BACKGROUND & AIMS: 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). METHODS: 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). RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05520320. IMPACT AND IMPLICATIONS: 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.

Adult Liver Transplantation Unit Department of Surgery and Gastroenterology Coimbra Hospital and University Center Coimbra Portugal

Chirurgia Generale 2 Hepato Biliary Pancreatic Unit and Liver Transplant Center Padova University Hospital Padova Italy

CHU Rennes Service de Chirurgie Hépatobiliaire et Digestive Rennes France

Department of Abdominal Transplantation Leuven Transplant Center University Hospitals Leuven Leuven Belgium

Department of General Surgery and Transplantation ASST Grande Ospedale Metropolitano Niguarda Milan Italy

Department of General Surgery and Transplantation IRCCS Azienda Ospedaliero Universitaria of Bologna University of Bologna Bologna Italy

Department of Organ Failure and Transplantation ASST Papa Giovanni XXIII Bergamo Italy

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

Department of Surgery Leiden University Medical Center Leiden the Netherlands

Department of Surgery Section of Epidemiology and Statistics University of Groningen and University Medical Center Groningen Groningen the Netherlands

Department of Surgery Section of HPB Surgery and Liver Transplantation University of Groningen and University Medical Center Groningen Groningen the Netherlands; Erasmus MC Transplant Institute University Medical Center Rotterdam Division of HPB and Transplant Surgery Rotterdam the Netherlands

Department of Surgery Section of HPB Surgery and Liver Transplantation University of Groningen and University Medical Center Groningen Groningen the Netherlands; UMCG Comprehensive Transplant Center Groningen the Netherlands

Department of Transplant Surgery University of Geneva Geneva Switzerland

Department of Transplant Surgery University of Munich Grosshaderm Germany

Department of Visceral Transplantation University Medical Center Hamburg Eppendorf Hamburg Germany

Division of Transplantation Medical University of Vienna Vienna Austria

Erasmus MC Transplant Institute University Medical Center Rotterdam Division of HPB and Transplant Surgery Rotterdam the Netherlands

Fundeni Clinical Institute Center of General Surgery and Liver Transplantation; Titu Maiorescu University Bucharest Romania

General and Liver Transplant Surgery Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Department of Pathophysiology and Transplantation Università degli Studi di Milano Milan Italy

General and Liver Transplant Surgery Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Department of Pathophysiology and Transplantation Università degli Studi di Milano Milan Italy; Transplantation Center and Lerner Research Institute Cleveland Clinic Ohio USA

General Surgery 2U Liver Transplant Centre Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino Turin Italy

Hepato Pancreato Biliary Surgery and Liver Transplantation Unit University of Modena and Reggio Emilia Modena Italy

Swiss HPB and Transplant Center Department of Visceral Surgery and Transplantation University Hospital Zurich Zurich Switzerland

Transplant Institute Sahlgrenska University Hospital Gothenburg Sweden

Transplant Surgery Department Institute for Clinical and Experimental Medicine Prague Czech Republic

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ClinicalTrials.gov
NCT05520320