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Author Topic: 2011 Kidney Donor Death Highlights Lingering Clip Ligation Problem  (Read 5460 times)

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Offline Karol

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2011 Kidney Donor Death Highlights Lingering Clip Ligation Problem

By: MITCHEL L. ZOLER, Internal Medicine News Digital Network

05/11/11

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.

http://www.internalmedicinenews.com/news/nephrology-urology/single-article/2011-kidney-donor-death-highlights-lingering-clip-ligation-problem/77f46be4aa.html
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Offline Donna Luebke

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Thanks Karol for posting this subsequent article.  Not only is the issue if the renal artery is cut too short--but that this is a pulsatile vessel with a high pressure gradient.  25% of our blood volume is coming to each kidney at all times.  When the artery is ligated or tied off, it still has to deal with blood coming to it until shunts over to the remaining kidney.  OK to use it on much smaller arteries like in GYN procedures or on veins.  Clearly these are all preventable deaths.  I hope that all these deaths or hemorrhagic complications due to the clip have been reviewed by the larger Department of Surgery at their Morbidity and Mortality conferences so all surgeons present can comment; not just by the transplant program surgeons.  Surveyors should look for this.  Would like to know if the surgeons were general surgeons or urologists?  When did UNOS send a memo?  John, can you get a copy of it?  If does exist and was sent, the large % who responded they never got a memo is very concerning.  However, the manufacturer would have provided the recall info to the surgeons as they are required by the FDA. 
Donna
Kidney donor, 1994    Independent donor advocate
MSN,  Adult Nurse Practitioner
2003-2006:  OPTN/UNOS Board of Directors, Ad Hoc Living Donor Committee, Ad Hoc Public Solicitation of Organs Committee, OPTN Working Group 2 on Living Donation
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Offline Clark

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Donna, I posted the new directives circulated by the FDA and OPTN/UNOS in this forum. I brought this to full board discussion more than two years ago and those in attendance at the time were aware of the FDA warning issued years before.  The new directive is much more strongly worded, with less possibility of reasonable defensibility in the event of another donor death due to clip failure in the future.  This means more hospitals, transplant centers, and all the professionals engaged in the surgery will receive legal and insurance advice to establish firm, accountable practices to avoid liability.  While I'm not aware of us being a particularly litigious demographic, the possibility of a wrongful death suit when the FDA and OPTN/UNOS warnings are so clear has to be of concern.  As for the "push back" in the literature, that may have provided a defense that reasonable professional views differed, I think the new directive, in the face of another fatality, will be very clear to any jury.  Unfortunately, the failure of the transplant surgery community to adequately address this among themselves has forced this regulatory intervention in professional practice.  As you know, this is an active boundary of OPTN/UNOS and FDA mandates, and a third rail during board discussions.
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Offline lawphi

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Anyone else disgusted that only 20% of centers responded? 

I asked my coordinator about the clips and she said they got rid of the clips years ago.  I wonder if that was a factor in the lack of response from most centers.

A large factor in med mal cases is the industry standard. If the major centers are no longer using the clips and the FDA advises against it, the center needs to adapt their practice quickly to maintain insurability.


Bridge Paired Exchange donor on behalf of my husband (re-transplant) at Johns Hopkins.

Offline Donna Luebke

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John,  I am looking for a copy of any UNOS communication to OPTN members. This memo is from HRSA and the FDA, not UNOS.  Not sure what you mean by an OPTN/UNOS communication.  If they knew about his clip in 2006 per the minutes of an Operations Committee meeting and again two years ago, where is the documentation of communication to members.  The first FDA warning was sufficiently worded in that the ONLY contraindicated use was in live donor nephrectomy.  It is 3 deaths since this warning that have prompted the recent memo.  I thank Dr. John Fung of the Cleveland Clinic for bringing these deaths to the forefront where action can be taken.  Not by UNOS but by HRSA and the FDA. 
Donna
Kidney donor, 1994    Independent donor advocate
MSN,  Adult Nurse Practitioner
2003-2006:  OPTN/UNOS Board of Directors, Ad Hoc Living Donor Committee, Ad Hoc Public Solicitation of Organs Committee, OPTN Working Group 2 on Living Donation
2006-2012:  Lifebanc Board of Directors

 

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