Meta-Analysis of Data from Trials of Machine Perfusion Technologies in Liver Transplantation Demonstrates Clinical Advantages of Hypothermic Oxygenated Machine Perfusion (HOPE), according to Bridge to Life Ltd.

News provided by

May 01, 2024, 08:00 ET

Results of late-breaker Cochrane review and meta-analysis confirmed significant improvement in several parameters with HOPE compared to static cold storage and normothermic machine perfusion (NMP). While both technologies proved to be superior to SCS, there is no good evidence that NMP has the same benefits over SCS in terms of these clinically relevant outcomes.

CHICAGO, May 1, 2024 /PRNewswire/ -- Hypothermic oxygenated machine perfusion (HOPE) of livers awaiting transplantation provides significantly greater outcomes than normothermic machine perfusion (NMP) and ice-box static cold storage (SCS), according to a Cochrane review and meta-analysis of seven clinical trials. The analysis, Machine perfusion in liver transplantation; Cochrane review and meta-analysis, by Samuel James Tingle, MD, et al, Newcastle University, Translational and Clinical Research Institute, Newcastle, United Kingdom; Freeman Hospital, Institute of Transplantation, Newcastle, United Kingdom; Newcastle University, NIHR Blood and Transplant Research Unit, Newcastle, United Kingdom Newcastle University, Translational and Clinical Research Institute, Newcastle, United Kingdom, was shown today in a late-breaker session during The 2024 International Congress of the International Liver Transplantation Society (ILTS) in Houston, Texas.

The analysis included seven randomized trials (1024 transplant recipients from 1301 randomized/included livers); four compared end-ischemic hypothermic oxygenated perfusion (HOPE) with SCS, and three compared normothermic machine perfusion (NMP) with SCS. When compared with SCS, HOPE was associated with improvement in the following clinically relevant outcomes: graft survival (Figure 1: HR=0.45, 95% CI=0.23-0.87; P=0.02; high‐certainty evidence), serious adverse events (OR=0.45, 0.22-0.91; P=0.03; moderate‐certainty evidence) and clinically significant ischemic cholangiopathy (OR=0.31, 0.11-0.92; P=0.03; high‐certainty evidence). NMP was not associated with improvement in any of these clinically relevant outcomes.

"In our meta-analysis, where the decision has been made to transplant a DCD (donation after cardiac death) or marginal DBD (donation after brain death) liver, end-ischemic HOPE will provide superior clinically relevant outcomes compared with SCS alone (graft survival, adverse events, cholangiopathy)," said Samuel James Tingle, MD, lead author of the meta-analysis. "NMP appears to improve utilization of grafts that would otherwise be discarded, but well-powered trials specifically designed to assess utilization are required," he added.

The authors used standard, extensive Cochrane search methods – a systematic review of research in health care and health policy that is published in the Cochrane Database of Systematic Reviews – to identify randomized machine perfusion trials. Data extraction was performed independently by two authors. Pairwise random-effects meta-analysis was performed. Bias was assessed using Risk of Bias 2 and used GRADE to assess certainty of evidence.

"We are pleased with the outcomes of this meta-analysis and Cochrane review, which complement our recently published interim results from our multicenter US pivotal study, Bridge to HOPE," remarked Don Webber, CEO of Bridge to Life Ltd. "These findings are consistent with our observations in various real-world scenarios across Europe and other regions outside the US, where VitaSmart has been available for several years. Its user-friendly design and competitive pricing set it apart from other devices in the market, making it the preferred choice for many transplant centers. We anticipate sharing our data with the FDA later this year."

Machine perfusion (MP) is a novel method for organ graft preservation before transplantation. In hypothermic oxygenated perfusion (HOPE), donor livers are perfused through the portal vein with a cold (4 °C), acellular, oxygenated fluid at low vascular pressures. Non-anastomotic biliary strictures (NAS) are 1 or more focal areas of narrowing of the bile ducts proximal to a biliary anastomosis, frequently occurring postoperatively in liver transplant patients.

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 hypothermic oxygenated 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.}

SOURCE Bridge to Life Ltd.