New US liver allocation policy increased number of transplants, cut deaths on waiting list after one year.

Deceased liver donor transplants have increased 9% while patient deaths on the waiting for a liver have decreased 23% since the inception of a new liver allocation policy in the US.

As a result, a year after the transplant community adopted the most radical change in liver allocation in the past 15 years, the chief architect of the new policy says the transplant community has enthusiastically embraced the new policy.

"There haven't been any huge surprises," Richard Freeman, MD, associate professor of surgery at Tufts University in Boston, MA, told Transplant News. "The system was implemented because we thought it likely to improve the waiting list mortality rate and it has. And we thought it would make the allocation of livers much more objective and it has. The transplant community's reaction has been one of approval and acceptance."

Freeman was the major force behind the development of the new plan and is credited with getting the transplant community and federal government to sign off on the change.

The United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) Liver and Intestine Committee, under Freeman's direction, spent more than 3 years meticulously developing the new policy - known as MELD-for Model for End-Stage Liver Disease and PELD-for Pediatric End-Stage Liver Disease-which was finally implemented in February of 2002.

MELD/PELD allocation policy directs that for all but the most severe and acute cases of liver failure, patients' priority for a transplant is based primarily on a formula that calculates their short-term risk of death without transplantation. Both MELD and PELD are based on common, objective tests that categorize patients on continuous scales of urgency with scores of less than 10 the least urgent, and more than 40 the most urgent.

Speaking to participants at UNOS' 11th Transplant Management Forum in New Orleans last week, Freeman said that the 6 month and 1 year survival rate for patients getting transplanted under MELD/PELD is identical at about 85%.

Freeman also noted that the number of retransplants are falling and continuing to do so in both adults and children. The reason, he said, is due to the fact that by the time patients got to the top of the list under the old system they had been very sick for a long time. The new system is transplanting urgent cases much more quickly.

When the new system was implemented, there was some concern that some transplant centers would "game the system," Freeman said, adding that that hasn't happened. In fact, he said, MELD scores listed for patients have actually slightly declined indicating centers are changing their listing procedures.

Freeman emphasizes at every opportunity that the MELD/PELD system is under constant review and changes and corrections are encouraged and expected.

"The whole system is going to be constantly updated and fine-tuned as we get more experience," Freeman said. "We expect there will be surprises."

When asked about specific changes, Freeman singled out how to deal with the great number of patients with hepatocellular cancer (HCC) that are flooding the system, regional differences in allocation between organ procurement organizations, and minimum listing criteria as the main areas of concern.

"We've got to figure out how to do a better job in prioritizing HCC patients," Freeman told Transplant News. "We probably overshot the mark with the initial rollout . It's becoming clearer that diagnosing someone with HCC for small tumors is relatively poor and giving someone high priority on the waiting list may or may not make sense. The point is that patients diagnosed earlier won't be taken off the list but just don't need to get a transplant as quickly because the data says its not likely to progress to high risk. We knew there wasn't a lot of data on HCC because of the way the system was set up. We are getting new data all the time."

Minimum listing criteria raises some big questions, Freeman said. "Should they be set or should they not? MELD will narrow the criteria but payers will not pay until someone is on the list. But if the criteria is high before they can be listed when will the payer pay? This is a big question and there's not an easy answer."

Finally, regional differences remain a concern in allocation. "There are still regional and geographical differences in how sick a patient is when they get transplanted," Freeman said. "We are now using a standard objective to measure and hopefully it will be easier to equalize the differences in the future. It could be that we'll have to consider another change in the future."

Freeman cautioned that the continuing shortage of organs is the single major impediment towards increasing patient and graft survival rates.

"MELD didn't result in getting more organs but centers are using more borderline organs so the numbers were up," Freeman pointed out. "Over time, the mortality on the liver waiting list under the MELD system will increase because of the lack of organs."

Freeman noted new data MELD/PELD will be presented at the American Transplant Congress, which will be held May 30-June 4 at the Wardman Park Hotel in Washington, DC.