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M. Almuhanna and W.-J. Lee284
increases the risk of perioperative complications and recurrence rates. For small
umbilical or incisional hernias, concurrent LSG and VH repair can be done safely.
However, a sequential LSG followed by VH repair is recommended for patients
with an asymptomatic VH with unfavorable anatomy or significant medical problems, such as large size (10 cm), BMI > 50, small hernia defect with large sac,
poorly controlled diabetes, heavy smokers, etc. Complexity of ventral hernia associated with obesity requires careful approach for such a treatment. Currently, there
is no consensus on the best treatment options for obese patients with ventral hernias. Successful treatment should be individualized based on patient’s symptoms
and concerns.
References
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Sleeve and Ventral Hernias
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285
Sphincter Augmentation
and Management
of Gastroesophageal Reflux with the
LINX® Device and Sleeve Gastrectomy
Helmuth T. Billy, Terry L. Simpson, Masoud S. Chopan
and Yuchen You
1 Introduction
Laparoscopic Sleeve Gastrectomy has become one of the most popular primary
operations for the treatment of morbid obesity worldwide. Between 2013 and 2015
sleeve gastrectomy accounted for 40.7% of all primary bariatric procedures performed internationally [1]. In some parts of the world and in countries with the
highest rates of morbid obesity, sleeve gastrectomy is the most common bariatric procedure performed, reaching 60% of recorded operations [2]. The popularity of sleeve gastrectomy as a primary operation for the treatment of morbid
obesity is easily understood. The operation is straightforward and simple to perform when compared to duodenal switch or the well-established Roux Y gastric
H. T. Billy (*)
Metabolic and Bariatric Surgery, St. John’s Regional Medical Center, Oxnard, CA, USA
e-mail: Htbilly@gmail.com
H. T. Billy
Metabolic and Bariatric Surgery, Community Memorial Hospital, Ventura, CA, USA
H. T. Billy
Bariatric Surgery, Hamad General Hospital, Doha, Qatar
T. L. Simpson
Ventura Advanced Surgical Associates, Ventura, CA, USA
e-mail: Tsimpson@gmail.com
M. S. Chopan · Y. You
Department of Surgical Education, Community Memorial Hospital, Ventura, CA, USA
e-mail: Mchopan@cmhshealth.com
Y. You
e-mail: You1@cmhshealth.com
© The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer
Nature Switzerland AG 2021
S. Al-Sabah et al. (eds.), Laparoscopic Sleeve Gastrectomy,
https://doi.org/10.1007/978-3-030-57373-7_30
287
H. T. Billy et al.288
bypass. Sleeve gastrectomy can be routinely performed as an outpatient operation
and does not involve anatomical rearrangement or surgical anastomoses. Sleeve
gastrectomy has no risk of internal hernia. Malnutrition secondary to malabsorption does not occur. It also has a relatively short operative time of 20–30 min. For
high-risk patients such as individuals suffering from end stage renal and liver disease, the super morbidly obese and the elderly, sleeve gastrectomy is an ideal and
safe operation with which to achieve adequate weight loss [3].
Sleeve gastrectomy can be routinely performed in an outpatient setting, increasing the available facilities performing bariatric surgery. By augmenting the number
of operations being performed as outpatient procedures and increasing the number of facilities capable of performing bariatric operations, sleeve gastrectomy has
a direct and positive impact on the number of patients having potential access to
care. With respect to weight loss outcomes, sleeve gastrectomy has been shown to
achieve results comparable to Roux Y Gastric bypass [4, 5]. Individuals who fail
to achieve their goals or who regain sufficient weight are easily revised to an alternative more aggressive operation as a second stage procedure. Sleeve gastrectomy
therefore has multiple reasons to maintain its popularity as a desirable operation
for the treatment of obesity and can be expected to be performed in high numbers
for the foreseeable future.
Despite the success and widespread popularity of sleeve gastrectomy, symptomatic reflux is now a commonly recognized side effect of the operation.
Esophageal reflux, esophagitis and possible Barrett’s esophagus following sleeve
gastrectomy has resulted in an ongoing controversy regarding the long-term
complications after this operation. Magnetic sphincter augmentation is a simplified approach to address post-operative reflux following sleeve gastrectomy.
The majority of symptomatic reflux patients have been typically converted to
Roux-en-Y gastric bypass following sleeve gastrectomy. This approach destroys
the benefits of sleeve gastrectomy, subjecting the patient to a lifetime risk of internal hernia, dumping syndrome, reactive hypoglycemia, malabsorption, malnutrition and intussusception. Magnetic sphincter augmentation preserves the anatomic
benefits of sleeve gastrectomy while eliminating post-operative reflux and will
be the focus of discussion in this chapter. The utilization of sphincter augmenta-
®
tion and the LINX
device is a straightforward, simple and low risk operation that
eliminates esophageal reflux, preserving the multiple benefits offered by sleeve
gastrectomy over gastric bypass procedures.
2 The Controversy of Gastroesophageal Reflux
Following Sleeve Gastrectomy
Gastroesophageal reflux following sleeve gastrectomy is not unusual. As recently
as 2014 the pathophysiology and anatomic changes exacerbating reflux was still
poorly understood. Although the problem was well recognized, most patients
reporting symptoms were treated rather successfully with simple PPI therapy.
Asymptomatic GERD following sleeve gastrectomy for the most part was not
Sphincter Augmentation and Management …
289
treated. Studies exploring the association Between GERD and sleeve gastrectomy
were small, single-center series and examined symptomatic reflux as only a secondary outcome measure. Resolution or control of reflux with PPI therapy typically eliminated reflux symptoms and did not result in secondary screening with
esophageal endoscopy. Patients with asymptomatic reflux were not the subject
of further investigation. These early small studies stimulated significant debate
regarding the significance of GERD following sleeve gastrectomy and whether
the problem was more widespread. The question as to whether reflux documented
prior to sleeve gastrectomy should be considered a contraindication for patients
considering sleeve gastrectomy has been an ongoing source of discussion.
The 2017 publication by Genco reporting their findings that erosive esophagitis and Barrett’s esophagus following sleeve gastrectomy was significantly higher
than what had been reported in the most current literature ignited an intense debate
on the issue of the relationship of GERD and sleeve gastrectomy [6]. To further
complicate the debate, severe reflux that is resistant to medical treatment has
become the leading cause for reoperation following sleeve gastrectomy. The most
common operation for this problem has become the conversion of sleeve gastrectomy to RYGB. This approach leads to a permanent destruction of the sleeve gastrectomy and the benefits of sleeve gastrectomy are forever lost [4, 5]. Genco’s
2017 report redirected scrutiny toward the relationship between sleeve gastrectomy and GERD and in particular the possible contribution sleeve gastrectomy
related reflux might have on any progression towards Barrett’s esophagus. The
renewed controversy generated by the Genco paper came shortly after The Fifth
International Consensus Conference for Sleeve Gastrectomy concluded that there
was still no consensus among expert surgeons regarding the absolute contraindication of GERD prior to sleeve gastrectomy [2].
GERD is still the primary risk factor for Barret’s Esophagus. Despite the debate
surrounding sleeve gastrectomy and postoperative GERD, the practice of routine
pre- and postoperative endoscopic screening for esophagitis and BE is also very
varied between practices. There is no standardization as to how to perform the
sleeve gastrectomy and as a result surgical technique and outcomes vary tremendously. The tremendous differences between surgical technique and the ensuing
results and outcome regarding postoperative GERD are also unknown. Although
patients are consented for the risk of GERD following sleeve gastrectomy, there
is no standard of care or consensus agreement as to the informed consent requirements regarding the risks of progressive esophagitis following sleeve gastrectomy
or Barrett’s esophagitis in particular. The relative lack of case reports demonstrating progression of Barrett’s esophagus to adenocarcinoma following sleeve gastrectomy contribute to the poor understanding regarding long term complications
following sleeve gastrectomy. Despite two decades of performing sleeve gastrectomy, variations in surgical technique and the effect these variations may play in
the incidence of reflux and are still yet to be determined [7].
As the current popularity of sleeve gastrectomy continues to increase, the
major drawback and controversy associated with this operation will continue to
be the potential development or worsening of gastroesophageal reflux disease
H. T. Billy et al.290
postoperatively. It is well established that the Achilles heel of sleeve gastrectomy
is the ongoing confirmation in publications reporting that sleeve gastrectomy can
worsen preexisting, or cause ‘‘de novo’’ GERD [6–8]. There is also a widespread
variation and discrepancy in preoperative criteria with some centers not offering
SG to those with GERD and some who do. If sleeve gastrectomy leads to worsening GERD in a subset of patients, there may be severe unintended consequences
for patient outcomes and implications for long-term GERD-related complications
in those individuals. This chapter explores the proper preoperative evaluation and
management and technique when utilizing Magnetic sphincter augmentation with
the LINX® device in eliminating reflux either preoperatively or postoperatively in
appropriate patients considering and undergoing sleeve gastrectomy.
3 The Anatomic Susceptibility for Reflux After Sleeve
Gastrectomy
The physiologic advantage magnetic sphincter augmentation provides when
addressing post-operative reflux following sleep gastrectomy is based on the work
by Korn and Stein and their 1997 model of lower esophageal sphincter function
[8]. The lower esophageal sphincter is not constructed with an annular muscular
ring typical in classical sphincter anatomy but rather between perpendicularly
located muscular bands. In the human gastroesophageal junction two distinct anatomic structures exist creating a complimentary set of forces that create a functional sphincter. Along the lesser curve side is a looping set of muscular fibers,
the clasp fibers, and opposite these fibers are a long set of oblique positioned sling
fibers (Fig. 1). The intersection and arrangement of these fibers create the high
pressure zone of the lower esophagus that can be measure manometrically. The
location and integrity of these fibers is crucial to maintaining a functional lower
esophageal sphincter. In order for the sphincter to remain closed both sets of muscular fibers must be in contact with each other and not disrupted.
Removal of the greater curvature such as occurs with sleeve gastrectomy,
occurs in close proximity to the angle of His and the location of the greater curvature sling fibers. By removing and resecting the greater curvature in this manner,
the contact and strength of the looped esophageal sphincter mechanism and sling
fibers is disrupted (Fig. 2).
It has been reported that almost 45% of obese patients suffer from gastroesophageal reflux disease [9]. The association between gastroesophageal reflux disease and morbid obesity is not well understood however an increased incidence of
hiatal hernia resulting in dilation of the gastric cardia can also interfere with the
clasp and sling fibers discussed by Korn. In addition, esophageal dysfunction is
reported and described in as high as 60% of patients with obesity [10].
Csendes, et al. reported that reflux symptoms are common in bariatric surgery
patients with 79% presenting with heartburn and 66% with regurgitation following sleeve gastrectomy. Shauer, et al. reported that the incidence of GERD is as
high as 50–100% in patients with severe esophagitis submitted for gastric bypass.
Sphincter Augmentation and Management …
Longitudinal muscle
Spiral Muscle
291
Sling Fibers
Fig. 1 Orientation of the Sling fibers of the gastroesophageal junction creates a unique antireflux valve mechanism that can be disrupted following sleeve gastrectomy
Laparoscopic sleeve gastrectomy is a well accepted surgical treatment for obesity
and utilizes staplers to resect the greater curvature, effectively removing the entire
fundus through the gastric cardia just lateral to the esophagus. By transecting
through the angle of His near the esophago- gastric junction a critical modification of the anatomy occurs. The sling fibers are partially transected and certainly
reduced in numbers. In converting to a straight tubular segment, long term reflux
producing damage can occur simply by cutting through and partially damaging the
sling fibers. The sling fibers as a result are misaligned and the sphincter loses its
proper contact and strength. This has been demonstrated to create an imbalance
of the lower esophageal sphincter mechanism between the sling fibers and clasp
fibers. The efficiency and natural balance between the sling fibers and clasp fibers
is disrupted and an incompetent lower esophageal sphincter is the clinical result in
many cases.
Braghetto et al. in 2010 demonstrated the manometric changes of the lower
esophageal sphincterafter sleeve gastrectomy in obese patients [11]. In his prospective study of 20 sleeve gastrectomy patients, all had a normal total and
abdominal length before sleeve gastrectomy however following sleeve gastrectomy the abdominal length and total length of the high pressure zone at the
esophagogastric junction (EGJ) were adversely affected. Six patients had normal
Outer longitudinal muscle
‘‘Clasp’’ Fibers
‘‘Sling’’ Fibers (divided)
H. T. Billy et al.292
Cut window in middle
circular muscle layer
Fig. 2 Orientation of the Sling fibers of the gastroesophageal junction creates a unique antireflux valve mechanism that can be disrupted following sleeve gastrectomy
total and abdominal LES length (total length > 3.5 and abdominal length > 1 cm).
With regards to the other 14 patients, five patients had total length = 3.5 cm but an
abdominal length < 1 cm and nine patients had a total < 3.5 cm and an abdominal
length equal to 0.5 cm. Resting LES pressures in the cohort decreased significantly
before, and six months after sleeve gastrectomy. More investigation into the mechanism of action causing these changes is needed since at least a partial resection
of the sling fibers can occur when performing a transection near the angle of His
during a sleeve gastrectomy. It is hypothesized that this partial resection results
in an imbalance between the lateral and longitudinal forces necessary to sustain a
competent lower esophageal sphincter.
The most important barriers that protect the esophagus from reflux is the Lower
Esophageal Sphincter (LES) (Fig. 3). There is sufficient evidence to demonstrate
that the LES is modified when a sleeve gastrectomy is performed. Division of
the sling fibers and provoking a decrease in the LES resting pressure, as shown
Sphincter Augmentation and Management …
293
Phrenoesophageal ligament
Lower Esophageal Sphincter
Angle of His
Parietal Peritoneum
Z-Line / Esophagogastric Junction
Rosette
Fig. 3 The anatomic location of the Linx device in order to position it at the gastroesophageal
junction overlying the lower esophageal sphincter. Dissection will require a 360° dissection and
takedown of the phrenoesophageal ligament and mobilization of the lower esophageal sphincter
into the abdomen
Respiratory Diaphragm
by Braghetto’s group may very well be the critical change affecting reflux [12].
Manometric changes occurring in the LES after sleeve gastrectomy demonstrates
the physiologic change. Braghetto’s study revealed a mean LES resting pressure
(LESRP) decreasing significantly after SG from 14.2 ± 5.8 to 10.5 ± 6.06 mmHg
(P = 0.01). Fifteen percent of patients maintained normal lower esophageal resting
pressure (23.1 ± 3.7 mmHg) while 85% were hypotensive producing a mean rest-
ing pressure of only 8.3 ± 2.6 mmHg. After sleeve gastrectomy, the length of the
high-pressure zone of the LES was also critically affected. 45% of patients now
had a shortened total LES length (shorter than 3.5 cm) and 70% of patients now
had an abdominal length less than 1 cm [11]. The presence of increased GERD,
H. T. Billy et al.294
clear endoscopic evidence of erosive esophagitis, and dilatation of the gastric cardia was also observed after sleeve gastrectomy increasing the likelihood that the
changes affecting LES function contributed to the outcome [12].
Laparoscopic sleeve gastrectomy has been accepted as an option for surgical treatment for obesity. It should come as no surprise that a large percentage
of patients undergoing sleeve gastrectomy will develop both symptomatic and
asymptomatic reflux. Sleeve gastrectomy modifies the anatomy of the esophagogastric junction in a significant way. The decrease in gastric luminal volume, by
converting it to a straight tubular segment and partially transecting some of the
sling fibers, contributes to a dysfunctional esophageal sphincter mechanism.
Magnetic Sphincter Augmentation, rather than revision to gastric bypass, restores
the physiologic function of the LES and addresses the mechanism of reflux
directly without subjecting the patient to additional risks commonly associated
with gastric bypass operations. Revision from sleeve gastrectomy to gastric bypass
eliminates the function, physiology and nutritional advantage of the sleeve gastrectomy in a nearly irreversible way. Conversion from a sleeve gastrectomy to
gastric bypass because of an incompetent LES results in limited treatment options
should complications arise. Problems that are unique to Roux Y Gastric bypass
such as carbohydrate intolerance, dumping syndrome, marginal ulceration and
reactive hypoglycemia have significantly reduced therapeutic options should they
occur as a complication of the gastric bypass operation following conversion.
The human gastroesophageal sphincter maintains it critical function due to the
arrangement and architecture of the muscular”clasp” and “sling” fibers surrounding the gastroesophageal junction and gastric cardia. Sleeve gastrectomy produces an important decrease in LES pressure, which can promote the appearance
of reflux symptoms and esophagitis after the operation due to the partial resection of the sling fibers during the gastrectomy. Magnetic Sphincter Augmentation
can preserve the anti-obesity benefits of sleeve gastrectomy in a safe, effective
and reproducible way and at the same time eliminate pathologic reflux despite the
alterations in LES function which occur following sleeve gastrectomy.
4 Magnetic Sphincter Augmentation and Resolution
of GERD Following Sleeve Gastrectomy
The LINX® is the only Magnetic Sphincter Augmentation device commercially
available and approved for use in the treatment of reflux disease. The LINX® procedure requires minimal surgical dissection and introduces a standardized procedure for patients with significant medically recalcitrant GERD. Clinical trials have
shown that augmentation of the lower esophageal sphincter is effective in decreasing esophageal acid exposure resulting in reduced symptoms and eliminating or
significantly reducing daily PPI dependence. Safety concerns typically arise with
questions regarding device erosions and migrations have proven to be rare and
can be resolved with device explantation. These uncommon events have not been