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Use of exception status listing and related outcomes during two heart allocation policy periods
Jessica R Golbus1, Yoon S Ahn2, Grace R Lyden2
1Division of Cardiovascular Diseases, Department of Internal Medicine, University of Michigan, MI; Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP) and Division of Cardiovascular Diseases, Department of Internal Medicine, University of Michigan, MI.
Insights
The 2018 heart transplant policy aimed to reduce exception status requests but led to a significant increase in their use. This policy shift impacted patient demographics and waitlist mortality, necessitating further evaluation.
Area of Science:
- Cardiology
- Transplantation Medicine
- Health Policy Analysis
Background:
- The 2018 heart allocation policy update aimed to reduce exception status requests for heart transplant candidates.
- Exception status is granted to patients not meeting standard criteria but perceived as having urgent need.
Purpose of the Study:
- To assess the utilization of exception status and its impact on waitlist outcomes before and after the 2018 policy change.
- To analyze changes in patient characteristics and transplant rates associated with exception status.
Main Methods:
- Utilized data from the Scientific Registry of Transplant Recipients (2015-2021) for adult heart transplant candidates.
- Compared exception status use and waitlist outcomes (transplant rate, mortality, delisting) pre- and post-policy.
- Employed multivariable logistic regression and Cox proportional hazard models.
Main Results:
- Heart transplants under exception status increased from 10.0% to 32.3% post-policy.
- Exception status candidates were more often from minority groups and had different underlying conditions and poorer hemodynamics.
- Exception status listing correlated with higher transplant rates; status 1 exception was linked to lower waitlist mortality.
Conclusions:
- The 2018 policy resulted in a dramatic rise in exception status listings.
- The policy shift altered the demographics of exception status patients and influenced waitlist mortality.
- Further evaluation of the policy's long-term impact is warranted.
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 prespecified criteria of illness severity. We assessed the 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 to 2021. We assessed (1) the 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 were assessed using Cox proportional hazard 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 postpolicy from 10.0% to 32.3%, with 20.6% of transplants performed for patients at status 2 exception. Exception status candidates postpolicy were more frequently Black or Hispanic/Latino and less likely to have hypertrophic or restrictive cardiomyopathy and had worse hemodynamics. Exception status listing was associated with higher transplant rates in both periods. Postpolicy, candidates listed status 1 exception had a lower likelihood for waitlist mortality or delisting (hazard ratio, 0.60; 95% CI, 0.37-0.99; and 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.
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