Abstract 11140: Outcomes after Pediatric Heart Transplantation with Use of the Berlin Heart EXCOR Pediatric Ventricular Assist Device
Background: Recent data from the recent FDA Humanitarian Use Exemption (HDE) Trial suggest the Berlin Heart EXCOR Pediatric VAD improves waiting list survival for pediatric heart transplant (PHT) candidates who fail optimal medical therapy. Little is known about their post-transplant outcomes. We hypothesized that children bridged to transplant with the EXCOR had similar early survival to status 1A PHT patients not transplanted from VAD support.
Methods: 95 patients < 16 years of age supported with the EXCOR who were implanted in the FDA HDE trial or on a compassionate use basis at the 16 trial centers from 10/07-11/11 were compared to a similarly aged cohort within the Organ Procurement and Transplant Network (OPTN) database from 5/07-12/10.
Results: In the EXCOR group, 12-month post-transplant survival (87.4%) was similar to survival for 840 OPTN children listed status 1A who were not on VAD support at transplant (89.3%, p=0.79) and were significantly better than 12-month survival in OPTN patients on ECMO at transplant (60.3%, p<0,001). Rejection (50%), infection (17%), and stroke (17%) were the most common causes of post-transplant death in the EXCOR group. Survival after transplant was lower in EXCOR congenital heart disease patients vs. those with cardiomyopathy (72.7% vs 91.8%,p=0.028), but not significantly different from the OPTN Status 1A congenital heart disease group (85.0%, p=0.39). Pre-implant variables including age, use of BiVAD support, and measures of renal and hepatic function did not affect post-transplant survival. 83 (87.4%) EXCOR patients had at least one serious adverse event while on the pump including major infection (50.5%), major bleeding (46.5%), and stroke (24.2%), which individually or in aggregate had no effect on survival.
Conclusions: 12 month PHT survival after heart transplantation with the EXCOR is comparable to overall PHT survival and superior to survival in PHT patients on ECMO at transplant. Congenital heart disease remains a greater risk for PHT mortality in EXCOR patients. Factors identified with pre-transplant mortality on the EXCOR do not affect post-transplant survival. Among children reaching transplant, adverse events experienced on EXCOR support did not appear to influence survival post-transplant.
- © 2012 by American Heart Association, Inc.