title: Intermediate outcomes with ex-vivo allograft perfusion for heart transplantation.
abstract: BACKGROUND
  The Organ Care System, an ex-vivo heart perfusion platform, represents an alternative to the current standard of cold organ storage that sustains the donor heart in a near-physiologic state. It is unknown whether using the Organ Care System influences 2-year outcomes after heart transplantation. We reviewed our institutional experience to compare 2-year outcomes for patients randomized to the Organ Care System or standard cold storage.
  
  
  METHODS
  Between 2011 and 2013, heart transplant candidates from a single tertiary-care medical center enrolled within the PROCEED II trial were randomized to either standard cold storage or the Organ Care System. Outcomes assessed included 2-year survival, freedom from cardiac allograft vasculopathy (CAV), non-fatal major cardiac events (NF-MACE), biopsy-proven cellular rejection (CMR) and biopsy-proven antibody-mediated rejection (AMR).
  
  
  RESULTS
  Thirty-eight patients were randomized to the Organ Care System (n = 19) or cold storage group (n = 19). There was no significant difference in 2-year patient survival (Organ Care System: 72.2%; cold storage: 81.6%; p = 0.38). Similarly, there were no differences in freedom from CAV, NF-MACE, CMR or AMR. The Organ Care System group had significantly longer total ischemia time (361 ± 96 minutes vs 207 ± 50 minutes; p < 0.001) and shorter cold ischemia time (134 ± 45 minutes vs 207 ± 50 minutes; p < 0.001) compared with the cold storage group.
  
  
  CONCLUSIONS
  The Organ Care System did not appear to be associated with significant differences in intermediate results compared with conventional strategies. These results suggest that this ex-vivo allograft perfusion system is a promising and valid platform for donor heart transportation.
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA; Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Joshua L
authors.initials: JL
authors.lastname: Chan
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Jon A
authors.initials: JA
authors.lastname: Kobashigawa
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA; Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Heidi J
authors.initials: HJ
authors.lastname: Reich
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA; Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Danny
authors.initials: D
authors.lastname: Ramzy
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Maria M
authors.initials: MM
authors.lastname: Thottam
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Zhe
authors.initials: Z
authors.lastname: Yu
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Tamar L
authors.initials: TL
authors.lastname: Aintablian
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Liou
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Jignesh K
authors.initials: JK
authors.lastname: Patel
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Michelle M
authors.initials: MM
authors.lastname: Kittleson
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA.
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Czer
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA; Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Trento
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California, USA; Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA. Electronic address: fardad.esmailian@cshs.org.
authors.forename: Fardad
authors.initials: F
authors.lastname: Esmailian
mesh_terms: D000328:Adult; D064591:Allografts; D015925:Cryopreservation / Q000379:methods*; D005112:Extracorporeal Circulation / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival; D016027:Heart Transplantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D038622:Internationality; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009926:Organ Preservation / Q000379:methods*; D010477:Perfusion / Q000295:instrumentation*; D011379:Prognosis; D011446:Prospective Studies; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D014019:Tissue Donors; D020858:Tissue and Organ Harvesting / Q000379:methods; D016896:Treatment Outcome
keywords: ex-vivo perfusion; heart preservation; heart transplantation; mechanical perfusion; organ care system