title: Normothermic ex vivo liver perfusion using steen solution as perfusate for human liver transplantation: First North American results.
abstract: The European trial investigating normothermic ex vivo liver perfusion (NEVLP) as a preservation technique for liver transplantation (LT) uses gelofusine, a non-US Food and Drug Administration-approved, bovine-derived, gelatin-based perfusion solution. We report a safety and feasibility clinical NEVLP trial with human albumin-based Steen solution. Transplant outcomes of 10 human liver grafts that were perfused on the Metra device at 37 °C with Steen solution, plus 3 units of erythrocytes were compared with a matched historical control group of 30 grafts using cold storage (CS) as the preservation technique. Ten liver grafts were perfused for 480 minutes (340-580 minutes). All livers cleared lactate (final lactate 1.46 mmol/L; 0.56-1.74 mmol/L) and produced bile (61 mL; 14-146 mL) during perfusion. No technical problems occurred during perfusion, and all NEVLP-preserved grafts functioned well after LT. NEVLP versus CS had lower aspartate aminotransferase and alanine aminotransferase values on postoperative days 1-3 without reaching significance. No difference in postoperative graft function between NEVLP and CS grafts was detected as measured by day 7 international normalized ratio (1.1 [1-1.56] versus 1.1 [1-1.3]; P = 0.5) and bilirubin (1.5; 1-7.7 mg/dL versus 2.78; 0.4-15 mg/dL; P = 0.5). No difference was found in the duration of intensive care unit stay (median, 1 versus 2 days; range, 0-8 versus 0-23 days; P = 0.5) and posttransplant hospital stay (median, 11 versus 13 days; range, 8-17 versus 7-89 days; P = 0.23). Major complications (Dindo-Clavien ≥ 3b) occurred in 1 patient in the NEVLP group (10%) compared with 7 (23%) patients in the CS group (P = 0.5). No graft loss or patient death was observed in either group. Liver preservation with normothermic ex vivo perfusion with the Metra device using Steen solution is safe and results in comparable outcomes to CS after LT. Using US Food and Drug Administration-approved Steen solution will avoid a potential regulatory barrier in North America. Liver Transplantation 22 1501-1508 2016 AASLD.
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Markus
authors.initials: M
authors.lastname: Selzner
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Goldaracena
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Juan
authors.initials: J
authors.lastname: Echeverri
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Johan M
authors.initials: JM
authors.lastname: Kaths
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Ivan
authors.initials: I
authors.lastname: Linares
authors.affiliation: Departments of Medicine, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Nazia
authors.initials: N
authors.lastname: Selzner
authors.affiliation: Perfusion Services, Multi-Organ Transplant Program, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Cyril
authors.initials: C
authors.lastname: Serrick
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Max
authors.initials: M
authors.lastname: Marquez
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Sapisochin
authors.affiliation: Departments of Medicine, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Eberhard L
authors.initials: EL
authors.lastname: Renner
authors.affiliation: Departments of Medicine, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Mamatha
authors.initials: M
authors.lastname: Bhat
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Ian D
authors.initials: ID
authors.lastname: McGilvray
authors.affiliation: Departments of Medicine, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Leslie
authors.initials: L
authors.lastname: Lilly
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Greig
authors.affiliation: Departments of Medicine, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Tsien
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Cattral
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Anand
authors.initials: A
authors.lastname: Ghanekar
authors.affiliation: Departments of Surgery, Toronto General Hospital, Toronto, Ontario, Canada. david.grant@uhn.ca.
authors.forename: David R
authors.initials: DR
authors.lastname: Grant
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D064591:Allografts / Q000502:physiology*; D050377:Cold Ischemia; D003911:Dextrans / Q000627:therapeutic use; D004912:Erythrocytes; D005240:Feasibility Studies; D006801:Humans; D007902:Length of Stay; D008099:Liver / Q000502:physiology*; D016031:Liver Transplantation; D008875:Middle Aged; D009656:North America; D009926:Organ Preservation / Q000379:methods*; D019188:Organ Preservation Solutions / Q000737:chemistry / Q000627:therapeutic use*; D010477:Perfusion / Q000295:instrumentation / Q000379:methods*; D010865:Pilot Projects; D011097:Polygeline / Q000627:therapeutic use; D015427:Reperfusion Injury / Q000517:prevention & control*; D012189:Retrospective Studies; D012709:Serum Albumin / Q000627:therapeutic use; D013696:Temperature; D055815:Young Adult
chemical_list: D003911:Dextrans; D019188:Organ Preservation Solutions; D012709:Serum Albumin; D011097:Polygeline