Real World Data from the ACTION Quality Improvement Network - Preliminary Experience with a Magnetically Levitated Ventricular Assist Device in US Pediatric Centers

Abstract

Purpose We sought to describe the off-label use to date of an intracorporeal, centrifugal, continuous flow ventricular assist device (cfVAD) characterized by a magnetically levitated impeller in US pediatric cardiac centers, in order to further inform device selection quality improvement initiatives. Methods Members of the ACTION (Advanced Cardiac Therapies Improving Outcomes Network) collaborative whose centers implanted ≥1 intracorporeal magnetically levitated cfVAD were identified. Centers submitted de-identified data on each implant through 10/21/18. Results are reported as count (percentage) or median (range) for summary statistics. Results Fourteen implants occurred at 6 centers; the number of implants per center was 1 - 4. Thirteen patients (93%) had dilated cardiomyopathy (DCM); one patient (7%) had congenital heart disease (CHD) with a Fontan circulation. Of the DCM patients, 3 had neuromuscular disease (2 with Duchenne and 1 with Becker muscular dystrophy). Device strategy included bridge to transplant in 8/14 (57%), bridge to candidacy in 4/14 (29%), and destination therapy in 2/14 (14%). Median age at implant was 15 y (12 y - 24 y), with median weight 70 kg (31 kg - 118 kg) and median body surface area (BSA) 1.8 m2 (1.3 m2 - 2.4 m2). Most patients (10/14, 71%) were INTERMACS category 2 at implant; 3/14 (21%) were category 3 and 1/14 (7%) was category 4. No biVADs were placed. Median support time was 32 d (5 d - 315 d). To date, 5/14 (36%) patients were discharged, 1/14 (7%) underwent heart transplantation, and 1/14 (7%) died on VAD support; the remainder are hospitalized with the device in place. For discharged patients, median hospital length of stay after implant was 26 d (12 d - 37 d). There were no episodes of stroke or pump thrombosis. Conclusion The intracorporeal, centrifugal, magnetically levitated cfVAD is a newer device being used with increasing frequency in the pediatric and CHD population. Utilization of the device has largely been limited to older, larger children with DCM. This preliminary data will contribute to our understanding of device selection in order to improve outcomes.