Re-emergence of Early Liver Transplant Access for Hepatocellular Carcinoma in the Era of Normothermic Machine Perfusion.

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Abstract

Since the FDA approval of normothermic machine perfusion (NMP) in September 2021, liver transplantation (LT) numbers dramatically increased with shortened waitlist times. This is generally a positive trend; however, this might allow hepatocellular carcinoma (HCC) candidates in the United States to receive LT without exception scores, for whom expedited transplant might not be ultimately beneficial. The objective of this study was to describe early transplant access and waitlist outcomes for HCC candidates during the era following FDA approval of NMP.Using the United Network for Organ Sharing (UNOS) database (2016-2023), 15,395 adult candidates listed for LT with HCC exceptions were divided into three listing periods: January 1, 2016 to May 18, 2019 (Delay and Cap), May 19, 2019 to September 27, 2021 (median MELD at transplant minus 3 [MMaT-3]), and September 28, 2021 to December 31, 2023 (NMP). Waitlist outcomes including LT or dropout were assessed using competing risk analysis.Transplant incidence within six months was 16.9% during the NMP era, versus <12% in earlier eras (P<0.001), thanks to aggressive use of extended criteria donors. Significant disparity in LT access among UNOS regions was observed. One-year graft survival after LT remained high, exceeding 90.0% across all eras (P = 0.85).The NMP era demonstrates increased access to LT for HCC candidates in the initial six months prior to qualifying for exception scores.The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request.

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