A long-awaited study co-authored by UPMC transplant pioneer Thomas Starzl says that during a three-year period, 66 percent of the patients who received liver transplants from living donors at UPMC suffered serious complications, and that the complication rate got worse as time went on.
The study not only raises questions about the quality of transplants that were done at UPMC but the broader question of whether transplants from living donors are too risky.
Although his name is never mentioned in the European Journal of Hepatology study, which is available online, Dr. Amadeo Marcos headed the liver transplant program during that time, and the study indicates his team did all 121 recipient surgeries between March 2003 and November 2006.
Dr. Marcos was forced to resign in March 2008 for violating UPMC's code-of-conduct policy after being accused of sexual misbehavior. But he has also been criticized by some former UPMC doctors for unnecessary deaths and complications due to his aggressive liver transplant practices.
UPMC officials declined to comment for this article, but in the past, they have insisted the quality of the liver transplant program did not suffer under Dr. Marcos.
Yet the 66-percent rate cited in the study is more than twice the national average of complications for such surgeries, said Dr. Goran Klintmalm, a liver transplant surgeon at the Baylor Regional Transplant Institute in Dallas and past president of the American Society of Transplant Surgeons.
"I think the study's authors are addressing a local problem in Pittsburgh that everybody knows about, but they also are bringing out the whole issue that we need to be careful and not just charge ahead and let cowboys do this procedure," said Dr. Klintmalm, who received his early training from Dr. Starzl.
The lead author of the study is UPMC liver surgeon J. Wallis Marsh, who is joined by Edward Gray of UPMC and Roberta Ness of the University of Texas School of Public Health. Dr. Ness is former chairwoman of the epidemiology department at the University of Pittsburgh Graduate School of Public Health.
But the analysis is most likely to get attention because it contains Dr. Starzl's name. He performed the world's first liver transplant and built UPMC's organ transplant program into a world power in the 1980s and 1990s. The medical center's transplantation institute is also named for him.
Dr. Starzl declined to comment for this article, but his study raises provocative questions about living donor transplants. In the procedure, surgeons remove part of the donor's liver and put it in the recipient's body after removing the diseased liver. Because liver tissue can regenerate itself, both the donor's and recipient's livers grow to full size after the surgeries.
The study acknowledged that the one-year survival rate of 91 percent of transplant recipients met national standards, but said the complication rate, which often required new surgeries to correct the problems, was troublesome.
The study looked specifically at operations in which the larger, right lobe of the donor's liver was removed, and said that "no matter how carefully right lobar [living donor liver transplant] is applied, the historical verdict on the ethics of this procedure may be harsh. There is no precedent of a surgical procedure that exposes healthy persons to such a high risk on behalf of others."
While all 121 liver donors were still alive at the time the study was written, more than 10 percent of them also suffered serious postoperative complications.
The study also concluded that while some people argue that living donor transplants keep recipients from becoming critically ill while waiting for an organ, "in a reversal of fortune," 11 of the 121 recipients became so sick after their initial transplants that they had to get second livers from deceased donors. Only five of the 11 were still alive at the time the study was written.
The analysis also noted that 70 percent of the recipients were relatively healthy, as measured by a common rating scale called the MELD score, for Model for End-Stage Liver Disease. Of the 121 patients, 87 had MELD scores of 15 or less. The scale ranges from 6, meaning very healthy, to 40, meaning extremely ill.
The study authors said UPMC and most other liver transplant centers have justified doing living donor operations on healthier patients with the arguments "that it helps avoid the donor despair caused by a bad recipient outcome," and avoids mistakes caused by rushing to get a donor ready to transplant someone who is more critically ill.
But they noted that this directly contradicts the policy used by the United Network for Organ Sharing, which oversees most organ transplants in America, for liver transplants from deceased donors. In those cases, sicker patients with higher MELD scores are first in line for donated organs.
A Wall Street Journal article last year said that during Dr. Marcos' six-year tenure at UPMC, about 35 percent of all liver transplants were done on people with MELD scores of 14 or less, compared with fewer than 7 percent in the period before his arrival.
Disagreement on transplanting healthier patients was one of the main reasons why UPMC's former transplant chief, Dr. John Fung, left the institution in 2004 to become chairman of general surgery at the Cleveland Clinic.
In an interview last year, Dr. Fung said that he had disagreed with transplanting healthier patients, because "they were taking patients who even under ideal circumstances might have had more risks than benefits from a transplant."
And even though Dr. Marcos technically reported to him, Dr. Fung said he had no real control over Dr. Marcos, which is one reason he ended up leaving.
The other reason, he said, is that in the 1990s, he led the fight by UPMC to try to establish the "sickest first" rule as a national standard, "and I had said for a long time that if I became aware that wasn't what [UPMC was] interested in doing, I would pull out."
The final point made by the Starzl and Marsh study is that the complications among liver recipients at UPMC actually increased as time went on, "the opposite of a learning curve."
"This observation could be viewed as a warning against relaxed vigilance once the operation becomes 'routine,' " they said.
The analysis did not recommend that living donor liver transplants be abandoned, but said the procedure needs more study, and warned that "the preferential transplantation of low-risk recipients bypasses the target population of candidates in which 'death by waiting' is most likely."
Correction/Clarification: (Published Aug. 3, 2009) Goran Klintmalm is a liver surgeon at the Baylor Regional Transplant Institute in Texas. His first name was misspelled in this story on living donor liver transplants as originally published Aug. 1, 2009.
Mark Roth can be reached at firstname.lastname@example.org or at 412-263-1130.