Abstract 16047: Bivalirudin Bridging to Oral Anticoagulation After Left Ventricular Assist Device Implantation
Introduction: Anticoagulation post-VAD implantation is necessary to prevent pump thrombosis; however, patients are at an increased risk of bleeding post-operatively. Different approaches to anticoagulant initiation have been utilized and reported in the literature. Some centers bridge to oral anticoagulation (OAC) with IV heparin, while others simply initiate OAC without parenteral bridging. Recently, at Cleveland Clinic, bivalirudin has been used post-VAD implantation as a bridge to therapeutic OAC. Currently, no literature exists for the use of bivalirudin post-VAD implantation in patients without heparin induced thrombocytopenia.
Hypothesis: The incidence of thrombosis and bleeding in patients bridged with bivalirudin to OAC would not be significantly different compared to a historical control group.
Methods: This was a non-interventional, retrospective, matched historical control (2:1) medical record review approved by the Cleveland Clinic IRB. The primary and secondary endpoints of thrombosis and bleeding up to 30 days post-VAD implantation were evaluated, respectively. Other secondary endpoints evaluated included mean medication cost per patient and mean patient dose of bivalirudin in mg/kg/hr.
Results and Conclusions: The bivalirudin and historical control cohorts included 35 patients and 70 patients, respectively. There were no differences observed in thrombosis [7/35, (20%) vs. 20/70, (28.6%); P=0.34] or bleeding [10/35, (28.6%) vs. 16/70, (22.9%); P=0.52] rates between the bivalirudin and historical control group, although power may have been limited. VTE was the most common thrombotic event in both groups. The need for transfusion with ≥2 units of PRBCs was the most common bleeding event noted in the two cohorts. In the bivalirudin cohort, the mean bivalirudin dose was 0.082 mg/kg/hr and mean cost of bivalirudin per patient was $6,190. In conclusion, no differences were identified using bivalirudin as a bridge to OAC in thrombosis or bleeding rates up to 30 days post-VAD implantation compared to a historical control group. Prospective trials with a longer follow-up period comparing bivalirudin to heparin and/or no parenteral bridging should be undertaken to assess the efficacy and safety of this practice.
- © 2013 by American Heart Association, Inc.