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Postendoscopic Zenker Esophagodiverticulostomy Leaks Associated With a Specific Stapler Cartridge
William J. Richtsmeier, MD, PhD;
Jose Raul Monzon, MD
Arch Otolaryngol Head Neck Surg. 2002;128:137-140.
ABSTRACT
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Objective To determine the cause of postoperative leaks in 2 patients with Zenker
diverticula treated with endoscopic staple-assisted esophagodiverticulostomy.
Design Medical chart review and simulated surgery.
Setting Teaching hospital.
Patients and Methods Two case reports of postoperative leaks in patients treated with endoscopic
staple-assisted esophagodiverticulostomy and experimental simulated surgery
to investigate the possible cause of this complication. Use of a TR45B, 3.5-mm
cartridge for an Endopath ETS Flex45 Endoscopic Articulation Linear Cutter
stapler was associated with complications, whereas use of a TR45W, 2.5-mm
cartridge in the same stapler was not.
Results In a simulated surgery model, the 3.5-mm cartridge staple line leaked
from the incision apex with pressure of less than 20 cm H2O, whereas
the apex remained dry when using the 2.5-mm cartridge. When pressure was increased
to 30 cm H2O, the staple line of the 2.5-mm cartridge had diffuse
weeping of fluid but no focal, apical leak.
Conclusions Endoscopic staple-assisted esophagodiverticulostomy continues to be
a relatively safe procedure; however, to provide maximum safety at the apex,
the surgeon needs to be aware of stapler cartridge differences.
INTRODUCTION
HUNDREDS OF cases treating Zenker diverticula using endoscopic staplers
have been reported in the United States1-2
and Europe.3-4 The staplers, invented
for general and thoracic surgery, have been widely accepted by head and neck
surgeons. The technique, endoscopic staple-assisted esophagodiverticulostomy
(ESED), has been celebrated for its simplicity and safety. We recently observed
postoperative leaks in 2 patients associated with a specific stapler cartridge,
different from staplers that were originally reported in the literature.5 The first studies of ESED in the United States and
Europe used an EndoGIA-30 stapler (US Surgical Corp, Norwalk, Conn). The experience
reported herein is with the Endopath ETS Flex45 Endoscopic Articulation Linear
Cutter stapler (Ethicon Endo-Surgery Inc, Cincinnati, Ohio) using a TR45B,
3.5-mm stapler cartridge without modifications.
PATIENTS AND METHODS
PATIENT 1
A 73-year-old woman with radiological evidence of a Zenker diverticulum
had a small, easily identified pouch at surgery. Endoscopic visualization
and video control were maintained throughout the procedure. A retraction suture
was placed using an endoscopic suture (Endostitch; US Surgical Corp) and was
used to retract the parting wall between the small diverticulum and the esophagus.
Firm retraction allowed entry of the tissue into the stapler reloaded with
the 3.5-mm, standard cartridge and subsequent division of the cricopharyngeus.
The surgery went uneventfully, and the patient was discharged from the hospital
the following morning eating a full diet. On postoperative day 3, the patient
presented with dysphasia and odynophagia. A computed tomographic scan showed
gas and fluid in the retropharyngeal space, and 4 mL of purulent material
was drained through the neck. The patient, treated with antibiotics and drainage,
was discharged after a 4-day hospitalization with no other adverse effects
and persistently improved swallow.
PATIENT 2
A 53-year-old man with a moderate-sized Zenker diverticulum pouch had
difficult exposure owing to the small transverse diameter of his jaw. Once
the laryngoscope was positioned, the esophagus and pouch were identified and
monitored as described previously.5 The Endopath
ETS Flex45 Endoscopic Articulation Linear Cutter (stapler) was reloaded with
the 3.5-mm, standard cartridge, and subsequent division of the cricopharyngeus
was carried out without difficulty. The patient initially complained of tongue
and throat pain. Two days after surgery he continued to have symptoms of odynophagia.
Plain radiographs showed air at the level of the pouch, and a computed tomographic
scan showed evidence of inflammation but no abscess. He was treated with antibiotics
for 5 days, and his symptoms resolved uneventfully with improved swallowing.
At the time of surgery, both patients bled more from the stapled edges
than at a previous experience of one of us (W.J.R.) with the EndoGIA-30 stapler.
In both circumstances, a 3.5-mm, standard stapler cartridge was used. In 12
other patients, the TR45W, 2.5-mm, vascular/thin stapler cartridge was used
in the Endopath ETS Flex45 Endoscopic Articulation Linear Cutter (stapler)
with no clinical evidence of leak. All 12 patients ate a normal diet and were
discharged from the hospital the following morning without antibiotic treatment.
In 1 patient, the initial cut was made using the 3.5-mm cartridge, and then
the difference between the staple cartridges was discovered. In the same procedure,
a second cut was performed through the apex using a second cartridge loaded
with the 2.5-mm cartridge. There was no adverse postoperative clinical outcome.
The Endopath ATW-45 stapler (Ethicon Endo-Surgery Inc), in common use
at Bassett Healthcare Cooperstown, NY, is supplied with a 2.5-mm stapler cartridge
referred to as "vascular/thin" by the manufacturer. The conformation of that
stapler cartridge is shown in Figure 1A.
Refills for that stapler can include a 3.5-mm cartridge, referred to as "standard"
by the manufacturer, the conformation of which is shown in Figure 1B. The 3 rows of staples and the extension of the staples
directly beyond the incision of the 2.5-mm stapler cartridge is similar to
the staple arrangement of the EndoGIA-30 stapler. The 3.5-mm cartridge has
3 distinct characteristics: only 2 rows of staples, a greater distance between
the medial staple line and the incision, and the arrangement of the most distal
medial staple and the end of the incision.
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Figure 1. The staple conformation of 2 cartridges
that fit the Endopath ETS Flex45 Endoscopic Articulation Linear Cutter system
(Ethicon Endo-Surgery Inc, Cincinnati, Ohio). A, The TR45W, 2.5-mm, vascular/thin
cartridge. B, The TR45B, 3.5-mm, standard cartridge. The TR45G, 4.1-mm-thick
cartridge has a staple arrangement similar to the 3.5-mm cartridge.
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METHODS
Because of differences in the staple configuration of the cartridges,
an experiment was undertaken to test the potential leak of the ETS45, 3.5-mm
cartridge. A glove made of natural rubber coated with neoprene (Magla Products
LLC, Morristown, NJ) was used as the experimental model. The stapler was introduced
in a fashion somewhat similar to that used for ESED, where the anvil of the
stapler was placed into the thumb of the glove and the cartridge into the
index finger. Care was taken to keep the material corresponding to the web
space of the fingers so as not to allow it to bunch up and leak from the initiation
point of the incision because of redundant material. The stapler was fired
in the usual manner as recommended by the manufacturer for each staple cartridge.
The glove, turned inside out for contrast (blue on white), was then filled
with methylene blue–dyed water and observed at the various water levels
above the apex of the suture line.
In similar experiments, 4 gloves were stapled with both cartridges,
placing the anvil of the ETS45 into the long finger and alternating one cartridge
into either the index finger or the ring finger. The gloves were then observed
at 22–cm H2O pressure. There was 1 misfire of the stapler
in which the last 2 rows of staples were not pressed into the glove material
using the 2.5-mm cartridge. The staples could be palpated and seen in the
end of the stapler, but the glove did not leak when subjected to 22–cm
H2O pressure. In each glove, a leak was observed from the apex
of the staple line closed by the TR45B cartridge, but no leak was observed
from the TR45W staple line.
RESULTS
In the first glove, the 3.5-mm cartridge suture line appeared to leak
from the apex with pressure of 17 to 20 cm H2O (Figure 2). No leak could be detected from the suture line produced
by the 2.5-mm cartridge under similar conditions. The second glove was then
sealed in the cuff area with a plastic disk, and additional hydrostatic pressure
was added by attaching tubing to the closed system. Once pressure exceeded
30 cm H2O, diffuse weeping of fluid was observed from each staple
hole of the 2.5-mm cartridge suture line. In this glove, the apex did not
leak as a focal area as it did with the lower pressure–stressed suture
line of the 3.5-mm cartridge.
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Figure 2. A glove made of natural rubber
coated with neoprene was stapled using the Endopath ETS Flex45 Endoscopic
Articulation Linear Cutter system (Ethicon Endo-Surgery Inc, Cincinnati, Ohio).
The stapler anvil was placed into the thumb and the cartridge into the index
finger, simulating the Zenker pouch and the esophagus, respectively. The glove
was then filled with water containing methylene blue for contrast. A, The
suture line created using the TR45B, 3.5-mm cartridge leaked with less than
20–cm H2O pressure. B, No leak was observed in the TR45W,
2.5-mm cartridge suture line under similar circumstances. In both photographs,
the distal thumb is retracted with a clamp to view the area immediately below
the apex of the staple line.
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COMMENT
The experience of Cook et al1 has shown
that ESED is safe and effective in treating Zenker diverticula, and the postoperative
complications of these 2 patients are unique in our experience to this point.
The only potential leak from a distal pouch laceration was identified and
repaired endoscopically as reported previously.5
It is possible that the mechanism of pouch laceration from the stapler anvil
was responsible in the patients reported herein, but careful inspection of
the pouch at the end of each procedure did not identify a laceration. Especially
careful was our inspection of patient 1 with the small pouch because of the
traction on the sutures allowing the cricopharyngeus to enter the stapler.
Other studies of complications of endoscopic surgery for Zenker diverticula
have not reported leaks or postoperative neck infections. Previous studies3-4 in the literature reference the EndoGIA-30
stapler. Two separate cases of stapler malfunction when using a transcervical
approach for an extensive repair have been reported.6-7
Such a stapler malfunction in an endoscopic case would present a formidable
repair challenge.
Philippesen et al2 described 14 patients
treated using the Ethicon system with a 35-mm staple line. A picture is shown
of what appears to be the 3 rows on each side, and they describe that the
stapler "seals the edges with 3 rows of staples." They presumably used the
TR35W cartridge, a shorter version of the stapler cartridge we report herein.
Using the ATW-45 stapler with the vascular/thin conformation of the 2.5-mm
staple length has not yielded any evidence of leaks in our small series of
patients. Although this experience does not ensure safety, it is our current
instrument of choice.
In contrast to the 2 post-ESED leaks reported herein, Feeley et al8 reported 2 fistulas in 24 patients treated with the
open, transcervical approach. In their review, 9 of 24 patients developed
significant complications. The 2 patients described herein are unique in the
hundreds of reported treated patients with ESED without such complications.
The ETS45 stapler has the advantage of being 15 mm longer than the EndoGIA-30,
allowing a longer cut without repositioning of the stapler. Fewer stapler
firings provides less chance of laceration of the pouch with the anvil. By
using the 2.5-mm cartridge, the ETS45 is nearly the same in stapler configuration,
especially at the end of the razor cut. We believe that the arrangement of
the 2.5-mm cartridge is similar to that of the EndoGIA-30, and when using
the Ethicon staplers for ESED, it is the stapler cartridge of choice. Because
the cephalad part of the incision can be made without repair, as in the Dolhman
procedure, it is the relationship between the distal staple line and the incision
that is critical.
In our experiments, the difference in leak pressures between the 2 staplers
suggests that the 3.5-mm cartridge should not be used for ESED in Zenker diverticula
if maximum safety of the apex is a concern. A second staple line fired through
the apex of the first incision using a different stapler secures the distal
cut (apex) and renders the initial cut and staple configuration moot. The
pressure in the pharyngoesophageal segment during swallow is estimated to
be 40 to 120 mm Hg,9-10 far higher
than the 20–cm H2O (1.5–mm Hg) pressure seen in our
experiments, which yielded a leak. Although the relatively thin glove used
in our experiment does not accurately recreate human tissues, it allows comparison
of the 2 staple conformations as far as preventing a leak from the apex of
the incision. The vascular/thin cartridge may staple the thin glove more tightly
than the standard cartridge throughout the suture line and is a source of
leak artifact.
A major safety aspect of the ESED approach depends on the staple line
existing beyond the razor cut. The 3.5-mm cartridge fits the ATW45 stapler
and is routinely used in gastrointestinal tract surgery. The obvious difference
in the staple arrangement between available cartridges for the ETS45 system
is evident on the cartridge surface but is not obvious from the cartridge
package. The package insert for the Ethicon stapler system clearly states
the differences in the staple conformation of the cartridges available. There
is no marking on the packages of any of the cartridge inserts other than to
indicate the difference in staple length between the TR45W (2.5 mm) and the
TR45B (3.5 mm). Surgeons who perform Zenker endoscopy should be aware of these
differences and should check the specific stapler cartridge conformation before
use in pharyngeal surgery.
In conclusion, ESED continues to be a relatively safe, efficient, and
simple procedure for Zenker diverticula. Surgeons should be aware of stapler
cartridge differences, the potential for leaks, and the need to inform patients
of possible transcervical surgery to treat complications.
AUTHOR INFORMATION
Accepted for publication August 30, 2001.
Corresponding author and reprints: William J. Richtsmeier, MD, PhD,
Bassett Healthcare, One Atwell Road, Cooperstown, NY 13326 (e-mail: william.richtsmeier{at}bassett.org).
From Bassett Healthcare, Cooperstown, NY.
REFERENCES
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