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

At a glance

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

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