BACKGROUND & AIMS: In Italy, since August 2014, LT candidates with MELD≥30 receive a national allocation priority. This multi-center cohort study aims to evaluate waiting time in the list, dropout rate, and graft survival before and after introducing the macroarea sharing policy.

METHODS: 4,238 patients registered from 2010 to 2018 have been enrolled and categorized in an ERA-1 Group (n=2,013; before August 2014) and an ERA-2 Group (n=2,225; during and after August 2014). Cox proportional hazard model was used to estimate the HR of receiving LT or death between the two ERAs. The Fine-Gray model was used to estimate the HR for dropout from the waiting list and graft loss, considering death as a competing risk event. A Fine-Gray model was also used to estimate risk factors of graft loss.

RESULTS: MELD≥30 patients had a lower median waiting time in the list for LT (4vs.12 days, p<0.001) and a higher probability to be transplanted (HR=2.27, 95%CI 1.78-2.90; p=0.001) in the ERA-2 when compared to ERA-1. The subgroup analysis on 3,515 LTs confirmed ERA-2 (odds ratio=0.56, 95%CI=0.46-0.68; p=0.001) as a protective factor for better graft survival rate. The protective variables for lower dropouts on the waiting list were: ERA-2, high volume centers, no competition centers, male recipients, and hepatocellular carcinoma. The protective variables for graft loss were high volume center and ERA-2, while MELD≥30 remained related to a higher risk of graft loss.

CONCLUSIONS: The national MELD≥30 priority allocation was associated with improved patient outcomes, although MELD≥30 had a higher risk of graft loss. The transplant centers volume and competition among centers may have a role in the recipient prioritization and outcome.

CLINICAL TRIAL NUMBER: NCT04530240 LAY SUMMARY: After introducing the Italian national MELD≥30 priority, more LT, fewer dropouts, and shorter waiting times were observed in patients with MELD≥30. However, a higher risk of graft loss still burdens these cases compared to MELD<30. The volume of transplant centers and competitions among centers may have a role in the recipient prioritization and outcome.