Read the full proposal (PDF - 280 K; 1/2018)

The OPTN/UNOS Board of Directors recently approved the Thoracic Organ Transplantation Committee’s (Committee) proposal to Modify the Adult Heart Allocation System during its December 2016 meeting. During the development of the proposal, the Committee received feedback from the heart transplant community voicing concerns that hypertrophic cardiomyopathy (HCM) and restrictive cardiomyopathy (RCM) candidates may be disadvantaged by the proposed policy. The Committee considered the following issues in HCM and RCM candidates:

• HCM/RCM physiology may not benefit from mechanical circulatory support devices (MCSDs), and the higher statuses are device driven
• A lack of uniform expertise in HCM/RCM physiology results in variability in Regional Review Board (RRB) decisions across the country
• Objectively quantifying the severity of illness is challenging

The Committee acknowledged that some HCM/RCM candidates may have higher mortality and may not be candidates for mechanical support options, but ultimately did not change proposed policy due to lack of objective data to support these assumptions. Instead, the exception and review process will accommodate these candidates, who can apply to the review board for an exception in any status as their medical urgency and potential for benefit would warrant. The Committee recognized that HCM/RCM expertise may be inconsistent across the review boards, thus potentially making evaluation and award of HCM/RCM exception requests vulnerable to variability. To help mitigate these potential inconsistencies, the Committee created guidance for the review boards with the goal of outlining objective criteria to standardize the evaluation and decision-making of HCM/RCM exception requests. Improved data collection required by the new policy should result in better assessment of whether specific subpopulations of HCM/RCM are disadvantaged by the status 4 assignment and may result in future policy changes to address any disadvantages.

This proposal aligns with the OPTN strategic goal of improving equity in access to transplant by providing objective criteria to review boards, potentially making evaluation and award of exception requests for HCM/RCM candidates more consistent, especially for those boards that lack an HCM/RCM expert. In addition, developing standardized exception criteria creates an intelligible pathway for more medically urgent HCM/RCM candidates to obtain access to higher urgency statuses, under which they may be transplanted more quickly, thereby potentially reducing waitlist mortality for those candidates.