title: Bridging children of all sizes to cardiac transplantation: the initial multicenter North American experience with the Berlin Heart EXCOR ventricular assist device.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Congenital Heart Surgery Division, Texas Children's Hospital, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA. dlmorale@texaschildrens.org
authors.forename: David L S
authors.initials: DL
authors.lastname: Morales
authors.forename: Christopher S D
authors.initials: CS
authors.lastname: Almond
authors.forename: Robert D B
authors.initials: RD
authors.lastname: Jaquiss
authors.forename: David N
authors.initials: DN
authors.lastname: Rosenthal
authors.forename: David C
authors.initials: DC
authors.lastname: Naftel
authors.forename: M Patricia
authors.initials: MP
authors.lastname: Massicotte
authors.forename: Tilman
authors.initials: T
authors.lastname: Humpl
authors.forename: Mark W
authors.initials: MW
authors.lastname: Turrentine
authors.forename: James S
authors.initials: JS
authors.lastname: Tweddell
authors.forename: Gordon A
authors.initials: GA
authors.lastname: Cohen
authors.forename: Robert
authors.initials: R
authors.lastname: Kroslowitz
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Devaney
authors.forename: Charles E
authors.initials: CE
authors.lastname: Canter
authors.forename: Francis
authors.initials: F
authors.lastname: Fynn-Thompson
authors.forename: Olaf
authors.initials: O
authors.lastname: Reinhartz
authors.forename: Michiaki
authors.initials: M
authors.lastname: Imamura
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Ghanayem
authors.forename: Holger
authors.initials: H
authors.lastname: Buchholz
authors.forename: Sarah
authors.initials: S
authors.lastname: Furness
authors.forename: Robert
authors.initials: R
authors.lastname: Mazor
authors.forename: Sanjiv K
authors.initials: SK
authors.lastname: Gandhi
authors.forename: Charles D
authors.initials: CD
authors.lastname: Fraser
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001830:Body Surface Area; D009202:Cardiomyopathies / Q000601:surgery; D002311:Cardiomyopathy, Dilated / Q000601:surgery*; D002648:Child; D002675:Child, Preschool; D005240:Feasibility Studies; D005260:Female; D006330:Heart Defects, Congenital / Q000601:surgery*; D016027:Heart Transplantation / Q000295:instrumentation* / Q000401:mortality; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009205:Myocarditis / Q000601:surgery*; D009656:North America; D012189:Retrospective Studies; D012307:Risk Factors; D012770:Shock, Cardiogenic / Q000601:surgery; D016896:Treatment Outcome