Heart failure is uncommon in children but carries a poor prognosis with 46% of children with severe systolic dysfunction dying or undergoing transplantation within five years. Survival among children after heart transplantation is 83% at 3 years, but the limited availability of donor hearts prolongs the waiting period, resulting in a high rate of death whilst on waiting lists. Options for mechanical circulatory support have been limited in children, with one choice being extracorporeal membrane oxygenation (ECMO); however, this is only capable of providing shot term support at best. More recently, the Excor Paediatric pulsatile-flow ventricular assist device (Berlin Heart) has become available in a wide range of sizes.
In this study Fraser et al. tested the efficacy of the Berlin Heart as a bridge to transplant. In a prospective single-group trial, using data from a matched historical control group undergoing ECMO as a comparator, patients 16 years of age or younger were divided into two cohorts according to body-surface area (cohort 1, <0.7 meters squared; cohort 2, 0.7 to <1.5 metres squared). The primary outcome was the time to death or weaning from the device with an unacceptable neurologic outcome; safety data were also gathered. The results in both cohorts strongly favoured the Excor device with cohort 1 not reaching the median survival time at 174 days, whereas in the matched ECMO group, the median survival was 13 days (P<0.001). For participants in cohort 2 and the matched ECMO group, the median survival was 144 days and 10 days, respectively (P<0.001). However, serious adverse events were common in both cohorts including major bleeding (in 42% and 50% of patients, respectively), infection (in 63% and 50%), and stroke (in 29% and 29%).
In paediatric patients with severe heart failure, survival rates are significantly higher with the Excor ventricular assist device than with ECMO. However, serious adverse events, including infection, stroke, and bleeding, still occur in a majority of patients.
- Fraser CD Jr, Jaquiss RD, Rosenthal DN, Humpl T, Canter CE, Blackstone EH, Naftel DC, Ichord RN, Bomgaars L, Tweddell JS, Massicotte MP, Turrentine MW, Cohen GA, Devaney EJ, Pearce FB, Carberry KE, Kroslowitz R, Almond CS. Prospective trial of a pediatric ventricular assist device. N Engl J Med. 2012 Aug 9;367(6):532-41.