Italian Studies Confirm Safety of HOPE (Hypothermic Oxygenated PErfusion) for Liver Transplantation and Value of HOPE in Identifying Biomarkers for Assessing Liver Viability

The three clinical trials are discussed in oral and mini-oral presentations at the 30th International Congress of The Transplantation Society (TTS 2024) in Istanbul, Turkey, September 22-25, 2024

CHICAGO, Sept. 23, 2024 /PRNewswire/ -- Bridge to Life is pleased to announce three Italian studies on HOPE (Hypothermic Oxygenated Perfusion) in liver transplantation are being presented this week at the 2024 30th Annual Meeting of the International Congress of The Transplantation Society (TTS 2024) in Istanbul, Turkey, from September 22-25, 2024. The studies focus on the safety of HOPE, its effectiveness in improving outcomes in redo-liver transplantation, and its potential for evaluating biomarkers of liver viability.

"Our academic research centre has been at the forefront of evaluating the impact of HOPE in several aspects of liver transplantation," said Dr Damiano Patrono, MD, Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino, Italy and principal investigator of the three trials. "We continue to be impressed with the value that the use of HOPE brings to increasing the supply of available livers for transplantation, potentially improving access for those in need of livers and reducing waiting time for transplantation," he further commented.

"These Italian studies are further support for the value that HOPE can contribute to the transplantation community worldwide," commented Don Webber, CEO and President of Bridge to Life Ltd., a leading provider of transplant solutions and a sponsor of the studies. "We are in the final stages of assessing the 1-year follow-up results of our HOPE Trial in the U.S. and look forward to bringing this innovative technology to U.S. transplant centers, organ procurement organizations, and, most importantly, to patients in need of viable livers," he added.

The three presentations include:

Outcomes of redo-liver transplantation using hypothermic oxygenated machine perfusion: a multicentre cohort study (REDO-HOPE), ID #373, D. Patrono (General Surgery 2U - Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino), et al

• Redo-liver transplantation (LT) is a challenging operation and is associated with an increased rate of postoperative complications and reduced graft and patient survival. Although optimal grafts are normally used for redo-LTs, these might not be readily available. By improving preservation and allowing prolonged preservation time, hypothermic oxygenated machine perfusion (HOPE) was shown to improve outcomes of redo-LT.
• REDO-HOPE is a multicentre cohort study aimed at investigating outcomes of redo-LT performed using grafts treated by HOPE. Adult (≥18-year-old) recipients of a second or third liver transplant performed between January 2016 and December 2023 were included. Outcomes of HOPE redo-LT were compared with benchmark values and with those of a matched group of redo-LT performed using static cold storage. Primary endpoint of 12-month graft survival were met. According to this preliminary analysis, HOPE may allow performing redo-LT with outcomes comparable to benchmark values despite the use of extended criteria donors (ECD) grafts.

Hypothermic oxygenated machine perfusion is not associated with an increased risk of infection in the recipient: A retrospective single-centre cohort study, ID #453, S. Corcione (General Surgery 2U - Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino), et al

• Use of machine perfusion (MP) in liver transplantation (LT) is gaining widespread acceptance. One potential drawback of MP is the risk of graft contamination due to the increased manipulation and exposure, determining infection in the recipient. Bacterial overgrowth resulting in severe recipient sepsis has been well documented during normothermic machine perfusion, but data on hypothermic oxygenated machine perfusion (HOPE) are scarce. Aim of this retrospective study was evaluating the risk of blood stream infection in recipient following HOPE versus static cold storage (SCS). Adult (≥ 18-year-old) LT recipients transplanted in the period March 2016 - June 2023 were included.
• The rate of bloodstream infection after LT were comparable between study groups. Of note, patients in HOPE group presented more positive microbiological samples, mostly from bile or tracheal aspirates, not associated with clinical symptoms.

Circulating cell-free DNA in liver transplantation: A pre- and post-transplant biomarker of graft dysfunction, ID #828, T. Carradori (General Surgery 2U - Liver Transplant Unit, AOU Città della Salute e della Scienza di Torino), et al

• Reliable biomarkers are needed to assess graft dysfunction after liver transplantation (LT) and facilitate graft monitoring. This study investigated cell-free DNA cfDNA) as a pre-and post-LT marker of graft dysfunction.
• Donor-derived cfDNA (dd-cfDNA) levels were determined at fixed timepoints in 45 consecutive LT recipients (baseline, from day 0 to day 7, week 2-3-4, 3 and 6 months). 22 (49%) patients received a graft treated by hypothermic oxygenated machine perfusion (HOPE) and 3 (7%) by normothermic machine perfusion. Perfusate levels of cfDNA and mitochondrial cfDNA (mt-cfDNA) were available for 20 recipients of a HOPE-treated graft. cfDNA and mt-cfDNA were correlated to other parameters of graft function and clinical outcome.
• In LT, dd-cfDNA correlates with hepatocyte necrosis and represents an aspecific yet sensible marker of graft dysfunction. When HOPE is used, perfusate mt-cfDNA correlates with liver injury and function after LT and may represent a further tool of liver viability assessment.

About Bridge to Life Ltd
Bridge to Life Ltd is a market leader in organ preservation solutions, offering premier products such as Belzer UW, EasiSlush and the VitaSmart¹ Machine Perfusion System. With a strong focus on product quality, innovation and accessibility, the company serves and partners with leading Transplant Centers and Organ Procurement Offices (OPO) globally.

^{1 VitaSmart is CE Marked and available for sale in several markets outside of the United States. VitaSmart is not approved for sale in the US. The company successfully completed its pivotal, multicenter, randomized clinical study in the US in 2023 and expects to submit its Premarket Approval submission to FDA later this year.}

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