The Berlin Heart EXCOR® Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children
Background—Recent data suggest the Berlin Heart EXCOR Pediatric ventricular assist device (VAD) is superior to ECMO for bridge-to-heart transplant. Published data are limited to one in four children who received the device as part of the US clinical trial. We analyzed outcomes for all US children who received the EXCOR to characterize device outcomes in an unselected cohort and identify risk factors for mortality to facilitate patient selection.
Methods and Results—Multi-center prospective cohort study involving all children implanted with the Berlin Heart EXCOR® Pediatric VAD at 47 centers from 5/2007-12/2010. Multiphase non-proportional hazards modeling was used to identify risk factors for early (<2 months) and late mortality. Of 204 children supported with the EXCOR, the median duration of support was 40 days (range 1, 435). Survival at 12 months was 75% including 64% who reached transplant, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, BIVAD support, and elevated bilirubin as risk factors for early mortality, and bilirubin extremes and renal dysfunction as risk factors for late mortality. Neurological dysfunction occurred in 29% and was the leading cause of death.
Conclusions—Use of the Berlin Heart EXCOR® has risen dramatically over the past decade emerging as a new treatment standard in the US for pediatric bridge-to-transplant. Three-quarters of children survived to transplant or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and BIVAD use were associated with mortality whereas ECMO pre-implant and CHD were not.
- mechanical circulatory support transplantation
- waitlist mortality
- ventricular assist device
- heart failure
- cardiac surgery
- Received December 14, 2012.
- Revision received March 11, 2013.
- Accepted March 18, 2013.