Bridging children of all sizes to cardiac transplantation: the initial multicenter North American experience with the Berlin Heart EXCOR ventricular assist device.
ABSTRACT 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.
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.
Median age and weight at VAD implant were 2.1 years (range, 12 days-17.8 years) and 11 kg (range, 3-87.6 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.
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.
Article: Current devices for pediatric extracorporeal life support and mechanical circulatory support systems in the United States.[show abstract] [hide abstract]
ABSTRACT: Extracorporeal life support (ECLS) and mechanical circulatory support (MCS) have become indispensable treatment tools for pediatric patients with congenital heart defects undergoing peri-operative or end-stage heart and/or lung failure. ECLS and MCS can serve as bridges to recovery, transplantation (heart or lung), destination therapy, or "bridge to bridge" long-term MCS. Dependent on patient condition, venoarterial ECMO (V-A ECMO) for heart and lung support, venovenous ECMO (V-V ECMO) for respiratory support, and MCS for uni- and biventricular support can be selected properly. Considering small patient body size, the access sites and cannulation should be selected carefully to obtain adequate blood flow, minimum injury, and easy management. The applying equipment, including tubing, cannulae, oxygenator and blood pump, need to be selected optimally in order to enable rapid setup and priming, successful cannulation and early support, and to reduce the risk of device-related morbidity and mortality. The aim of this review manuscript was to discuss briefly the current devices for pediatric ECLS and MCS available in US.Bio-medical materials and engineering 01/2013; 23(1):57-62. · 1.23 Impact Factor