Use of Exception Status Listing and Related Outcomes During Two Heart Allocation Policy Periods.

BACKGROUND: The October 2018 update to the heart allocation policy was intended to decrease exception status requests, whereby candidates are listed at a specific status due to perceived need despite not meeting pre-specified criteria of illness severity. We assessed use of exception status and waitlist outcomes before and after the 2018 policy.

METHODS: We used data from the Scientific Registry of Transplant Recipients on adult heart transplant candidates listed from 2015-2021. We assessed (1) use of exception status across patient characteristics between the two periods and (2) transplant rate and waitlist mortality or delisting due to deterioration in each period. Patients listed by exception versus standard criteria were compared with multivariable logistic regression and waitlist outcomes assessed using Cox proportional hazards models with medical urgency and exception status as time-dependent covariates.

RESULTS: During the study period (n=19,213), heart transplants under exception status increased post-policy, from 10.0% to 32.3%, with 20.6% of transplants performed for patients at status 2 exception. Exception status candidates post-policy were more frequently Black or Hispanic/Latino, less likely to have hypertrophic or restrictive cardiomyopathy, and had worse hemodynamics. Exception status listing was associated with higher transplant rates in both periods. Post-policy, candidates listed status 1 exception had a lower likelihood for waitlist mortality or delisting (HR, 0.60; 95% CI, 0.37-0.99; P=0.05).

CONCLUSIONS: Under the 2018 policy, exception status listings dramatically increased. The policy change shifted the population of patients listed by exception status and affected waitlist mortality, which suggests a need to further evaluate the policy's impact.