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Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children.

Abstract：

BACKGROUND:Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data are limited to 1 in 4 children who received the device as part of the US clinical trial. We analyzed outcomes for all US children who received the EXCOR to characterize device outcomes in an unselected cohort and to identify risk factors for mortality to facilitate patient selection. METHODS AND RESULTS:This multicenter, prospective cohort study involved all children implanted with the Berlin Heart EXCOR Pediatric ventricular assist device at 47 centers from May 2007 through December 2010. Multiphase nonproportional hazards modeling was used to identify risk factors for early (<2 months) and late mortality. Of 204 children supported with the EXCOR, the median duration of support was 40 days (range, 1-435 days). Survival at 12 months was 75%, including 64% who reached transplantation, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, biventricular assist device support, and elevated bilirubin as risk factors for early mortality and bilirubin extremes and renal dysfunction as risk factors for late mortality. Neurological dysfunction occurred in 29% and was the leading cause of death. CONCLUSIONS:Use of the Berlin Heart EXCOR has risen dramatically over the past decade. The EXCOR has emerged as a new treatment standard in the United States for pediatric bridge to transplantation. Three-quarters of children survived to transplantation or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.

journal_name

Circulation

journal_title

Circulation

authors

Almond CS,Morales DL,Blackstone EH,Turrentine MW,Imamura M,Massicotte MP,Jordan LC,Devaney EJ,Ravishankar C,Kanter KR,Holman W,Kroslowitz R,Tjossem C,Thuita L,Cohen GA,Buchholz H,St Louis JD,Nguyen K,Niebler RA,Walt

doi

10.1161/CIRCULATIONAHA.112.000685

subject

Has Abstract

pub_date

2013-04-23 00:00:00

pages

1702-11

issue

eissn

0009-7322

issn

1524-4539

pii

CIRCULATIONAHA.112.000685

journal_volume

127

pub_type

临床试验,杂志文章,多中心研究

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Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children.