Discarded livers tested by normothermic machine perfusion in the VITTAL trial: secondary end points and 5-year outcomes
Mergental, Hynek Laing, Richard W Kirkham, Amanda J Clarke, George Boteon, Yuri L Barton, Darren Neil, Desley A H Isaac, John R Roberts, Keith J Abradelo, Manuel
Mergental, Hynek
Laing, Richard W
Kirkham, Amanda J
Clarke, George
Boteon, Yuri L
Barton, Darren
Neil, Desley A H
Isaac, John R
Roberts, Keith J
Abradelo, Manuel
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2023-12-15
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Abstract
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).
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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. Discarded livers tested by normothermic machine perfusion in the VITTAL trial: Secondary end points and 5-year outcomes. Liver Transpl. 2024 Jan 1;30(1):30-45. doi: 10.1097/LVT.0000000000000270. Epub 2023 Dec 15
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