Key result
Omission of LMWH bridging in HeartMate 3 LVAD outpatients with subtherapeutic INR did not significantly increase hemocompatibility-related adverse events (1.20% vs 0% with bridging).
Why the study?
Prior studies of anticoagulation bridging for low INR in CF-LVAD outpatients showed variable impacts and focused on older devices with concomitant aspirin, rather than the HeartMate 3.
Does bridging with therapeutic LMWH prevent hemocompatibility-related adverse events in outpatients with a HeartMate 3 CF-LVAD and subtherapeutic INR compared to not bridging?
Observational (n=79)
Does bridging with therapeutic LMWH prevent hemocompatibility-related adverse events in outpatients with a HeartMate 3 CF-LVAD and subtherapeutic INR compared to not bridging?
Omission of LMWH bridging for subtherapeutic INRs in outpatients with a HeartMate 3 LVAD appears safe and does not significantly increase hemocompatibility-related adverse events.
Bridging during low INR in HM3 outpatients remains uncertain; leaves open optimal strategy in modern CF-LVADs.
BACKGROUND: Prior studies of anticoagulation bridging during periods of low International Normalized Ratio (INR) in outpatients with a durable, continuous flow left ventricular assist device (CF-LVAD) have shown a variable impact on thrombotic and bleeding events. These studies include predominantly older devices such as the HeartMate 2 (HM2) and HeartWare HVAD, which are known to experience more overall thrombotic events than the HeartMate 3 (HM3) device. The majority of these patients also received concomitant aspirin. METHODS: The primary objective of this study was to compare hemocompatibility-related adverse events (HRAEs) occurring while bridging subtherapeutic (≤ 1.7) INRs with therapeutic low-molecular weight heparin (LMWH) versus not bridging in outpatients with an HM3 CF-LVAD, many of whom were not receiving concomitant aspirin. RESULTS: Of the 79 patients eligible for inclusion in this study, 64 were not bridged and 15 were bridged at least once during the study period. In the non-bridged group, there were a total of 12 HRAEs of 997 bridging opportunities (BOs) (1.20%) versus 0 of 39 BOs in the bridged group. Of the 12 HRAEs in the non-bridged group, 10 were bleeding events; the 2 thrombotic events were minor venous thromboembolisms. CONCLUSION: Omission of LMWH bridging in HM3 CF-LVAD patients with a subtherapeutic INR and low rates of background aspirin use did not result in a statistically significant or clinically relevant increase in the rate of HRAEs.
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James et al. (2025) conducted an observational in HeartMate 3 left ventricular assist device with subtherapeutic INR (n=79). Low-molecular weight heparin (LMWH) bridging vs. Not bridging was evaluated on Hemocompatibility-related adverse events (HRAEs). Omission of LMWH bridging in HeartMate 3 LVAD outpatients with subtherapeutic INR did not significantly increase hemocompatibility-related adverse events (1.20% vs 0% with bridging).
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