Bridging children of all sizes to cardiac transplantation: The initial multicenter North American experience with the Berlin Heart EXCOR ventricular assist device

David L.S. Morales, Christopher S.D. Almond, Robert D.B. Jaquiss, David N. Rosenthal, David C. Naftel, M. Patricia Massicotte, Tilman Humpl, Mark W. Turrentine, James S. Tweddell, Gordon A. Cohen, Robert Kroslowitz, Eric J. Devaney, Charles E. Canter, Francis Fynn-Thompson, Olaf Reinhartz, Michiaki Imamura, Nancy S. Ghanayem, Holger Buchholz, Sarah Furness, Robert MazorSanjiv K. Gandhi, Charles D. Fraser

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191 Scopus citations

Abstract

Background Beginning in 2000 and accelerating in 2004, the Berlin Heart EXCOR (Berlin Heart Inc Woodlands, TX) became the first pediatric-specific ventricular assist device (VAD) applied throughout North America for children of all sizes. This retrospective study analyzed the initial Berlin Heart EXCOR pediatric experience as a bridge to transplantation. Methods Between June 2000 and May 2007, 97 EXCOR VADs were implanted in North America at 29 different institutions. The analysis is limited to 73 patients (75%) from 17 institutions, for which retrospective data were available. Results Median age and weight at VAD implant were 2.1years (range, 12 days17.8 years) and 11 kg (range, 387.6 kg), respectively. The primary diagnoses were dilated cardiomyopathy in 42 (58%), congenital heart disease in 19 (26%), myocarditis in 7 (10%), and other cardiomyopathies in 5 (7%). Pre-implant clinical condition was critical cardiogenic shock in 38 (52%), progressive decline in 33 (45%), or other in 2 (3%). Extracorporeal membrane oxygenation was used as a bridge to EXCOR in 22 patients (30%). Device selection was left VAD (LVAD) in 42 (57%) and biventricular assist devices (BiVAD) in 31 (43%). The EXCOR bridged 51 patients (70%) to transplant and 5 (7%) to recovery. Mortality on the EXCOR was 23% (n = 17) overall, including 35% (11 of 31) in BiVAD vs 14% (6 of 42) in LVAD patients (p = 0.003). Multivariate analysis showed younger age and BiVAD support were significant risk factors for death while on the EXCOR. Conclusions This limited but large preliminary North American experience with the Berlin Heart EXCOR VAD as a bridge to cardiac transplantation for children of all ages and sizes points to the feasibility of this approach. The prospective investigational device evaluation trial presently underway will further characterize the safety and efficacy of the EXCOR as a bridge to pediatric cardiac transplantation.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalJournal of Heart and Lung Transplantation
Volume30
Issue number1
DOIs
StatePublished - Jan 1 2011

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Keywords

  • extracorporeal circulation
  • heart-assist device
  • pediatrics
  • transplantation

ASJC Scopus subject areas

  • Transplantation
  • Cardiology and Cardiovascular Medicine
  • Pulmonary and Respiratory Medicine
  • Surgery

Cite this

Morales, D. L. S., Almond, C. S. D., Jaquiss, R. D. B., Rosenthal, D. N., Naftel, D. C., Massicotte, M. P., Humpl, T., Turrentine, M. W., Tweddell, J. S., Cohen, G. A., Kroslowitz, R., Devaney, E. J., Canter, C. E., Fynn-Thompson, F., Reinhartz, O., Imamura, M., Ghanayem, N. S., Buchholz, H., Furness, S., ... Fraser, C. D. (2011). Bridging children of all sizes to cardiac transplantation: The initial multicenter North American experience with the Berlin Heart EXCOR ventricular assist device. Journal of Heart and Lung Transplantation, 30(1), 1-8. https://doi.org/10.1016/j.healun.2010.08.033