Background: The US heart allocation system ranks candidates using six categorical status levels. Transplant programs can request exceptions to increase a candidate's status level if they believe their candidate has the same medical urgency as candidates who meet the standard criteria for that level. We aimed to determine if exception candidates have the same medical urgency as standard candidates.
Methods: Using the Scientific Registry of Transplant Recipients, we constructed a longitudinal waitlist history dataset of adult heart-only transplant candidates listed between October 18, 2018 and December 1, 2021. We estimated the association between exceptions and waitlist mortality with a mixed-effects Cox proportional hazards model that treated status and exceptions as time-dependent covariates.
Results: Out of 12,458 candidates listed during the study period, 2273 (18.2%) received an exception at listing and 1957 (15.7%) received an exception after listing. After controlling for status, exception candidates had approximately half the risk of waitlist mortality as standard candidates (hazard ratio [HR] 0.55, 95% confidence interval [CI] [0.41, 0.73], p < .001). Exceptions were associated with a 51% lower risk of waitlist mortality among Status 1 candidates (HR 0.49, 95% CI [0.27, 0.91], p = .023) and a 61% lower risk among Status 2 candidates (HR 0.39, 95% CI [0.24, 0.62], p < .001).
Conclusions: Under the new heart allocation policy, exception candidates had significantly lower waitlist mortality than standard candidates, including exceptions for the highest priority statuses. These results suggest that candidates with exceptions, on average, have a lower level of medical urgency than candidates who meet standard criteria.
Keywords: equity; exceptions; heart transplant; medical ethics; waitlist mortality.
Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.