TY - JOUR
T1 - Long-term outcomes after hypothermic oxygenated machine perfusion and transplantation of 1,202 donor livers in a real-world setting (HOPE-REAL study)
AU - Eden, Janina
AU - Brüggenwirth, Isabel M A
AU - Berlakovich, Gabriela
AU - Buchholz, Bettina M
AU - Botea, Florin
AU - Camagni, Stefania
AU - Cescon, Matteo
AU - Cillo, Umberto
AU - Colli, Fabio
AU - Compagnon, Philippe
AU - De Carlis, Luciano G
AU - De Carlis, Riccardo
AU - Di Benedetto, Fabrizio
AU - Dingfelder, Jule
AU - Diogo, Dulce
AU - Dondossola, Daniele
AU - Drefs, Moritz
AU - Fronek, Jiri
AU - Germinario, Giuliana
AU - Gringeri, Enrico
AU - Györi, Georg
AU - Kocik, Matej
AU - Küçükerbil, Efrayim H
AU - Koliogiannis, Dionysios
AU - Lam, Hwai-Ding
AU - Lurje, Georg
AU - Magistri, Paolo
AU - Monbaliu, Diethard
AU - Moumni, Mostafa El
AU - Patrono, Damiano
AU - Polak, Wojciech G
AU - Ravaioli, Matteo
AU - Rayar, Michel
AU - Romagnoli, Renato
AU - Sörensen, Gustaf
AU - Uluk, Deniz
AU - Schlegel, Andrea
AU - Porte, Robert J
AU - Dutkowski, Philipp
AU - de Meijer, Vincent E
N1 - Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.
PY - 2025/1
Y1 - 2025/1
N2 - BACKGROUND & AIM: We aimed to assess long-term outcome after transplantation of 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 a HOPE-treated liver transplanted between January 2012 and December 2021. Analyses were stratified for brain-dead (DBD) and circulatory-dead (DCD) donor livers, 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 ischemic cholangiopathy (IC).RESULTS: We report on 1202 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 for DBD and DCD was 95%, 92%, and 91%, vs. 92%, 87%, and 81%, respectively (logrank p=0.003). Within DBD and DCD-strata, death-censored graft survival was similar among risk groups (logrank 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 the implementation of HOPE in routine clinical practice.IMPACT AND IMPLICATIONS: This study demonstrates the excellent long-term performance of HOPE-treatment of DCD and DBD liver grafts irrespective of their individual risk profile in a real-world setting, outside the evaluation of randomized 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 the implementation of HOPE in routine clinical practice.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05520320.
AB - BACKGROUND & AIM: We aimed to assess long-term outcome after transplantation of 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 a HOPE-treated liver transplanted between January 2012 and December 2021. Analyses were stratified for brain-dead (DBD) and circulatory-dead (DCD) donor livers, 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 ischemic cholangiopathy (IC).RESULTS: We report on 1202 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 for DBD and DCD was 95%, 92%, and 91%, vs. 92%, 87%, and 81%, respectively (logrank p=0.003). Within DBD and DCD-strata, death-censored graft survival was similar among risk groups (logrank 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 the implementation of HOPE in routine clinical practice.IMPACT AND IMPLICATIONS: This study demonstrates the excellent long-term performance of HOPE-treatment of DCD and DBD liver grafts irrespective of their individual risk profile in a real-world setting, outside the evaluation of randomized 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 the implementation of HOPE in routine clinical practice.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05520320.
U2 - 10.1016/j.jhep.2024.06.035
DO - 10.1016/j.jhep.2024.06.035
M3 - Article
C2 - 38969242
SN - 0168-8278
VL - 82
SP - 97
EP - 106
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 1
ER -