A new data report (PDF - 1 MB) contains key measures of adult heart allocation based on an emergency policy change (PDF - 557 KB) approved by the OPTN Executive Committee on July 11, 2022 and implemented on July 14, 2022. The policy allows for a heart status exception for candidates who have had an implanted assist device that is subject to a product recall.
Early monitoring shows a heart ‘device recall exception’ was submitted for a small percentage of candidates between July 14, 2022, and Jan. 13, 2023, accounting for:
- 82 (1.58 percent) of all adult heart transplant candidates who spent any time waiting on the waitlist
- 51 (2.65 percent) of adult heart transplant recipients transplanted in this time period
The report notes additional trends since implementation, including:
- Adult Status 2 and Status 3 patients represent the largest number of candidates for whom a ‘device recall exception’ was submitted.
- As a percentage of heart transplants performed by recipient status, those in adult Status 1 with a device recall exception represented the largest proportion of recipients (3.98 percent). However, in terms of the actual number of recipients by status, the highest total of recipients with a device recall exception were in adult Status 2 (34 total). The difference is largely due to the greater number of Status 2 compared to Status 1 patients.
The OPTN Heart Transplantation Committee will continue to monitor this policy, and subsequent monitoring reports will be published on the OPTN website on an ongoing basis.