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Modify Guidance for Pediatric Heart Exception Requests to Address Temporary Mechanical Circulatory Support Equipment Shortage

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Background

Children with a heart condition called dilated cardiomyopathy (DCM) often need a special device to help their heart pump blood while they wait for a transplant. These devices are called mechanical circulatory support devices (MCSDs). Currently, there’s a shortage of these devices and the equipment needed to use them. This has made it harder for some children—especially those weighing 10kg or more—to qualify for the highest pediatric heart transplant status, Status 1A. In response to this potential patient safety issue, the OPTN Board of Directors approved an emergency action, which went into effect on June 12, 2025 that allows programs to make a Status 1A exception request for children who can’t get the device due to the shortage. This guidance update will be reviewed within 90 days of implementation to decide if it should stay in place.

Supporting presentation

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Updated guidance

  • Allows National Heart Review Board for Pediatrics (NHRB) members to consider approving Status 1A exception requests for pediatric DCM patients that meet the following criteria:
    • Acknowledged shortage of pediatric MCSDs and/or supporting equipment
    • No acceptable alternatives available
    • The candidate is greater than 10kg
    • The candidate’s clinical condition demonstrates poor systemic perfusion while supported by high dose inotropes as defined in Table 1 of the guidance

Anticipated impact

  • What it's expected to do
    • Ensure impacted patients are prioritized for transplant appropriately
    • Protect patient safety
  • What it won't do
    • Will not change OPTN policy

Terms to know

  • Mechanical Circulatory Support Device: An artificial device that performs some or all of the functions of the heart
  • Dilated cardiomyopathy: A condition where the heart becomes enlarged and weaker than normal, resulting in the heart not being able to pump blood to the body effectively

Click here to search the OPTN glossary

Read the full proposal (PDF)

Provide feedback

eye iconComments

Region 7 | 09/12/2025

Sentiment: 5 strongly support, 4 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: None

Region 8 | 09/12/2025

Sentiment: 2 strongly support, 7 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee stated that this policy offers an important bridge to allow standardized guidance for change in listing acuity for patients that do not have access to lifesaving MCS devices. It will be important to maintain consistent follow-up with industry partners regarding availability of device equipment to remove this policy change when it is no longer appropriate.

Region 11 | 09/11/2025

Sentiment: 10 strongly support, 7 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. A member strongly supports the OPTN Board’s emergency policy change allowing Status 1A exceptions for pediatric heart transplant candidates with dilated cardiomyopathy due to a shortage of mechanical support devices. The policy ensures critically ill children receive appropriate transplant priority and reflects a swift, patient-centered response to a serious safety issue. The member urges that this guidance remain in place for as long as the shortage continues, to protect the most vulnerable patients.

Region 3 | 09/10/2025

Sentiment: 4 strongly support, 6 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: No comments

Advanced Cardiac Therapies Improving Outcomes Network (ACTION) | 09/09/2025

The ACTION Network appreciates the recognition by the OPTN of the current shortage and ongoing challenges in mechanical support devices for small children. We are in favor of this emergency guidance as well as the proposed timeline for reassessment. We would also encourage collaboration with partner organizations in Pediatric Heart Transplantation to ensure that education on this guidance is disseminated widely to ensure that exception requests are being handled appropriately. 

Terri Milton | 08/27/2025

Strongly Support

Deipanjan Nandi | 08/27/2025

When this guidance was issued, there was a shortage of both Berlin cannulas and Berlin drivers. While there is clearly a continued shortage of Berlin heart drivers, there is no longer a shortage of Berlin cannulas, which are thought by many to be the best cannulas for durable use. Berlin cannulas with other pumps, including CentriMag and PediMag, is a long-standing practice, and even safer than in the past with use of bivalirudin and coated connectors, etc. I personally do not think this exception guidance is needed any longer, and feel that there has been a slight slide towards using this guidance as a way to get 1A status in smaller children who are not quite as ill as those patients on device.

If the guidance must be kept for now, one way to know when to call the shortage at an end, would be to review with the Berlin Heart company their current IKUS driver waitlist, recently numbering in the 20s. If this number were to consistently fall to being low single digits for weeks at a time, the driver shortage would be essentially over.

Anonymous | 08/27/2025

Strongly Support

Anonymous | 08/27/2025

Strongly Support