Istanbul, Turkey – September 23, 2024 – Three pivotal studies from Italy on Hypothermic Oxygenated Perfusion (HOPE) in liver transplantation were presented at the 30th International Congress of The Transplantation Society (TTS 2024), held from September 22-25 in Istanbul. These studies focus on the safety of HOPE, its efficacy in improving outcomes for redo-liver transplants, and its potential for identifying biomarkers that assess liver viability.
Dr. Damiano Patrono, MD, the principal investigator from the Liver Transplant Unit at AOU Città della Salute e della Scienza di Torino, highlighted the significance of the findings. “Our research underscores the transformative potential of HOPE in increasing the availability of viable livers for transplantation, ultimately improving access and reducing waiting times for patients in need,” he stated.
Don Webber, CEO and President of Bridge to Life Ltd., which sponsored the studies, expressed optimism about the research. “These Italian studies reinforce the global value of HOPE technology. We are also nearing completion of our one-year follow-up results from a U.S. HOPE trial, and we look forward to introducing this innovative method to U.S. transplant centers,” he said.
Overview of the Studies
The three presentations from the Italian studies are detailed below:
- REDO-HOPE: Outcomes of Redo-Liver Transplantation Using HOPE
Study ID: #373
This multicenter cohort study aimed to evaluate outcomes for patients undergoing redo-liver transplantation (LT) with grafts treated using HOPE. Redo-LT is notoriously challenging, often associated with higher rates of postoperative complications and lower survival rates for both grafts and patients. Given that optimal grafts may not always be available, the study investigated whether HOPE could improve preservation and extend preservation time, thereby enhancing outcomes for these complex procedures.
The study included adult recipients (≥18 years) who received second or third liver transplants from January 2016 to December 2023. The outcomes for HOPE-treated grafts were compared to benchmark values and a 
matched cohort that received grafts preserved via static cold storage (SCS). Preliminary results indicated that HOPE might allow for redo-LT with 12-month graft survival rates comparable to benchmark values, even when using extended criteria donors (ECD). This suggests that HOPE can facilitate the use of less-than-optimal grafts without compromising patient outcomes.- Infection Risks in Recipients Using HOPE
Study ID: #453
Conducted as a retrospective single-center cohort study, this research evaluated the risk of bloodstream infections in recipients following liver transplantation with grafts treated by HOPE versus those preserved by static cold storage. While machine perfusion has gained acceptance, concerns about potential graft contamination and subsequent infections have emerged.
This study included adult LT recipients transplanted between March 2016 and June 2023. The findings revealed that the incidence of bloodstream infections was comparable between the HOPE and SCS groups. Interestingly, although the HOPE group had a higher rate of positive microbiological samples—primarily from bile or tracheal aspirates—these did not correlate with clinical symptoms of infection. This suggests that while HOPE may increase the likelihood of microbiological findings, it does not necessarily lead to adverse clinical outcomes, alleviating concerns regarding infection risks associated with machine perfusion. - Cell-Free DNA as a Biomarker for Graft Dysfunction
Study ID: #828
This study focused on the potential of circulating cell-free DNA (cfDNA) as a pre- and post-transplant biomarker for graft dysfunction in liver transplantation. Reliable biomarkers are essential for monitoring graft health and identifying potential complications early.
In this investigation, donor-derived cfDNA (dd-cfDNA) levels were measured at various time points in 45 consecutive LT recipients. Among these, 22 patients (49%) received grafts treated with HOPE, while 3 (7%) received grafts preserved by normothermic machine perfusion. Researchers correlated levels of cfDNA and mitochondrial cfDNA (mt-cfDNA) with other indicators of graft function and clinical outcomes.
The findings indicated that dd-cfDNA is a sensitive, albeit nonspecific, marker of graft dysfunction, correlating with hepatocyte necrosis. Notably, in patients who received HOPE-treated grafts, the levels of mt-cfDNA in the perfusate were associated with liver injury and overall graft function. This positions mt-cfDNA as a promising tool for assessing liver viability and monitoring graft status in clinical practice.
matched cohort that received grafts preserved via static cold storage (SCS). Preliminary results indicated that HOPE might allow for redo-LT with 12-month graft survival rates comparable to benchmark values, even when using extended criteria donors (ECD). This suggests that HOPE can facilitate the use of less-than-optimal grafts without compromising patient outcomes.Significance of HOPE Technology
The implications of these studies are substantial. HOPE has the potential to significantly enhance the quality of liver transplants, particularly for patients who require redo procedures or those with grafts from extended criteria donors. The studies demonstrate that HOPE not only maintains the safety of transplantation procedures but also supports the development of biomarkers that could revolutionize the monitoring of graft health.
Bridge to Life Ltd. is at the forefront of organ preservation solutions, with products like Belzer UW, EasiSlush, and the VitaSmart1 Machine Perfusion System. The company emphasizes quality and innovation and collaborates with leading transplant centers and organ procurement organizations globally.
The VitaSmart system, which has completed a pivotal clinical study in the U.S., is expected to submit for FDA approval later this year. While currently not approved for sale in the U.S., the successful results from ongoing trials could pave the way for its introduction, further expanding the options available to transplant surgeons and patients alike.
Conclusion
As liver transplantation continues to evolve, the findings from these Italian studies provide hope for improved patient outcomes and expanded access to vital organ transplants. The continued research into HOPE technology and its implications for liver viability and graft monitoring underscores a promising future for patients facing liver disease.
For further information, please contact: Jennifer Guzman
Global Marketing Director
760-291-7245
J.guzman@B2LL.com
