Introduction
The OverStitch system (Apollo Endosurgery Inc., Austin, Texas, United States) is an
endoscopic suturing device that is used clinically for placing full-thickness sutures
within the gastrointestinal tract. Endoscopic suturing is performed for a variety
of indications, including primary or revision endoscopic bariatric procedures, closure
of partial or full-thickness defects, stent fixation, hemostasis, and other applications.
When using the Overstitch device in the upper gastrointestinal tract, an esophageal
overtube is generally recommended but sold separately [1].
Esophageal overtubes were originally developed to protect the esophagus during procedures
requiring repeated intubations, or for peroral endoscopic removal of a sharp or potentially
traumatic foreign object from the esophagus or stomach [2]. Use of an esophageal overtube with the OverStitch device theoretically prevents
esophageal trauma during passage and removal of the device, but may not be required.
Overtubes themselves are associated with risks, including mucosal tears, esophageal
perforation and bleeding. Prospectively collected data demonstrate that at least minor,
but sometimes serious, esophageal trauma may occur in more than 70 % of cases employing
an overtube [3]
[4]
[5]
[6]
[7]. Furthermore, placement of an esophageal overtube adds to the time, complexity and
cost of the procedure.
With increasing experience using the OverStitch system, it has become our group’s
practice to perform OverStitch procedures without an esophageal overtube, with rare
exceptions including posterior oropharyngeal and esophageal stenosis. We hypothesize
that upper gastrointestinal endoscopic suturing using the OverStitch system can be
performed safely and more efficiently from a cost perspective, without the use of
an overtube, thereby eliminating the risks and cost associated with it.
Patients and methods
We conducted a review of the electronic medical records of all patients who underwent
endoscopic suturing for various indications between January 2013 and January 2018
at the Mayo Clinic, Rochester, Minnesota, United States. Data were abstracted for
patient demographics, procedural indications and adverse events, and clinical outcomes.
The Fisher exact test (SAS Institute, Cary, North Carolina, United States) was performed
to assess for statistical differences in adverse event rates between patients who
underwent endoscopic suturing with and those without an overtube. Transanal (lower
gastrointestinal) or transabdominal suturing cases were excluded.
Upper endoscopic suturing procedures were all completed with endotracheal tube intubation.
A diagnostic upper endoscopy was completed to determine the safety of proceeding with
intended suturing. If the decision was made to use an overtube, the diagnostic upper
endoscope shaft was loaded with an esophageal length 25-cm overtube (Guardus, US Endoscopy,
Mentor, Ohio, United States). Given the retrospective nature of the study, the reasoning
behind the decision to use or not use an overtube was not possible to determine in
most cases. The OverStitch endoscopic suturing device was then attached to the therapeutic
double channel endoscope (GIF-2TH180, Olympus, Center Valley, Pennsylvania, United
States) and advanced through the mouth or overtube to complete the intended therapeutic
intervention. Carbon dioxide insufflation was used for all procedures.
Data on adverse events (AEs) were collected and categorized. Esophageal mucosal injury
was defined as any change in the endoscopic appearance of the mucosa seen on scope
withdrawal at the end of the procedure as compared to initial intubation and examination.
Luminal stenosis, for the purposes of this study, was defined as narrowing of the
esophagus not permitting easy passage of the upper endoscope. Perforation was defined
as a full-thickness tissue defect of the bowel wall caused by the endoscopic procedure.
The study protocol was approved by the Institutional Review Board of Mayo Clinic (IRB
#18-007239).
Results
A total of 719 patients (57 % men; mean age 57.2 years [range 18 – 88]) underwent
upper gastrointestinal tract endoscopic suturing during the study period. Patient
and procedural characteristics are shown in [Table 1]. Endoscopic suturing was performed for bariatric procedures in 262 (36.4 %), stent
fixation in 258 (35.9 %), mural defect closure in 190 (26.4 %), and hemostasis in
9 (1.3 %) cases. An esophageal overtube was used in 186 procedures (25.9 %) and more
commonly during endoscopic bariatric cases. Technical success of placing the intended
tissue plication(s) was achieved in all cases (100 %). Minor esophageal mucosal trauma
was reported in 15 cases (8.1 %) with overtube placement as opposed to none in cases
without an overtube (P < 0.0001). No esophageal perforation or bleeding related to overtube placement or
endoscopic suturing occurred ([Table 2]). Other non-esophageal AEs that occurred during suturing procedures using an overtube
included one abdominal fluid collection after endoscopic sleeve gastroplasty, which
was drained endosonographically, and one symptomatic stenosis of a revised gastrojejunal
anastomosis, which required endoscopic dilation. In the group without use of an overtube,
one case of intraprocedural hemorrhage during gastrojejunal anastomotic reduction
occurred that was managed with epinephrine injection and clip placement.
Table 1
Patient and procedural characteristics
|
Patient characteristics (n = 719)
|
|
Gender (male)
|
408 (57 %)
|
|
Age (years)
|
58.3 ± 14.3
|
|
Procedural characteristics
|
|
Indication for endoscopic suturing
|
Total cases (%)
|
Overtube used (%)
|
|
Bariatric procedures
|
262 (36.4)
|
155 (59.2)
|
|
Stent fixation
|
258 (35.9)
|
15 (5.8)
|
|
Defect closure
|
190 (26.4)
|
14 (7.3)
|
|
Hemostasis
|
9 (1.3)
|
2 (22.2)
|
Table 2
Adverse events
|
Adverse event
|
Overtube used
(n = 186)
|
Overtube not used
(n = 533)
|
P value
|
|
Esophageal mucosal injury
|
15
|
0
|
< 0.0001
|
|
Abdominal fluid collection
|
1
|
0
|
0.26
|
|
Luminal stenosis
|
1
|
0
|
0.26
|
|
Hemorrhage
|
0
|
1
|
1.0
|
|
Perforation
|
0
|
0
|
–
|
Discussion
In our large cohort of patients, use of an overtube to prevent esophageal trauma from
the OverStitch device was associated with an increased incidence of clinically insignificant
esophageal injury across a wide variety of indications for endoscopic suturing. There
were no differences in rates of technical success and AEs between the groups of endoscopic
suturing with and without an overtube. Furthermore, use of an esophageal overtube
increases equipment cost and procedural time for endoscopic suturing procedures.
While use of an overtube for upper endoscopic procedures that require multiple esophageal
intubations or retrieval of sharp objects is warranted, we speculate that its utilization
during gastrointestinal endoscopic suturing is associated with increased intraluminal
pressure due to the sealing mechanism of the overtube around the endoscope, thus hampering
the usual venting of gas. While our data suggest that risk of perforation or pneumoperitoneum
is not significantly different whether or not an overtube is used, we believe an overtube,
without judicious use of carbon dioxide insufflation, may lead to increased insufflation-related
events, such as post-procedure abdominal pain and bloating, and in the worst case
scenario, barotrauma injury, including pneumoperitoneum and perforation. Furthermore,
use of an overtube can potentially hinder successful completion of endoscopic suturing
for particular situations, such as repair of an acute perforation or stent fixation
in the upper or mid-esophagus, which explains why an overtube was so rarely used for
stent fixation.
Our experience should be interpreted with some caution because 75 % of overtube placements
occurred during the first 33 % of endoscopic suturing cases, suggesting that with
time and experience, providers may become more comfortable using the OverStitch device
without concomitant use of an esophageal overtube. The increased rate of use of an
overtube earlier in our experience of endoscopic suturing may also be a confounding
factor for interpreting the increased rate of AEs with use of an overtube. However,
as all OverStitch users were experienced advanced endoscopists, presumably adept at
esophageal overtube placement, this should not explain the increased rate of esophageal
mucosal injuries in cases using an overtube. It is conceivable that an overtube may
protect from esophageal trauma early on in the utilization of the OverStitch device,
but may no longer be needed with increased experience. While the exact number of cases
required to feel comfortable using the OverStitch device is not known, a prior study
has suggested that procedural time is reduced after performing seven procedures [8]. We would also caution that there are select situations in which overtube placement
may be prudent independent of experience level, including expected difficult passage
of the device through an esophageal stenosis or when repeated esophageal intubations
are anticipated. Our study will ideally be followed by a randomized controlled trial
of OverStitch with and without an esophageal overtube to confirm these findings.
Conclusion
In conclusion, endoscopic suturing using the OverStitch device may be performed safely
for a variety of indications, including endoscopic bariatric procedures, defect repair,
stent fixation and hemostasis, with or without use of an esophageal overtube. In the
hands of experienced operators of the OverStitch device, use of an overtube can be
forgone in most cases as it adds to procedural time and cost without a benefit in
regards to AEs.
