Association of the 2018 U.S. Heart Allocation Policy Change and the Survival Benefit of Heart Transplantation

Background: In 2018, the U.S. heart allocation policy underwent a major change designed to increase the transplantation of the most medically urgent candidates. Objectives: This study aims to determine the association between the 2018 policy change and the survival benefit of heart transplantation. Methods: Observational study of the 23,043 U.S. adult heart transplant candidates listed before the policy change (October 2013 to October 2016) and a seasonally matched cohort listed after the policy change (October 2018 to October 2021). The main study outcome was the survival benefit of transplantation as defined by the increase in average days alive within 3 years following transplantation. The authors estimated survival with and without heart transplantation using a mixed-effects Cox proportional hazards model with transplant and status as time-dependent covariates and a random center-level intercept and transplant effect. Results: Of the 11,022 candidates in the pre-policy cohort and 12,021 candidates in the post-policy cohort across 111 centers, 7,165 (65.0%) in the pre-policy cohort and 8,941 (74.4%) in the post-policy cohort underwent heart transplantation. Absolute 3-year survival benefit among the highest priority status candidates more than doubled after the policy change (327.8 days pre-policy vs 699.8 days post-policy; P < 0.001). All statuses experienced a positive long-run survival benefit of transplantation. The average 3-year survival benefit across all statuses increased from 217.1 days to 241.2 days per donor heart (P < 0.001). Overall, during the first 3 years after implementation, the 2018 heart allocation policy change was associated with an additional 1,645 life-years saved from transplantation (4,259 vs 5,904; P < 0.001). Conclusions: The 2018 heart allocation policy change has led to better stratification and prioritization of candidates by clinical acuity, resulting in higher survival benefit of transplantation performed. Combined with higher transplantation rates, the 2018 heart allocation policy has saved thousands of life-years and achieved one of its major goals.