Long-term outcomes after hypothermic oxygenated machine perfusion and transplantation of 1,202 donor livers in a real-world setting (HOPE-REAL study)
Authors: Janina Eden, Isabel M.A. Brüggenwirth, Gabriela Berlakovich, Bettina M. Buchholz, Florin Botea, Stefania Camagni, Matteo Cescon, Umberto Cillo, Fabio Colli, Philippe Compagnon, Luciano G. De Carlis, Riccardo De Carlis, Fabrizio Di Benedetto, Jule Dingfelder, Dulce Diogo, Daniele Dondossola, Moritz Drefs, Jiri Fronek, Giuliana Germinario, Enrico Gringeri, Georg Györi, Matej Kocik, Efrayim H. Küçükerbil, Dionysios Koliogiannis, Hwai-Ding Lam, Georg Lurje, Paolo Magistri, Diethard Monbaliu, Mostafa el Moumni, Damiano Patrono, Wojciech G. Polak, Matteo Ravaioli, Michel Rayar, Renato Romagnoli, Gustaf Sörensen, Deniz Uluk, Andrea Schlegel, Robert J. Porte, Philipp Dutkowski, Vincent E. de Meijer
Journal: Journal of Hepatology (2024)

Despite strong evidence for improved preservation of donor livers by machine perfusion, longer post-transplant follow-up data are urgently needed in an unselected patient population. We aimed to assess long-term outcomes after transplantation of hypothermic oxygenated machine perfusion (HOPE)-treated donor livers based on real-world data (i.e., IDEAL-D stage 4). In this international, multicentre, observational cohort study, we collected data from adult recipients of HOPE-treated livers transplanted between January 2012 and December 2021. Analyses were stratified by donation after brain death (DBD) and donation after circulatory death (DCD), sub-divided by their respective risk categories. The primary outcome was death-censored graft survival. Secondary outcomes included the incidence of primary non-function (PNF) and ischaemic cholangiopathy (IC). We report on 1,202 liver transplantations (64% DBD) performed at 22 European centres. For DBD, a total number of 99 benchmark (8%), 176 standard (15%), and 493 extended-criteria (41%) cases were included. For DCD, 117 transplants were classified as low risk (10%), 186 as high risk (16%), and 131 as futile (11%), with significant risk profile variations among centres. Actuarial 1-, 3-, and 5-year death-censored graft survival rates for DBD and DCD livers were 95%, 92%, and 91%, vs. 92%, 87%, and 81%, respectively (log-rank p = 0.003). Within DBD and DCD strata, death-censored graft survival was similar among risk groups (log-rank p = 0.26, p = 0.99). Graft loss due to PNF or IC was 2.3% and 0.4% (DBD), and 5% and 4.1% (DCD). This study shows excellent 5-year survival after transplantation of HOPE-treated DBD and DCD livers with low rates of graft loss due to PNF or IC, irrespective of their individual risk profile. HOPE treatment has now reached IDEAL-D stage 4, which further supports its implementation in routine clinical practice. ClinicalTrials.gov Identifier: NCT05520320. This study demonstrates the excellent long-term performance of hypothermic oxygenated machine perfusion (HOPE) treatment of donation after circulatory and donation after brain death liver grafts irrespective of their individual risk profile in a real-world setting, outside the evaluation of randomised-controlled trials. While previous studies have established safety, feasibility, and efficacy against the current standard, according to the IDEAL-D evaluation framework, HOPE treatment has now reached the final IDEAL-D stage 4, which further supports its implementation in routine clinical practice.