Re-emergence of early liver transplant access for hepatocellular carcinoma in the era of normothermic machine perfusion.

BACKGROUND

Since the Food and Drug Administration (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 candidates with hepatocellular carcinoma (HCC) in the United States to receive LT without exception scores, for whom expedited transplant might not be ultimately beneficial. This study aimed to describe early transplant access and waitlist outcomes for candidates with HCC during the era after FDA approval of NMP.

METHODS

Using the United Network for Organ Sharing (UNOS) database (2016-2023), 15,395 adult candidates listed for LT with HCC exceptions were divided into 3 listing periods: January 1, 2016, to May 18, 2019 (Delay and Cap); May 19, 2019, to September 27, 2021 (median Model for End-Stage Liver Disease at transplant minus 3); and September 28, 2021, to December 31, 2023 (NMP). Waitlist outcomes, including LT or dropout, were assessed using competing risk analysis.

RESULTS

Transplant incidence within 6 months was 16.9% during the NMP era vs <12% in earlier eras (P <.001) thanks to aggressive use of extended criteria donors. Significant disparity in LT access among UNOS regions was observed. Of note, 1-year graft survival after LT remained high, exceeding 90.0% across all eras (P =.85).

CONCLUSION

The NMP era demonstrated increased access to LT for candidates with HCC in the initial 6 months before qualifying for exception scores.