ISHLT Response to OPTN Proposal to Modify Guidance for Pediatric Heart Exception Requests to Address Temporary Mechanical Circulatory Support Equipment Shortage

Published 1 October 2025

• OPTN Comment

The International Society for Heart and Lung Transplantation (ISHLT) welcomes the opportunity to review the OPTN Proposal "Modify Guidance for Pediatric Heart Exception Requests to Address Temporary Mechanical Circulatory Support Equipment Shortage.”

ISHLT Strongly Supports this Emergency Action intended to ensure that pediatric heart transplant candidates for whom MCS devices are not available have appropriate waiting list priority. Furthermore, we support the plan for the OPTN Heart Transplant Committee to reevaluate the status of shortage by September 10, 2025, and make a recommendation to the OPTN Board regarding whether the updated guidance should remain in place.

ISHLT offers three additional recommendations:

1. Given the ongoing Berlin heart device shortages and potential tariff challenges, the Committee and/or the Board may wish to establish objective criteria to be used to determine whether the shortage has ended (e.g. waiting time to access MCS devices) and establish a frequency (e.g. every 6 months) that these criteria will be reassessed. This reassessment should include evaluation of available alternative cannula and device options to provide mechanical circulatory support for this unique population.
2. If the guidance is extended beyond September 10, the Committee and/or the Board may wish to consider whether documentation that an appropriate device is not available is submitted with exception requests.
3. Once the shortage is ended, rather than removing the additional guidance language, the Board may wish to consider keeping the language intact but changing the wording from “In the event of a recognized national shortage…” to “In the event that the OPTN Board determines that there is a national shortage…”