Preliminary Single Center North American Experience With The Berlin Heart Pediatric EXCOR Device

Abstract

For children requiring mechanical circulatory support as a bridge to cardiac transplantation in North America, options previously were limited to extracorporeal membrane oxygenation (ECMO) or centrifugal pump ventricular assist, both of which were suitable for only very short term application and were associated with significant complications and limitations. The Berlin Heart EXCOR ventricular assist device (VAD) was recently introduced into practice in North America to address this deficiency. We report a preliminary single center experience with the EXCOR in 17 children, 13 who received only a left-sided pump and four who required biventricular support. Before EXCOR placement, six patients were on ECMO, and one was on a centrifugal VAD. Eleven children were bridged to transplantation, one was bridged to recovery, and one remains on support. Three children died during support and one died after explantation. There was one late death nearly 2 years after transplant. Complications included stroke in seven patients, two of which were ultimately fatal. Five patients required re-operations for bleeding or evacuation of hematoma. Despite a disappointing rate of neurologic morbidity, our preliminary experience with the EXCOR has been very encouraging.

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.…”

Antithrombotic Therapy in Neonates and Children

“…[580][581][582] However, on the basis of adult data and the basic pathophys-ital or acquired) as either bridge to transplantation or to cardiac recovery. [621][622][623][624][625][626] There are a variety of VADs available, many specifi cally developed for pediatric use. 621 Studies of these devices in infants and children are mainly retrospective case series with outcomes being survival to transplant or to cardiac recovery.…”

Mechanical circulation support of the treatment for children with end-stage chronic heart failure

“…С 1989 года компания Berlin Heart® GmbH модифицировала систему EXCOR паракорпораль-ного подключения искусственных желудочков сер-дца (ИЖС) для детей младшего возраста [37], а с 2011 года после 10-летнего клинического приме-нения в Европе эта система получила разрешение FDA на применение в клиниках США и до сих пор остается единственной официально разрешенной длительной системой МПК для новорожденных и детей младшего возраста [38].…”

“…В 16-м официальном отчете по педиатрической трансплантации сердца Международного общества трансплантации сердца и легких [52] была проана-лизирована выживаемость после ТС группы детей (c 2004-го по 2014 г.) с предварительным примене-нием EXCOR по сравнению с пациентами без пред-варительной МПК.…”