title: Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial.
abstract: After extensive experimentation, outcomes of a first clinical normothermic machine perfusion (NMP) liver trial in the United Kingdom demonstrated feasibility and clear safety, with improved liver function compared with standard static cold storage (SCS). We present a preliminary single-center North American experience using identical NMP technology. Ten donor liver grafts were procured, four (40%) from donation after circulatory death (DCD), of which nine were transplanted. One liver did not proceed because of a technical failure with portal cannulation and was discarded. Transplanted NMP grafts were matched 1:3 with transplanted SCS livers. Median NMP was 11.5 h (range 3.3-22.5 h) with one DCD liver perfused for 22.5 h. All transplanted livers functioned, and serum transaminases, bilirubin, international normalized ratio, and lactate levels corrected in NMP recipients similarly to controls. Graft survival at 30 days (primary outcome) was not statistically different between groups on an intent-to-treat basis (p = 0.25). Intensive care and hospital stays were significantly more prolonged in the NMP group. This preliminary experience demonstrates feasibility as well as potential technical risks of NMP in a North American setting and highlights a need for larger, randomized studies.
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.|Members of the Canadian National Transplant Research Project (CNTRP), Edmonton, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Bral
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.|Members of the Canadian National Transplant Research Project (CNTRP), Edmonton, Canada.
authors.forename: B
authors.initials: B
authors.lastname: Gala-Lopez
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Bigam
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.|Members of the Canadian National Transplant Research Project (CNTRP), Edmonton, Canada.
authors.forename: N
authors.initials: N
authors.lastname: Kneteman
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.|Members of the Canadian National Transplant Research Project (CNTRP), Edmonton, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Malcolm
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Livingstone
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Andres
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Emamaullee
authors.affiliation: OrganOx, Oxford, UK.
authors.forename: L
authors.initials: L
authors.lastname: Russell
authors.affiliation: Institute of Biomedical Engineering, University of Oxford, Oxford, UK.
authors.forename: C
authors.initials: C
authors.lastname: Coussios
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.|Members of the Canadian National Transplant Research Project (CNTRP), Edmonton, Canada.
authors.forename: L J
authors.initials: LJ
authors.lastname: West
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: P J
authors.initials: PJ
authors.lastname: Friend
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, Canada.|Members of the Canadian National Transplant Research Project (CNTRP), Edmonton, Canada.
authors.forename: A M J
authors.initials: AM
authors.lastname: Shapiro
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005112:Extracorporeal Circulation; D005260:Female; D006085:Graft Survival; D006801:Humans; D008111:Liver Function Tests; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009926:Organ Preservation / Q000379:methods*; D010477:Perfusion / Q000379:methods*; D011183:Postoperative Complications; D014019:Tissue Donors; D052096:Warm Ischemia; D055815:Young Adult
keywords: clinical research/practice; clinical trial; liver transplantation/hepatology; organ perfusion and preservation; organ procurement and allocation