PHILADELPHIA – At least five live-kidney donors died worldwide since 2005 from catastrophic hemorrhages attributable to insecure ligation of their renal artery by a locking clip rather than by transfixion.

The most recent of these deaths occurred earlier this year, despite concerns raised during 2004-2006 about the safety of clip ligations and a Food and Drug Administration temporary ban in 2006 on the U.S. sale of polymer locking clips, Dr. Amy L. Friedman said at the American Transplant Congress. Following reintroduction of the polymer locking clips in late 2006, two other deaths attributable to severe renal artery hemorrhages in live kidney donors occurred in 2008, said Dr. Friedman, professor of surgery and director of transplants at Upstate Medical University Hospital in Syracuse, N.Y.

"It’s clear that this is not a frequent event, but even though it’s infrequent it is catastrophic," Dr. Friedman said in an interview. The relative infrequency "does not justify it. We ask surgeons to please respect the privilege of operating on a living kidney donor and not use" a polymer clip to close off the donor’s severed renal artery. Dr. Friedman also noted several other cases since 2003 where patients did not die but had severe hemorrhages because of unreliable artery ligations that produced near-death events.

Dr, Friedman admitted that alternative closure techniques that use transfixion are "challenging." The options are suture ligature, oversewing, or stapling. The most commonly used, safe closure is stapling, which has the drawback of using more of an artery’s length. "If the patient has early branching" of their renal artery, this closure may produce two small arteries instead of one larger one" on the removed kidney, "forcing you to sew them together and making the kidney harder to transplant." But any added inconvenience in transplanting the donated kidney does not outweigh safely closing the donor’s artery, she said. "The stapler is the best alternative to the clip," she said.

The surgeons performing nephrectomies for transplantable kidneys from living donors most commonly are transplant surgeons, urologists, and minimally-invasive surgeons. "There has been extensive pushback" arguing in favor of continued clip use in the urology literature, Dr. Friedman said at the meeting cosponsored by the American Society of Transplant Surgeons.

"The urology community uses clips more frequently, especially for nephrectomies done for other purposes," she said. "In those cases, the length of renal artery that they leave is much longer," experience that seems to have convinced urologists that clipping is safe even when the renal artery is shorter. "What we clearly know is that when the artery stump is left very short to allow a long length of artery to remain with the kidney, clips cannot be used." Some clip proponents also note that clips are less expensive than staples are, and many surgeons also cite personal experience performing hundreds of uneventful renal-artery closures with clips. Dr. Friedman contends that this is not surprising since the severe adverse event rate from clips is very low, but even a handful of deaths is too many.

Many transplant surgeons remain skeptical of the risk because they want to see case reports from deaths and other severe sequelae, data that the FDA, the Centers for Medicare & Medicaid Services, and the United Network for Organ Sharing (UNOS) have generally not shared.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

These agencies "make it hard, but these data should be easily available. If surgeons knew that there have been at least five deaths since 2005, it’s hard to imagine that they would not be convinced. I’m doing my best to get the information out," she said.

The five deaths from unstable renal artery closures in kidney donors using locking polymer clips comprised two cases in 2005, two in 2008, and the most recent case reported by UNOS earlier this year. Dr. Friedman said that she had also reviewed a report of a possible sixth death in February 2005, but it remains unclear whether this was the same case as one of the other 2005 deaths she cited. In addition, Dr. Friedman said she was aware of five additional cases of severe hemorrhage complications in living kidney donors treated with polymer clips since 2005.

Following notification by UNOS of the most recent death in February of this year, and a reminder to transplant surgeons not to use polymer clips for artery ligations, Dr. Friedman sent out an electronic survey in March to the members of the American Society of Transplant Surgeons (ASTS). From the 1,095 members she received 217 replies (20%). In reply to a question whether the ASTS members had received the UNOS notification, about two-thirds said they had not. She also asked the ASTS members whether their institutions continued to use hemostatic clips to ligate the renal arteries of live kidney donors. About 20% of all 201 respondents to this question, and more than 10% of the U.S.-based surgeons who responded said that their institutions used clips at least sometimes for these ligations.

Dr. Friedman said that she and her associates have no relevant financial disclosures.

2011 Kidney Donor Death Highlights Lingering Clip Ligation Problem