EX SITU END ISCHEMIC HYPOTHERMIC OXYGENATED PERFUSION (HOPE) VERSUS STATIC COLD STORAGE PRIOR TO LIVER TRANSPLANTATION-EARLY RESULTS OF THE BRIDGE TO HOPE PIVOTAL MULTICENTER RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE SAFETY AND EFFECTIVENESS OF THE VITASMART LIVER MACHINE PERFUSION SYSTEM (CLINICALTRIALS.GOV: Nct05045794)
Recommended Citation
Reich DJ, Schlegel A, Rizzari M, Hashimoto K, Florman SS, De Vera ME, Foley DP, Mao SA, Chapman WC, Roll G, Pinna A, Saharia A, Merani S, Bohorquez HE, Akoad M, Kubal CA, and Alexopoulos S. EX SITU END ISCHEMIC HYPOTHERMIC OXYGENATED PERFUSION (HOPE) VERSUS STATIC COLD STORAGE PRIOR TO LIVER TRANSPLANTATION-EARLY RESULTS OF THE BRIDGE TO HOPE PIVOTAL MULTICENTER RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE SAFETY AND EFFECTIVENESS OF THE VITASMART LIVER MACHINE PERFUSION SYSTEM (CLINICALTRIALS.GOV: Nct05045794). Hepatol 2023; 77(5):E124-E125.
Document Type
Conference Proceeding
Publication Date
2-20-2023
Publication Title
Hepatology
Abstract
Background: Ex-situ end-ischemic hypothermic oxygenated perfusion (HOPE) is a simple technique to improve liver transplant (LT) results and the donor shortage. HOPE after static cold storage (SCS) reduces ischemia reperfusion injury, early allograft dysfunction (EAD), cholangiopathy and other poor outcomes. A pivotal, US multicenter RCT opened in early 2022 to compare HOPE after SCS to HOPE alone for LT using extended criteria DBD and DCD grafts.
Methods: Consented adults matched to a higher risk donor liver that the investigator committed to transplant were randomized 1:1 to SCS followed by HOPE at the transplant center or to SCS only. Livers randomized to the HOPE arm were perfused with the VitaSmart machine, through the portal vein only, at <4 mm Hg pressure, using actively oxygenated (pO2>60 kPa) Belzer machine perfusion solution, for 1.5-5 hr. The primary efficacy endpoint is EAD and the primary safety endpoints are patient and graft survival. Other endpoints include primary non-function (PNF), ischemic cholangiopathy, adverse events, and length of stay (LOS). A centralized, blinded radiologist evaluated cholangiograms for cholangiopathy. Recipients were assessed post-transplantation on days 1-7, 14 and 30, and months 3, 6 and 12 post-LT. Target total enrollment is 244 patients completing transplant.
Results: The study has reached the 25% enrollment milestone (61 of 244 targeted LTs, at 11 centers), with key outcomes depicted below. There were no device malfunctions or device-related AEs.
Conclusion: Early results of this first US RCT of end-ischemic portal venous HOPE with VitaSmart for LT of extended criteria donor livers reveal promising outcomes, including device safety, lower risk of EAD and shorter hospital LOS.
Volume
77
Issue
5
First Page
E124
Last Page
E125
