title: Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial.
abstract: BACKGROUND
  The Berlin Heart EXCOR(®) ventricular assist device has been approved for use in the United States as a bridge to heart transplantation in children. We sought to characterize neurological events in children supported with the Berlin Heart EXCOR(®) device.
  
  
  RESULTS
  The multicenter prospective cohort consisted of all 204 children implanted with the Berlin Heart EXCOR(®) device at 47 centers in North America between May 2007 and December 2010. There were 73 neurological events in 59 patients, with 29% of the cohort experiencing ≥1 neurological event. Events included 52 strokes in 43 patients (21% of the cohort). The neurological event rate was 0.51 events per 100 patient-days. Many of the neurological events occurred early in the course of support, with 30 events recorded during the first 14 days of support. The mortality rate in participants with at least 1 neurological event was 42% (25 of 59), significantly higher than the 18% mortality rate (26 of 145) for those who did not have a neurological event (P=0.0006). Risk-factor analysis did not identify significant preimplantation predictors of neurological injury.
  
  
  CONCLUSIONS
  Of children treated with the Berlin Heart EXCOR(®) device as a bridge to transplant, 29% experienced at least 1 neurological event. The majority of neurological events were ischemic strokes, and many of those occurred early in the course of support. Neurological injury was the leading cause of death after implantation of the Berlin Heart EXCOR(®) device. Risk stratification for stroke or neurological injury is not possible based on baseline preimplantation characteristics.
  
  
  BACKGROUND
  www.clinicaltrials.gov. Unique Identifier: NCT00583661.
authors.affiliation: Division of Pediatric Neurology, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN (L.C.J.).
authors.forename: Lori C
authors.initials: LC
authors.lastname: Jordan
authors.affiliation: Department of Neurology, The Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (R.N.I.).
authors.forename: Rebecca N
authors.initials: RN
authors.lastname: Ichord
authors.affiliation: Department of Cardiac Surgery, Stanford University, Palo Alto, CA (O.R.).
authors.forename: Olaf
authors.initials: O
authors.lastname: Reinhartz
authors.affiliation: Department of Critical Care Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada (T.H.).
authors.forename: Tilman
authors.initials: T
authors.lastname: Humpl
authors.affiliation: Department of Radiology, Vanderbilt University School of Medicine, Nashville, TN (S.P.).
authors.forename: Sumit
authors.initials: S
authors.lastname: Pruthi
authors.affiliation: Berlin Heart, Inc, The Woodlands, TX (C.T.).
authors.forename: Christine
authors.initials: C
authors.lastname: Tjossem
authors.affiliation: Department of Pediatrics, Stanford University, Palo Alto, CA (D.N.R.).
authors.forename: David N
authors.initials: DN
authors.lastname: Rosenthal
mesh_terms: D002648:Child; D002675:Child, Preschool; D015199:Extracorporeal Membrane Oxygenation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality* / Q000601:surgery*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000401:mortality; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D010372:Pediatrics; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D020521:Stroke / Q000209:etiology* / Q000401:mortality; D015996:Survival Rate; D016896:Treatment Outcome; D014850:Waiting Lists
keywords: cardiomyopathy; heart failure; pediatrics; stroke