title: Prospective trial of a pediatric ventricular assist device.
abstract: BACKGROUND
  Options for mechanical circulatory support as a bridge to heart transplantation in children with severe heart failure are limited.
  
  
  METHODS
  We conducted a prospective, single-group trial of a ventricular assist device designed specifically for children as a bridge to heart transplantation. Patients 16 years of age or younger were divided into two cohorts according to body-surface area (cohort 1, <0.7 m(2); cohort 2, 0.7 to <1.5 m(2)), with 24 patients in each group. Survival in the two cohorts receiving mechanical support (with data censored at the time of transplantation or weaning from the device owing to recovery) was compared with survival in two propensity-score-matched historical control groups (one for each cohort) undergoing extracorporeal membrane oxygenation (ECMO).
  
  
  RESULTS
  For participants in cohort 1, the median survival time had not been reached at 174 days, whereas in the matched ECMO group, the median survival was 13 days (P<0.001 by the log-rank test). For participants in cohort 2 and the matched ECMO group, the median survival was 144 days and 10 days, respectively (P<0.001 by the log-rank test). Serious adverse events in cohort 1 and cohort 2 included major bleeding (in 42% and 50% of patients, respectively), infection (in 63% and 50%), and stroke (in 29% and 29%).
  
  
  CONCLUSIONS
  Our trial showed that survival rates were significantly higher with the ventricular assist device than with ECMO. Serious adverse events, including infection, stroke, and bleeding, occurred in a majority of study participants. (Funded by Berlin Heart and the Food and Drug Administration Office of Orphan Product Development; ClinicalTrials.gov number, NCT00583661.).
authors.affiliation: Texas Children's Hospital and Baylor College of Medicine, Houston, Texas 77030, USA. cdfraser@texaschildrens.org.
authors.forename: Charles D
authors.initials: CD
authors.lastname: Fraser
authors.forename: Robert D B
authors.initials: RD
authors.lastname: Jaquiss
authors.forename: David N
authors.initials: DN
authors.lastname: Rosenthal
authors.forename: Tilman
authors.initials: T
authors.lastname: Humpl
authors.forename: Charles E
authors.initials: CE
authors.lastname: Canter
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Blackstone
authors.forename: David C
authors.initials: DC
authors.lastname: Naftel
authors.forename: Rebecca N
authors.initials: RN
authors.lastname: Ichord
authors.forename: Lisa
authors.initials: L
authors.lastname: Bomgaars
authors.forename: James S
authors.initials: JS
authors.lastname: Tweddell
authors.forename: M Patricia
authors.initials: MP
authors.lastname: Massicotte
authors.forename: Mark W
authors.initials: MW
authors.lastname: Turrentine
authors.forename: Gordon A
authors.initials: GA
authors.lastname: Cohen
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Devaney
authors.forename: F Bennett
authors.initials: FB
authors.lastname: Pearce
authors.forename: Kathleen E
authors.initials: KE
authors.lastname: Carberry
authors.forename: Robert
authors.initials: R
authors.lastname: Kroslowitz
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Almond
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D015199:Extracorporeal Membrane Oxygenation; D054143:Heart Failure, Systolic / Q000401:mortality / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D011474:Prosthesis Design; D015996:Survival Rate; D014850:Waiting Lists