Article

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

Congenital Heart Surgery Division, Texas Children's Hospital, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation (impact factor: 3.54). 01/2011; 30(1):1-8. DOI:10.1016/j.healun.2010.08.033 pp.1-8
Source: PubMed

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.

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    Article: Current devices for pediatric extracorporeal life support and mechanical circulatory support systems in the United States.
    Akif Undar, Shigang Wang
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    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
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.

Keywords

17 institutions
 
22 patients
 
29 different institutions
 
73 patients
 
97 EXCOR VADs
 
Berlin Heart EXCOR
 
Berlin Heart EXCOR VAD
 
cardiac transplantation
 
congenital heart disease
 
EXCOR bridged 51 patients
 
first pediatric-specific ventricular
 
LVAD patients
 
Median age
 
pediatric cardiac transplantation
 
Pre-implant clinical condition
 
primary diagnoses
 
retrospective data
 
retrospective study analyzed
 
VAD implant
 
younger age