Doctors Call for Regulator to Certify Living-Donor Liver Transplant Programs

"There is no regulation on this procedure," said Dr. James Trotter, a liver specialist at the University of Colorado Health Sciences Center in Denver.

Trotter and his colleagues also endorsed creation of a national registry to record information about living liver donor outcomes, including mortality, and urged adoption of uniform medical criteria for selection of living donors and recipients.

The call for more regulation came as a USA Today survey of all 60 transplant centers that have performed adult-to-adult living donor liver transplants since 1991 found vast differences in how potential donors are screened and informed of the risks.

Data from the United Network for Organ Sharing also showed that of the 49 hospitals that performed 509 adult-to-adult living donor liver transplants last year, 39 performed fewer than nine procedures, and more than half performed fewer than five.

"This fact could compromise the outcomes for donors and recipients at the less experienced centers," Trotter and his colleagues wrote.

Transplant surgeons are in broad agreement that highly complex and dangerous surgery of this kind is more likely to be successful at a medical center that performs a relatively high number of the operations each year.

"It's alarming for a center that does a low volume with no experience in innovative liver surgery to be doing one or two of these a year," said David Cronin, a transplant surgeon at the University of Chicago.

But beyond the technical surgical challenges lies the challenge of making sure that donors really understand the risks -- not just the estimated one percent risk of mortality, but the far higher risk of surgical complications.

"The exact risk of complications among donors is difficult to assess, given the lack of uniformity in the evaluation of donors, surgical technique, and the skill of the surgical team," Trotter said.

He said the most common complication for liver donors is a bile duct leak, which has been estimated to occur about 5 percent of the time. Some require more surgery. Between 9 and 19 percent of donors have some other form of surgical complication, such as a wound infection, obstruction of the small bowel or a hernia.

One study found that 71% of donors complained of mild, ongoing abdominal symptoms, which they related to the surgery.

"This is a lifesaving procedure and it has done a lot of good," said Dr. Owen Surman, a psychiatrist at Massachusetts General Hospital in Boston who wrote an accompanying editorial on the ethics of the procedure in the New England Journal of Medicine. "But there is a duty to make sure it is done the right way.

"The proposal by the American Society of Transplant Surgeons and the National Institutes of Health that a registry be established to collect needed information about risks to donors is highly appropriate," Surman said. "We need this informaiton so we can make decisions that achieve a balance between individual choice and community interests with respect to living-donor liver transplantation."