NEW YORK (Reuters Health) – When preparing deceased-donor livers for transplant, portable normothermic blood-based machine perfusion improves transplant outcomes and leads to more livers being transplanted than ischemic cold storage, the current standard, according to results of the PROTECT trial.
Machine perfusion (MP) is “poised to change the face of liver transplant,” write the authors of an editorial published with the study in JAMA Surgery.
The PROTECT trial compared outcomes for 300 individuals who were actively listed for liver transplant on the United Network of Organ Sharing national waiting list and were randomly assigned to receive livers preserved using either MP or ischemic cold storage.
Livers that underwent normothermic MP had significantly less early allograft dysfunction, decreased histologic evidence of ischemia-reperfusion injury, and decreased ischemic biliary complications at six and 12 months relative to livers preserved in cold storage, report Dr. James Markmann of Massachusetts General Hospital in Boston and colleagues.
MP also led to significantly higher use of livers from donors after cardiac death: 28 of 55 (51%) versus 13 of 51 (26%) for cold storage.
The PROTECT trial met its safety endpoint and showed low rates of liver graft-related severe adverse events within 30 days after transplant.
“While these results are important and impressive, many questions remain,” Dr. Ralph Quillin III and Dr. Shimul Shah with University of Cincinnati College of Medicine in Ohio note in their commentary.
“Which livers warrant the use of MP to optimize recipient outcomes? Should MP only be used for marginal or donation after circulatory death (DCD) allografts? Is perfusion cost-effective in these cases? Who bears the responsibility of perfusion, organ procurement organizations or transplant center?”
“One thing is for certain, MP will add to the already increasing cost and complexity of liver transplant seen following the implementation of acuity circles and broader sharing,” the editorial writers say.
“Overall, it is impactful and carefully designed studies like the PROTECT trial that will move our field forward and show the clinical impact of normothermic MP as Markmann et al have shown in this article. But results like this also raise more issues that we will need to face as a community,” Dr. Quillin and Dr. Shah conclude.
This PROTECT study was supported by TranMedics Inc.
SOURCE: https://bit.ly/3mUNYcw and https://bit.ly/3346t7g JAMA Surgery, online January 5, 2022.
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