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R. F. Cubas et al.
Magnetic Sphincter Augmentation
forManagement ofGastroesophageal
31
Reflux Disease
MarkG.Hausmann andKarlA.LeBlanc
31.1 Introduction
Gastroesophageal reux disease (GERD) occurs when gastric contents ow retrograde from the stomach to the esophagus. The most common anatomic issue that
can allow this to occur is diminished function of the lower esophageal sphincter.
Medical therapies reduce the acidity of the reuxate, but do not address the mechanism of the reux. Antireux surgeries are intended to recreate the anatomic valvelike barrier that prevents reux at the gastroesophageal (GE) junction.
The surgical management of GERD has had many modications over the years.
Rudolph Nissen performed the rst fundoplication in 1955. Multiple other iterations of the fundoplication have evolved over the years including procedures such as
the Belsey Mark IV (1952), Collis gastroplasty (1957), the Dor (1962), Toupet
(1963), and Hill (1967) fundoplications among the more better-known modications [1]. During this path of operative innovations, the Angelchik device (introduced in 1979) was developed. This was a C-shaped ring of silicon that was placed
around the gastroesophageal junction. While its introduction was seen as a signicant advance, it soon fell out of favor due to complications of dysphagia, migration
and erosion. Through these years of development of these methods, the surgical
approach to GERD management and hiatal hernia repair has been modied from
laparotomy or thoracotomy to laparoscopy, and now most recently to robotic
approaches (Table31.1)
Magnetic sphincter augmentation (LINX
has been shown to be an effective alternative to fundoplication, with a favorable side
effect prole. This device is composed of a ring of individually interconnected
®
, Torax Medical, Inc., Shoreview, MN)
M. G. Hausmann (*) · K. A. LeBlanc
Our Lady of the Lake Physician Group, Baton Rouge, LA, USA
e-mail: mark.hausmann@fmolhs.org
© Springer Nature Switzerland AG 2019
K. A. LeBlanc (ed.), Robotic Assisted Hernia Repair,
https://doi.org/10.1007/978-3-030-23025-8_31
475
476
ab
Table 31.1 Chronology of hiatal hernia surgery
Year Surgical approach/proponent
1919 Transabdominal repair/Soresi
1950 Transthoracic repair/Sweet
1951 Association of incompetent LES and reux esophagitis (crural sling)/Allison
1952 Transthoracic approach for extensive esophageal mobilization/Belsey (Mark IV)
1954 Importance of the restoration of the cardiophrenic angle/Barrett
1955 Transabdominal approach to restore the angle (full wrap)/Nissen
1962 Partial anterior wrap/Dor
1963 Partial posterior wrap/Toupet
1965 Gastric patch for esophageal stricture/Thal
1967 Anchoring of phrenoesophageal bundles to median arcuate ligament/Hill
1977 “Floppy” Nissen and division of short gastric vessels/Donahue
1986 Two cm wrap to reduce bloat and dysphagia/Johnson and DeMeester
2008 Initial animal implantations of LINX
2012 FDA approval of the LINX
®
LINX
System
device
®
®
device
M. G. Hausmann and K. A. LeBlanc
Bolus
Swallow
LES
Stomach
Fig. 31.1 (a) Prevention of acid reux with closed LINX® device in place. (b) Opening of the
®
LINX
device to allow food bolus to pass
titanium beads with magnetic cores that augment the lower esophageal sphincter
without disruption of the normal gastric anatomy. These beads will separate upon
the passage of a food bolus thereby allowing the introduction of food into the stomach (Figs.31.1 and 31.2) [2].
Initial animal studies were completed in 2008 [3], followed by human feasibility
studies [4], which led to FDA approval in March 2012. The magnetic sphincter
augmentation was initially described via a laparoscopic approach with minimal dissection for small hiatal hernias, leaving the phrenoesophageal membrane intact.
This signicantly limited the introduction of this technology but with further experience the technique has evolved to include larger hiatal hernias along with full dis-
®
section of the hiatus. While the initial introduction of the LINX
was with the
Stomach
Titanium beads
Magnetic cores
titanium wires
a
31 Magnetic Sphincter Augmentation forManagement ofGastroesophageal Reux…
477
Independent
b
Multi-directional
locking clasp
Fig. 31.2 (a) Cutaway image of LINX device closed—provided by J&J/Ethicon. (b) Cutaway
image of LINX device open—provided by J&J/Ethicon
478
M. G. Hausmann and K. A. LeBlanc
laparoscopic insertion, as the robot technology has evolved and expanded, many
surgeons have found benet in the use of the robot for the performance of the hiatal
dissection, closure of the hernia and insertion of the LINX® device.
®
One common concern that is noted is that the magnets within the LINX
device
may preclude magnetic resonance imaging (MRI) studies. However, the current
LINX® device is approved for magnetic resonance imaging (MRI) systems up to
1.5T.As over 80% for MRI machines in the U.S. are 1.5T or lower, this has not
proven to be a signicant issue [5]. The potential effect of the use of one of the other
MRI machines is the de-magnetization of the magnets of the LINX® device. This
would render the device ineffective thereby allowing the recurrence of GERD.If
®
needed, the LINX
could be removed and replaced. This is a very rare occurrence
to date.
31.2 Surgical Indications
Surgical management of GERD should be considered in individuals that have inadequate or incomplete symptom control with medical management or those with
complications of GERD (Table31.2). The indications for the LINX
different than the traditional surgical treatment of GERD.
®
The initial trials using the LINX
Reux Management System included patients
with heartburn, abnormal esophageal acid exposure, and normal esophageal peristalsis. Anatomic exclusion criteria included a hiatal hernia size ≥3cm (as determined by endoscopy), Los Angeles grade B, C or D erosive esophagitis (Table31.3),
and body mass index >35 [6] so as to limit treatment and patient variability and by
exclusion of reux patients with complicated reux disease [7–9].
®
device are no
Table 31.2 Surgical
indications of GERD
Table 31.3 Los Angeles classication
Grade Mucosal breaks
A One or more <5mm in maximal length
B One or more >5mm in maximal length without continuity across mucosal folds
C Continuous between >2 mucosal folds involving <75% of the esophageal circumference
D Involves >75% of the esophageal circumference
Inadequate symptom control with medical management
Regurgitation
Nocturnal recumbent reux and/or aspiration
Atypical symptoms (chest pain, sore throat, hoarseness,
dental decay)
Patient desire to eliminate medical therapy
Barrett’s esophagus/dysplastic mucosal changes
Cameron’s ulcerations
Esophageal stricture
31 Magnetic Sphincter Augmentation forManagement ofGastroesophageal Reux…
479
Rona etal., studied hiatal hernia repair in conjunction with magnetic sphincter
augmentation in patients with more advanced reux disease including hiatal hernia
as large as 7cm. They found the frequency of improvement or resolution of symptoms as well as the percentage of patients requiring intervention for dysphagia was
similar to patients with less complex reux disease and smaller hernias [10].
Buckley etal. studied 200 patients with hiatal hernias greater than 3cm and demonstrated similar results as those reported from studies of hiatal hernias ≤3cm [11].
Research such as these have resulted in the expansion of the use of the LINX
beyond the limited indications when this device was initially introduced.
®
There are reports regarding the use of LINX
in patients as an option for patients
who have severe reux symptoms following sleeve gastrectomy surgery and with
reux following Roux-en-Y gastric bypass [12, 13]. The results from these studies
as well as ample anecdotal experience has provided patients with these difcult situations and limited options with a new surgical option. This is especially benecial
when these individuals have failed medical therapy. While most studies describe
magnetic sphincter augmentation via a laparoscopic approach, many surgeons using
robotic technology for the hiatal dissection are very likely to place the LINX
device robotically as well. It is anticipated that the results utilizing robotic methods
will be published in the near future.
31.3 Preoperative Evaluation
®
®
The evaluation of the foregut is paramount in the surgical treatment of GERD.This
requires both radiologic and functional testing. The initial evaluation includes radiographic contrast evaluation of the esophageal and upper gastrointestinal tract. While
necessary, these tests do not provide the mucosal evaluation of these tissues that
upper GI endoscopy provides. It is preferred, when feasible, that the operating surgeon performs the endoscopic evaluation to better appreciate the anatomy that is to
be treated. Additional functional tests will be needed and will depend upon the experience and requirements of the surgeon and may include esophageal manometry, the
Bravo™ (Medtronic, Minneapolis, MN) pH study or the impedance pH probe study.
Nuclear medicine gastric emptying evaluation may be considered in selected patients
(i.e. when this issue may be the source of reux). It should be assumed that these
studies are complementary rather than exclusive [14]. Especially for the consider-
®
ation of the LINX
device, more information rather than less is preferred.
The esophagram provides a radiographic assessment of the foregut anatomy.
Videoesophagography provides a radiographic image of the foregut and some surgeons have applied a modication to assess motility radiographically. This protocol
assesses the food bolus transit with the patient prone in 15° Trendelenburg position.
Adequate esophageal clearance is considered to be the allowance of passage of the
food bolus within 2 esophageal peristaltic strips [15]. This evaluation may not be
familiar to many radiologists but in our practice, this has proven to be a viable
option to those patients that are unable or unwilling to undergo the traditional functional studies.
480
M. G. Hausmann and K. A. LeBlanc
Due to the innate function of the LINX® device, esophageal motility is one of the
most important considerations in the selection of this option in these patients.
Magnetic sphincter augmentation can be considered in hiatal hernia and reux
patients with adequate motility. While all of the important considerations of esophageal motility are beyond the scope of this chapter, the general parameters regarding
esophageal motility (in which this device can be an option) would require a distal
esophageal amplitude of ≥35mmHg, distal contractile integral ≥500 by Chicago
classication, and ≥70% peristaltic propagation. This can be evaluated effectively
by high resolution manometry [16, 17].
Physiologic conrmation of acid reux may be obtained via a Bravo™ pH study.
There is a plethora of patients that exhibit a varied presentation of acid reux complaints. Many of these have some other source of symptomology and not reux. It
is critical to differentiate these individuals to ascertain the best course of clinical
treatment. If nonacid reux is a consideration, impedance pH may be the test of
choice. This method of study is quite important but must be critically interpreted to
determine the results [18].
If there is suspicion of delayed gastric emptying, (excessive nausea, vomiting or
bloating) the addition of a nuclear medicine gastric emptying study should be considered. As is well known, this entity can cause GERD symptoms and the anti-reux
procedures will not alleviate these problems and, in fact, could make them worse.
31.4 Surgical Technique
The procedure is performed under general anesthesia, with the patient in the supine
position. The initial entry in the abdomen is via an 8mm robotic trocar with transparent obturator superior to the umbilicus, about 15cm below the xyphoid, just to
the left of midline (2–3cm) so that the camera trocar is to the left of the falciform
ligament. Another form of entry is the use of a 5mm laparoscopic optical trocar at
this location. If this is selected, this trocar will be exchanged for an 8mm robotic
trocar after insertion of additional trocars. After laparoscopic exploration of the
abdomen, the patient is then placed in 10–20° of reverse Trendelenburg position.
This will vary slightly based upon the habitus of the patient. The technique described
below is for the Da Vinci Xi system by Intuitive Surgical but can be modied for
other systems such as the Da Vinci Si or X platform. The pneumoperitoneum is
established at a pressure of 15mmHg. Two additional robotic ports are then placed
parallel to the camera port in the left anterior axillary line just above the reection
of the left colon (arm 4). The next port (arm 3) is placed midway between trocars 2
and 4 in order to maximize the robotic arm position which results in a location
approximately in the left mid-clavicular line. Because the fourth port on the right
side of the abdomen (arm 1) will be used to measure the circumference of the esophagus at the lower esophageal sphincter, it is placed higher than the initial 3 trocars
(Fig.31.3). It is positioned in the mid-clavicular line or more lateral just below the
costal margin. This location is necessitated so that the approach to the GE junction
®
of the esophagus by the LINX
sizing device is perpendicular to the that anatomy.
Port Placement
31 Magnetic Sphincter Augmentation forManagement ofGastroesophageal Reux…
Fig. 31.3 Port placement
Retractor
Bipolar
Camera
Vessel
Sealer
Tip-Up
481
Alternatively, this robotic port can be placed in line with the initial 3 ports and an
accessory port can be positioned in the immediate subcostal position and used as
access for the measurement of the lower esophageal sphincter circumference.
We prefer to use the Nathanson liver retractor that is placed in the subxiphoid
region to retract the left lobe of the liver anteriorly to expose the hiatus. It is preferred to place the Nathanson at this point so that the liver position is established
prior to introduction of the right sided trocar through which sizing of the esophagus will take place. The smallest sized Nathanson retractor that accommodates the
left lobe is preferred, so as to limit the prole and avoid interference with the
robotic arms.
A Fenestrated Bipolar Grasper is placed in arm 1, the Vessel Sealer or the newer
Vessel Sealer Extend in arm 3 and Tip-up Fenestrated Grasper in arm 4. Some sur-
®
geons may prefer to use the Harmonic ACE
Curved Shears in arm 3, but the benet
of articulation of the Vessel Sealer is sacriced.
482
M. G. Hausmann and K. A. LeBlanc
The dissection is initiated at the superior pole of the spleen whereupon the peritoneum is incised from this area to the Angle of His. The short gastric vessels do not
require division since mobilization of the funds is not required for fundoplication.
The left crus is exposed to the point where the right crus can be visualized posteriorly. The gastrohepatic ligament is then divided exposing the right crus. The right
crus is dissected to expose its entire length and the phrenoesophageal membrane is
divided to achieve circumferential exposure of the hiatus. These are the critical
aspects of the procedure to assure that an adequate mobilization of the GE junction
has been achieved. The Tip-up instrument is critical to provide the needed exposure
of these areas during this dissection. It will then be used to provide retraction of the
esophagus by passing it behind the right side of the GE junction, exing it at a right
angle and retracting inferiorly. Alternatively, one might prefer to place a Penrose
drain around the GE junction to be used as the aid for retraction of the esophagus. It
is critical that any noted hernia sac is completely reduced from the mediastinum.
The esophagus must be mobilized circumferentially to the extent needed to assure
that the proximal dissection into the mediastinum allows for maximal increase of
the intra-abdominal esophageal length. A minimum of 2cm of intra-abdominal
esophagus should be obtained.
The start of the repair will be the posterior cruraplasty. The crural approximation
should not be so tight that it is constrictive of the esophagus. The cruraplasty can be
performed with permanent sutures in an interrupted fashion or in a running fashion
using a suture according to surgeon preference. To assess the adequacy of the crural
closure, the retraction of the esophagus itself should be relaxed. After this maneuver, the inspection should insure that the crural closure is not constrictive on the
relaxed esophagus. A short plane is then developed between the posterior surface of
the esophagus and the posterior vagus nerve just above the GE junction. This is the
®
space that the LINX
device will be placed. This dissection should be limited to
keep the space small as the retained adventitia superiorly and inferiorly are intended
to limit the migration of the device until it is encapsulated by scar tissue. A siliconebased Penrose drain can be placed to maintain this tunnel location for the measure-
®
ment of the esophageal circumference and the placement of the LINX
device. The
circumference of the esophagus is measured at this site from the right subcostal
®
trocar (arm 1). The LINX
sizing device has a stiff shaft with the actual sizing
mechanism at the end consisting of a exible tube with a magnet on its end. The
exible portion is passed around the circumference of the GE junction and will connect with another magnet on the end of the sizing instrument shaft. The sizing
device should be tightened until the tubing is close to the esophageal circumference,
but not constrictive in any fashion (Fig.31.4). The measurement on the sizing device
coincides with the numbers on the proximal portion of the shaft which correlate
®
with the number of beads of the LINX
device (from 13 beads to 17 beads) to be
selected. We recommend that this sizing should be done in at least triplicate fashion
to assure appropriate selection. The sizer should be tightened slowly as it is manipulated to assess the space between it and the esophagus and the ability to move it
around the esophagus. As it is tightened, it will be appreciated that its movement
becomes restricted and ultimately, the magnets of the sizing device will separate.
31 Magnetic Sphincter Augmentation forManagement ofGastroesophageal Reux…
Fig. 31.4 Sizing the
LINX device
Esophagus
Crural closure
Magnets of
sizing device
Penrose
483
The appropriately sized device should allow movement of the sizer. This will differ
from patient to patient and represents the most critical portion of the procedure. This
cannot be overstated. If it is too large, reux will be poorly controlled; if too tight,
dysphagia can result. If any question, we recommend to “size up” the selected
device. In other words, if needed one should select one size larger than that noted by
the sizing device if the exact size to be selected is not perfectly assured.
®
The LINX
device is introduced through the 8mm metal robotic trocar to the
right of the patient, the robotic arm should be undocked, and the cap removed from
the trocar. The magnetic beads will adhere to the proximal well of the metal trocar,
so the beads must be directed into the cannula portion of the trocar. The cap can then
®
be replaced and the LINX
pushed down the cannula with a 5mm laparoscopic
instrument. (If introducing through an accessory laparoscopic port, the LINX®
device requires an 8mm Medtronic (Minneapolis, MN) or Ethicon (Sommerville,
NJ) trocar, but will t down a 5 mm trocar by Applied Medical (Rancho San
Margarita, CA)
®
The appropriately sized LINX
device is then passed through the tunnel between
the Penrose and the esophagus and buckled (Fig.31.5a,b). Using an instrument via
the right subcostal trocar (arm 1) the path over the Penrose drain (and posterior to
®
the esophagus) is followed and one of the sutures at the end of the LINX
device is
grasped and pulled gently through the tunnel, stopping when 2 beads are visible on
the right side of the esophagus. This will allow the buckling to occur on the right
anterolateral aspect of the esophagus. If the beads are pulled too far through the tunnel, the beads making up the clasp will be positioned on the left side of the esophagus, making visualization more difcult. When buckling the clasp, hold the suture
of one of the clasping beads still and bring the other clasping bead near and allow
them to mate magnetically. In order to seat the clasp, the sutures should be pulled
perpendicular to the orientation of the beads and 180° from each other. Then the
clasping beads are nessed until the clasp is buckled securely. Full engagement of