Background & Aims: In Italy, since August 2014, liver transplant (LT) candidates with model for end-stage liver disease (MELD) scores ≥30 receive national allocation priority. This multicenter cohort study aims to evaluate time on the waiting list, dropout rate, and graft survival before and after introducing the macro-area sharing policy. Methods: A total of 4,238 patients registered from 2010 to 2018 were enrolled and categorized into an ERA-1 Group (n = 2,013; before August 2014) and an ERA-2 Group (n = 2,225; during and after August 2014). A Cox proportional hazards model was used to estimate the hazard ratio (HR) of receiving a 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: Patients with MELD ≥30 had a lower median time on the waiting list (4 vs.12 days, p <0.001) and a higher probability of being transplanted (HR 2.27; 95% CI 1.78–2.90; p = 0.001) in ERA-2 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 was associated with a higher risk of graft loss. Transplant center volumes and competition among centers may have a role in recipient prioritization and outcomes. Clinical trial number: NCT04530240 Lay summary: Italy introduced a new policy in 2014 to give national allocation priority to patients with a model for end-stage liver disease (MELD) score ≥30 (i.e. very sick patients). This policy has led to more liver transplants, fewer dropouts, and shorter waiting times for patients with MELD ≥30. However, a higher risk of graft loss still burdens these cases. Transplant center volumes and competition among centers may have a role in recipient prioritization and outcomes.

Ravaioli, M., Lai, Q., Sessa, M., Ghinolfi, D., Fallani, G., Patrono, D., Di Sandro, S., Avolio, A. W., Odaldi, F., Bronzoni, J., Tandoi, F., De Carlis, R., Pascale, M. M., Mennini, G., Germinario, G., Rossi, M., Agnes, S., De Carlis, L., Cescon, M., Romagnoli, R., De Simone, P., Impact of MELD 30-allocation policy on liver transplant outcomes in Italy, <<JOURNAL OF HEPATOLOGY>>, 2022; 76 (3): 619-627. [doi:10.1016/j.jhep.2021.10.024] [https://hdl.handle.net/10807/303472]

Impact of MELD 30-allocation policy on liver transplant outcomes in Italy

Avolio, Alfonso Wolfango;Agnes, Salvatore;
2022

Abstract

Background & Aims: In Italy, since August 2014, liver transplant (LT) candidates with model for end-stage liver disease (MELD) scores ≥30 receive national allocation priority. This multicenter cohort study aims to evaluate time on the waiting list, dropout rate, and graft survival before and after introducing the macro-area sharing policy. Methods: A total of 4,238 patients registered from 2010 to 2018 were enrolled and categorized into an ERA-1 Group (n = 2,013; before August 2014) and an ERA-2 Group (n = 2,225; during and after August 2014). A Cox proportional hazards model was used to estimate the hazard ratio (HR) of receiving a 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: Patients with MELD ≥30 had a lower median time on the waiting list (4 vs.12 days, p <0.001) and a higher probability of being transplanted (HR 2.27; 95% CI 1.78–2.90; p = 0.001) in ERA-2 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 was associated with a higher risk of graft loss. Transplant center volumes and competition among centers may have a role in recipient prioritization and outcomes. Clinical trial number: NCT04530240 Lay summary: Italy introduced a new policy in 2014 to give national allocation priority to patients with a model for end-stage liver disease (MELD) score ≥30 (i.e. very sick patients). This policy has led to more liver transplants, fewer dropouts, and shorter waiting times for patients with MELD ≥30. However, a higher risk of graft loss still burdens these cases. Transplant center volumes and competition among centers may have a role in recipient prioritization and outcomes.
2022
Inglese
Ravaioli, M., Lai, Q., Sessa, M., Ghinolfi, D., Fallani, G., Patrono, D., Di Sandro, S., Avolio, A. W., Odaldi, F., Bronzoni, J., Tandoi, F., De Carlis, R., Pascale, M. M., Mennini, G., Germinario, G., Rossi, M., Agnes, S., De Carlis, L., Cescon, M., Romagnoli, R., De Simone, P., Impact of MELD 30-allocation policy on liver transplant outcomes in Italy, <<JOURNAL OF HEPATOLOGY>>, 2022; 76 (3): 619-627. [doi:10.1016/j.jhep.2021.10.024] [https://hdl.handle.net/10807/303472]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/303472
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