Improved outcomes after hypothermic oxygenated machine perfusion in liver transplantation-Long-term follow-up of a multicenter randomized controlled trial.
Journal
Hepatology communications
ISSN: 2471-254X
Titre abrégé: Hepatol Commun
Pays: United States
ID NLM: 101695860
Informations de publication
Date de publication:
01 Feb 2024
01 Feb 2024
Historique:
received:
04
09
2023
accepted:
30
11
2023
medline:
5
2
2024
pubmed:
5
2
2024
entrez:
5
2
2024
Statut:
epublish
Résumé
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). 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. 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). 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 38315126
doi: 10.1097/HC9.0000000000000376
pii: 02009842-202402010-00016
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Study of Liver Diseases.
Références
Nephrol Dial Transplant. 2011 Oct;26(10):3176-81
pubmed: 21325352
BMC Gastroenterol. 2019 Mar 12;19(1):40
pubmed: 30866837
Ann Surg. 2015 Nov;262(5):764-70; discussion 770-1
pubmed: 26583664
J Hepatol. 2014 Apr;60(4):765-72
pubmed: 24295869
Ann Surg. 2013 Jul;258(1):1-7
pubmed: 23728278
J Hepatol. 2019 Jan;70(1):50-57
pubmed: 30342115
Clin Transplant. 2022 Oct;36(10):e14638
pubmed: 35279883
Ann Surg. 2023 Nov 1;278(5):662-668
pubmed: 37497636
Hepatol Commun. 2020 Dec 05;5(3):526-537
pubmed: 33681684
Gastroenterology. 2019 Oct;157(4):1166-1167
pubmed: 31351055
Ann Intern Med. 2008 Feb 19;148(4):295-309
pubmed: 18283207
Liver Int. 2019 Feb;39(2):228-249
pubmed: 30129192
J Clin Med. 2020 Mar 20;9(3):
pubmed: 32244972
Ann Surg. 2021 Nov 1;274(5):705-712
pubmed: 34334635
Am J Transplant. 2022 Jul;22(7):1842-1851
pubmed: 35315202
J Hepatol. 2023 Apr;78(4):783-793
pubmed: 36681160
Am J Transplant. 2015 Jan;15(1):161-9
pubmed: 25521639
Am J Transplant. 2010 Feb;10(2):372-81
pubmed: 19958323
Br J Surg. 2022 Feb 1;109(2):e31-e32
pubmed: 34904161
Br J Surg. 2017 Jun;104(7):907-917
pubmed: 28394402
Am J Transplant. 2022 Oct;22(10):2401-2408
pubmed: 35671067
Ann Surg. 2009 Aug;250(2):187-96
pubmed: 19638912
Am J Transplant. 2022 May;22(5):1382-1395
pubmed: 35150050
N Engl J Med. 2021 Apr 15;384(15):1391-1401
pubmed: 33626248