Effect of a Conservative Enoxaparin Bridging Protocol for HeartMate 3 Left Ventricular Assist Devices.

Abstract

Bridging subtherapeutic international normalized ratios (INRs) in patients with left ventricular assist devices is not well studied and may cause harm. This retrospective, single-center, pre- and post-cohort study assessed whether a more conservative enoxaparin bridging protocol for patients with subtherapeutic INRs correlated with a reduction in major bleeding and thrombotic events in patients with HeartMate 3 devices. Eighty-two patients and 237 subtherapeutic episodes were included. The rate of the primary composite outcome was numerically lower in the post-group (5.7% vs. 1.5%, p = 0.075). The secondary composite outcome of major bleeding events or thrombotic events within 30 days was significantly reduced in the post-group (10.5% vs. 3.8%, p = 0.041). The rate of major bleeding events within 30 days was reduced in the post-group (10.5% vs. 3.0%, p = 0.019). In a subgroup of patients taking concomitant antiplatelet therapy, the primary composite outcome was significantly reduced in the post-group (5.1% vs. 0.0%, p = 0.044). Routine bridging of subtherapeutic INRs in patients with an HM3 device may be both unnecessary and harmful. A conservative bridging protocol may reduce major bleeding events without increasing the rate of thrombotic events among HM3 patients. Larger studies are necessary to confirm the results.