Impact of HeartWare ventricular assist device discontinuation on the pediatric population: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry analysis

Abstract

Background: The HeartWare ventricular assist device (HVAD) was discontinued in July 2021. The study aims to describe the impact the discontinuation the HVAD had on pediatric ventricular assist device (VAD) utilization and outcomes.

Methods: The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry was queried for type of VAD utilization and outcomes/adverse event rates in patients with a body surface area of 0.7 to 1.4 m2. Results were compared from before and after July 2021. All patients in the registry implanted with an HVAD were reported to determine overall outcomes of these patients and define who remains on the device.

Results: The HeartMate 3 (HM3) primarily replaced the HVAD in pediatric patients increasing from 29 of 258 (11%) of implants before July 2021 to 31 of 109 (29%) of implants after. A small increase in the use of the Berlin Heart EXCOR (40 of 258, 16% before to 20 of 109, 18% after) and paracorporeal continuous flow devices (116 of 258, 45% before to 58 of 109, 53% after) was also observed. The rate of ischemic stroke increased in the overall population and a decrease in bleeding complications in the EXCOR group was observed. Of the 187 pediatric patients implanted with an HVAD in the registry, 7 patients remain supported, 1 patient transitioned from the HVAD to an HM3, and 6 patients were lost to follow-up.

Conclusions: The HM3 has been the primary replacement for the HVAD in the medium-sized pediatric population. The rate of ischemic stroke was higher after July 2021.