PEDS4: Postoperative anticoagulation with bivalirudin versus heparin for HeartMate 3 in children

Abstract

Background: Bivalirudin has become the standard of care for paracorporeal VAD support in children, although its utilization and outcomes in children with intracorporeal VADs have not been thoroughly studied. We compared the outcomes in children receiving bivalirudin versus unfractionated heparin (UFH) for early (<14 days) post-operative thromboprophylaxis. Methods: Using the ACTION network registry, we conducted a multicenter, retrospective analysis with all patients receiving bivalirudin or UFH for HeartMate 3 (HM3). Survival and adverse events in 14 days post VAD implantation were compared between patients receiving bivalirudin, UFH, or both agents. Results: Between 4/1/18-7/31/22, 171 patients with median age 15.3 years (IQR 12.9-17.3) and weight 62 kg (IQR 45-81) underwent HM3 implantation. Of these, 65 (38%) received bivalirudin, 91 (53%) received UFH and 15 (8.7%) received both agents. At 2 weeks, there was 100% survival in the bivalirudin group, 98% survival in the UFH group, and 100% survival in the bivalirudin/UFH group (p=0.65). Stroke incidence was similar across all anticoagulation agents [4 (6.1%) bivalirudin, 5 (5.5%) UFH, 1 (6.7%) bivalirudin/UFH, p=0.99]. Major bleeding incidence was similar across the anticoagulation agents [2 (3%) bivalirudin, 5 (5.5%) UFH, 1 (6.7%) bivalirudin/UFH, p=0.6). Hemolysis was lower in patients treated with bivalirudin [3 (4.6%)] versus UFH [7 (7.6%)] and bivalirudin/UFH [3 (33%)], p=0.006. Conclusions: In pediatric patients with a HeartMate3, anticoagulation with bivalirudin resulted in similar survival, stroke-free survival, and bleeding-free survival compared to UFH, with lower hemolysis with bivalirudin. More evaluation is required to understand the burden of post-operative hemocompatibility related adverse events.