Six-month monitoring report for heart policy following a device recall now available

Published on: Monday, July 3, 2023

A new data report contains key measures of adult heart allocation based on an emergency policy change 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.