Outcomes of systemic anticoagulation with bivalirudin for Impella 5.0
Research article published in International journal of artificial organs (2021)
Abstract
Temporary mechanical circulatory support (tMCS) devices are used for the management of cardiogenic shock. The Impella 5.0 (Abiomed; Danvers, MA) (IMP5) is a commonly used, surgically implanted, tMCS device that requires systemic anticoagulation and purge solution to avoid pump failure. To avoid heparin-induced thrombocytopenia (HIT) from unfractionated heparin (UFH) use, our program has explored the utility of bivalirudin (BIV) for systemic anticoagulation in IMP5. This single center, retrospective study included patients supported on IMP5 with BIV based AC. The efficacy and safety end points were recovery, bridge to left ventricular assist device (LVAD), cardiac transplant (HTX), or death as well as clinically significant bleeding, incidence of Tissue Plasminogen Activator (tPA) use for suspected pump thrombosis, stroke, and device failure. There were 31 patients included, and 26 (84%) received BIV purge solutions. The median duration of IMP5 was 6 (IQR 4-10) days. Most patients were bridged to LVAD (39%, 12); 16% (5) were bridged to HTX, 16% (5) recovered, and 29% (9) died. One patient (3%) suffered from ischemic stroke and 12% (4) patients developed clinically significant bleeding. tPA was administered to 8 (26%) patients. Logistic regression analysis demonstrated that duration of IMP5 was a significant predictor of tPA use (OR 1.28; 95% Confidence Interval 1.04-1.56). There were no cases of pump failure. Our experience highlights the feasibility of utilizing BIV for routine AC use in IMP5.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Outcomes of systemic anticoagulation with bivalirudin for Impella 5.0.
Why This Matters for Hirudotherapy
This single-center retrospective study of 31 patients evaluated bivalirudin—a synthetic direct thrombin inhibitor modeled on hirudin, the principal anticoagulant of medicinal leech saliva—as systemic anticoagulation for the surgically implanted Impella 5.0 circulatory support device, reporting outcomes including bridge to LVAD (39%), bridge to transplant (16%), recovery (16%), death (29%), ischemic stroke (3%), clinically significant bleeding (12%), and tPA use for suspected pump thrombosis (26%), with no pump failures. For ASH/hirudotherapy, this work illustrates a contemporary clinical application of a leech-secretome-derived therapeutic principle, demonstrating how hirudin-based anticoagulation extends beyond traditional leech therapy into advanced mechanical circulatory support settings. However, as a small, single-center observational series without a comparison arm, the study demonstrates feasibility only and cannot establish comparative efficacy or safety against heparin-based or alternative anticoagulant regimens.
Citation
Outcomes of systemic anticoagulation with bivalirudin for Impella 5.0
Fabrizio C et al. · International journal of artificial organs, 2021
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