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Maximizing deceased donation

Monday September 23, 2024 - 16:50 to 18:30

Room: Emirgan 2

261.4 Pilot, open, randomized, multicenter trial for the comparison of hypothermic versus normothermic ex-situ liver preservation in DCD liver transplantation with extended ischemia time (DCDNet trial)

Davide Ghinolfi, Italy

Doctor
Division of hepatic surgery and liver transplantation
Azienda Ospedaliero Universitaria Pisa

Abstract

Pilot, open, randomized, multicenter trial for the comparison of hypothermic versus normothermic ex-situ liver preservation in DCD liver transplantation with extended ischemia time (DCDNet trial)

Gabriele Catalano1, Damiano Patrono2, Daniele Pezzati1, Caterina Martinelli1, Giuseppina Basta3, Serena Del Turco3, Serena Babboni3, Pier Giuseppe Vacca1, Jessica Bronzoni1, Nicola De Stefano2, Arianna Trizzino1, Lorenzo Petagna1, Lara Russo3, Renato Romagnoli2, Davide Ghinolfi1.

1Hepatic Surgery and Liver Transplantation, Pisa University Hospital, Pisa, Italy; 2General Surgery 2U, Liver Transplant Centre, A.O.U. Città della Salute e della Scienza, Torino, Italy; 3Institute of Clinical Physiology, National Research Council, Pisa, Italy

Background: In Italy, 20 minutes of continuous, flat-line, electrocardiogram are required for death declaration, which significantly increases the risks of complications after DCD liver transplantation. Despite prolonged warm ischemia time, Italian centers reported good outcomes in DCD liver transplantation by combining normothermic regional (NRP) and end-ischemic machine perfusion. However, there are no studies in this particular setting comparing the two main ex-situ preservation techniques: dual hypothermic oxygenated machine perfusion (D-HOPE) versus normothermic machine perfusion (NMP).
Methods: DCDs donors offered to two different high-volume transplant centers were retrieved after a period of NRP. Graft eligibility for transplantation was assessed on NRP parameters. Grafts were then transported to the centers and randomized to NMP or D-HOPE.
Results: Between January 2021 to February 2023, 42 liver grafts were procured and eventually transplanted, being 20 randomized to the D-HOPE and 22 to the NMP group. Donor characteristics and ischemic times were comparable between the two Groups. No difference in terms of post-reperfusion syndrome rate was observed (41% versus 25% in NMP and D-HOPE respectively, p=0.33), CCI-index (31.6 vs 20.9, p=0.34) and hospital stay (17 vs 13 days, p=0.23). There were 5 cases of biliary complications in the NMP group (2 anastomotic strictures and 3 leakages) vs 1 (anastomotic stricture) in the D-HOPE group (23% vs 5%; p=0.19). At a median follow up of 10 months graft survival and patient survival in D-HOPE and NMP were 85% vs 100% and 90% vs 100%; p=0.06 and p=0.13 respectively.
Conclusions: The sequential use of NRP and end-ischemic machine perfusion is a safe method to perform DCD liver transplants with extended warm ischemia time. No major differences between D-HOPE and NMP have been showed. Further data are needed to draw definitive conclusions.

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