Normothermic ex vivo liver perfusion using steen solution as perfusate for human liver transplantation: First North American results
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 degC 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.
Liver transplantation official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society