The European trial investigating NEVLP as preservation technique for liver transplantation uses Gelafusine, a non-FDA approved bovine derived gelatin-based perfusion solution. In contrast, we report the first clinical NEVLP experience with Steen solution, a human-based albumin-based perfusate approved for lung perfusion.

Methods: Eight human liver grafts were preserved on the Metra device and perfused at 37C with Steen solution plus 3 units of erythrocytes. Epoprostenol, Taurocholic acid, heparin, and insulin were added during the perfusion. Data is expressed as median and range.

Results: Eight liver transplantations (6 NDD, 2 DCD) were performed. Donor age and BMI were 46 years (22-60yrs) and 24 (20-26). Preservation time was 11hr (9-13) with a perfusion duration of 6 hr (4-8hrs). Peak ALT level during perfusion was 444 U/L (152 – 1460U/L). Lactate decreased in all grafts during the perfusion. Bile production during perfusion was 10ml/hr (7-24ml/hr). AST and ALT levels 24hrs after transplantation were 312U/L (54 – 2858U/L) and 156U/L (21 – 1383U/L) respectively. All patients had excellent graft function with INR and bilirubin levels of 1.2 (1.05 – 1.3) and 1.3mg/dl (0.8-13mg/dl) 3 days after transplantation. ICU and hospital stay were 1day (0-5days) and 12days (9-26days). Two patients were fast tracked without post-transplant ICU care. No severe complication (Dindo-Clavien >3) occurred after transplantation.

Conclusion: Normothermic ex vivo perfusion with the Metra device using Steen solution is feasible and can result in good outcome after human liver transplantation. Using FDA approved Steen solution will avoid a potential regulatory barrier (the use of bovine based materials) to the clinical development of NEVLP in North America.

CITATION INFORMATION: Selzner M, Goldaracena N, Echeverri J, Linares I, Kaths M, Selzner N, Cattral M, Renner E, Ghanekar A, Lilly L, Greig P, McGilvray I, Grant D. Normothermic Ex Vivo Liver Perfusion (NEVLP) Using Steen Solution as Preservation Technique for Liver Transplantation-First Clinical Results. Am J Transplant. 2016;16 (suppl 3).

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