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ESOPHAGUS
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9
which can be particularly relevant for patients who are either being
considered for lung transplantation or have already undergone transplantation. The decision and timing of ARS in this setting should be
made in discussion with the patient’s pulmonologist.
Contraindications to Antireflux Surgery
Patients with a normal DeMeester score and normal distal acid
exposure on ambulatory pH testing should not be considered for
ARS. Symptomatic patients who do not demonstrate objective findings of abnormal reflux should undergo further workup to identify
an alternative diagnosis. The use of impedance or pharyngeal pH
monitoring to confirm pathologic GERD is controversial and should
be evaluated with caution. On the other hand, patients may have
abnormal ambulatory pH monitoring, but complete preoperative
workup demonstrates another diagnosis altogether such as achalasia,
esophageal cancer, or a large paraesophageal hernia. In these cases,
the primary diagnosis is not GERD, and patients should be treated
appropriately for these other disorders. Finally, obesity is a relative
contraindication for ARS. Patients with a BMI >40 should be referred
for bariatric surgery evaluation to be considered for Roux-en-Y
gastric bypass, as this procedure addresses the broader spectrum of
obesity-related health problems, which includes GERD.
SURGICAL TECHNIQUE
In 1937, Rudolf Nissen performed the first known fundoplication
in which he wrapped the stomach to buttress an esophagogastric
anastomosis as part of the repair for a penetrating esophageal ulcer.
Later in the 1950s, he utilized this technique for the first time as a
treatment for reflux. Since then, the eponymous 360-degree wrap has
become the gold standard in ARS. Although advances in technology
have introduced laparoscopic and robotic-assisted approaches to
ARS, the surgical principles remain the same with the goal of restoring intraabdominal esophageal length, closing the hiatal defect, and
creating a one-way flap valve. Newer endoscopic approaches such as
the transoral incisionless fundoplication only accomplishes one of
these three goals, and long-term outcomes are still unknown. Here,
we describe a laparoscopic Nissen fundoplication, which continues
to be our favored procedure for GERD, and a laparoscopic Toupet
fundoplication, which we perform in patients with ineffective esophageal motility (Fig. 2).
Steps of the Procedure: Initial Setup, Hiatal
Dissection, and Closure of the Crura
The initial steps in performing a laparoscopic fundoplication are
similar, regardless of whether a partial or complete fundoplication
is being constructed. We use the same instruments (Box 2), patient
positioning, and port placement (Fig. 3) for both a Nissen and a
Toupet fundoplication. Although the hiatal dissection can begin on
either side of the gastroesophageal junction, we prefer to first expose
the left crus and then enter the mediastinum starting on the left, as
follows.
1. Patient positioning and port placement
a. The patient is positioned supine in the split leg position with
padded straps secured around both thighs (some prefer lithotomy). The surgeon stands between the patient’s legs while the
assistant stands on the left side of the patient. Before draping,
the operating table should be tested in the steep reverse Trendelenburg position in which the procedure is performed to
ensure that the patient is secure and not at risk of shifting or
sliding during the operation.
b. A Veress needle is used to access and insufflate the abdomen,
and the ports are placed as shown in Figure 3. The patient is
then placed in steep reverse Trendelenburg before elevating
the left lateral segment of the liver using a liver retractor
(we use a Nathanson retractor). We typically use a 5-mm
30-degree scope.
2. Exposing and opening the hiatus on the left side (note that some
prefer to start on the right)
a. The fundus is retracted caudally to expose the membranous
avascular phrenogastric attachments between the fundus and
the diaphragm. These attachments are divided to begin exposure of the left crus.
b. The gastrosplenic ligament is divided near the inferior pole of
the spleen to enter the lesser sac. The gastrosplenic ligament
and the associated short gastric vessels are then divided with a
vessel-sealing energy device to mobilize the fundus. The posterior attachments of the stomach are divided to ensure that
the fundus is completely mobilized.
c. With the fundus retracted medially, the left crus should
be clearly exposed. Additional medial traction on the gastroesophageal junction places the phrenogastric ligament
on tension, exposing this white membranous connection
between the medial border of the left crus and the intraabdominal esophagus. This membrane is carefully divided at
the posterior base of the left crus, opening a space to the left
of the esophagus. The correct mediastinal plane contains thin
areolar connective tissue that can typically be easily developed
with blunt dissection using the tip of a suction device or other
instrument. Once the correct plane is identified, the left phrenoesophageal membrane is continually placed on stretch as it is
divided, progressing anteriorly and sweeping tissue away from
the membrane toward the esophagus to avoid injury to the
anterior vagus nerve. Care is taken not to denude the peritoneum off the crus, as this can weaken the crural closure.
d. A blunt instrument can then be inserted behind the esophagus
to create a retroesophageal window from the left side.
3. Exposing and opening the hiatus on the right side
a. The gastrohepatic ligament is divided starting at the pars
flaccida and continuing cephalad toward the anterior aspect
of the esophageal hiatus to expose the right crus. If a sizeable
accessory or replaced left hepatic artery is encountered, this
should be preserved.
b. The retroperitoneal fat attached to the right crus above the
left gastric artery can be retracted toward the patient’s left to
expose the right phrenoesophageal membrane. This should
be divided to enter the same mediastinal plane that was developed on the left. The dissection can then be carried out circumferentially in similar fashion as on the left side, following
the same principles of preserving the peritoneal covering over
the right crus while bluntly sweeping tissue toward the esophagus to identify and preserve both anterior and posterior vagal
nerves (Fig. 4).
c. Once the phrenoesophageal membrane has been circumferen-
tially opened around the esophagus, a ½-inch Penrose drain is
inserted and encircled around the gastroesophageal junction,
and then secured to itself using either suture or clips. This
provides the assistant a handle to retract the esophagus during
mobilization of the distal esophagus.
4. Distal esophageal mobilization
a. The dissection is carried circumferentially around the esoph-
agus, identifying and preserving both vagal nerves as the
dissection progresses up into the mediastinum. Direct arterial
branches from the aorta to the esophagus can be ligated using
a vessel-sealing energy device. Care should be taken to avoid
dissecting into the retroperitoneal fat overlying the aorta, as
this is where the thoracic duct resides.
b. The parietal pleura when identified should be swept laterally
to avoid injury and creation of a capnothorax. If the pleura
is entered inadvertently, it is important to communicate
this finding with the anesthesia provider. If the opening in
the pleura is easily identified, we typically choose to close
this defect in an effort to limit the temporary physiologic
10 SURGICAL MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE
C
AB
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Wrap
Esophagus
Wrap
Esophagus
180˚
140˚± 20
Esophagus
Wrap
FIG. 2 The most common types of fundoplication. (A) 360-degree
Nissen fundoplication. (B) 180-degree anterior Dor fundoplication. (C)
270-degree posterior Toupet fundoplication. (From Yates RB, Oelschlager BK,
Pelligrini CA. Gastroesophageal reflux disease and hiatal hernia. In Townsend etal.,
eds. Sabiston Textbook of Surgery. 20th ed. Philadelphia: Elsevier; 2017:1043–
1064.)
derangements associated with a capnothorax. However, when
closure of a pleural defect is not easily achievable, expectant
management and lowering of the intraabdominal insufflation
pressure will typically suffice as this allows the patient to
compensate physiologically for the carbon dioxide introduced
into the hemithorax. Usually after a few minutes, parameters
such as decreased blood pressure, increased ventilatory pressure, and increased end-tidal CO
surgeon to proceed with the operation.
c. The lower esophagus should be mobilized to achieve 3 to 5 cm
of intraabdominal length without tension.
will stabilize, allowing the
2
5. Closure of the crura
posterior to the esophagus. We prefer to use interrupted 2-0
silk without pledgets. This closure is performed until the
esophageal hiatus approximates the diameter of the esophagus
without any notable gaps. At the same time, the hiatal closure
should not apply any external compression on the esophagus.
b. On rare occasion, we will place a single anterior suture to
close the anterior hiatus if there is concern that the posterior
closure is bringing the esophagus so far anterior that it may be
creating an angle as the esophagus exits the chest.
BOX 2 Equipment for Laparoscopic Antireflux
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Surgery
Basic Laparoscopic Supplies
0- and 30-degree laparoscope, camera, and video equipment
5- and 12-mm ports
Veress needle
Suction-irrigation device
Laparoscopic Energy Devices
Hook electrocautery
Bipolar or ultrasonic vessel-sealing device
Specialized Equipment
Liver retractor (e.g., Nathanson)
52-Fr Bougie (optional for partial fundoplication)
Laparoscopic suturing supplies
½-inch Penrose drain
Equipment for upper endoscopy
FIG. 3 Port placement for laparoscopic antireflux surgery. The camera
port is positioned approximately 15 cm below the left costal margin, 2 cm
to the left of midline. The Nathanson liver retractor is inserted through a
stab incision in the epigastrium to the left of midline.
Steps of the Procedure: Creating a 360-Degree
Nissen Fundoplication
As previously discussed, we prefer to perform a complete fundoplication in patients with normal esophageal motility. We believe this
provides a more durable repair, and we find that the geometry of a
complete fundoplication lends itself to greater reproducibility from
a technical standpoint.
1. Orientation of the wrap
a. The fundus and greater curve of the stomach is retracted
medially, and a marking stitch is placed on the posterior
ESOPHAGUS
FIG. 4 Completion of the circumferential crural dissection. This illustration
depicts the view immediately before insertion of the Penrose drain.
(From Yates RB, Oelschlager BK, Pelligrini CA. Gastroesophageal reflux disease
and hiatal hernia. In: Townsend etal., eds. Sabiston Textbook of Surgery. 20th ed.
Philadelphia: Elsevier; 2017:1043–1064.)
11
fundus approximately 3 cm below the angle of His and 2 cm
inside the greater curve.
b. The posterior fundus is passed behind the esophagus, and the
point on the stomach where the marking stitch was placed is
lifted anteriorly against the right side of the esophagus.
c. A point on the anterior fundus is identified that mirrors the
location where the marking stitch was placed posteriorly
(approximately 3 cm away from the angle of His and 2 cm
from the greater curvature of the stomach). This point on the
stomach is pulled up along the left side of the esophagus.
d. A “shoe-shine” maneuver is performed to assess the symme-
try of the fundoplication before bringing the two sides of the
fundus together anterior to the esophagus (Fig. 5). With this
construction, the greater curve of the fundus should run longitudinally posterior and to the left of the esophagus (and thus
is no longer visible when suturing the fundoplication).
2. Suturing the fundoplication
a. The first stitch is placed, bringing the anterior and posterior
fundus together at the points identified in the previous steps.
The marking stitch and Penrose drain are then removed. A
52F bougie is then passed down the esophagus and into the
stomach.
b. The remaining two or three sutures are placed with the bougie
in place to complete the fundoplication. The bougie is then
removed (see Fig. 5).
c. We place a coronal suture on each side of the wrap that incor-
porates the top of the fundus/wrap, a partial thickness bite
of the esophagus, and the ipsilateral crus. This helps fix the
orientation of the fundoplication in the abdomen (see Figs. 2A
and 5).
d. We also typically place a suture between the posterior aspect
of the fundoplication and where it naturally rests against the
crural closure as an additional fixation point.
e. We perform routine upper endoscopy upon completion of
the fundoplication to evaluate and document the appropriate
appearance of the newly augmented flap valve.
Steps of the Procedure: Creating a 270-Degree
Posterior Toupet Fundoplication
In patients with manometric evidence of ineffective esophageal
motility, we typically recommend a partial fundoplication. When
12 SURGICAL MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE
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2. Completing left side of the fundoplication
a. The anterior fundus is pulled laterally to remove the redun-
dant stomach from behind the esophagus.
b. A left coronal suture is placed, incorporating the anterior fun-
dus, a partial bite of the esophagus, and the left crus (again,
just like the Nissen orientation).
c. Two additional sutures are placed between the esophagus (to
the left of the anterior vagus nerve) and posterior fundus,
completing the left side of the fundoplication (see Fig. 2C).
d. We routinely perform an upper endoscopy upon completion
of the fundoplication to evaluate and document the appropriate appearance of the newly augmented flap valve.
POSTOPERATIVE CARE, SURGICAL
COMPLICATIONS, AND OUTCOMES
Postoperatively, acid suppression therapy is routinely discontinued,
and all medications are administered in either crushed or liquid form
for 4 weeks. We typically admit patients to the hospital on a liquid
diet and monitor for appropriate pain control and PO intake before
discharge the following day. Although some surgeons routinely
obtain a barium esophagram on the first postoperative day, we have
not adopted this practice. Instead, patients who are able to tolerate a
liquid diet without issue are advanced to a soft esophageal diet upon
discharge on the first postoperative day, and this diet is maintained
52-French
bougie
FIG. 5 Creating a 360-degree Nissen fundoplication. The “shoe-shine”
maneuver is performed by grasping the posterior and anterior fundus with
the left and right hand, respectively, 3 cm from the angle of His, and 2 cm
from the greater curvature of the stomach. (From Oelschlager BK, Eubanks
TR, Pellegrini CA. Hiatal hernias and gastroesophageal reflux disease. In: Townsend
CM, Beauchamp RD, Evers MB, etal., eds. Sabiston Textbook of Surgery. 19th ed.
Philadelphia: Elsevier; 2012.)
considering the geometry of a 270-degree (Toupet) fundoplication,
the inner circumference of the fundoplication should approximate that of the esophagus, while the outer circumference should
be appropriately redundant, resembling a crescent with rounded
corners in cross-section. This geometry provides volume to the
fundoplication, which supports the intended flap-valve effect. The
constructed geometry should be very similar to that of a Nissen, just
without bringing the stomach together, thus the following description is very similar. Of note, we do not routinely use an esophageal
bougie when performing a partial fundoplication.
1. Orienting and creating the right half of the wrap.
a. The fundus and greater curve of the stomach is retracted
medially, and a marking stitch is placed on the posterior
fundus approximately 3 cm below the angle of His and 2 cm
inside the greater curve.
b. The posterior fundus is passed behind the esophagus, and the
lifted anteriorly against the right side of the esophagus.
c. A coronal suture is placed on the right side, incorporating the
posterior fundus, a partial thickness bite of the esophagus, and
the right crus (just like in a Nissen).
d. A posterior stitch is placed to fixate the wrap to where it nat-
urally lies against the crural closure.
e. Two additional sutures are placed between the esophagus (to
the right of the anterior vagus nerve) and posterior fundus,
completing the right side of the fundoplication (see Fig. 2C).
for 4 weeks.
Mild dysphagia is very common following ARS, and patients
should be counseled to expect this during their preoperative and
postoperative diet education. Similarly, patients are typically unable
to belch or vomit following ARS, and many patients may experience
mild bloating discomfort, abdominal distention, or epigastric pain.
For most patients, both dysphagia and gas bloat should improve
after 6 to 8 weeks. If these symptoms persist beyond this timeframe,
endoscopic dilation of the wrap may be considered.
Long-term outcomes associated with laparoscopic ARS can
be measured by examining patient-reported symptoms, objective
measures of distal esophageal acid exposure, resumption of PPI use,
complications of GERD, or rates of reoperation. Thus, depending on
the primary outcome examined, definitions of success and failure
vary across studies. In general, available studies demonstrate a 15%
to 30% recurrence rate for GERD at 10 years in patients following
laparoscopic ARS. Most patients with recurrent GERD are medically
managed with acid suppression therapy, while a minority (less than
5%–10%) undergo reoperation. As mentioned previously, ARS is
associated with higher complication rates compared with acid suppression therapy. In studies that focus on patient-reported outcomes,
ARS generally outperforms medical therapy when patients are
surveyed on GERD-related symptoms and quality of life. Patient-reported satisfaction following ARS consistently approaches 90% or
higher.
SPECIAL CONSIDERATIONS
It is important to distinguish ARS from paraesophageal hernia
repairs as the surgical evaluation and approach to GERD differs
from that of paraesophageal hernias. This can be confusing because
fundoplications are often performed in conjunction with paraesophageal hernia repairs, thus the anatomic result following completion
of both procedures is essentially identical. However, in the absence
of a paraesophageal hernia, adequate circumferential mobilization of
the distal esophagus should almost always provide enough intraabdominal length to obviate the need for an esophageal lengthening
procedure. When performing ARS in patients with a small- to
moderate-sized sliding hiatal hernia, the lower esophageal sphincter
should (by definition) reach the intraabdominal cavity. Thus, we
reserve the discussion of Collis gastroplasty and esophageal lengthening procedures for chapters focused on paraesophageal hernia
repair. In the same vein, although the use of absorbable mesh has
ESOPHAGUS
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13
been studied and debated in the context of paraesophageal hernia
repairs, there is no real indication for mesh use in laparoscopic ARS
for GERD.
In patients who develop recurrent GERD symptoms following
ARS, it is important to review the prior operative records and obtain
a complete workup as described earlier in this chapter. Herniation
of the wrap cephalad into the mediastinum is the most common
cause of anatomic failure in patients with a previous fundoplication
(Fig. 6). Failure can also result from an inappropriately constructed
fundoplication that incorporates the body of the stomach (Fig. 7) or
simply from loosening of the wrap over time. Anatomic failures can
lead to recurrent GERD and new symptoms of dysphagia, odynophagia, or epigastric pain. Just as in the initial management of GERD,
patients presenting with typical reflux symptoms following ARS can
often be managed medically. In patients with persistent dysphagia,
epigastric pain, or poorly controlled reflux symptoms despite medical therapy, surgical revision may be considered after careful evaluation to identify anatomic causes of failure while ruling out other
possible etiologies. In general, caution should be exercised when
considering a surgical revision as the complication rates associated
with revisional surgery are higher than for first-time ARS.
FIG. 6 Upper gastrointestinal barium esophagram depicting
herniated fundoplication. Original radiographs (top). Herniated
position of fundoplication is outlined in black (bottom). Yellow
arrowheads depict diaphragmatic impression.
When approaching a revisional operation, the surgeon should
always plan to take down the prior fundoplication as this is the only
way to evaluate the construction of the prior wrap and ensure the
correct construction of a new fundoplication. After both halves of
the fundoplication have been dissected free, the right half should be
passed behind the esophagus to restore the normal orientation of
the stomach and confirm that the wrap has been completely taken
down before creating a new fundoplication. Importantly, we have
encountered many barium esophagrams with radiology reports
suggesting complete dehiscence of a previous fundoplication. In
our institution’s collective experience performing revisions, we have
never encountered a complete dehiscence in the operating room.
There is always a wrap that needs to be properly identified and taken
down. Finally, when evaluating patients who have failed two prior
antireflux procedures, we generally do not consider a third attempt to
redo the wrap. If indications arise to consider another revision after
multiple prior failures, a revision may be considered, but the surgeon
and patient should be prepared for the possibility of a partial gastrectomy and Roux-en-Y reconstruction with either a gastrojejunostomy
or potentially an esophagojejunostomy. This is, of course, is a major
operation, and the associated risks and lifelong dietary modifications
14 NEW APPROACHES TO GASTROESOPHAGEAL REFLUX DISEASE (LINX)
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should be weighed against the severity of the patient’s symptoms
when counseling patients who have failed multiple attempts at ARS.
S u g g e S t e d R e a d i n g S
B
A
A
Correct
Incorrect
B
B
A
A
B
Gunter RL, Shada AL, Funk LM, Wang X, Greenberg JA, Lidor AO. Long-
Term quality of life outcomes following Nissen versus Toupet fundoplication in patients with gastroesophageal reflux disease. J Laparoendosc Adv
Surg Tech A. 2017;27(9):931–936.
Håkanson BS, Lundell L, Bylund A, Thorell A. Comparison of laparoscopic
270° posterior partial fundoplication vs total fundoplication for the
treatment of gastroesophageal reflux disease: a randomized clinical trial.
JAMA Surg. 2019;154(6):479–486.
Lødrup A, Pottegård A, Hallas J, etal. Use of proton pump inhibitors after
antireflux surgery: a nationwide register-based follow-up study. Gut.
2014;63:1544–1549.
Morrow E, Bushyhead D, Wassenaar E, Hinojosa M, Loviscek M, Pellegrini C,
Oelschlager B. The impact of laparoscopic anti-reflux surgery in patients
with Barrett’s esophagus. Surg Endosc. 2014;28(12):3279–3284.
Raghu G, Pellegrini CA, Yow E, etal. Laparoscopic anti-reflux surgery for the
treatment of idiopathic pulmonary fibrosis (WRAP-IPF): a multicentre,
randomised, controlled phase 2 trial. Lancet Respir Med. 2018;6(9):707–
714.
FIG. 7 A wrap can be incorrectly constructed by suturing the fundus to
the body of the stomach. (From Smith CD, McClusky DA, Rajad MA, Lederman
AB, Hunter JG. When fundoplication fails: redo? Ann Surg. 2005;241[6]:861–869.)
New Approaches to
Gastroesophageal
Reflux Disease (LINX)
Tom R. DeMeester, MD
etween the early 1960s and early 1970s, Drs. Rudolf Nissen,
Ronald Belsey, and Lucius Hill introduced the golden era of
B
antireflux surgery. These physicians designed procedures that took
down a hiatal hernia, altered the anatomy of the gastroesophageal
junction with a fundoplication of various degrees, and stopped reflux
of gastric juice into the esophagus. In 1975, the first randomized
controlled study confirmed the superiority of surgical over medical
therapy with antacids. Surgery was off and running.
All came to a dramatic halt when the Nobel Prize was awarded
to Sir James W. Black in 1988. He discovered an approach to
drug development called rational drug design structure. Simply
stated, if the pathophysiology of a disease is properly understood,
a specific drug could be synthesized to interrupt key points in
the pathogenesis and cure the disease. He used this concept to
discover the beta and H
cimetidine. Cimetidine became the first drug ever to exceed
$1 billion per year in sales. The methodology eventually led to
the development of proton pump inhibitors (PPIs), which block
the secretion of acid by the parietal cells. The aim of these drugs
is to increase the pH of the gastric juice, which, along with the
lower esophageal sphincter, contribute to gastroesophageal reflux
receptor antagonists, propranolol and
2
disease (GERD). By the 1980s, the clinical benefits of PPIs were
demonstrated dramatically by the abolishment of GERD symptoms and the virtual elimination of acid-induced reflux esophagitis, strictures, and giant Barrett’s ulcers. Now medicine was off
and running.
WHY A NEW SURGICAL ANTIREFLUX
PROCEDURE?
After 35 years of experience with more than 20 million GERD
patients on prescribed PPIs, physicians have developed some
concerns. Despite the introduction and use of the new powerful
acid-suppression drugs over this period, the incidence of GERD
continues to increase by 30% every 10 years, and 30% to 40% of
patients on PPI therapy have only partial relief of their symptoms.
Between 2% and 3.5% of the 20 million patients with GERD receiving PPI therapy develop Barrett’s esophagus every year, of which
0.5% to 1% progress to esophageal adenocarcinoma. Despite this
high percentage of patients with a partial response and disease progression on PPI therapy, less than 1% seek surgical therapy. These
concerns have given rise to the thought that the time has come for
a change in the treatment strategy of GERD. The current treatment
strategy focuses only on one of the two determinants of the disease,
the acid composition of the gastric juice, whereas the other determinant, failure of the lower esophageal sphincter (LES), is ignored.
This focus on PPIs and disregard for the LES is likely the result of a
historical misunderstanding that GERD is primarily an acid peptic
disease. The primary abnormality in GERD is the loss of an effective LES to keep the gastric juice in the stomach. This was pointed
out in 2003 in a publication by Dr. G. Wetscher and colleagues
from Innsbruck, Austria. They showed that the recurrence of reflux
Distension or dilation
Effacement of the LES
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symptoms and/or endoscopic esophagitis in patients on PPIs was
related to the functional status of the LES and esophageal body.
Patients with both a defective LES and esophageal contractions had
an 80% recurrence rate compared with 39% in those patients with
a defective LES and normal esophageal body contractions, or 8%
in those with both a normal LES and normal esophageal contractions. They concluded that the status of the LES is a critical factor
in the effectiveness of PPI therapy. The medication works well in
patients with a normal LES and not so well in patients who have
a defective LES. In the latter situation, reflux episodes continue at
the same frequency whether the patient is off or on the medication.
The only difference is a change in the pH of the refluxed gastric
juice. As a consequence, 85% of patients on PPIs still experience
GERD-related symptoms, and in 35% the symptoms have reached
the level to cause dissatisfaction with PPI therapy. In an effort to
improve symptom control, the prescriptions for double-dose PPIs
have increased by 50% in the past 7 years, and 42% of patients supplement their prescription with other acid-suppression medication
in an effort to gain relief. Of greatest concern is that 10% to 15%
of patients have disease progression while on PPI therapy, and the
longer the disease persists, the greater the number of patients who
progress.
Over the past 35 years, antireflux surgery has not fared much
better. Even though the surgery can be performed through a laparoscope and achieve effective control of reflux symptoms and heal
esophagitis, the outcomes vary in their effectiveness and durability,
and the early surgical revision rate is too high. The procedures have
significant side effects in that patients are unable to belch or vomit,
risk having increased flatulence and postprandial bloating, and have
a small possibility of bothersome dysphagia. When performed by
the occasional surgeon, only 61% of patients are completely satisfied
with their operation. These results discourage patients against antireflux surgery, and at present less than 1% of GERD patients have
surgical therapy. Unless there are some fundamental improvements
in surgical therapy, it appears that the use of surgery for the treatment
of GERD will reach a standstill.
NEW SURGICAL APPROACH TO GERD
The ideal surgical procedure to improve the function of the LES in a
patient with GERD would be a minimally invasive, short, outpatient
procedure that augments the LES function without causing anatomic
alterations. Based on the effectiveness of the Nissen fundoplication,
it should have a greater than 80% probability of normalizing esophageal acid exposure and a 90% probability of eliminating GERD-related symptoms. It should allow an unrestricted diet and cause no
long-term side effects such as persistent dysphagia, symptomatic
bloating, increased flatus, or the inability to belch or vomit. Further,
it must be reversible without sequelae.
Over the past 10 years, studies on the pathophysiology of the LES
have opened the door for technology to design a new device that
meets the ideal requirement for a new surgical procedure for the
treatment of GERD. These studies have shown that gastric distension
or dilation after meals can cause effacement of the LES, resulting in
progressive shortening of its length and, as a consequence, loss of
its competency (Fig. 1). This process exposes the effaced squamous
mucosa of the distal esophagus and the underlying muscle of the
LES to gastric juice. The inflammatory injury that occurs destroys
the squamous mucosa, heals by the induction of metaplastic cardiac
mucosa, and induces permanent damage to the muscle of the LES,
resulting in a loss of its abdominal length, overall length, and pressure. The resulting structurally defective LES allows repetitive LES
effacement to occur with ease, resulting in escalation of the degrees
of esophageal exposure to acidic bile containing gastric juice. Placing
a loose ligature or ring around the inferior border of the LES can
stop the effacement and has formed the basis for the design of new
devices to augment LES function.
ESOPHAGUS
FIG. 1 Effacement and shortening of the length of the lower esoph-
ageal sphincter (LES) that occurs with gastric distension or dilation
after meals and, as a consequence, loss of its competency. The process
exposes the effaced squamous mucosa of the distal esophagus (red line)
and the underlying muscle of the LES (black area below the red line) to
gastric juice.
15
LINX ANTIREFLUX DEVICE
One of the new devices is the LINX Reflux Management System
(Torax Medical, St. Paul, MN). It is a simple procedure, performed
laparoscopically, that does not alter gastric or gastroesophageal junctional anatomy, augments the LES as a functional barrier to reflux,
and can be reversed easily if necessary, thereby preserving the option
for fundoplication or other therapies in the future. The LINX procedure is designed to limit technical variability, which will result in
more standardization of antireflux surgery and more consistent clinical outcomes. The LINX device consists of a series of titanium beads
with magnetic cores hermetically sealed inside (Fig. 2). The beads
are interlinked with independent titanium wires to form a dynamic
ring designed to conform to the changing physiologic movements
of the esophagus during swallowing. The device was designed to
use the magnetic attraction between adjacent beads to prevent the
opening of the LES by distal to proximal effacement and shortening
of its length caused by episodes of gastric distension or postprandial
gastric dilation secondary to adaptive relaxation. The device is sized
to fit around the external circumference of the esophagus at the
distal end of the LES without compressing the esophageal musculature. The beads separate to allow the transport of a food bolus into
the stomach, to relieve gastric distension by belching or nausea by
vomiting (Fig. 3).
The LINX device was not designed to deter reflux episodes
caused by pressure challenges that affect the whole abdominal environment. To deter these challenges requires sufficient esophageal
length in the abdominal domain to allow the LES to be compressed
by changes in the abdominal environmental pressure that occur with
daily living and working. For this reason, it is recommended that,
if possible, the LINX device be implanted with minimal disruption
of the phrenoesophageal ligament to preserve sufficient length of
esophagus in the abdominal domain.
LINX IMPLANTATION PROCEDURE
The LINX magnetic sphincter augmentation device is implanted
laparoscopically under general anesthesia. Surgical ports are placed
similar to the pattern used for the laparoscopic Nissen fundoplication with one exception. The dissection port in the patient’s right
upper quadrant is placed far laterally to optimize the visualization
and sizing of the esophagus at the gastroesophageal junction. A limited focus dissection is ideal for implantation of the LINX device in
a patient without a hiatal hernia. When performing a limited focus
16 NEW APPROACHES TO GASTROESOPHAGEAL REFLUX DISEASE (LINX)
Closed Open
AB
tanium
LINX device
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Ti
wires
Roman
arch
Magnetic
core
FIG. 2 Engineering schematic of the magnetic sphincter augmentation device. The device consists of an expansible bracelet of magnetic beads designed to
be placed surgically around the exterior surface of the distal end of the lower esophageal sphincter (LES). Each bead is composed of a titanium case con-
taining a magnetic core of small disk-shaped magnets. The beads are connected by titanium wires of specific lengths that limit the distance any two individual
beads can move apart. When the device is closed (A), the magnetic force is sufficient to prevent effacement and opening of the LES yet is weak enough to
allow the device to open (B) with esophageal peristalsis. When the device is closed, the Roman arch construction prevents compression of the esophageal
tissues.
Titanium
case
Diaphragm
Esophagus
LES
Stomach
A
FIG. 3 The LINX magnetic sphincter augmentation device is implanted around the inferior border of the lower esophageal sphincter (LES), as shown.
(A) The magnetic device is shown in the closed position, which prevents effacement and opening of the LES and subsequent reflux. Each magnetic bead
rests on the adjacent beads to prevent compression of the esophageal tissues. (B) The device is shown in the open position, which allows transport of food
by esophageal peristalsis, belching of an overdistended stomach, and vomiting when necessary.
dissection, the surgeon must preserve and not dissect the phrenoesophageal ligament.
The surgical dissection begins by mobilizing the posterior gastric
fundic wall off the lateral surface of the left crus to expose the caudal
anterior edge of the left crus. In doing so, as few short gastric vessels
as possible are divided. A 1-cm segment along the anterior margin
of the left crus just above the crural decussation is identified. At this
location, a medial dissection is performed just beneath the esophagus
to form a pocket target for the right-sided tunnel dissection. In performing this dissection, care is taken not to enter the mediastinum.
After the pocket target is made, the dissection is switched to the
right side of the esophagus. The gastrohepatic ligament is opened by
making two windows, a small one just superior to the hepatic branch
of the anterior vagal nerve and a larger one inferior to the hepatic
branch. The inferior window allows access to construct a retroesophageal tunnel through a 1- to 2-cm incision in the peritoneum along
the anterior edge of the right crus just above the crural decussation.
Using a dissector placed through the far lateral right upper quadrant
port and the inferior window in the gastrohepatic ligament, a gentle
dissection is made toward the left crus just to identify the posterior
Bolus
LINX device
B
vagal nerve as it leaves the esophagus and drops posterior to the celiac
plexus (Fig. 4A). Bleeding from the small vessels can obscure the
dissection and is controlled with judicial use of cautery. Delicately, a
tunnel is dissected in a right-to-left direction, between the posterior
vagal nerve and the posterior esophageal wall, to connect with the
previously constructed pocket target on the anterior margin of the
left crus. Entering the mediastinum during the tunnel dissection
should be avoided. The dissector is passed through the pocket target
and into the left upper quadrant. The dissector is removed from the
left upper quadrant, drawing a ¼-inch Penrose drain through the
tunnel and securing its right and left ends for retraction. In line with
the expected position of the device, the fibroareolar tissue from the
right and left lateral esophageal surfaces is removed, and a trench
is constructed through existing fat on the anterior surface of the
esophagus below the inferior leaf of the phrenoesophageal ligament.
The circumference of the esophagus then is measured to choose
the proper size of the LINX device to be implanted. The sizing tool
is a laparoscopic instrument with a soft, circular curved tip that is
actuated by coaxial tubes through a handset. The handset contains a
numerical indicator that corresponds to the size range of the LINX
ESOPHAGUS
n = 31
n = 25
% of patients achieving pH normalization
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17
A
FIG. 4 Intraoperative images. (A) Dissection of the tunnel between the posterior vagal nerve and the posterior esophageal wall at the inferior border of
the lower esophageal sphincter (LES). (B) The position of the sizing tool to measure the circumference of the esophagus at the lower border of the LES.
(C) Completed implantation of the LINX device around the lower border of the LES with the clasps connected.
B
C
device. The sizing tool is inserted through the far-lateral placed right
upper quadrant port and then passed through the dissected tunnel
between the posterior vagal nerve and esophageal wall and around
the esophagus (see Fig. 4B). Anterior retraction on the previously
placed Penrose drain simplifies this maneuver. When making the
measurement, the surgeon must not intubate the esophagus or
compress its muscular wall by the measuring device. Two measurements should be taken. If the measurement is between two sizes, the
larger size is selected. The most common size is 14, and smaller sizes
should be used sparingly and with caution. The appropriate size of
device is selected and pulled through the tunnel in a left to right
direction. Again, anterior retraction of the Penrose drain simplifies
this maneuver. The ends of the device are brought anteriorly around
the esophagus, the left end around the Angle of His and the right end
over the gastrohepatic branch of the anterior vagal nerve. The clasps
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
P = 1.000
23/31
(74%)
Limited focused dissection
18/25
(72%)
Extended dissection
are connected, and the anterior portion of the device is placed in the
trench if present (see Fig. 4C). If the right and left crura appear to
diverge from one another above the crural decussation, one or two
figure-of-8 sutures can be placed to approximate them, provided no
further dissection is required. A small hiatal hernia less than 3cm in
size can be effectively repaired by this maneuver. The surgical time is
usually less than 1 hour. The patient is discharged the same day or, if
FIG. 5 The degree of dissection necessary to implant the LINX antireflux
device and normalization of esophageal acid exposure. With either dissection (limited focus or extended), the esophageal acid exposure was normalized in more than 70% of patients. The durability of competency with
a limited focus dissection is beyond 5 years. The durability of competency
with an extended dissection is unknown.
an afternoon procedure, the next morning. The patient is instructed
to slowly return to a normal diet over the next week and discontinue
the use of acid-suppression medication.
For patients with a hiatal hernia greater than 3 cm, a more
extended and less focused dissection can be done to allow dissection and reduction of the hernia into the abdomen, approximation
of the crura around a 2- to 3-cm length of abdominal esophagus,
and implantation of the LINX device. An extended dissection also
provides a fallback solution when greater exposure is necessary to
implant the LINX device for reasons other than a hiatal hernia. Normalization of esophageal acid exposure is similar in patients after a
limited focus or extended dissection (Fig. 5). Again, when doing an
extended dissection, it is important to approximate the crura around
the esophagus in a manner that maintains 2 to 3cm of esophagus
in the abdominal environment. When this is not done, the ability to
deter the reflux of gastric juice into the esophagus caused by episodes
of increased abdominal environmental pressure is compromised.
recently. The final 5-year results of the US Food and Drug Administration’s approved trial provides a careful analysis of the safety and
effectiveness of the LINX device. The studied population consisted
of 100 adults who had GERD for at least 6 months or longer, were
partially responsive to daily PPIs, and had abnormal esophageal
acid exposure on 24-hour pH testing. The LINX device was placed
using standard laparoscopic techniques. In this study, 85 subjects
were followed for 5 years and evaluated for quality of life (GERDHRQL score), reflux control (postoperative 24-hour pH testing at
1 year), use of PPIs, and side effects. A quality of life questionnaire
was administered at baseline to patients on and off PPIs and after
placement of the LINX device yearly for 5 years. Over the follow-up
period, no device erosions, migrations, or malfunctions occurred.
At baseline, the median GERD-HRQL scores were 27 when patients
LONG-TERM CLINICAL OUTCOMES
OF THE LINX MAGNETIC SPHINCTER
AUGMENTATION DEVICE
Long-term outcomes of patients who had the LINX magnetic sphincter augmentation device implanted for GERD have been reported
were not taking PPIs, 11 when taking PPIs, and decreased to 4 at 5
years after LINX placement (Fig. 6). All patients were taking daily
PPIs at baseline, and this decreased to 15.3% at 5 years (Figs. 7 and 8).
Moderate to severe heartburn occurred in 89% of patients at baseline
but only 11.9% at 5 years (see Fig. 7). Moderate to severe regurgitation occurred in 57% of patients at baseline, but only 1.2% at 5 years
18 NEW APPROACHES TO GASTROESOPHAGEAL REFLUX DISEASE (LINX)
baseline
baseline
30
25
20
15
10
100
<
Percent
Baseline Year 1Year 2Year 4Year 5Year 3
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27
11
5
0
FIG. 6 Median total GERD-HRQL scores measured at baseline without
and with proton pump inhibitors, as compared with 5 years after implantation of the LINX sphincter augmentation device. Higher scores indicate
worse symptoms. P < 0.001 for all comparisons with baseline.
Without
proton-pump
inhibitors at
With
proton-pump
inhibitors at
4
5 yr after
sphincter
augmentation
90
80
70
60
None PRN QD BID
100
90
80
70
60
50
40
30
20
10
0
FIG. 8 The use of PPIs at baseline and yearly throughout the 5 years. PPI
use was categorized as none, as needed (PRN), once a day (QD), and twice
a day (BID) at each yearly visit based on the prior 30 days. Patients who
required BID PPIs decreased from 36% at baseline to 2.4% at 5 years.
50
40
Percent of patients
30
20
10
0
Baseline
FIG. 7 Reflux control of moder-
ate-severe heartburn, moderate-severe regurgitation, PPI dependency,
and dissatisfaction with therapy. P <
0.001 between baseline and yearly
follow-up evaluation out to 5 years
for all comparisons. Of the six
patients who were dissatisfied at 5
years, five reported daily use of PPIs.
Heartburn 89 3.2 5.6 8 9.3 11.9
(N = 100)
57 2.1 1.1 2.3 3.4 1.2Regurgitation
100 9.3 7.8 7.9 8.1 15.3PPI dependence
95 3.2 3.3 3.4 5.8 7.1Dissatisfaction
(see Fig. 7). All patients reported the ability to belch and vomit if
needed. Bothersome dysphagia was present in 5% at baseline and in
6% at 5 years (Fig. 9). Bothersome gas bloat was present in 52% at
baseline and decreased to 8.3% at 5 years (see Fig. 9). No significant
complications occurred. No new safety risks emerged over the 5 years
of follow-up. On the basis of this and other reported studies, LINX is
Year 1
(N = 95)
P
.001 for comparision between baseline and all follow-ups
Year 2
(N = 90)
Year 3
(N = 87)
Year 4
(N = 86)
Year 5
(N = 84)
an effective fundic-sparing, antireflux procedure with minimal side
effects. It is applicable to patients who have a partial response to PPIs,
a desire to be off PPIs, or endoscopic/histologic signs of progression
while on PPI therapy. A hiatal hernia is likely not a contraindication
to the use of the LINX device, but long-term results regarding the
recurrence rate of the hiatal hernia are needed.
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