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Lack of livers for transplants makes doctors less selective
Sunday, May 09, 2004

Because of the chronic shortage of livers available for transplant, the University of Pittsburgh Medical Center and hospitals across the country are turning to "expanded-criteria" donors to recover livers that previously would have been passed over.

The practice raises ethical questions, some believe, and the New York Health Department announced last month it would create a committee to study the trend in the wake of an investigation at a liver transplant unit in Rochester, N.Y.

The current transplant chief at UPMC ran the Rochester unit during some of the years investigated by New York officials.

Although these livers are obtained from donors who are older or sicker than considered optimal, it's far from clear that there's anything wrong with the trend.

Use of livers from expanded-criteria donors helped UPMC in 2002 reverse a 12-year decrease in the number of liver transplants performed at Oakland hospitals. Patient and graft survival for 2002 showed one of the best outcomes ever for the Pitt program, said transplant administrator William Morris.

Dr. Goran Klintmalm, chairman of the Baylor Regional Transplant Institute in Dallas, said it's still not clear whether there's a higher incidence of impaired liver function -- and worse patient survival -- after these transplants, but he remains a strong proponent.

The practice is simply a continuation of an old story in which surgeons experiment to see which organs can be used, so more people can be helped, he said.

"There is nothing today that would say these organs, in the long term, provide a worse survival or worse function -- we don't have the data to say that," said Klintmalm. "What we can say is that the rate of primary nonfunction of livers has gone down over the years, in spite of expanding the donor criteria."

A conflict involving the allocation of expanded-criteria organs culminated last year with the transplant program at the VA Pittsburgh Healthcare System breaking away from the University of Pittsburgh Medical Center. New York investigators noted several instances where it was unclear if patients at Strong Memorial Hospital in Rochester were told about the "expanded-criteria" status of the donors from which livers were recovered.

Part of the problem in assessing how well livers from expanded-criteria donors work is that there is no single definition that describes them.

Some are simply old. Initially, donors over the age of 50 were thought to provide livers that didn't perform well, but donors in that age group now provide nearly 30 percent of all livers, wrote Dr. Ronald Busuttil, the liver transplant chief at the University of California Los Angeles, in a paper published last year.

Organs that have been on ice for a long time, and therefore have a greater risk of what's called "ischemic injury," also fall into this category. These injuries can impair liver function.

Expanded-criteria donors can have any of a variety of health problems, such as hepatitis or high levels of fat in the liver. Depending on the health problem, doctors use different strategies to minimize the risk to recipients.

Even gender can be a factor, according to Busuttil. A transplanted liver is more likely to fail when male recipients receive female donor organs, he wrote.

Because of the heterogeneous nature of the expanded category, there aren't good numbers that show how many are used each year. Nor are there good studies that show how well they work, said Dr. Andrew Klein, a transplant surgeon at Johns Hopkins University.

Klein does not necessarily oppose surgeons using the organs, but noted a key ethical question raised by the practice.

"It's clear that the organs recovered from patients who are physically extending the criteria, those livers will work better in someone who is less sick," Klein said. "Is it ethically justifiable to expose someone who is not in immediate need of liver replacement to a liver that may have an increased risk of not functioning? That's really where the rubber hits the road."

That's also a question raised by the recent investigation in New York.

The New York Health Department issued a $20,000 fine in April to Strong Memorial Hospital in Rochester for problems in its liver transplant unit.

In one case, the hospital failed to document why a patient who had a favorable short-term survival rate without a transplant was given a liver from an expanded-criteria donor. Problems subsequently occurred with the liver, forcing the patient to undergo a second liver transplant.

When that patient was treated at Strong Memorial Hospital, Dr. Amadeo Marcos had already left the Rochester transplant program for his current position as liver transplant chief at UPMC. But Marcos was still at Strong Memorial in the first half of 2002, when another recipient received care that was questioned by state investigators.

The 2002 patient required a second transplant after the organ from an expanded-criteria donor failed. But there was no clear documentation that the patient was informed that such a transplant was being offered, investigators said, nor was it clear that the risks were communicated.

Marcos would not grant an interview for this article. William Morris, the transplant administrator at UPMC, said his program would not comment on patients treated elsewhere. Morris was director of the organ procurement organization at Strong Memorial Hospital at the time of the 2002 transplant, however.

In general, UPMC fully informs patients of the risks and benefits of transplant surgeries by having them sign a detailed consent form, Morris said.

Morris could not say how many expanded-criteria livers UPMC has used since August 2002, when Marcos came to Pittsburgh. But in general, the organs have worked well.

"Outside of live donors, we have not seen any significant difference in graft survival between any kind of donors used at UPMC, in Dr. Marcos' tenure or before," he said. "The definition of both patients who can benefit instead of dying, and organs that will serve is in constant evolution."

Livers from expanded-criteria donors often are not a good match with the sickest patients, said Dr. Abraham Shaked, a liver transplant surgeon at the University of Pennsylvania. Therefore, the livers are sometimes poorly handled by the current allocation system, which often directs donor livers to the sickest patients on the waiting list, he said.

That was UPMC's argument in last year's dispute with the VA, where VA officials were concerned that VA patients were being bypassed in favor of patients at UPMC who were less sick.

Expanded-criteria donors have become a large part of the liver supply at Penn, Shaked said, and the results have often been encouraging. But he questioned how any center could affirmatively state that livers from marginal donors are doing as well as livers from all other donors.

"If they were doing so well, why would you call them marginal donors to begin with?" he asked.

To bioethicist Arthur Caplan, it is dangerous territory.

"There are enormous ethical problems," said Caplan, also from Penn. "The pressures to find more organs are enormous, so judgments about what's marginal are clouded by the shortage and scarcity. ... There's both the drive to save lives and the desire to stay busy, so to speak. They're both there."

First published on May 9, 2004 at 12:00 am
Christopher Snowbeck can be reached at csnowbeck@post-gazette.com or 412 263-2625.
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