sciences, University of Turin, Politecnico di Torino, Turin, Italy
Cardiovascular Department, Maria Cecilia Hospital, Gruppo Villa Maria Care and Research, Cotignola, Italy
Vienna Medical University, Vienna, Austria
Department of Thoracic and Cardiovascular Surgery, University Hospital Würzburg, Würzburg, Germany
Herz- und Diabeteszentrum North Rhine-Westphalia, Bad Oeynhausen, Germany
Katholieke Universiteit Leuven, Leuven, Belgium
EUROMACS (European Registry for Patients With Mechanical Circulatory Support), EACTS House, Windsor, United Kingdom
Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum der Charité, Berlin, Germany
Charité–Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
German Centre for Cardiovascular Research, Partner Site Berlin, Berlin, Germany

Cardiovascular and Thoracic Department
Department of Medical Sciences
Cardiac Intensive Care Unit
Thorax Center
University Heart and Vascular Center Hamburg
Thorax Center
Department of Cardiothoracic Surgery
Karolinska University Hospital
Department of Medicine
Institute for Clinical and Experimental Medicine
Ege University Hospital
Heart Center
Department of Surgical Sciences
PhD Programme in Bioengineering and Medical-Surgical Sciences
Cardiovascular Department
Vienna Medical University
Department of Thoracic and Cardiovascular Surgery
Herz- und Diabeteszentrum North Rhine-Westphalia
Katholieke Universiteit Leuven
EUROMACS (European Registry for Patients With Mechanical Circulatory Support)
Department of Cardiothoracic and Vascular Surgery
Charité–Universitätsmedizin Berlin
German Centre for Cardiovascular Research

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