title: Pneumatic paracorporeal ventricular assist device in infants and children: initial Stanford experience.
abstract: BACKGROUND
  Mechanical circulatory support with the Berlin Heart EXCOR pediatric ventricular assist device (VAD) has been used successfully in Europe for children with cardiac failure. Eighty-seven devices have been placed in North America through February 2007. We describe our single-center experience in 8 children.
  
  
  METHODS
  Eight children (ages 4 to 55 months), with median weight of 9.6 kg and body surface area of 0.48 m(2), received the Berlin Heart VAD as a bridge to transplantation. All patients were in cardiogenic shock requiring multiple inotropes. Primary diagnoses were idiopathic dilated cardiomyopathy (n = 4), congenital heart disease (n = 3) and restrictive cardiomyopathy (n = 1). After device insertion, all patients were treated with an anti-coagulant (heparin or coumadin) and one or more platelet inhibitors (aspirin with clopidogrel or dipyridamole).
  
  
  RESULTS
  Five patients received support with a left ventricular assist device (LVAD) and 3 with a biventricular device (BiVAD). Duration of support ranged from 2 to 234 days (median 57 days). Five patients (63%) were successfully bridged to transplantation; of these, 4 were discharged home and 1 died from early graft failure. Five patients developed post-operative neurologic events. Of these 5 events, 4 could be explained by embolism or hemorrhage. Device exchange was performed in 4 patients in the intensive care unit.
  
  
  CONCLUSIONS
  In selected children, the Berlin Heart VAD can be used as a bridge to transplantation. In contrast to the published European experience, neurologic events occur frequently. Anti-coagulation and platelet inhibition strategies continue to evolve. Device exchange is technically feasible at the bedside and should be considered at the earliest visualization of thrombus formation.
authors.affiliation: Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, California 94305-5407, USA.
authors.forename: S Chris
authors.initials: SC
authors.lastname: Malaisrie
authors.forename: Marc P
authors.initials: MP
authors.lastname: Pelletier
authors.forename: James J
authors.initials: JJ
authors.lastname: Yun
authors.forename: Kapil
authors.initials: K
authors.lastname: Sharma
authors.forename: Tomasz A
authors.initials: TA
authors.lastname: Timek
authors.forename: David N
authors.initials: DN
authors.lastname: Rosenthal
authors.forename: Gail E
authors.initials: GE
authors.lastname: Wright
authors.forename: Robert C
authors.initials: RC
authors.lastname: Robbins
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Reitz
mesh_terms: D002311:Cardiomyopathy, Dilated / Q000401:mortality / Q000601:surgery*; D002423:Cause of Death; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival; D006330:Heart Defects, Congenital / Q000401:mortality / Q000601:surgery*; D016027:Heart Transplantation / Q000379:methods / Q000401:mortality*; D006353:Heart-Assist Devices; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007362:Intensive Care Units; D008297:Male; D012189:Retrospective Studies; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome; D014850:Waiting Lists