Log in to MyACC
Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children
Study Questions:
What are the outcomes of infants and children receiving the Berlin Heart EXCOR Pediatric ventricular assist device (VAD)?
Methods:
A multicenter, prospective cohort study was performed, including all children implanted with the Berlin Heart VAD at 47 US centers between May 2007 and December 2010. The cohort included both patients enrolled in the investigational device exemption (IDE) trial, as well as those receiving the device for compassionate use.
Results:
The median duration of support for the 204 children undergoing device implantation was 40 days (range 1-435 days). Overall survival at 12 months was 75%; 64% reached transplantation, 6% recovered, and 5% remained on the device. Risk factors for early mortality on multivariable analysis included lower weight, biventricular assist device support, and elevated bilirubin. Risk factors for late mortality included bilirubin extremes and renal dysfunction. Neurological dysfunction occurred in 29% and was the leading cause of death. For infants <5 kg (n = 33), 21 (64%) died, including 42% (8/19) with cardiomyopathy and 93% (13/14) with congenital heart disease. Survival for patients with single-ventricle coronary heart disease was 58% as compared with 42% in patients with two-ventricle congenital heart disease.
Conclusions:
The Berlin Heart EXCOR device is an effective form of circulatory support for children, with three-quarters of children surviving to transplant or recovery. Neurologic dysfunction remains a significant concern.
Perspective:
This study included all patients implanted with the Berlin Heart EXCOR pediatric VAD over a 3.5-year time period. End-organ dysfunction has emerged as a significant risk factor for long-term mortality. Patient selection remains critically important. On univariate analysis, center volume was closely linked to mortality. The differences in mortality based on center volume were no longer significant after adjusting for patient characteristics at the time of device implantation, suggesting that improved survival at higher volume centers is due to patient selection. Finally, outcomes for patients <5 kg with congenital heart disease were dismal (93% mortality), indicating the need for continued research into the optimal strategy for this complex and high-risk patient population.
Keywords: Child, Cause of Death, Infant, Heart Defects, Congenital, Compassionate Use Trials, Heart-Assist Devices, Cardiomyopathies, Berlin, Bilirubin, Coronary Disease, Heart Transplantation
< Back to Listings
