Clinical Experience With Berlin Heart Excor in Pediatric Patients in Argentina: 1373 days of Cardiac Support

Abstract

The objective of this study was to describe our experience (1373 days of support) with the Berlin Heart Excor (BH) ventricular-assist device (VAD) as bridging to cardiac transplantation in pediatric patients with end-stage cardiomyopathy. This study involved a retrospective observational cohort. Records of patients supported with the BH VAD were reviewed. Data regarding age, sex, weight, diagnosis, preoperative condition, single versus biventricular support, morbidity, and mortality were collected. Criteria for single versus biventricular support and intensive care unit management were registered. The procedure was approved by our Institutional Ethics Committee, and informed consent was obtained. Between March 2006 and March 2010, 12 patients with diagnosis of dilated (n = 10) and restrictive (n = 2) cardiomyopathy were supported. Median age was 56.6 months (range 20.1-165.9); mean weight was 18.3 kg (range 8.5-45); and nine patients were female. Every patient presented with severe heart failure refractory to pharmacological therapy. Biventricular support was necessary in four patients. Nine patients underwent heart transplantation. No child was weaned off the BH VAD because of myocardial recovery. Mean length of support was 73 days (range 3-331), and the total number of days of support was 1373. Three patients had fatal complications: 2 had thrombo-hemorrhagic stroke leading to brain death, and one had refractory vasoplegic shock. The BH VAD is a useful and reasonable safe device for cardiac transplantation bridging in children with end-stage heart failure. Team experience resulted in less morbidity and mortality, and time for implantation, surgical procedure, anticoagulation monitoring, and patient care improved.

Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

“…5,6,[17][18][19][20][21][22][23] The wide variability in risk estimates stems from limitations of earlier studies, including small sample size 18,19,22,24 or single-institution experiences, 6,24,25 which has made it difficult for clinicians to know precisely when to offer EXCOR support to their patients or to provide families with or a standardized device treatment protocol 6,25 with uniform adverse event definitions, anticoagulation guidelines, and algorithm for pursuing BIVAD support, thus precluding the ability to know whether adverse events are related to the device itself or differences in patient management. Moreover, studies have tended to pool bridge-to-transplantation and bridge-to-recovery patients, 6,25 making it difficult to interpret transplantation success rates.…”

Pediatric Mechanical Circulatory Support Systems in Latin America

“…The Berlin Heart EXCOR is the most used long‐term MCS in this population, with more than 57 devices (48 in Argentina, with 40 of them at the Hospital Gaharran) . The use of long‐term implantable devices (implantable rotary or axial pumps and the Total Artificial Heart), mainly in the older pediatric population, are currently limited to a very few centers in the region.…”

Ventricular assist device use in congenital heart disease with a comparison to heart transplant

“…Subsequently, adult VADs have shown utility in the larger pediatric population. Since the IDE study, multiple reports have investigated the utility of VADs in the pediatric population with a survival rate between 75 and 100% and a longer duration of support than possible with ECMO (Table 1) [9–18]. Recent data have suggested that patients who receive VAD support prior to HT have equivalent survival to those who do not and an improved survival over patients supported with ECMO [2,19].…”