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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

View presentation

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)

eye iconComments

Transplant Families | 10/03/2025

Transplant Families fully supports the statement submitted by the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and the OPTN Pediatric Committee.

We echo this support and strongly urge the adoption of this emergency guidance. The ongoing shortage of mechanical circulatory support devices and associated equipment poses a direct and serious patient safety risk. Children are waiting longer and longer for lifesaving heart transplants, and in many cases do not have access to the primary support therapy that would bridge them to transplant. This reality creates devastating inequities in access and outcomes.

This emergency guidance is a necessary step to ensure that pediatric candidates, particularly those with dilated cardiomyopathy who are not eligible for currently available devices are given fair and timely access to status 1A priority. Without such action, children may face increased waitlist mortality simply because of equipment shortages beyond their control.

We also encourage the OPTN to:

  • Continue collaboration with ACTION and other pediatric transplant partners to ensure this guidance is widely disseminated and implemented consistently.
  • Maintain ongoing reassessment of the shortage and extend or adjust this guidance as needed until the device supply issue is resolved.

Region 2 | 10/01/2025

Sentiment: 2 strongly support, 3 support, 7 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 noted that this policy should only be limited to the time of the lack of temporary MCS and that pressure should be put on the manufacturers for this life saving therapy.

Region 1 | 10/01/2025

Sentiment: 5 strongly support, 1 support, 5 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 inquired about the review process for this proposal once the device shortage ends.

Luis Mayen | 10/01/2025

Pediatric patients awaiting heart transplants are uniquely vulnerable, and timely access to organs can be life-saving. I support modifying guidance to address temporary shortages of mechanical circulatory support equipment, ensuring that children who need exceptions are not disadvantaged by circumstances beyond their control. Clear, consistent policies help protect these patients and ensure equitable access during critical periods.

Region 4 | 10/01/2025

Sentiment: 2 strongly support, 10 support, 11 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. One attendee commented that adding exceptions has the potential to decrease equity. Another attendee commented that there are alternatives to the Berlin Heart device and introducing additional exceptions to this population has the potential to increase inequities based on different approaches to the treatment of the same patients.

OPTN Pediatric Transplantation Committee | 10/01/2025

The OPTN Pediatric Transplantation Committee (the Committee) supports this guidance update as a necessary response to the national shortage of pediatric ventricular assist devices and related equipment. Allowing certain pediatric candidates with dilated cardiomyopathy to be considered for Status 1A by exception when durable MCS therapies are unavailable helps ensure that medical urgency is accurately reflected and patient safety is prioritized.

At the same time, the Committee stresses the need for clear education to transplant programs and National Heart Review Board members so this guidance is not misinterpreted as automatically making all inotrope-dependent candidates eligible for Status 1A. Exception requests should include documentation of both clinical deterioration and the inability to access MCS equipment. The Committee also recommends ongoing monitoring of how often this guidance is used and transparent reporting of those data, as well as further clarification on how shortages should be determined. Overall, we believe this update is appropriate and timely but requires careful oversight to ensure consistent and appropriate application.

Donor Network West | 09/30/2025

Donor Network West, serving Northern California and Nevada, supports the proposal to modify guidance for pediatric heart exception requests to address temporary shortages of mechanical circulatory support equipment. Ensuring that pediatric candidates are not disadvantaged by circumstances beyond their control is essential to maintaining equity and fairness in the allocation system, and we commend the Committee for proactively addressing this issue.

Joseph Hillenburg | 09/30/2025

Strongly Support

American Society of Transplantation | 09/30/2025

The American Society of Transplantation (AST) supports the guidance document updates reviewed in the retrospective public comment document, “Modify Guidance for Pediatric Heart Exception Requests to Address Temporary Mechanical Circulatory Support Equipment Shortage.” In addition to what is outlined, the AST recommends an ongoing, periodic evaluation of the status of this shortage. To perform this evaluation efficiently and consistently, the AST suggests that the OPTN consider criteria to determine when there is an appropriate supply of these devices that would prompt the expiration of these updates to be scheduled. One factor that would be important to examine is geographical differences in access to these needed devices. Finally, with these evaluations, the OPTN would also be well suited to provide regular public updates on the device shortage problem and progress being made.

Region 9 | 09/30/2025

Sentiment: 3 strongly support, 2 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplant Surgeons | 09/30/2025

Please see attachment.

View attachment from American Society of Transplant Surgeons

Lorrinda Gray-Davis | 09/29/2025

Strongly Support

Advocate Health-Carolinas Medical Center and Advocate Christ | 09/29/2025

Please reference attachment.

View attachment from Advocate Health-Carolinas Medical Center and Advocate Christ

Rebecca Baranoff | 09/29/2025

Strongly Support

American Society for Histocompatibility and Immunogenetics (ASHI) | 09/26/2025

This proposal is not pertinent to ASHI or its members.

VA Pittsburgh Healthcare System | 09/26/2025

Neutral/Abstain

International Society for Heart and Lung Transplantation | 09/26/2025

Please reference attachment.

View attachment from International Society for Heart and Lung Transplantation

Family Lifestyle Solutions LLC | 09/26/2025

There should not be any shortage for children’s healthcare, whether they’re living or have passed. We are not in a foreign country. We are in America and we should have the best equipment and enough of the equipment to ensure that our children lives are saved. I read about how the circulatory component works and I never had an ideal before, but wow, modern medicine is a blessing, but I just ask that we could change it to Work to make sure that we have what we need for our communities.

Region 5 | 09/24/2025

Sentiment: 5 strongly support, 13 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

Region 10 | 09/24/2025

Sentiment: 5 strongly support, 8 support, 6 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. One attendee noted that they do not have concerns with the proposal, but that it needs to happen urgently.

OPTN Transplant Coordinators Committee | 09/23/2025

The Transplant Coordinator Committee thanks the Heart Transplantation Committee for their work on Modify Guidance for Pediatric Heart Exception Requests. The Committee is overall supportive of this proposal. In reviewing potential monitoring options, members suggested tracking the VAD shortage through the waitlist length of Berlin Hearts for pediatric candidates. Other members suggested monitoring waitlist mortality for patients listed by exception under this guidance. Further, members suggested increased education for patients and patient families around device options and offers. Overall, the Committee is appreciative of the quick timeline of this proposal and found this guidance helpful.

Gift of Life Michigan | 09/22/2025

We appreciate the National Heart Review Board’s (Pediatric) efforts to mitigate the problems created by equipment/supply shortages and to protect children in need of heart transplantation.

We support the proposal while emphasizing that there must be compliance with the Board’s proposal to monitor equipment availability, and if/when supplies and equipment are available that the temporary change reverts to pre-condition terms. We believe it is incumbent upon the OPTN to ensure transparency and trust in the system and to ensure temporary measures do not inadvertently become permanent.

Vanderbilt University Medical Center | 09/22/2025

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on this proposal.  We support this proposal in the event that an active equipment shortage persists.  However, if the shortage has been resolved, the guidance is no longer relevant, and the established expiration timeline should remain in effect.

Region 6 | 09/19/2025

Sentiment: 0 strongly support, 3 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

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, 5 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose


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