Discarded livers tested by normothermic machine perfusion in the VITTAL trial: Secondary end points and 5-year outcomes.
Date
2024-01-01ICR Author
Author
Mergental, H
Laing, RW
Kirkham, AJ
Clarke, G
Boteon, YL
Barton, D
Neil, DAH
Isaac, JR
Roberts, KJ
Abradelo, M
Schlegel, A
Dasari, BVM
Ferguson, JW
Cilliers, H
Morris, C
Friend, PJ
Yap, C
Afford, SC
Perera, MTPR
Mirza, DF
Type
Journal Article
Metadata
Show full item recordAbstract
Normothermic machine perfusion (NMP) enables pretransplant assessment of high-risk donor livers. The VITTAL trial demonstrated that 71% of the currently discarded organs could be transplanted with 100% 90-day patient and graft survivals. Here, we report secondary end points and 5-year outcomes of this prospective, open-label, phase 2 adaptive single-arm study. The patient and graft survivals at 60 months were 82% and 72%, respectively. Four patients lost their graft due to nonanastomotic biliary strictures, one caused by hepatic artery thrombosis in a liver donated following brain death, and 3 in elderly livers donated after circulatory death (DCD), which all clinically manifested within 6 months after transplantation. There were no late graft losses for other reasons. All the 4 patients who died during the study follow-up had functioning grafts. Nonanastomotic biliary strictures developed in donated after circulatory death livers that failed to produce bile with pH >7.65 and bicarbonate levels >25 mmol/L. Histological assessment in these livers revealed high bile duct injury scores characterized by arterial medial necrosis. The quality of life at 6 months significantly improved in all but 4 patients suffering from nonanastomotic biliary strictures. This first report of long-term outcomes of high-risk livers assessed by normothermic machine perfusion demonstrated excellent 5-year survival without adverse effects in all organs functioning beyond 1 year (ClinicalTrials.gov number NCT02740608).
Collections
Subject
Humans
Aged
Liver Transplantation
Prospective Studies
Constriction, Pathologic
Quality of Life
Liver
Perfusion
Organ Preservation
Research team
Clin Trials & Stats Unit
Language
eng
Date accepted
2023-08-27
License start date
2024-01-01
Citation
Liver Transplantation, 2024, 30 (1), pp. 30 - 45
Publisher
LIPPINCOTT WILLIAMS & WILKINS