Abstract 12471: Bleeding Challenges in Pediatric Ventricular Assist Devices- A Study From the ACTION Registry

Abstract

Background: Ventricular assist devices (VAD) are increasingly used in children with end-stage heart failure. Bleeding is a major complication of VAD, but most reports have focused on central nervous system (CNS) bleeding. Our objective was to determine the incidence & consequences of non-CNS bleeding in pediatric VADs. Methods: We examined adverse events (AE) & outcomes of all patients implanted with a VAD at Advanced Cardiac Therapies Improving Outcomes Network (ACTION) centers between 9/2018-5/2021. Major bleeding event (MBE) was defined as an episode of suspected bleeding resulting in death, reoperation, hospitalization or blood transfusion (>7days after implant). Variables were analyzed using chi square & Mann Whitney test and outcomes were assessed by Kaplan Meier (KM) survival curves. Results: A total of 407 patients were prospectively enrolled in the ACTION registry, of which 82 (20.1%) had a MBE. The median duration of support was 72 days (range 6-1101). MBE was most common in paracorporeal continuous flow devices (42/82 devices, 51%). MBE was gastrointestinal in 30.3% & thoracic in 38.5%. Patients with MBE were more likely to have congenital heart disease (CHD) or previous cardiac operation & were less likely to have had VAD as a bridge to transplant (Table). Within 14 days post MBE, 31 subjects had another major AE (14 major infection, 13 another MBE, 2 stroke and 1 device malfunction). Unadjusted survival in patients with MBE was significantly worse than those without (p<0.001) (Figure). Conclusion: MBE after VAD implant was seen in 20% of pediatric VAD patients, a higher proportion of whom had CHD. MBE was associated with other major AEs post-VAD and also with worse survival.