Page 39 - World Association of Laparoscopic Surgeons - Journal

WJOLS
10.5005/jp-journals-10007-1143
Techniques to Secure Renal Hilum in Laparoscopic Donor Nephrectomy
REVIEW ARTICLE
Techniques to Secure Renal Hilum in Laparoscopic

Donor Nephrectomy

Santhosh Narayana Kurukkal

ABSTRACT of the renal artery during a laparoscopic living-donor
nephrectomy because of serious risks to the donor. 1 The
Laparoscopic donor nephrectomy is the standard of care in
donor kidney procurement for renal transplantation. Use of clips may become dislodged, which can lead to uncontrolled
nonabsorbing polymer locking clips for securing the renal artery bleeding, additional surgery or death of the donor. In 2006,
in this procedure is widely practiced. The US FDA has given the manufacturer added this contraindication to the
instructions contraindicating the use of Hem-o-lok clips in
securing renal artery in donor nephrectomy. This article reviews ‘Instructions for Use’ after receiving 15 reports of 12 injuries
the modalities for securing renal artery in laparoscopic and three deaths which occurred between 2001 and 2005.
nephrectomy published in the last decade. Since, the contraindication issued in 2006, there have been
Keywords: Laparoscopy, Donor nephrectomy, Renal artery, three more kidney donor deaths, all associated with the
Hem-o-lok, Clips, Staples. contraindicated use.

How to cite this article: Kurukkal SN. Techniques to Secure I searched online in the FDA MAUDE database
Renal Hilum in Laparoscopic Donor Nephrectomy. World J Lap (Manufacturer And User Facility Device Experience) from
Surg 2012;5(1):21-26. 1/1/2001 to 6/30/2011, found two cases of death following
2
Source of support: Nil use of Hem-o-lok clips in donor nephrectomy. One of the
patient undergone laparoscopic donor nephrectomy in 2008
Conflict of interest: None declared
and died on the following day. The incident was reported
as approximately 8 hours postoperative, a male donor
INTRODUCTION
nephrectomy developed difficulty in breathing and became
Laparoscopic donor nephrectomy is the standard of care unresponsive. He was returned to surgery where an
for live renal procurement in transplantations. Generally, exploratory laparotomy was performed and intraperitoneal
clips were used to secure renal artery, but at least five deaths bleeding was encountered and evacuated from the
from catastrophic postoperative hemorrhage following abdominal cavity. It was noted the clip that had been placed
laparoscopic donor nephrectomy were reported since 2005 on the renal artery stump during the nephrectomy was not
attributable to insecure ligation of their renal artery by a visible. A 1.5 cm tear was noted at the aorta, which was
locking clip. US FDA issued a safety information on clamped and repaired. The renal artery appeared thin and
5/6/2011 that Hem-o-lok clips are contraindicated in ligating friable. The patient developed DIC and expired.
renal artery in laparoscopic donor nephrectomy. 1 The The other report stated that a donor died a few hours
alternatives are suture ligature, oversewing or stapling. after a live, donor nephrectomy. The event occurred at the
Techniques that use transfixion are difficult to perform, national university hospital. No details were available. The
time-consuming and challenging. This article reviews the manufacturer (Weck, Teleflex Medical Research Triangle
modalities used to secure renal hilum in laparoscopic Park NC) examined the batch of Hem-o-lok clips and
nephrectomy. reported: Pulsatile pump testing was performed which
simulates the environment, the clips are subjected to during
MATERIALS AND METHODS
surgery with respect to closure. The blood pressure that the
An extensive electronic search of the medical literature clips are subjected to is approximately twice the normal
published in the last decade using the keywords laparoscopy, blood pressure in humans. The clips were tested for 24 hours
hand-assisted laparoscopic donor nephrectomy (HALDN), and had an acceptance criteria of no clip slippage off the
Hem-o-lok clips, staples for renal artery. Included the vessels and no failure to the locking mechanism of the clips.
articles mentioning securing of renal artery in laparoscopic At the end of the 24 hours period, no solution was observed
nephrectomy for other indications. Excluded articles on the from the distal end of the clips. The results of the pulsatile
mass ligation of renal pedicle. pump testing show the product performed satisfactory.
Based on review of the information provided and testing of
RESULTS
like product, the device could have been functioning as
FDA issues safety alert to healthcare providers that Weck intended, and we cannot conclude that the reported incident
Hem-o-lok ligating clips should not be used for the ligation was caused by a failure of the Hem-o-lock clip.

World Journal of Laparoscopic Surgery, January-April 2012;5(1):21-26 21