Delineating survival outcomes in children <10 kg bridged to transplant or recovery with the berlin heart EXCOR ventricular assist device

Objectives: The goal of this study was to delineate outcomes of children weighing<10 kg supported with the Berlin Heart EXCOR Pediatric Ventricular Assist Device (EXCOR Pediatric, Berlin Heart Inc., The Woodlands, Texas) and to identify factors that increased the risk of all-cause mortality in this population. Background: Ventricular assist devices have been shown to be an effective bridge to transplant, with improved outcomes compared with use of extracorporeal membrane oxygenation. Smaller patients may be at greatest risk for pooroutcomes, but it remains unclear if mortality is uniform across all smaller candidates. Methods: Patients included in the analysis were part of a multicenter prospective cohort study examining the use of the Berlin Heart EXCOR Pediatric Ventricular Assist Device as a bridge to transplant. All children who received the device between May 9, 2007 and December 31, 2010, and who were enrolled in the sponsor's U.S. regulatory database, were identified and analyzed. Multivariable analysis was performed to determine risk factors associated with mortality. Results: A total of 97 children weighing<10 kg were included (median age 6.2 months; median weight 6.2 kg; median duration of support 26 days). Successful outcomes were achieved in 56.7% of patients. Independent risk factors for mortality in smaller children included pre-existing congenital heart disease (odds ratio: 4.8 [95% confidence interval: 1.5 to 15.0]; p= 0.007) and an elevated bilirubin level (odds ratio: 5.3 [95% confidence interval: 2.0 to 14.3]; p= 0.001). Conclusions: Overall results for children weighing<10 kg were inferior to those of their larger counterparts. Thisoutcome was primarily influenced by congenital heart disease and presence of elevated pre-implant bilirubin levels. These factors should be taken into consideration at decision making because reasonable outcomes can be achieved in aselect population of children weighing<10 kg.