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OPTN/UNOS Board approves revised adult heart allocation system, clarifies exception points for liver transplant candidates with hepatocellular carcinoma

St. Louis – The OPTN/UNOS Board of Directors, at its meeting Dec. 5 and 6, approved a major update of the system used to allocate hearts for adult transplant candidates nationwide.

“These are significant changes, meant to address rapid developments in the technology of cardiac care and ensure we are fairly addressing the needs of all patients,” said Stuart Sweet, M.D., Ph.D., OPTN/UNOS President. “We believe this new system will reduce waiting list deaths by providing the most urgent candidates more immediate access to available organs.”

The newly approved heart policy establishes six new medical urgency status levels to replace the current three used to prioritize adult heart candidates. Each status assesses candidates’ relative risk of dying short-term without a transplant. Since the most recent substantive revision of heart allocation policy in 2006, use of mechanical circulatory support such as ventricular assist devices (VADs) and extracorporeal membrane oxygenation (ECMO) has become much more common; the updated statuses provide more detailed criteria for when and how these treatments are used for individual candidates.

The policy also alters the sequence of allocation for the most urgent candidates. Hearts from deceased donors age 18 years or older will be offered first to compatible adult status 1 and pediatric (younger than 18) status 1A candidates within the local donation service area (DSA) plus a 500-mile radius from the donor hospital, then to compatible adult status 2 candidates within the DSA plus a 500-mile radius. While the overall number of candidates in the highest two statuses will be relatively small, they are at the greatest risk of dying imminently without a transplant. If no matches are made for these candidates, hearts will then be offered to candidates in lower urgency statuses beginning at the local DSA. The new system will also incorporate a detailed monitoring plan to help ensure the new statuses accurately reflect the current level of candidates’ medical urgency.

In other action, the Board approved policy changes to refine automatic approval of exception points for liver transplant candidates with hepatocellular carcinoma (HCC), a form of liver cancer. Patients with HCC often can benefit from a timely liver transplant, but their disease tends to progress in a way not accurately reflected by the Model for End-Stage Liver Disease (MELD) formula. For this reason, HCC candidates that meet qualifying medical criteria are granted exception scores that better reflect the candidate’s disease severity. The modified policy updates and clarifies criteria for automatic approval to increase equity in access to transplantation between HCC candidates and non-HCC candidates.

While no Board action was planned or taken to address liver distribution, the Board hosted additional public discussion about the status of efforts to reduce the disparity in medical urgency scores at transplant encountered by liver transplant candidates in different areas of the country. The Liver and Intestinal Organ Transplantation Committee will consider this input as it continues to study various alternatives, with the goal of developing a revised policy proposal in the near future.

The Organ Procurement and Transplantation Network (OPTN) is operated under contract with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation, by United Network for Organ Sharing (UNOS). The OPTN brings together medical professionals, transplant recipients and donor families to develop national organ transplantation policy.

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