TY - JOUR
T1 - Bridging children of all sizes to cardiac transplantation
T2 - The initial multicenter North American experience with the Berlin Heart EXCOR ventricular assist device
AU - Morales, David L.S.
AU - Almond, Christopher S.D.
AU - Jaquiss, Robert D.B.
AU - Rosenthal, David N.
AU - Naftel, David C.
AU - Massicotte, M. Patricia
AU - Humpl, Tilman
AU - Turrentine, Mark W.
AU - Tweddell, James S.
AU - Cohen, Gordon A.
AU - Kroslowitz, Robert
AU - Devaney, Eric J.
AU - Canter, Charles E.
AU - Fynn-Thompson, Francis
AU - Reinhartz, Olaf
AU - Imamura, Michiaki
AU - Ghanayem, Nancy S.
AU - Buchholz, Holger
AU - Furness, Sarah
AU - Mazor, Robert
AU - Gandhi, Sanjiv K.
AU - Fraser, Charles D.
N1 - Funding Information:
This study was supported in part by a grant from the FDA, Office of Orphan Product Development ( R01 FD003557–01 ). Dr Almond is supported by Orphan Product Grant ( R01 FD 03557 ) by the FDA's Office of Orphan Product Development. The Berlin Heart EXCOR IDE Clinical Trial is supported by the same grant ( R01 FD-03557 ).
PY - 2011/1
Y1 - 2011/1
N2 - 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.
AB - 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.
KW - extracorporeal circulation
KW - heart-assist device
KW - pediatrics
KW - transplantation
UR - http://www.scopus.com/inward/record.url?scp=78649962152&partnerID=8YFLogxK
U2 - 10.1016/j.healun.2010.08.033
DO - 10.1016/j.healun.2010.08.033
M3 - Article
C2 - 21145473
AN - SCOPUS:78649962152
VL - 30
SP - 1
EP - 8
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
SN - 1053-2498
IS - 1
ER -