Warfarin and Aspirin Versus Warfarin Alone in Patients With HeartMate 3 Left Ventricular Assist Device: A Systematic Review and Meta-Analysis.

Abstract

Background and aims: HeartMate 3 (HM3), a fully magnetically levitated ventricular assist device (LVAD), has been associated with reduced thromboembolic events compared to HeartMate II. However, bleeding events remained significant. Among patients undergoing HM3 implantation, the standard antithrombotic regimen comprises both warfarin and aspirin (ASA), but there is a lack of evidence on the optimum antithrombotic therapy. We performed a systematic review and meta-analysis assessing the impact of combined ASA and warfarin therapy compared to warfarin alone on the incidence of non-surgical bleeding events in patients with HM3 LVAD.

Methods: MEDLINE, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) and observational studies comparing warfarin alone with warfarin combined with ASA in patients with HM3 LVAD. Binary endpoints were analyzed using computed risk ratios (RRs) with 95% confidence intervals (CIs). A random-effect model was applied for all endpoints.

Results: Five studies (one RCT and four observational) encompassing 869 patients were included, with 424 (48.8%) prescribed warfarin alone, and 662 (76.2%) being male. Compared with the combined anticoagulation regimen, warfarin alone significantly reduced non-surgical bleeding (RR 0.30; 95% CI 0.09-0.95; p = 0.04) and gastrointestinal bleeding (RR 0.26; 95% CI 0.12-0.58; p < 0.001). There was no statistically significant difference between the groups for all-cause mortality (RR 1.02; 95% CI 0.45-2.32; p = 0.963).

Conclusions: Our findings indicate that the use of warfarin alone for anticoagulation in HM3 patients is associated with a reduced risk of bleeding events when compared to the combined therapy with ASA.