BACKGROUND: While 4 randomized controlled clinical trials confirmed the early benefits of hypothermic oxygenated machine perfusion (HOPE), high-level evidence regarding long-term clinical outcomes is lacking. The aim of this follow-up study from the HOPE-ECD-DBD trial was to compare long-term outcomes in patients who underwent liver transplantation using extended criteria donor allografts from donation after brain death (ECD-DBD), randomized to either HOPE or static cold storage (SCS). METHODS: Between September 2017 and September 2020, recipients of liver transplantation from 4 European centers receiving extended criteria donor-donation after brain death allografts were randomly assigned to HOPE or SCS (1:1). Follow-up data were available for all patients. Analyzed endpoints included the incidence of late-onset complications (occurring later than 6 months and graded according to the Clavien-Dindo Classification and the Comprehensive Complication Index) and long-term graft survival and patient survival. RESULTS: A total of 46 patients were randomized, 23 in both arms. The median follow-up was 48 months (95% CI: 41-55). After excluding early perioperative morbidity, a significant reduction in late-onset morbidity was observed in the HOPE group (median reduction of 23 Comprehensive Complication Index-points [p=0.003] and lower incidence of major complications [Clavien-Dindo ≥3, 43% vs. 85%, p=0.009]). Primary graft loss occurred in 13 patients (HOPE n=3 vs. SCS n=10), resulting in a significantly lower overall graft survival (p=0.029) and adverse 1-, 3-, and 5-year survival probabilities in the SCS group, which did not reach the level of significance (HOPE 0.913, 0.869, 0.869 vs. SCS 0.783, 0.606, 0.519, respectively). CONCLUSIONS: Our exploratory findings indicate that HOPE reduces late-onset morbidity and improves long-term graft survival providing clinical evidence to further support the broad implementation of HOPE in human liver transplantation.

Berlin Institute of Health at Charité Universitätsmedizin Berlin BIH Academy Clinician Scientist Program Berlin Germany

Department of Gastroenterology and Hepatology Maastricht University Medical Center Maastricht The Netherlands

Department of General Surgery and Liver Transplantation Fundeni Clinical Institute Bucharest Romania

Department of General Visceral and Transplant Surgery Ludwig Maximilians University Munich Munich Germany

Department of General Visceral and Transplantation Surgery University Hospital Heidelberg Heidelberg Germany

Department of Hepatology and Gastroenterology Campus Charité Mitte | Campus Virchow Klinikum Charité Universitätsmedizin Berlin Germany

Department of Internal Medicine 3 University Hospital RWTH Aachen Aachen Germany

Department of Surgery and Transplantation University Hospital RWTH Aachen Aachen Germany

Department of Surgery Campus Charité Mitte | Campus Virchow Klinikum Charité Universitätsmedizin Berlin Germany

Department of Transplantation Surgery Institute for Clinical and Experimental Medicine Prague Czech Republic

Institute for Biometry and Clinical Epidemiology Charité Universitätsmedizin Berlin Campus Charité Mitte Berlin Germany

Institute for Laboratory Animal Science and Experimental Surgery University Hospital RWTH Aachen Aachen Germany

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