title: 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.
  
  
  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.
authors.affiliation: The Heart Center, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School, 300 Longwood Ave, Boston, MA 02115, USA. christopher.almond@childrens.harvard.edu
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Almond
authors.forename: David L
authors.initials: DL
authors.lastname: Morales
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Blackstone
authors.forename: Mark W
authors.initials: MW
authors.lastname: Turrentine
authors.forename: Michiaki
authors.initials: M
authors.lastname: Imamura
authors.forename: M Patricia
authors.initials: MP
authors.lastname: Massicotte
authors.forename: Lori C
authors.initials: LC
authors.lastname: Jordan
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Devaney
authors.forename: Chitra
authors.initials: C
authors.lastname: Ravishankar
authors.forename: Kirk R
authors.initials: KR
authors.lastname: Kanter
authors.forename: William
authors.initials: W
authors.lastname: Holman
authors.forename: Robert
authors.initials: R
authors.lastname: Kroslowitz
authors.forename: Christine
authors.initials: C
authors.lastname: Tjossem
authors.forename: Lucy
authors.initials: L
authors.lastname: Thuita
authors.forename: Gordon A
authors.initials: GA
authors.lastname: Cohen
authors.forename: Holger
authors.initials: H
authors.lastname: Buchholz
authors.forename: James D
authors.initials: JD
authors.lastname: St Louis
authors.forename: Khanh
authors.initials: K
authors.lastname: Nguyen
authors.forename: Robert A
authors.initials: RA
authors.lastname: Niebler
authors.forename: Henry L
authors.initials: HL
authors.lastname: Walters
authors.forename: Brian
authors.initials: B
authors.lastname: Reemtsen
authors.forename: Peter D
authors.initials: PD
authors.lastname: Wearden
authors.forename: Olaf
authors.initials: O
authors.lastname: Reinhartz
authors.forename: Kristine J
authors.initials: KJ
authors.lastname: Guleserian
authors.forename: Max B
authors.initials: MB
authors.lastname: Mitchell
authors.forename: Mark S
authors.initials: MS
authors.lastname: Bleiweis
authors.forename: Charles E
authors.initials: CE
authors.lastname: Canter
authors.forename: Tilman
authors.initials: T
authors.lastname: Humpl
mesh_terms: D049628:Body Size; D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D015897:Comorbidity; D057176:Compassionate Use Trials; D004867:Equipment Design; D015199:Extracorporeal Membrane Oxygenation / Q000706:statistics & numerical data; D005260:Female; D006330:Heart Defects, Congenital / Q000097:blood / Q000601:surgery; D006331:Heart Diseases / Q000097:blood / Q000601:surgery; D016027:Heart Transplantation / Q000706:statistics & numerical data; D006353:Heart-Assist Devices; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D006932:Hyperbilirubinemia / Q000453:epidemiology; D007223:Infant; D007674:Kidney Diseases / Q000453:epidemiology; D008107:Liver Diseases / Q000453:epidemiology; D008297:Male; D009026:Mortality; D009102:Multiple Organ Failure / Q000453:epidemiology; D016016:Proportional Hazards Models; D012306:Risk; D020521:Stroke / Q000453:epidemiology; D015996:Survival Rate; D016896:Treatment Outcome; D014850:Waiting Lists