Original Clinical Science
Use of exception status listing and related outcomes during two heart allocation policy periods

https://doi.org/10.1016/j.healun.2023.05.004Get rights and content

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.

Section snippets

Study cohort

This study used data from the Scientific Registry of Transplant Recipients (SRTR). The SRTR data system includes data on all donors, waitlisted candidates, and transplant recipients in the United States submitted by the members of OPTN and has been described elsewhere.5 The Health Resources and Services Administration, U.S. Department of Health and Human Services, provides oversight of the activities of the OPTN and SRTR contractors.

The analysis was limited to adults (18 years or older) listed

Baseline characteristics of waitlisted patients

From November 1, 2015, to September 30, 2021, 19,213 adult patients were listed for heart transplantation. Of these, 9,624 (49.9%) candidates were listed during the prepolicy period and 9,589 (50.1%) during the postpolicy period. At the time of initial listing, 328 (3.4%) candidates were listed by exception status during the prepolicy period compared to 1,704 (17.8%) candidates listed by exception status during the postpolicy period, a more than 5-fold increase (Figure 1, Table 1). The increase

Discussion

The current study evaluates the impact of the October 2018 change to the heart allocation policy on exception status listings and waitlist outcomes for patients listed by exception. Unlike previous work, our analyses allowed medical urgency and exception statuses to change over time and estimated the effect of exception status listing at each level of medical urgency. We found a dramatic 5.2 times increase in exception status listings following the policy change, with 32.2% of all candidates

Disclosure statement

Golbus receives funding from the National Institutes of Health (NIH; L30HL143700) and receives salary support from an American Heart Association (AHA) grant (20SFRN35370008). Nallamothu is a principal investigator or co-investigator on research grants from the NIH, Veterans Affairs Health Services Research and Development Service, the AHA, and Janssen and receives compensation as the Editor-in-Chief of Circulation: Cardiovascular Quality and Outcomes, a journal of the AHA. Colvin is an

Funding

None.

CRediT authorship contribution statement

All authors take responsibility for the content of the manuscript. All authors contributed to the conceptualization of the work and study design. Lyden and Ahn performed the analyses under the supervision of Israni and Zaun. The first draft of the manuscript was prepared by Golbus. It was reviewed and edited by all authors, all of whom made the decision to submit the manuscript.

Acknowledgments

This work was conducted under the auspices of the Hennepin Healthcare Research Institute (HHRI), contractor for the Scientific Registry of Transplant Recipients (SRTR), as a deliverable under contract no. 75R60220C00011 (U.S. Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, and Division of Transplantation). The U.S. Government (and others acting on its behalf) retains a paid-up, nonexclusive, irrevocable, worldwide license for all

References (8)

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Twitter: @JRGolbus

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