Chapter  7: Human Experimentation

Section 4. Reading

TRANSPLANT TURMOIL

Live-Donor Procedures Carry Risks, Experts Say

By Ridgely Ochs
STAFF WRITER

August 19, 2002

The operation to transfer a section of liver from a living donor has developed, experts concede, with little oversight, no long-term data on outcomes and perplexing ethical issues.

". . . Surgeons have acknowledged that perhaps there is no greater ethical dilemma than to operate and remove an organ from a perfectly healthy individual to help another," a National Institutes of Health workshop stated in 2000.

The kidney and liver are the two organs that can most easily be transplanted from a live donor: That's because the liver regenerates within weeks, and a person can live with only one kidney. But a kidney transplant is less technically demanding and has better results. After one year, 94.5 percent of those who received a kidney from a live donor are alive; the one-year survival rate for live-donor liver recipients is 74.6 percent, according to United Network for Organ Sharing, the nonprofit national organ procurement group.

The first liver transplant from an adult to a child took place in 1989, and two years later the first adult-to-adult live donor transplant was performed. Last year, there were 408 live donor adult-to-adult liver transplants, and 104 such pediatric transplants, according to the group.

But the adult-to-adult version is technically different and more demanding, according to an article last year in the New England Journal of Medicine.

The pediatric operation takes the smaller left lobe, while the adult version takes the right - between 60 and 70 percent of a liver. And surgeons don't agree on the safest and most effective procedure - or on which candidates are best for surgery, the article said.

That was also the conclusion of the NIH workshop in 2000. The head of the workshop, Dr. Mitchell Shiffman, director of the transplantation center at Virginia Commonwealth University Medical System in Richmond, has advocated confining such procedures to eight medical centers, which the NIH has proposed to designate as a part of a clinical trial that would follow donors and recipients for seven years.

The limited data so far show this is not a risk-free operation for the donor. In the February issue of the journal Liver Transplantation, a review of 12 studies involving 409 donors found the most common side effects were bile leaks and intestinal obstruction. The studies were small, and ranged from one reporting no side effects to another reporting nine problems among 15 patients.

However, the authors, from the University of North Carolina in Chapel Hill, said the findings may be lower than the true incidence. That's because there is no standardized reporting system, and only three of the studies stated how long patients were followed; the longest two were a little more than a year.

A survey published last year in Liver Transplantation found complications in eight of 24 donors; four were considered serious, including two with bile leaks. Nevertheless, all said they would go through the operation again.

It is such profound altruism combined with the lack of hard, long-term data that worries many. There is no oversight of each center's informed consent process - the means by which a hospital informs a patient of the risks. And some question whether a transplant center - with vested interests in performing the transplant - can fairly represent the interests of both the donor and recipient.

Dr. Francis Delmonico, director of the renal transplant program at Massachusetts General Hospital, heads the subcommittee on the Health and Human Services advisory panel on organ transplantation that is developing a consent document for use across the country. But he acknowledged that donor advocates, independent of the transplant team, may be necessary as well. Delmonico said establishing a national registry to track donors long term is also being discussed, as is a "process of certification that verifies that the transplant center has the capability to do live liver transplants." No group or agency oversees or accredits the 120 hospitals that perform the surgery.

Also unanswered is whether a liver section from a live donor is as good long term as a whole liver from a cadaver - although the scarcity of the latter often makes the issue moot.

For recipients, short-term survival is similar for both groups: At one year, 79.7 percent who received a cadaver liver are alive, as are 74.6 percent of those who got a liver section from a living donor, according to UNOS, the organ-sharing group, which tracks survival rates. After three years, 70.2 percent of the "cadaver" recipients were alive, as were 71.9 percent of the live donor recipients.

But experts point out that most of the latter were in better health initially than those who received cadaver organs: One has to be very sick to be among the 17,491 on the group's waiting list for a liver from a cadaver.

They also point out problems special to live donor transplants: The incomplete liver section leaves the recipient vulnerable until the organ regains full size, which takes a few weeks. And 15 to 32 percent of recipients have complications related to the tiny ducts that drain bile from the liver cells, according to an April review in the New England Journal of Medicine.

Shiffman in June presented results of a study at the International Liver Transplant Society meeting in Chicago comparing 58 patients who had received live donor livers to 123 who had gotten cadaver organs. About a year and a half after transplant, 45 percent with live-donor organs had had bile duct or hepatic vein strictures or obstructions, compared with 2 percent of those who received whole livers from cadavers. The long-term health impact is unclear, he said.

Copyright 2002, Newsday, Inc.

 

 

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