White paper on TIF with Esophyx

White Paper

Transoral Incisionless Fundoplication (TIF)
Using the EsophyX® Device

Written by:

Reginald CW Bell, MD1
Miguel Burch, MD2
Anthony A Starpoli, MD3
Karim S Trad, MD4
Alexander Porter, MD5

1
Swedish Medical Center, Englewood, CO, 2Boston Medical Center, Boston, MA,
3
Lenox Hill Hospital , New York, NY, 4Reston Hospital Center, Reston, VA,
5
EndoGastric Solutions Inc., Redmond, WA

TABLE OF CONTENTS

1. INTRODUCTION.......................................................................................... 1
2. TIF OVERVIEW............................................................................................ 2
3. TIF2 PRINCIPLES ....................................................................................... 3
4. PATIENT SELECTION ................................................................................ 4
5. TECHNICAL ASPECTS OF TIF2............................................................... 5
5.1. Location, Anesthesia, Positioning........................................................... 5
5.2. Introduction of the EsophyX Device ...................................................... 5
5.3. Fastener Placement ................................................................................. 6

6. ADVANCED CONSIDERATIONS ............................................................ 10
6.1. Starting Corner (Initial Engagement Site) ............................................ 10
6.2. Fastener Deployment ............................................................................ 11
6.3. Completion of the Procedure ................................................................ 13
6.4. Use of the Z-line Window..................................................................... 13

7. SPECIAL CONSIDERATIONS.................................................................. 14
7.1. Loss of Insufflation ............................................................................... 14
7.2. Bleeding ................................................................................................ 15
7.3. Laryngeal and Esophageal Perforation ................................................. 15

8. REFERENCES ............................................................................................ 17

The information contained in this document is the sole property of EndoGastric Solutions, Inc. Any reproduction in whole or in
part without written permission of EndoGastric Solutions, Inc. is prohibited.

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1. INTRODUCTION

The purpose of this white paper is to describe a transoral incisionless fundoplication
(TIF) technique using the EsophyX device to recreate the anatomic esophago-gastric
flap valve in patients suffering from gastroesophageal reflux disease (GERD).

EsophyX is an over the endoscope device capable of placing full-thickness
transluminal fasteners (Figure 1). The safety and effectiveness of TIF were
demonstrated in clinical trials, and the device was cleared by the U.S. Food and Drug
Administration (FDA) in September 2007 for use in transoral tissue approximation,
full-thickness plication and ligation in the GI tract, for the treatment of symptomatic
chronic GERD in patients who require and respond to pharmacologic therapy, and for
use in narrowing the GE junction and reducing hiatal hernias of ≤ 2 cm. The device
and procedure have been used successfully in over 1,500 cases worldwide. Published
results with the first iteration of procedure, TIF1, indicate that the procedure is
effective in treating GERD symptoms, reducing small hiatal hernia, increasing LES
pressure and reducing gastroesophageal reflux [1-3].

The safety, mechanism of action, immediate post-procedural anatomic impact on the
gastroesophageal (GE) junction and short-term efficacy of a second iteration of the
procedure (TIF2) have been evaluated in a sham-controlled randomized study using a
canine model [4]. Furthermore, based on initial human studies and reports, TIF2
results appear superior to those obtained with TIF1. Several observational and
controlled randomized human trials are currently underway in U.S. and Europe to
compare the efficacy of TIF2 with that of PPIs or sham. Results from those trials are
expected to be published in 2011.

Figure 1. EsophyX Es ceeviceophyX
Figure 1. devi D
Second generation transoral surgical device indicated for the treatment
Second Generation
of gastroesophageal reflux disease.
for the treatment of


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2. TIF OVERVIEW

The EsophyX device is passed over a flexible endoscope into the stomach with the
patient under general anesthesia. There are several components to the device that aid
the operator in performing a transoral
fundoplication (Figure 2). Basically, combined
in one device, the operator is provided with a
grasper, retractor and suturing apparatus to
perform the procedure and modify it as needed.
A tissue mold is retroflexed towards the device
and used to appose the fundus of the stomach to
the distal esophageal wall. The helical retractor
extended from the distal end of the device can
be used to grasp the lip of the gastroesophageal
(GE) valve and pull that section of the lip
downward resulting in a fold of tissue up to 5
cm in length. Closure of the articulated tissue
mold holds the tissue layers of the stomach and
esophagus firmly against the chassis of the
device. Suction holes on the distal portion of
the EsophyX device secure the esophageal wall
to the device, enabling reduction of small hiatal
hernia and improvement in the extent of the
fundoplication created.

When the helical retractor, tissue mold and
suction device are all in place and engaged, the
stylets are advanced passing from the distal
esophageal portion of the device through Figure 2. Internal Portion of Device
esophageal and fundic walls into the gastric (Patient Interface)
Top: Posterior Side of the Tissue Mold folds forward
cavity. Over these stylets, self-righting, away from reader to close against the chasis; Helical
Retractor is in extended position
polypropylene, H-shaped fasteners are gently Bottom: Anterior Side of Tissue Mold (Side that faces
deployed to fix the fundoplication. The tissue when closed); Closure of (stylet) ports brings
the tip just short of the fastener
the Tissue Mold

suction, tissue mold and helical retractor are
then released and moved to a different location of the GE valve’s circumference and
the process is repeated.
NOTE: It may be possible to leave the helical retractor in a single “12 o’clock”
position (see detailed procedure description below) and move the device around this
central location.

The TIF2 technique when properly performed on properly selected patients can result
in fundoplications of greater than 240 degrees in circumference and over 4 cm in
length tightly adhered to the endoscope upon visual inspection at the end of the
procedure.


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The controls to maneuver the different components of the device rest outside of the
patient within the handle (Figure 3).

Figure 3. External Portion of Device ceophyX
Figure 1. Es Devi
Left: The controls forSecond Generation
the anterior side of stylet and fastener delivery system are on the same side as the tissue mold knob.
Right: The fastener cartridge in place andof lock for the helical retractor used to maintain tension on the tissue pulled by the
for the treatment the
operator. The stylet and fastener delivery system for the posterior side of the device are on this side of the device.

3. TIF2 PRINCIPLES

As this is a procedure visualized with the endoscope
in retroflexed position, certain nomenclature
conventions have been adopted for clarity.

When the GE valve is visualized with the endoscope,
certain anatomic features can be appreciated. A
typical view of an abnormal valve is seen in Figure 4.
The greater curve of the stomach is past the lower
right of the screen, and the lesser curve is hidden by
the endoscope. A detailed description of the
procedure depends upon adopting an orientation
based on the circumference of the existing valve. A
clock-face nomenclature is utilized with the lesser
curve being defined as 12 o’clock and the portion of
the valve facing the greater curve defined as the 6
o’clock position (Figure 4).

The goal of the TIF2 procedure is to:
1. Create an esophagogastric plication of 1-2 cm
at the anterior corner (1 o’clock) and at the
posterior corner (11 o’clock) Figure 4. Conventions
2. Create an esophagogastric apposition of 3-4 The lesser curve (shown above and
depicted below behind the endoscope)
cm depth at the 4-5 o’clock and 7-8 o’clock establishes the 12 o’clock reference point
positions
3. Create a 1 cm lip on the lesser curve side
(from 11 o’clock to 1 o’clock)


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4. Reduce any hiatal hernia so that the GE
junction is at the distal end of the
fundoplication

All of the principles cited above for TIF2 have analogous counterparts in the open
and laparoscopic fundoplications. Conventional surgical fundoplication involves
mobilizing and then folding a portion of the stomach around the lower esophageal
sphincter (LES) and attaching that gastric tissue segment to the esophagus at a level
above the anatomic z-line. This typically places it at the level of the high pressure
zone (HPZ) and augments the HPZ in patients with a LES pressure. The
fundoplication also restores the angle of his and the anatomy of the sling fibers and
recreates a flap valve. Additionally, reduction of any small existing hiatal hernia
increases intra-abdominal length of the esophagus (improving valve efficacy) and
reapproximates the crura to the esophagus (improving the crural effect on valve
efficacy). Small hiatal hernias can be reduced and it appears that in doing so the
phrenoesophageal membranes are imbricated into the plication and slightly tighten
the crura.

The TIF procedure is performed intragastric and, thus, it is impossible to gain access
to and close crural defects. The procedure has, therefore, been limited to patients
with a reducible hiatal hernia of 2 cm or less. A more critical factor may be the
transverse dimensions of the crural defect rather than axial height. In general, a small
hernia has small crural transverse dimensions. Clinical experience with TIF2 as well
as earlier transoral procedures done with the EsophyX device have demonstrated that
occasionally a large crural defect can be present and not fully appreciated until the
stomach is fully distended and the diaphragm completely relaxed. Clinical
observations of the TIF2 indicate that the hiatal defect at its largest transverse
diameter should be less than 2 cm. As most endoscopes used with the EsophyX
device are about 1 cm in diameter, hiatal defects on retroflex more than twice the
diameter of the scope may be beyond the limits of the current TIF2 procedure and
EsophyX device.

4. PATIENT SELECTION

Patient selection for antireflux surgery includes failure of medical management or
patient desire for surgery despite successful medical management. Patient workup for
antireflux surgery is the same for the TIF2 procedure as for laparoscopic surgery.

Patients should not be considered for the TIF2 procedure if:
1. Axial height of the hiatal hernia is > 2 cm on EGD or barium swallow or in
instances where a hiatal hernia of 2 cm or less cannot be reduced 1

1
Axial height is not a reliable indicator of hiatal hernia. Mucosal changes from squamous lining to columnar lined
distal esophagus can occur in patients with GERD without a hiatal hernia. GERD Reflux to Esophageal
Adenocarcinoma, Chandrasoma,P., Demeester, T., Chapter 8, pg. 147, Academic Press, 2006.


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2. Transverse dimension of the hiatus on retroflex endoscopy with gastric
distension, either preoperatively or at the time of the procedure, is >2 cm
3. Severe erosive esophagitis, long-segment Barrett’s esophagus, and recurring
strictures. As short-segment Barrett’s (SSBE) is quite variable in its extent,
some patients with SSBE may be appropriate candidates for the TIF2 if they
have a limited extent of SSBE
4. Hill grade 4 valve
5. BMI > 35
6. Adherence to limitations in diet and activity for 1 month postoperatively is not
possible
7. Narrowing in the hypopharynx or esophagus is present causing problems with
safe accommodation of a 58 Fr dilator without difficulty

5. TECHNICAL ASPECTS OF TIF2
5.1.Location, Anesthesia, Positioning

The TIF2 procedure may be performed in a GI Lab or Operating Room. It is a
clean but not sterile procedure and requires general anesthesia with full
diaphragmic relaxation. Consideration of liberal use of antiemetics, along with
short term PPI therapy post-operatively (to reduce risk of gastric bleeding) and
anticholinergics (to reduce salivary secretions) should be given.

The patient is usually positioned in a left lateral decubitus position. This opens up
the hiatus and eases manipulation of the EsophyX device. However, some
operators have been quite adept at introducing the device and performing the
procedure with the patient in the supine position which may be preferable if the
patient has a large liver that is impinging on the stomach.

5.2.Introduction of the EsophyX Device

Before opening the device, it is recommended to assess the dimensions of the
hiatus to ensure the patient is an acceptable candidate using a flexible endoscopy
with the patient anesthetized.

Some surgeons have reported that dilation with a 56-60 Fr Maloney
(or comparable Savary) for 5 minutes prior to introduction of the device aids in
insertion.

During insertion of the device attention should be paid to:
1. Ensuring that the endoscope is in the esophageal lumen prior to beginning
passage of the device
2. Orienting the device so that the handle is to the patient’s left shoulder


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3. Gentle manipulation of the elbow of the device in particular past the
hypopharynx
4. Ensuring the retainer band snaps back as the endoscope is withdrawn from
the tissue mold
5. Visualizing tissue mold in retroflex view

5.3.Fastener Placement

Once the endoscope and tissue mold are retroflexed, landmarks of the lesser curve
and the anterior and posterior margins of the fundoplication are observed. The
TIF2 procedure consists of placing plications in at least the four following
positions to create a valve of > 240 degrees and > 3 cm length, with 12 o’clock
landmark being the lesser curve: 1 o’clock, 4-5 o’clock, 7-8 o’clock, and 11
o’clock (refer to Figure 4). The following is a template for constructing such a
valve.

Posterior 11 o’clock Corner:
With the scope and tissue mold in retroflexion
the device is rotated clockwise (on the screen)
to the 11 o’clock (posterior) position. The helical
retractor is placed into the gastric mucosa within
5 mm of the z-line, released from the tissue
mold, and used to pull the tissue caudad (Figure 5).
With gentle tension on the helical retractor, the
captured tissue is manipulated into the tissue mold
as the mold is closed and rotated clockwise (screen
view) further into the corner. The endoscopist
can assist this by desufflating the stomach during
this maneuver of caudal tension on the helix (pulling
back on the retractor control located at the handle)
and tucking the tissue mold further into the corner
(Figure 6). The tissue mold and helical retractor are Top:

then locked into position. Bottom:
engagement

Figure 5. Posterior Corner
Top: Helical Retractor Engaged in tissue.
The esophageal mucosa can be seen.
Bottom: 11 o’clock helical engagement
illustrated


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Figure 6. Tucking “Shoehorning” in the Corners
Left: Less aggressive tucking staring near helical engagement and rotating
further into the corner
Right: More aggressive tucking, helical placement at 11 o’clock, the stomach
tissue is moved from 8 o’clock to a similar resting spot as the left panel

Suction on the tissue invaginator can be applied either after the helical retractor is
deployed or after closing the tissue mold and locking the helical retractor and
tissue mold. Applying suction before closure of the tissue mold and advancing
the device helps create space between the GE valve and the diaphragm to allow
the tissue mold to be tucked further into the corner. Applying suction after the
tissue mold and helical retractor are locked into position allows the device to be
counter-rotated, enabling re-alignment of the tissue mold that has been assertively
rotated into a corner, and opening up more space between the tissue mold and
gastric wall for safer fastener deployment.
NOTE: More aggressive tucking can be attempted by turning the device to the 8
or 9 o’clock position, AFTER placing the helix, but PRIOR to pulling the tissue to
the desired level. Once in position, the operator can pull the tissue to the desired
level and then rotate the tissue into the corner. However, the tradeoff here is that
more aggressive tucking or shoe horning can result in thicker tissue in the corner
and greater difficulty with placing fasteners.

As a further note on thickness of tissue and the use of the tissue invaginator, it has
been documented in a laparoscopic examination of patient who underwent the TIF
procedure that fasteners can be placed through the diaphragm and crus capturing
as much as a few cm from the edge of the crus. Such thickened tissue capture
may place considerable strain on the fasteners and cause a failure of the plication
in that area or possibly a small hole in the esophagus.

Excessive fastener stress is most likely a result of the close proximity of the
diaphragm, mediastinum and pleural space at the level of the GE junction, which
are probably at particular risk of being pierced by stylets and fasteners. If the
operator attempts to create a long flap valve by pulling the EsophyX device
cranially to move the stylet ports or if the operator tries to place fasteners far into
the corners (anatomically the posterior corner should pose the greatest risk given
its proximity to the deep sulci and the rights crus) and high above the z-line
increased fastener stress may occur. Whether working on the shallower fastener
placements at 1-2 cm above the z-line in the corner or on the deeper fastener
placement at 3 or more cm above the z-line, this risk should be substantially
minimized by using the tissue invaginator (waiting 30 – 60 seconds after engaging


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the invaginator) to advance the device and tissues into the abdomen a couple of
centimeters
NOTE: If the operator pulled the device out, as described above, in order to get
more length, then the goal should be to advance further into the abdomen than
the distance the device was withdrawn.

The device should slide the esophagus and the stomach over any diaphragmatic
tissue which should be stiffer and more anchored in place with the invaginator
engaged. In theory, the diaphragm remains in place while the desired esophageal
and stomach tissue is allowed to slide over it.
NOTE: This may not completely eliminate the capture of undesired underlying
structures and tissue, but it should leave only a thin portion of the edges of the
crus involved.

Avoid developing a false sense of security from simply observing the stylets
advancing into the lumen of the stomach but rather pay attention to analyzing the
anatomical position. This technique described above should aid the clinician in
avoiding trauma to and/or incorporation of the aforementioned critical structures
during the creation of the valve.

As a further safe guard against capturing too thick a portion of tissue, the stylet, in
typical deployments, should have 1/3 to 1/2 of the available travel distance visible
prior to placement of the fasteners. The more the stylet has to be advanced before
it is seen through all the tissue layers, the more likely the tissue captured is too
thick and may have a portion of the diaphragm or the crus involved.

Once in position, the anterior stylet (which is more easily seen as it is further
away from the corner) is advanced. If the tissue mold has been used to assertively
tuck tissue into the corner, counter rotation of the device (out of the corner) with
the tissue invaginator connected to suction may be needed to align the tissue
mold, so that the stylet exits through the opening in the tissue mold. The fastener
is then gently advanced over the stylet and deployed. In general, the operator will
experience resistance as the fastener is advanced through the tissue planes. Once
the fastener has begun to appear, the arrowhead tip of the stylet is retracted while
pressure is maintained on the fastener pusher. In this fashion, the fastener is
deployed over the stylet. At the very last, it may be helpful to push the fastener
out a little more as the stylet is retracted. The posterior stylet is advanced and the
fastener deployed following the same sequence of steps.

After the first two fasteners have been placed at 11 o’clock, the device is
reloaded. The helical retractor lock and suction are released, but the helical
retractor is left attached. The tissue mold is loosened slightly and the steps of the
procedure are repeated. The tissue mold is used to slide the tissue a little further
into the posterior corner or to gain a bit more length. Two additional fasteners are
then deployed in a slightly different position from the first set of fasteners. The


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result is that four fasteners have been placed: 2 firings at the 11 o’clock position
and two firings at the 11:30 o’clock position.

Anterior 1 o’clock Corner:

After releasing suction, the tissue mold and the helical
retractor are all released and the device is rotated
counterclockwise (screen view) to the 1 o’clock position.
A mirror-image of the posterior 11 o’clock engagement
and fastener deployment are performed (Figure 7). Figure 7. Anterior Corner
The anterior corner, number 1, is the
location for the 2nd helical retractor
placement at 1 o’clock

Esophagus-Greater Curve Side 4-5 o’clock:
The goal of this and the 7-8 o’clock engagement and deep fixation is to lengthen
the HPZ, increasing intra-abdominal esophageal length and recreation of the flap
valve mechanism.

The helical retractor is engaged within 5 mm of the z-line at roughly the 4 or 5
o’clock position (Figure 8). The tissue is then pulled caudally to move the z-line
below the stylet openings resulting in fasteners being placed 3-4 cm above the z-
line. The tissue mold is closed with continued downward tension on the helical
retractor and desufflation of the stomach. As the tissue mold is closed the device
may be counter-rotated (screen view) to tuck the tissues towards or up into the
corner. The amount of tissue engaged by the tissue mold may be significantly
more here than at the corners, and so very slow and deliberate advancement of the
H-fasteners may be required for successful deployment. (The H-fasteners are
elastomeric and can be stretched from 6mm up to
10 mm if done slowly). Two fasteners are deployed.
(Anatomic variations may allow for placement up to
4.5 cm above the z-line if done with caution.
Conversely, in early stage anatomical deterioration,
the external attachments may act to tether the tissue
somewhat resulting in a slightly reduced ability to pull
tissue.)

An alternative approach to gaining length is to pull the
EsophyX device cranially to move the stylet ports
proximal to the z-line placing fasteners 3-4 cm above
the z-line. Caution should be used at all times when
employing this technique, with consideration of the
structures immediately adjacent to the esophagus Figure 8. Anterior Deep
particularly while working in the corners. Moving Top: Helical retractor engaged in tissue
Bottom: 5 o’clock helical engagement
the device cranially and rotating into the corners illustrated
may increase the risk of traversing the pleural space


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with stylets and fasteners. Although very rare, there have been a few documented
cases of a pneumothorax and serosanguinous pleural effusion that may have
resulted from such maneuvers.

As outlined above, the operator should give careful consideration to thickness of
the tissue and the high placement of fasteners. The maneuver of using the tissue
invaginator to aid in pushing tissues away from the diaphragm after the tissue
mold has been closed and locked in place should be used on these deep fasteners
placements as well. (Refer to the 11 o’clock position section above.)

Esophagus-Greater Curve Side 7-8 o’clock:
This is a mirror-image of the 4 or 5 o’clock
engagement and deep fastener placement. During
this part of the procedure the helical retractor is placed
at the 7-8 o’clock position and the movement of tissue Figure 9. Posterior Deep
(if done) is towards the posterior corner (Figure 9). The posterior engagement is placed at
7 o’clock on the posterior side of
midline (6 o’clock)

6. ADVANCED CONSIDERATIONS
6.1.Starting Corner (Initial Engagement Site)

The decision to begin at the posterior or anterior corner is user dependent. The
posterior corner appears to be the more difficult corner to visualize and many
operators will begin here in order to get it out of the way. The posterior corner
appears to typically have more tissue mobility than the anterior corner and
changes made here help give the operator a quick reference point for the
remainder of the procedure.

The anterior corner is the more difficult corner for tissue mobilization and tissue
mold alignment for fastener delivery. The short gastric vessels seem to tether the
fundus on this side. The heart is nearby and can decrease operative space and
present another ‘wall’ to the tissue mold. These factors can sometimes affect the
overall shape of the plication, resulting in some puckering in or near this corner
behind the esophagus along the lesser curvature, if the posterior corner is done
first. The tucking maneuvers described for gaining access to the corners may
reduce this puckering. In addition, the following strategies may be considered.

1. ‘Alternate Starting Point’: Starting in the anterior corner may avoid
problems with puckering
2. ‘Prepping the Anterior Corner’: Starting in the anterior corner with a
preparatory fastener, the posterior corner and both deep fixations are
completed. The operator returns to the anterior corner as the last step
in the procedure


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3. ‘Castle Walling the Corners’: Sequential firings of fasteners building
upon previous fixations can be used to move the buildup
progressively into the corners

In all three options, the goal is to pull, or cinch up the tissue in the area to
minimize or eliminate the puckering gap if possible. Notably, the majority of
cases progress smoothly regardless of which corner is chosen to start.

For the deep fixation sequence at 5 o’clock, the operator may choose to rotate the
stomach tissue towards the 3 o’clock position or the anterior corner PRIOR to
fastener deployment, to try and to recreate a sling effect at this upper margin of
the neo-valve. The corollary to traditional fundoplication would be the placement
of multiple sutures in a line at the margins of the wrap (e.g. Toupet). However,
the TIF2 procedure is not a ‘wrap’ in the truest sense, but a recreation of the
anatomic flap valve through the recreation of the angle of His. As such, deep
tissue movement at these positions may not contribute much to the overall
function of the neo-valve.

Additionally, the further the operator turns the device into the corner, the more
likely that the fasteners will incorporate a portion of the phrenoesophageal
ligament. The benefit would be to decrease tension on the corner fasteners.
However, these deep fasteners will be placed through thicker tissue and will be
under more tension.

6.2.Fastener Deployment

A challenging aspect of the TIF2 procedure is the deployment of the H-shaped
fasteners. Proper fastener deployment necessitates the flat apposition of the
trailing leg of the fastener against the internal mucosa of the esophagus. The
leading leg rides the stylet through the esophageal and gastric walls and then
opens up to lie flat against the stomach mucosa.

The mechanics of fastener deployment involve the trailing leg catching onto the
wall of the esophagus and applying a pulling force on the leading leg of the
fastener. On occasion this tension is great enough that the leading leg is pulled
off the stylet once enough of the leading leg has passed through all layers of
tissue. However, in the majority of cases, more consistent fastener delivery is
obtained by pushing the fastener pusher until the tip of the leading leg is seen
endoscopically. At this point, the pusher is held in place putting constant tension
on the leading leg while the stylet is pulled back. The majority of the stylet wire
is cylindrical, and the slot in the leading leg allows the fastener to travel over the
stylet like a monorail car on its track. However, the tip of the stylet is a flat
spearhead blade, and when the leading leg comes over this head the leading leg
derails, allowing it to rotate and flatten.


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Many operators have found that pushing too fast or too hard on the fastener makes
it more prone to ‘misfires’ or, potentially, breakage of the fasteners. The
mechanics of delivery are such that the operator faces first an increase in
resistance as the fastener starts to follow around a fairly sharp corner in the shaft
just prior to exiting the device. The fastener is almost perpendicularly facilitating
passage through the tissue layers. A second high resistance point is encountered
as the fastener attempts to follow the track of the stylet through the tissue planes.

Standard practice is to brace the fingers that are deploying the fasteners so that
any sudden gives in resistance do not result in uncontrolled rapid fastener
deployments. This is analogous to introducing a trocar into the abdomen, bracing
against sudden gives in resistance.

An alternative approach to fastener deployment has been introduced by Dr. Blair
Jobe. Dr. Jobe’s, shuffle technique, relies on the stiffness of the stylet to aid in the
transport of the fastener around the bend. The fastener delivery is best described
in a stepwise fashion:

Step 1: Carefully and safely deploy stylet
Step 2: Advance pusher until the first level of resistance (usually due to
the fastener entering the curved area of the channel)
Step 3: Retract the stylet 2-3 mm without completely removing the stylet
from the tissue
Step 4: Advance the stylet and fastener pusher forward together 2-3 mm
Step 5 Repeat steps 3 and 4 until the tip of the fastener is seen on the
screen at which point pressure on the fastener is maintained and
the stylet is retracted until the fastener flips into position

This method substantially decreases the amount of resistance felt during fastener
deployment as the fastener moves through the corner of the stylet channel and the
tissue itself. In addition, the repetitive movement of the stylet back and forth
through the tissue may help to dilate and increase the pliability of the tissue track
that the stylet is making in the tissue resulting in easier travel of the leading
through the tissue planes.

As with the delivery method described above, more consistent fastener delivery is
obtained by holding the fastener pusher in place and maintaining constant
pressure while the stylet is pulled back as soon as the tip of the fastener’s leading
leg is seen. Alternatively, once the fastener tip begins to appear a slower
deployment can be obtained by positioning the arrowhead tip of the stylet to be
just visible at the outer edge of the tissue mold. At this point, millimeter by
millimeter, the shuffle maneuver is continued slowly until the fastener deploys.

Due to the elastomeric material of the fasteners slow deliberate pressure can
stretch the middle web, between the leading and trailing, from 6 mm legs to


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almost twice the distance. The rate of deployment must be very slow to avoid
breaking or pulling the entire fastener through all layers of the tissue. The
fastener stretches at a rate of approximately 2 mm per minute. Therefore, unless
care is taken, the operator may experience a higher rate of misfires. Another
possible consequence of more aggressive positioning into the corners is that tissue
bulking is more apt to cause misalignment of the tissue mold with the chassis
resulting in the stylets striking or bumping the tissue mold preventing proper
deployment of the stylets until the alignment has been corrected.

6.3.Completion of the Procedure

The resultant TIF2 valve, as depicted in Figure 10, has
fasteners > 1 cm above the z-line at the anterior and
posterior corners (1 and 11 o’clock on retroflex view).
The deep fasteners are > 3cm above the z-line towards
the greater curvature (5 and 7 o’clock on retroflex view).
Prior to device removal, the tissue mold and suction
are released, the helical retractor loosened and
brought back to the safe home position. The tissue
mold is straightened out under direct endoscopic vision
and the EsophyX device pulled back into the esophagus.

Prior to completely removing the device, the operator
can choose to ‘park’ the EsophyX device in the mid
esophagus and re-introduce the scope into the stomach
in order to evaluate the repair in the retroflexed position.
From this vantage the operator can determine if there are
any additional areas that should be addressed. Any
bleeding sites should be evaluated and managed as needed.

Endoscopy will also reveal the level of the fasteners above
the z-line as shown in Figure 10. The distal fasteners seen
correspond to the fasteners placed in the anterior and
posterior corners. The proximal fasteners, approximately Figure 10. Completed Repair
3 cm above the z-line, relate to the fasteners placed along Top: Completed neo-valve seen from
stomach lumen with long, deep anterior
the anterior edge of the valve. Any lacerations in the wall
Bottom: Completed neo-valve seen from
stomach or esophagus can be evaluated and if present, esophageal lumen showing deep fasteners
managed appropriately (e.g. endoclip, epinephrine, higher on the esophageal wall (foreground)

fibrin glue, contrast study, antibiotics, limiting
oral intake, prolonged observation).

6.4.Use of the Z-line Window

The z-line window aids the operator in seeing the z-line when it is not readily
visualized from the retroflexed scope view. Most often this will be seen in


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conjunction with a hiatal hernia that was not reduced during introduction of the
device. In the majority of cases, the z-line is readily seen and reduced partially
due to the drag of the esophagus along with the device due to its relatively large
size (18 mm diameter).

When initially designed, the z-line window was meant to precisely place the stylet
openings, which sit at the distal edge of the window, at the level of the z-line. An
alternative is to employ the segmentation of the chassis of the device to gauge
tissue length as each of the main segments is approximately 1 cm in length. This
works very well as a visual reference point during the procedure.

In cases where the z-line cannot be seen, the z-line window can help the operator
to identify the squamocolumnar junction (SCJ). Once identified, the SCJ can be
placed at the proximal edge of the window. With the aid of the tissue invaginator
the operator can advance the SCJ back towards the operative area in the stomach.
Typically, this maneuver will position the tissue mold just above the lip; thus,
facilitating placement of the helical retractor. Once the helical retractor has been
engaged, the invaginator can be shut off allowing the operator to pull the tissue to
the desired length. At which point, the invaginator can be used as described
above.

7. SPECIAL CONSIDERATIONS
7.1.Loss of Insufflation

Insufflation is the key to good visualization of the operative field. The operator
should be prepared to ferret out the source of problems with insufflation.
Occasionally the insufflation port of the endoscope or the water reservoir of the
endoscopic may not be functioning and/or connected properly.

However, the source may at times be related to the EsophyX device and/or the
TIF2 procedure. In particular, care should be taken to make certain that the
stopcock at the end of the suction tubing to the invaginator holes is not open to air
or venting to reduce the chance that the holes are acting as a bypass for air.

Further, the inherent rigidity of the device with its inner braided shaft offers the
operator good torque response for performing the procedure. This same braided
shaft may be a source of minor gaps between the device and the esophageal
opening in cases where the device is excessively bent at the mouth of the patient.
On occasion, the operator can encounter loss of esophageal seal by repositioning
the device at the SCJ and making certain that excessive bending or tortuous
manipulation of the device outside of the patient is avoided as these movements
may be translated distally due to the ‘stiffness’ of the device.


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Several operators have moved to using a secondary insufflation source such as a
laparoscopic CO2 insufflator through the working channel of the scope. Pressures
of 15-18 mm may be used with moderate to high flow rates; however, there is an
increased risk of pneumoperitoneum or pneumomediastinum with these pressures.
A ‘benign’ pneumoperitoneum has been described by experienced operators.
Although typically benign, these findings should not simply be ascribed to the
insufflation and should be evaluated thoroughly. Carbon dioxide insufflation
appears to prevent some post-operative gas related pains.

7.2.Bleeding

Occasionally bleeding may occur at the site of fastener placement or helical
retractor engagement. In all cases of bleeding the first maneuver would be to hold
pressure with the tissue mold. The tissue mold itself should be tightened and held
in place without movement for a period of at least 5 to 10 minutes. The majority
of bleeding should be controlled in this fashion. However, if bleeding can not be
controlled after a reasonable amount of time using this maneuver, the use of
endoscopic clips is advocated. Additional endoscopic hemostatic techniques
(injection, argon plasma coagulation, etc) are available. Fibrin glue and
epinephrine have been used successfully in a limited number of cases. Patients
who develop brisk arterial bleeding may require endoscopic clipping and should
be watched carefully for post operative recurrence of bleeding, especially in the
seven to ten days post procedure. Hemostatic control with plasma coagulation
has not been reported to date following TIF, and should therefore be used with
caution.

7.3.Laryngeal and Esophageal Perforation

Although very rare, there have been three documented cases of esophageal
perforation at the cervical level greater than 1,500 cases worldwide. Generally,
these were felt to be due to excessive force being used to introduce the device
particularly at the critical juncture of where the tip of the device is navigating the
bend in the oropharynx. Care should also be taken with the introduction of the
device into the patient.

Safe insertion of the EsophyX device has been demonstrated in nineteen pediatric
patients. Despite this, there have been cases of esophageal perforations. Another
potential for perforation exists during fastener deployment. This can occur by
multiple blank firings with the pusher through the same stylet deployment or
positions close to the initial deployment. Once a blank fastener deployment has
occurred, loosening of the tissue mold and repositioning should occur to avoid
firing in the same area twice.


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Potential maneuvers that may aid in safe introduction of the device are the
following:
1. Jaw thrust or mandible lift
2. Left lateral decubitus positioning of the patient (generally the position of
choice for the operation)
3. Digital assistance of the tip of the device by the operator
4. Bougie dilator of 56-60 Fr introduced prior to the device (as described above)


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8. REFERENCES

1. Cadiere GB, Buset M, Muls V, et al. Antireflux transoral incisionless
fundoplication using EsophyX: 12-month results of a prospective multicenter
study. World J Surg 2008;32:1676-1688
2. Cadiere GB, Rajan A, Germay O, Himpens J. Endoluminal fundoplication by a
transoral device for the treatment of GERD: A feasibility study. Surg Endosc
2008;22:333-342
3. Cadiere GB, Van Sante N, Graves JE, Gawlicka AK, Rajan A. Two-year results
of a feasibility study on antireflux transoral incisionless fundoplication (TIF)
using EsophyX. Surg Endosc 2009;23:957-964
4. Jobe BA, O'Rourke RW, McMahon BP, et al. Transoral endoscopic
fundoplication in the treatment of gastroesophageal reflux disease: the anatomic
and physiologic basis for reconstruction of the esophagogastric junction using a
novel device. Ann Surg 2008;248:69-76


Confidential 17

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