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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1116_Библиотеки_им_академика_М_И_Перельмана.pdf
Sphincter Augmentation and Management …
Gastric Sleeve
295
associated with any device related mortality and in the event they occur do not
eliminate conversion to gastric bypass as a final option for treatment.
The concept is simple as the mechanical device is designed to augment the
physiologic barrier to reflux created by the clasp and sling fibers of the lower
esophageal sphincter (LES). This is accomplished through the use of magnetic
force. The LINX® is particularly suitable to augmenting the injured lower esophageal sphincter by adding a circular mechanism of action to the clasp and oblique
sling fibers which currently make up the physiology of the sphincter (Fig. 4). In
order to function as a relaxing and constricting augmentation of the natural LES,
the LINX® is designed based on a series of biocompatible titanium beads with
magnetic cores hermetically sealed inside. The beads are connected individually with independent titanium wires which allow the ring to be both flexible and
expandable. In its resting, relaxed position, each bead is in contact with adjacent
beads via the individual magnetic cores. The beads can move independent of the
adjacent beads, creating an adjustable ring that does not compress the esophagus.
The range of motion complements the natural oblique and lateral fibers of the LES
by adding a third circumferential ring created by the LINX®. The LINX® is therefore able to accommodate a wide array of physiologic situations including swallowing, belching, and vomiting. For reflux to occur, the intragastric pressure must
overcome the resistance to opening of both the patient’s native LES pressure and
the magnetic bonds of the device.
(Reduced Stomach)
Linx
Fig. 4 Final location of the Linx device following sleeve gastrectomy for severe post operative
gastroesophageal reflux disease
H. T. Billy et al.296
Once implanted the device becomes encapsulated in fibrous tissue but remains
separated from and not incorporated into the esophagus itself. It remains a distinct
and separate implant. The LINX® can be explanted by releasing the fibrous capsule overlying each bead.
Utilization of Magnetic Sphincter Augmentation as a treatment for severe reflux
following sleeve gastrectomy was reported by Hawasli in 2016 [13]. In addition
Desart and Ben David reported the first case series of seven patients having undergone anti reflux therapy using the LINX® system in 2015 [14]. These early reports
had greatly improved gastroesophageal reflux symptoms 2–4 weeks following
implantation of the device. Significant and successful improvement in the severity
and frequency of their reflux, regurgitation, epigastric pain, fullness, dysphagia,
and cough symptoms was uniformly reported postoperatively compared to their
initial preoperative evaluation. There were no reported perioperative complications
and Magnetic Sphincter Augmentation appeared to be a safe and effective option
for the treatment of severe reflux following sleeve gastrectomy.
5 Operative Concerns and Patient Selection
Fear of device erosion is the primary concern voiced by surgeons preferring conversion to Roux Y gastric bypass over magnetic sphincter augmentation in patients
with severe intractable reflux. Most surgeons today have had no experience with
the Angelchik device however it is commonly discussed as a historical reference
for concern regarding safety of gastroesophageal devices. More recently, adjustable gastric banding which was widely used as an a minimally invasive weight loss
device, is cited as another example demonstrating adverse outcomes and device
erosions when placing implantable devices at the gastric cardia near the gastroesophageal junction.
Device erosion in adjustable gastric banding is a commonly experienced
complication of the device. Occurring primarily in the first 18 months following
implantation, the complication was a significant issue, often leaving the lower
esophagus and proximal stomach with a significant inflammatory reaction There
was typically a perforation that required repair and as a result subsequent bariatric operations were more difficult and at times challenging. In contrast however,
esophageal erosion following magnetic sphincter augmentation with the LINX
device has remained a relatively uncommon and rare occurrence. The safety profile of LINX® was studied in a multicenter review of the first 1000 implants which
had been performed at multiple hospitals around the world. This study included
the 82 hospitals involved in the first 1000 device implants. The readmission rate
was 1.3%. There was a 3.4% reoperation rate and a 5.6% endoscopic dilation
rate [15]. Erosion was reported in only one patient (0.1%). All reoperations were
performed on a non-emergent basis for device removal and 36 patients underwent device removal. The most common symptoms requiring device removal was
dysphagia and recurrence of reflux symptoms. Another recent study focusing on
reoperations following LINX® reported a median follow-up of 48 months and a
®
Sphincter Augmentation and Management …
297
device removal rate of 6.7%. 11 of 164 patients who underwent a laparoscopic
LINX® implant were explanted at a later date. Of the main presenting symptom
requiring device removal was regurgitation or heartburn in 46%, dysphagia in
37%, and chest pain in 18%. Only two patients (1.2%) developed a full-thickness
erosion of the esophageal wall with partial endoluminal penetration of the device
[16]. Device explant occurred at 12–24 months after initial implant in 82% of the
patients that required explant.
Bonevina, et al. reported 6 year follow up on 100 patients who had undergone
implantation of a LINX® device for treatment of GERD. There were no reported
device erosions or migrations in the study group [17]. Several additional series
have reported various erosion rates as a low occurance. Alicuban, et al. published
a 2018 review of the worldwide experience of device erosion following magnetic
sphincter augmentation [18]. Their review of all devices placed worldwide from
February 2007 to July 2017 included 9453 devices identified in the manufacturers database. In a total of 9453 device implants, only 29 reported cases of erosion
were discovered. The risk of erosion was determined to be 0.3% at four years after
implantation. Explantation was commonly done via a combined endoscopic followed by a delayed laparoscopic removal. At 58 days post removal there were no
complications. Of the 29 patients, 24 patients had returned to baseline and four
patients reported mild persistent dysphagia.
Erosion following magnetic sphincter augmentation is a relatively rare occurrence. The device is designed to be implanted after careful measurement using a
calibration tool. Devices that are more commonly associated with erosion were
small 12 bead devices which were found to have a 4.93% erosion rate. Our own
series of utilization of the LINX® device for treatment of severe reflux following
sleeve has limited use to devices with 15 or 17 beads with no erosion over the
past three years. Alicuban identified that most patients with erosions presented
between 1 and 4 years after device implantation. Only a very few patients presented with erosions within the first year following implantation. 26 months was
the median time to erosion in the review. The most common presenting symptom
was dysphagia in 26 patients (90%) followed by chest pain in 7 patients. Reflux,
cough, vomiting and weight loss were other, less common symptoms. At 1 year
after implantation The risk of erosion was 0.05% increasing to 0.3% at 4 years
post implantation.
Risk factors for developing erosion have been discussed and identification of
these risk factors may lead to a lower erosion rate in patients following sleeve gastrectomy. Device size mismatch appears to be the most common risk factor which
is easily modified to decrease the risk following implantation. Smaller devices
are more commonly associated with the development of erosions. The LINX
®
device was available in sizes ranging from 11 to 17 beads. Our most commonly
implanted size for treatment of reflux following sleeve gastrectomy is evenly
divided between 15 beads and 17 bead sizes. Alibuban identified in their review of
over 9000 implanted devices that the centers with the highest utilization of smaller
devices also reported the highest erosion rates of 4–20 times other centers. Larger
sized devices appear to have similar efficacy in obtaining reflux control as smaller
H. T. Billy et al.298
devices with a lower reported rate of erosion [18]. The 12 bead device was responsible for 62% of erosions and is no longer available commercially.
It is important to utilize proper technique when determining device size. To
obtain the optimal size, we recommend the technique popularized by Lipham.
There are two visual cues which improve proper device selection. A specific sizing device is positioned around the esophagus prior to device selection. The sizer
is specifically designed to encircle the esophagus and locks gently with a magnetic
link to itself. When the device rests comfortably around the esophagus and when
no compression is noted the surgeon then ratchets the sizer down until it releases
itself from its magnetic link. The size of the release is noted and two sizes above
this release size number is the appropriate size for device choice. The two sizes are
compared from these two visual evaluations and if there is a discrepancy the larger
of the two sizes is selected.
Surgical technique may also play a significant role in the avoiding or development of erosion following LINX® implantation. Early operative technique supported a minimal esophageal dissection, however, current operative technique
favors a full hiatal dissection. Better exposure of the distal esophagus and proximal stomach allows complete evaluation of the crura, improved and more accurate crural repair can be achieved, reduction of any hiatal hernia and avoidance of
injury to the posterior esophageal wall.
Patient specific risk factors may also play a role including conditions contributing to tissue weakening and breakdown. Connective tissue disorders, steroid use,
poorly controlled diabetes, and immunosuppression are all conditions that must be
considered prior to any decision for sphincter augmentation.
6 Preoperative Evaluation
Patients with significant reflux following sleeve gastrectomy are candidates for
magnetic sphincter augmentation and preservation of the benefits of sleeve gastrectomy. Evaluation for possible sphincter augmentation device placement is
straightforward. Diagnostic testing is recommended for patients with GERD [19].
Essential preoperative testing prior to LINX
troduodenoscopy (EGD), ambulatory pH monitoring, esophageal high-resolution
manometry, and esophagram [19, 20]. Each testing modality has a specific role
in the clinical evaluation and appropriateness of possible magnetic sphincter augmentation. No single test alone can substitute for the overall clinical appropriateness of device placement in any single patient [21].
Evaluation of individual anatomy, motility and evidence of GERD must be
defined in each individual patient preoperatively. As outlined above each initial
evaluation includes upper GI swallow (esophagram) in order to elicit radiographic
evidence of reflux. In addition, this study is essential to evaluate the gastric sleeve
for signs of proximal dilation, narrowing or obstruction of the angularis incisura,
®
placement includes esophagogas-
Sphincter Augmentation and Management …
kinking, twisting or other evidence of a mechanical etiology possibly contributing
to reflux. Comparison of this study to any previously obtained postoperative studies is useful to determine if significant changes are present from studies done early
after surgery. Patients with evidence of mechanical obstruction are not good candidates for magnetic sphincter augmentation with the LINX® device.
Preoperative esophagoduodenoscopy is essential and performed in all patients.
Esophagodudenoscopy, preferentially by the operating surgeon, is needed to evaluate the severity of any esophagitis. Biopsy to evaluate for helicobacter pylori is
done at the time of EGD as well as biopsy of the gastroesophageal junction to
evaluate for possible Barrett’s changes. EGD can assess the Los Angeles classification for severity of reflux and visualize the extent to which any bile reflux is
occurring. Preoperative treatment of severe esophagitis can be initiated. Once the
assessment by EGD and upper GI swallow is complete, and if the patient appears
appropriate for further evaluation, an esophageal manometry study is arranged. A
BRAVO pH study can be ordered but in many patients this can be reserved for
cases where the presence of GERD is only reported by history or is still unclear.
299
7 Esophageal High-resolution Manometry
In addition to upper endoscopy and esophageal pH testing, a preoperative evaluation should include high resolution manometry. Normal esophageal motility
is essential in avoiding post-operative dysphagia following magnetic sphincter
augmentation. Post-operative dysphagia is the most common cause for device
explantation in patients undergoing MSA. Evaluation of the quality of esophageal function via manometry testing is the only modality available to determine
if esophageal motility meets the minimum criteria for a good outcome following device placement [20, 22]. Esophageal transnasal high resolution manometry
measures the pressure in the upper and lower esophageal sphincters, measures the
effectiveness and coordination of peristalsis, and detects abnormal contractions.
Differentiation between pure GERD and other esophageal motility disorders can
be accomplished via high resolution manometry and can be used to evaluate and
exclude esophageal motility disorders such as achalasia, esophageal spasm, and
lower esophageal sphincter hypotension and hypertension [20].
8 Surgical Technique
Surgical technique utilizes the same positioning and trocar placement as with
sleeve gastrectomy. The patient can be positioned either supine or in the French
position. Generally, there are four trocars and a fifth incision for placement of a
retractor to expose the hiatus. Meticulous lysis of adhesions is done to expose the
esophagus, the hiatus of the diaphragm and the gastric body.
H. T. Billy et al.300
The critical steps in the exposure of the distal esophagus are as follows.
a. Complete exposure of the right crus, the left crus and division of the phrenoe-
sophageal ligament.
b. Reduction of any hiatal hernia and distalization of the esophagus to decrease
the chance of recurrence.
c. Identification of the posterior vagus nerve.
d. Removal of all tubes/bougies from the esophagus and release and retraction
like penrose drains to avoid stretching the esophagus. The esophagus must be
in the resting state.
e. Placement of the LINX® system sizer between the posterior vagus nerve and
the esophagus.
f. Repeat the measurement using the LINX® system sizer multiple times to con-
firm size and accuracy and prevent placement of the wrong size device.
g. The LINX® device is then selected and introduced into the abdomen.
h. The LINX® is placed around the esophagus but anterior to the posterior vagus
nerve (between the esophagus and nerve).
i. The LINX® system is magnetically locked into place.
j. Repair and re approximation of the posterior crural defect is completed.
Our technique is described in the following paragraphs with corresponding images
to clarify the technique. The first step after dissection and exposure of the upper
foregut and positioning of appropriate liver retraction is division of the gastrohepatic ligament and visualization of the right crus (Figs. 5 and 6). The right crus is
carefully dissected to preserve the fascial integrity overlying the crus while gaining entry into the mediastinum (Figs. 7 and 8). The dissection is carried anteriorly
to allow division of the peritoneum on the anterior surface of the gastroesophageal
junction below the insertion of the phrenoesophageal ligament (Fig. 9). A wide
exposure of the esophageal hiatus is performed to maximize exposure in order to
insure against injury to the esophageal structure which can occur when trying to
utilize a minimal dissection approach (Figs. 10 and 11).
The lateral surface of the left crus is freed from any scar or retained fundus
which has occurred as a result of previous dissection at the angle of His. Complete
exposure of the posterior confluence of the right and left crus is accomplished.
Fig. 5 Initial dissection
and release of the liver from
residual adhesions from
previous sleeve gastrectomy
Sphincter Augmentation and Management …
Fig. 6 Initial dissection is to
define the right crus, releasing
it from previous scar
Fig. 7 Dissection of the right
crus and takedown of the
phrenoesophageal ligament
and exposure of previous
crural repair sutures in
order to perform a complete
360° dissection of the
gastroesophageal junction
301
Fig. 8 Removal of all
previous crural repair sutures
to expose the posterior retroesophageal space and the
posterior vagus nerve
Fig. 9 Complete dissection
of the angle of His and release
of the esophagus ateriorly
H. T. Billy et al.302
Fig. 10 Complete 360° dissection and retraction of the esophagus using a penrose drain will
avoid injury to the esophagus and facilitate exposure of the posterior vagus nerve which must be
dissected to create a path for the sphincter augmentation device between the esophagus and the
vagus neve at the gastroesophageal junction
Fig. 11 Completed 360°
dissection
Fig. 12 Posterior vagus
nerve exposed
Preparation of the retroesophageal window is completed to facilitate placement
of a penrose drain. The penrose drain is used for retraction of the gastric cardia
in order to maximize exposure while dissecting the distal esophagus and crural
structures. Once the dissection is complete the identification of the posterior vagus
nerve can proceed (Fig. 12).
Sphincter Augmentation and Management …
Fig. 13 Completing
dissection of the posterior
vagus nerve as close to the
gastroesophageal junction
as possible. The sphincter
augmentation device will
be positioned in the path
between the posterior vagus
nerve and the esophagus
303
Fig. 14 Proper positioning of the sizing guide is essential. The sizing device is positioned as
far distal as possible against the gastroesophageal junction. Selecting the proper size is done by
allowing the magnetic lock to secure in place on the sizing guide and then gently ratcheting the
sizing guide closed until the magnetic lock spontaneously releases itself
The gastrohepatic ligament was previously opened above and below the hepatic
branch to facilitate the preparation of the retroesophageal window is extended as
necessary. A penrose drain can be passed if necessary to improve exposure and
dissection using the drain as a retractor (Fig. 13).
Gentle dissection from the right side is made toward the left crus just above the
crural decussation to identify the posterior vagus nerve.
A tunnel is then created between the vagus and the posterior esophageal wall,
and the Penrose drain is repositioned and passed in a left-to-right direction.
The circumference of the esophagus is measured to determine the proper size
of the LINX® device to be implanted. The sizing tool is a laparoscopic instrument
with a soft, circular curved tip actuated by the surgeon using the handset on the
instrument (Fig. 14). The handset contains a number that changes as the instru-
ment is ratcheted down onto the esophagus. The number corresponds to the size
range of the LINX
®
device. The sizing tool is placed around the esophagus in
the dissected space between the esophageal wall and the posterior vagus nerve
H. T. Billy et al.304
bundle (Fig. 15). As it is tightened it will spontaneously release allowing the sur-
geon to see the corresponding number associated with the point of release. The
surgeon adds “2” to the number indicated to determine the appropriate device size
(Fig. 16).
Once the appropriate LINX® device has been selected, it is introduced through
the posterior tunnel and positioned between the esophagus and the posterior vegus
nerve (Fig. 17). The opposing ends are then brought to the anterior surface of the
esophagus and connected together by engaging the two clasps (Figs. 18, 19, 20
and 21).
The decision to proceed with a posterior crural repair depends on the size of the
hernia that is found intraoperatively (Fig. 22). Operative time is generally less than
1 hour. Patients are discharged the same day of surgery or on the first postoperative day and are counseled to gradually return to a normal diet and to discontinue
use of acid suppression medication (Figs. 23, 24, 25 and 26).
Fig. 15 It is essential to release any esophageal retraction and preform the sizing test under a
zero tension, relaxed esophagus. Once the sizing guide releases itself from the magnetic lock the
surgeon examines the guide to determine the proper size of the Linx device. In this example the
sizing guide released at “15”. The proper size Linx device would be to add “2” to the measured
size which would indicate a size “17” device would be the proper device to choose
Fig. 16 Sizing device size