A Randomized Controlled Trial of Dual Hypothermic Oxygenated Machine Perfusion in Donation after Circulatory Death Liver Transplantation

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Purpose: Transplantation of livers from donation after circulatory death (DCD) donors is associated with an increased risk of non-anastomotic biliary strictures (NAS). Hypothermic oxygenated machine perfusion of livers may reduce the incidence of biliary complications, but data from prospective controlled studies are lacking. Method: In this multicenter, controlled trial we randomly assigned patients undergoing transplantation of a DCD liver to receive that liver after dual hypothermic oxygenated machine perfusion or conventional static cold storage alone (control group). The primary end point was the occurrence of NAS within 6 months after transplantation. Secondary end points included other graft-related and general complications. Results: A total of 156 patients were enrolled; 78 participants received a machine perfused liver and 78 received a liver after static cold storage only. NAS occurred in 6% of the patients in the machine perfusion group and 18% of the controls (risk ratio, 0.36; 95%CI, 0.14-0.94; P= 0.03). Post-reperfusion syndrome occurred in 13% of the recipients of a machine perfused liver and in 27% of the controls (risk ratio, 0.43; 95%CI, 0.20-0.91; P = 0.03). Early allograft dysfunction occurred in 26% of machine perfused livers vs. 40% of controls (risk ratio 0.61; 95%CI, 0.39-0.96; P = 0.03). Cumulative number of treatments for NAS was almost 4-fold lower after machine perfusion, compared to controls. There were no significant differences in adverse events. Conclusion: In this randomized trial, hypothermic oxygenated machine perfusion led to a lower risk of NAS, post-reperfusion syndrome and early allograft dysfunction after DCD liver transplantation than conventional static cold storage.