Author + information
- Received February 4, 2014
- Revision received July 17, 2014
- Accepted July 28, 2014
- Published online January 1, 2015.
- Jennifer Conway, MD∗,
- James St. Louis, MD†,
- David L.S. Morales, MD‡,
- Sabrina Law, MD§,
- Christine Tjossem, BS‖ and
- Tilman Humpl, MD∗∗ ()
- ∗The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada
- †University of Minnesota, Amplatz Children's Hospital, Minneapolis, Minnesota
- ‡Cincinnati Children’s Hospital, Cincinnati, Ohio
- §Seattle Children’s Hospital, Seattle, Washington
- ‖Berlin Heart Inc., The Woodlands, Texas
- ↵∗Reprint requests and correspondence:
Dr. Tilman Humpl, Department of Critical Care Medicine and Pediatrics, Division of Cardiology, 555 University Avenue, Toronto, Ontario M5G1X8, Canada.
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 poor outcomes, 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. This outcome 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 a select population of children weighing <10 kg.
Dr. Morales has served on the medical advisory board for Cormatrix; has served as a proctor for TAH for SynCardia; was a member of the clinical events committee for Berlin Heart; and has served as an advisor for Thoratec and HeartWare. For all services, the companies paid for Dr. Morales’s travel, but no personal monies were paid. Dr. Tjossem is an employee of Berlin Heart Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 4, 2014.
- Revision received July 17, 2014.
- Accepted July 28, 2014.
- American College of Cardiology Foundation