Outcomes of Infants and Children with Stage 1 Single Ventricle Implanted with Ventricular Assist Devices: An Analysis of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry

Abstract

<h3>Purpose</h3> Ventricular assist device (VAD) use in patients with congenital heart disease is increasing. Data on VAD outcomes in infants/children with stage 1 single ventricle (SV) are limited. Our study aims to characterize the outcomes of this population using multi-center registry data. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of stage 1 SV patients undergoing VAD implantation between March 2018 - June 2020. ACTION data are collected from 30 centers, and major adverse events undergo central adjudication using pre-specified event definitions. Clinical characteristics, major adverse events, and survival are reported. <h3>Results</h3> During the study period, 27 stage 1 SV patients underwent VAD implant with median age of 1 month (range 0.1-44), weight 3.7kg (2.4-17), and BSA 0.24 m² (0.18-0.65). Pre-implant comorbidities were frequent: ventilator support (85%), ECMO (37%), history of cerebral vascular accident (CVA, 30%), and pre-implant dialysis (18.5%). Device strategy included paracorporeal continuous-flow VAD in 11 patients, paracorporeal pulsatile VAD (12), and multiple devices (4). Concomitant surgical procedure was performed in 4 patients. Median support duration was 56 days (2-271). A positive clinical outcome, defined as transplant, weaned, or alive on device was obtained in 59%, with 12 patients transplanted while 11 died on device (Fig 1). Adverse events on VAD support included neurologic dysfunction (18.5%, with n=2 CVA), bleeding (22%), infection (48%), renal dysfunction (15%), and device malfunction (4%). <h3>Conclusion</h3> Stage 1 SV patients undergoing VAD support have frequent and severe pre-implant comorbidities, which likely contributed to the significant morbidity and mortality post-implant. A variety of device types and surgical strategies are employed by centers to support this challenging physiology.