Routine End-ischemic Hypothermic Oxygenated Machine Perfusion in Liver Transplantation from Donors After Brain Death: A Randomized Controlled Trial.

Abstract

To assess whether end-ischemic hypothermic oxygenated machine perfusion (HOPE) is superior to static cold storage (SCS) in preserving livers procured from donors after brain death (DBD). There is increasing evidence of the benefits of HOPE in liver transplantation, but predominantly in the setting of high-risk donors. In this randomized clinical trial, livers procured from DBDs were randomly assigned to either end-ischemic dual HOPE for at least 2h or SCS ( 1:3 allocation ratio). The Model for Early Allograft Function (MEAF) was the primary outcome measure. The secondary outcome measure was 90-day morbidity. (ClinicalTrials. gov, NCT04812054). Of the 104 liver transplantations included in the study, 26 were assigned to HOPE and 78 to SCS. Mean MEAF was 4.94 and 5.49 in the HOPE and SCS group (P=0.24), respectively, with the corresponding rates of MEAF >8 of 3.8% (1/26) and 15.4% (12/78; P=0.18). Median comprehensive complication index was 20.9 after transplantations with HOPE and 21.8 after transplantations with SCS (P=0.19). Transaminases activity, bilirubin concentration, and international normalized ratio were similar in both the groups. In the case of donor risk index >1.70, HOPE was associated with significantly lower mean MEAF (4.92 vs. 6.31; P=0.037) and lower median comprehensive complication index (4.35 vs. 22.6; P=0.050). No significant differences between HOPE and SCS were observed for lower donor risk index values. Routine use of HOPE in DBD liver transplantations does not seem justified as the clinical benefits are limited to high-risk donors.