NEW YORK (Reuters Health) – When preparing deceased-donor livers for transplantation normothermic blood-based machines improve transplant outcomes and leads to more livers being transplanted than ischemic cold storage the current standard, as per results of the PROTECT trial.
Machine perfusion (MP) is “poised to transform the face of liver transplantation,” write the authors of an editorial in conjunction with the study in JAMA Surgery.
The PROTECT study compared the outcomes for 300 individuals who were actively listed for liver transplantation on the United Network of Organ Sharing waiting list nationwide and were randomly allocated to receive preserved livers by either MP or ischemic cold storage.
Livers that underwent normothermic MMP had significantly lower allograft dysfunction, decreased histologic evidence of ischemia and reperfusion injury and a decrease in ischemic biliary complications at 6 and 12 months compared to livers stored in cold storage, say Dr. James Markmann of Massachusetts General Hospital in Boston and colleagues.
MP also saw a higher percentage of livers donated following the death of a cardiac patient: 28 out of 55 (51%) versus thirteen of 51 (26 percent) cold storage.
The PROTECT trial met its safety criteria and demonstrated low rates of liver graft-related serious adverse events within the first 30 days after transplant.
“While these results are significant and impressive, a lot of questions remain,” Dr. Ralph Quillin III and Dr. Shimul Shah from the University of Cincinnati College of Medicine in Ohio write in their commentary.
“Which livers warrant the use of MP to improve recipient outcomes? Should MP be utilized only to donate marginal or after the death of the circulatory system (DCD) allografts? Is perfusion cost-effective in these situations? Who is responsible for perfusion organ procurement companies, organ procurement organizations, or transplant center?”
The editors of the editorial say that MP will increase the cost and complexity of liver transplants.
“Overall it’s an impactful and well-designed studies like the PROTECT trial that will move our field forward and demonstrate the clinical benefits of normothermic MP as Markmann and colleagues have demonstrated in this article. However, such results also raise new issues we’ll have to address as a community,” Dr. Quillin concluded and Dr. Shah agreed.
TranMedics Inc. supported the PROTECT study.
SOURCE: https://bit.ly/3mUNYcw and https://bit.ly/3346t7g JAMA Surgery, online January 5, 2022.
