Abstract

Background In the United States heart allocation system, when transplant centers submit applications for status exceptions to increase waitlist priority, patients obtain the requested status upgrades immediately while their applications are sent to the regional review boards (RRBs) and reviewed retrospectively. How much time elapses between obtaining a status upgrade through exception and application receipt by the RRBs and how often transplants occur during this period is unknown.

Methods Using the Scientific Registry of Transplant Recipients (SRTR), we identified all adult heart transplant candidates listed between October 18, 2018 and December 31, 2023 with submitted applications for status exceptions. We assessed 1) the amount of time elapsed between submission of exception applications and their receipt by the RRBs and 2) the rate of heart transplantation during this “travel” time, stratified by whether the applications were eventually approved or denied. Additionally, using complete match run data, we estimated how many listed patients were skipped by candidates who received transplants with exceptions that were ultimately denied.

Results 135 transplant centers submitted status exception requests on behalf of 8,269 adult candidates during the study period, of whom 608 (7.4%) received a denial at least once. The median time from obtaining higher priority statuses immediately via exceptions to application receipt by the RRBs was 3 days. 2,087 out of 8,269 (25.2%) patients received transplants before the RRBs even received their applications, with 115 (18.9%) among 608 with eventual denials and 1,972 (25.7%) among 7,661 with approvals. The cumulative incidence of heart transplantation before application receipt for eventual denials was 19.1% (95% CI [16.0%, 22.3%]) and that for approvals was 26.2% (95% CI [25.2%, 27.1%]) (p < 0.001) at 2 weeks. Based on match run data, the 115 patients who received transplants with denied exceptions bypassed more than seven thousand potential transplant recipients.

Conclusions More than 25% of patients with status exception requests receive heart transplants before their applications are even received by their respective RRBs, let alone reviewed. This raises significant concerns about the efficacy and fairness of retrospective review of exception requests for the allocation of valuable donor hearts.

Competing Interest Statement

Conflict of Interest Disclosures: Nikhil Narang was a speaker for Boehringer Ingelheim and AstraZeneca and provided consulting services for BridgeBio. All other authors do not report any financial disclosures or other conflicts of interest.

Funding Statement

William Parker, one of the co-authors, was funded by R01 LM014263

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study used publicly available, deidentified human data from the Scientific Registry of Transplant Recipients. All data files utilized in this study can be requested from them. This study was exempted by the University of Chicago and Stanford University Institutional Review Boards.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All of the data files used for study in this manuscript are available upon reasonable request to the Scientific Registry of Transplant Recipients, who can be contacted via this email: srtrsrtr.org. To obtain access to such data, one must typically submit a research proposal in order to receive a data use and access agreement. The statistical code written to perform the analyses in the manuscript are available here in this Github repository: https://github.com/danieljaechulahn/Retrospective-Heart-Exceptions

https://github.com/danieljaechulahn/Retrospective-Heart-Exceptions

AbbreviationsHRSAHealth Resources and Services AdministrationOPTNOrgan Procurement and Transplantation NetworkSRTRScientific Registry of Transplant RecipientsPTRPotential Transplant RecipientRRBRegional Review Board