The modifications are aimed at better stratifying the most medically urgent heart transplant candidates and address geographic disparities that impact access to donor organs. The modifications also take into account changes since the current policy was put into place in 2006, including the increasing effectiveness and growing use of mechanical circulatory support devices (MCSDs) used to treat heart disease.
Here are our five key takeaways from the policy change and guidance on what your program should be doing to prepare.
- More categories will better stratify medically urgent cases. One of the driving goals behind UNOS' wide-ranging changes was to decrease mortality rates for transplant-eligible patients of the waitlist. Concerned that the existing three-tier system was not sufficiently prioritizing medically urgent cases, UNOS is implementing a six-tiered system with more specific guidelines for each tier. UNOS hopes that narrow delineations between each tier will more precisely identify the most medically urgent patients. For detailed definitions of each tier, see this UNOS tool.
- Extra Corporeal Membrane Oxygenation (ECMO) patients will receive top priority. ECMO patients represent the sickest and most medically urgent cases and will now be considered first in organ allocation. By highly prioritizing ECMO patients, UNOS expects to drastically cut waitlist mortality. On the other hand, some believe that this change may result in worse on-average outcomes, as well as the possibility that hearts will be given to patients who will experience a smaller marginal benefit than other patients would. For more information on ECMO program development, see our briefing.
- VADs and other MCSDs are now seen as viable, long-term alternatives to transplant. Barring MCSD complications, which places patients into the top tier of transplant eligibility, patients with VADs and other MCSDs will be moved to the third tier. This change reflects the technical and clinical improvements in these technologies in recent years. Advances have improved efficiency, size, durability, and overall patient outcomes. As a result, these patients have less pressing need for donor hearts than they did a decade ago. Payers and providers are more comfortable recommending MSCDs as destination therapy, rather than as bridges to transplant. In deprioritizing patients on MCSDs, UNOS is responding to this paradigm shift.
- Principles guiding geographic organ distribution are also changing. Over the past year, UNOS has changed the way that lungs and livers are distributed to patients on a geographic basis. The new policy largely jettisons the 11 donor service areas (DSA) that for decades have dictated how organs are allocated, instead creating zones around the donor hospital to determine the pool of candidates eligible for the organ. This policy will be extended with slight modifications to guide the geographic distribution of donor hearts. Although priority will be given to patients within the DSA of the donor hospital, if no local patients match, the heart will be considered by hospitals within 500 nautical miles of the donor hospital, and then 1,000 nautical miles, and so on. These changes are expected to cut down on geographic disparities in organ matching, while keeping organ preservation time as short as possible.
- All new policies will be reevaluated in six months. The moment that these changes are implemented, UNOS will begin studying how they impact waitlist mortality, outcomes, and provider and patient satisfaction. UNOS agreed to revisit the policies in April 2019 to measure progress against their goals. While this touchpoint is unlikely to result in a total reversion to current standards, UNOS has stated that it is open to feedback and is flexible to changes.
Changes to the UNOS heart transplant allocation policy are far-reaching. For further information, assistance, and teaching tools, refer to the UNOS adult heart allocation toolkit.
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