title: Berlin Heart EXCOR use in patients with congenital heart disease.
abstract: BACKGROUND
  Management of mechanical circulatory support in children with congenital heart disease (CHD) is challenging due to physiologic variations and anatomic limitations to device placement. In this study we examine the use of Berlin Heart EXCOR in CHD patients.
  
  
  METHODS
  CHD patients were identified from the EXCOR Pediatric Study data set (2007 to 2010). Mortality and serious adverse events were compared between CHD and non-CHD cohorts, and predictors of poor outcomes in the CHD cohort were identified.
  
  
  RESULTS
  CHD was present in 29% (n = 59, 18 with 1-ventricle physiology) of all EXCOR patients (N = 204). Successful bridge (transplant or wean) was less likely in CHD patients compared with non-CHD patients (48% vs 80%; p < 0.01). Among CHD patients, no neonates, 25% of infants (30 days to 1 year) and 65% of children (>1 year) were successfully bridged. Pre-implant congenital heart surgery (CHS) and extracorporeal membrane oxygenation (ECMO) on the same admission occurred in 60% of children ≤1 year of age (83% of neonates, 50% of infants), with 8% survival. Regardless of age, patients who did not have CHS and ECMO had 61% survival. Smaller pump, pre-implant bilirubin >1.2 mg/dl and renal dysfunction were independently associated with mortality.
  
  
  CONCLUSIONS
  End-organ function at implant reliably predicts adverse outcomes and should be considered when making implant decisions. EXCOR use in neonates and infants with CHD should be approached cautiously. If patients have undergone pre-implant CHS and ECMO, EXCOR support may not provide any survival benefit. EXCOR support in non-infants with CHD is challenging but can be consistently successful with appropriate patient selection.
authors.affiliation: The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. Electronic address: david.morales@cchmc.org.
authors.forename: David L S
authors.initials: DLS
authors.lastname: Morales
authors.affiliation: The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
authors.forename: Farhan
authors.initials: F
authors.lastname: Zafar
authors.affiliation: Lucile Packard Children's Hospital, Palo Alto, California, USA.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Almond
authors.affiliation: St. Louis Children's Hospital, St. Louis, Missouri, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Canter
authors.affiliation: Boston Children's Hospital, Boston, Massachusetts, USA.
authors.forename: Francis
authors.initials: F
authors.lastname: Fynn-Thompson
authors.affiliation: Stollery Children's Hospital, Edmonton, Alberta, Canada.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Conway
authors.affiliation: Texas Children's Hospital, Houston, Texas, USA.
authors.forename: Iki
authors.initials: I
authors.lastname: Adachi
authors.affiliation: The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: Lorts
mesh_terms: D006348:Cardiac Surgical Procedures / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D004867:Equipment Design; D015199:Extracorporeal Membrane Oxygenation / Q000379:methods*; D005260:Female; D006330:Heart Defects, Congenital / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D016027:Heart Transplantation; D006352:Heart Ventricles / Q000503:physiopathology; D006353:Heart-Assist Devices / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: EXCOR; congenital heart disease; congenital heart surgery; mechanical circulatory support; ventricular assist device