Abstract 11366: Outcomes of Children Supported with the Berlin Heart EXCOR Pediatric VAD: Impact of Patient Characteristics at Implant on Mortality
BACKGROUND: Recent data suggests that selected children may benefit from bridge-to-heart transplant support with the Berlin Heart EXCOR Pediatric ventricular assist (VAD). Outcomes of children receiving the device outside of study inclusion criteria on a compassionate-use (CU) basis have not been reported.
METHODS: All children supported with the Berlin Heart EXCOR Pediatric VAD in North America between May 2007 and December 2010 were included. All children who met clinical criteria for study inclusion regardless of center implanted were defined as the Investigational Device Exemption IDE Clinical Criteria cohort, where as all other children were defined as the CU cohort. The primary endpoint was death on the waiting list.
RESULTS: Of 204 children implanted with the EXCOR, 123 (60%) met IDE clinical criteria; 81 (40%) met CU criteria. For the overall cohort (N=204), the median age was 18.6 months (IQR 6.3, 64.9), the median weight was 10.0 kg (IQR, 6.5, 16.6), 30% had congenital heart disease (CHD), 53% were INTERMACS profile 1 (cardiogenic shock), 41% were supported with ECMO at implant, 77% were ventilated, and 5% had an estimated creatinine clearance (CrCL)<30th %-ile at implant. Overall 51/204 (25%) of children died on EXCOR support [18% of the IDE Clinical Criteria Cohort vs. 36% in the CU cohort (P<0.01, chi-square test)]. CU subjects were more likely to have CHD, be on ECMO pre-implant, be classified as INTERMACS profile 1, have severe renal dysfunction, and a bilirubin level >1.2 mg/dL (P<0.01 for all). For the overall cohort, clinical subgroups at higher risk of waiting list mortality include those with CHD (46% vs. 16% without), ECMO pre-implant (34% vs. 19% without), age<1 year (40% vs. 19% without), weight <5 kg (64% vs. 16% without), severe renal dysfunction, and total bilirubin>1.2 (40% vs. 15% without).
CONCLUSIONS: In the overall cohort of children supported with the EXCOR in the current era, one in four died on the waiting list. Children implanted under compassionate use clinical criteria were more likely to die than children who met clinical criteria for IDE study inclusion. The difference may be explained in part by differences in patient characteristics prior to device implant.
- © 2011 by American Heart Association, Inc.