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Long-term outcomes after hypothermic oxygenated machine perfusion and transplantation of 1,202 donor livers in a real-world setting (HOPE-REAL study)
J. Eden, IMA. Brüggenwirth, G. Berlakovich, BM. Buchholz, F. Botea, S. Camagni, M. Cescon, U. Cillo, F. Colli, P. Compagnon, LG. De Carlis, R. De Carlis, F. Di Benedetto, J. Dingfelder, D. Diogo, D. Dondossola, M. Drefs, J. Fronek, G. Germinario,...
Jazyk angličtina Země Nizozemsko
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie
- MeSH
- dárci tkání statistika a číselné údaje MeSH
- dospělí MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- perfuze * metody přístrojové vybavení MeSH
- přežívání štěpu * MeSH
- senioři MeSH
- terapeutická hypotermie metody MeSH
- transplantace jater * metody škodlivé účinky MeSH
- uchovávání orgánů * metody MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
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.
CHU Rennes Service de Chirurgie Hépatobiliaire et Digestive Rennes France
Department of Organ Failure and Transplantation ASST Papa Giovanni XXIII Bergamo Italy
Department of Surgery Leiden University Medical Center Leiden 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
Fundeni Clinical Institute Center of General Surgery and Liver Transplantation
Titu Maiorescu University Bucharest Romania
Transplant Institute Sahlgrenska University Hospital Gothenburg Sweden
Transplant Surgery Department Institute for Clinical and Experimental Medicine Prague Czech Republic
Transplantation Center and Lerner Research Institute Cleveland Clinic Ohio USA
UMCG Comprehensive Transplant Center Groningen the Netherlands
Citace poskytuje Crossref.org
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- $a Long-term outcomes after hypothermic oxygenated machine perfusion and transplantation of 1,202 donor livers in a real-world setting (HOPE-REAL study) / $c J. Eden, IMA. Brüggenwirth, G. Berlakovich, BM. Buchholz, F. Botea, S. Camagni, M. Cescon, U. Cillo, F. Colli, P. Compagnon, LG. De Carlis, R. De Carlis, F. Di Benedetto, J. Dingfelder, D. Diogo, D. Dondossola, M. Drefs, J. Fronek, G. Germinario, E. Gringeri, G. Györi, M. Kocik, EH. Küçükerbil, D. Koliogiannis, HD. Lam, G. Lurje, P. Magistri, D. Monbaliu, ME. Moumni, D. Patrono, WG. Polak, M. Ravaioli, M. Rayar, R. Romagnoli, G. Sörensen, D. Uluk, A. Schlegel, RJ. Porte, P. Dutkowski, VE. de Meijer
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- $a 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.
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