Background— Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data are limited to 1 in 4 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 to identify risk factors for mortality to facilitate patient selection. Methods and Results— This multicenter, prospective cohort study involved all children implanted with the Berlin Heart EXCOR Pediatric ventricular assist device at 47 centers from May 2007 through December 2010. Multiphase nonproportional 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 days). Survival at 12 months was 75%, including 64% who reached transplantation, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, biventricular assist device 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. The EXCOR has emerged as a new treatment standard in the United States for pediatric bridge to transplantation. Three-quarters of children survived to transplantation or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.

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Objectives We sought to evaluate predictors of stroke on LVAD from data available prior to implantation, and quantify stroke-related morbidity and mortality Background Stroke is a major complication after LVAD. Pre-implant factors that influence stroke are not well understood. Methods We evaluated all patients in the INTERMACS registry who were implanted with continuous-flow LVADs from May 1, 2012 to March 31, 2015. Preoperative risk factors for stroke, and stroke incidence, morbidity, and mortality were analyzed. Results During the study period, 7112 patients underwent CF LVAD placement. Median follow-up was 9.79 months (range 0.02–34.96 months). Of all patients, 752 (10.57%) had at least one stroke, with an incidence rate of 0.123 strokes per patient-year. 447 (51.38%) strokes were ischemic and 423 (48.62%) were hemorrhagic. Patients with hemorrhagic stroke had worse survival than those with ischemic strokes (30-day survival 45.3% vs. 80.7, p <0.001). Of patients with a first stroke, 13% had a second stroke. Pre-implant predictors of stroke were female gender (HR 1.51, 95% CI 1.25–1.82, p <0.001), pre-implant systolic blood pressure (HR 1.01, 95% CI 1.00–1.01, p = 0.002), heparin-induced thrombocytopenia (HIT) (HR 3.68, 95% CI 1.60–8.47, p = 0.002), intra-aortic balloon pump (IABP) (HR 1.21, 95% CI 1.01–1.46, p = 0.043), and primary cardiac diagnosis (ischemic/other/unknown) (p = 0.040). Conclusion Despite improvements in LVAD technology, stroke-related morbidity and mortality is substantial. Further investigation is necessary to decrease the risk of this devastating complication.