E x t r a l u m i n a l A p p ro a c h e s

t o G a s t ro e s o p h a g e a l
Reflux Disease
James M. Tatum, MDa, John C. Lipham, MDb,c,*

KEYWORDS
 GERD  LINX  Magnetic sphincter augmentation  Fundoplication  EndoStim

KEY POINTS
 Before considering surgical therapy of gastroesophageal reflux disease, it is incumbent on the sur-
geon to confirm the presence of pathologic reflux, adequate esophageal motility, and the absence
of other explanatory or complicating esophageal or gastric diseases.
 The gold standard extraluminal surgical intervention for gastroesophageal reflux disease is com-
plete or partial gastric fundoplication of the esophagus and hiatal hernia repair.
 Novel modalities, including the LINX and EndoStim, offer less invasive and perhaps equivocal or
even superior alternatives to fundoplication in appropriately selected patients.

INTRODUCTION now a nearly universally laparoscopic procedure.

Options for fundoplication include the complete
The surgical treatment of gastroesophageal reflux or partial fundoplication as well as the maturing
disease (GERD) has been one of the great suc- extraluminal magnetic sphincter augmentation de-
cesses of laparoscopy in the past decades, even vice and the experimental lower esophageal
in the face of major advances in the medical ther- sphincter (LES) stimulation device. In addition to
apy of the condition. The obesity epidemic and a host of procedures to address the tone of the
modern behavioral vices make reflux a disease of LES, understanding the importance of the hiatus
relatively high prevalence (between 3% and in the physiology of antireflux surgery is of tanta-
33%), which coupled with growing concerns of mount importance.2,3
the side effects of popular proton pump inhibitors
used to treat the symptoms of the disease make
DIAGNOSTIC STUDIES
surgical intervention both attractive to and indi-
cated for patients with GERD.1 GERD typically presents with well-known symp-
The surgical therapies available to treat GERD toms of water-brash, regurgitation, and pyrosis
have evolved and multiplied over the past de- or dysphagia. Atypical symptoms and complaints
cades. The gastric fundoplication, once performed are also common, including vomiting, chronic
through a thoracic or open transabdominal cough or laryngitis, and even serious lung or sinus
approach has become in all but the most compli- diseases. Some combination of these symptoms
cated cases a transabdominal procedure, and is sensitive but not specific for reflux disease.

Disclosure: Dr J.M. Tatum has nothing to disclose. J.C. Lipham is a paid consultant for Johnson & Johnson
Corporation.
thoracic.theclinics.com

a
Department of Surgery, Division of General and Laparoscopic Surgery, Keck School of Medicine, University of
Southern California, 1450 San Pablo Street HCC 4, Suite 6200, Los Angeles, CA 90033, USA; b Division of Gen-
eral Surgery, Keck School of Medicine, University of Southern California, 1450 San Pablo Street HCC 4, Suite
6200, Los Angeles, CA 90033, USA; c Division of Minimally Invasive Surgery, Keck School of Medicine, University
of Southern California, 1450 San Pablo Street HCC 4, Suite 6200, Los Angeles, CA 90033, USA
* Corresponding author. 1450 San Pablo Street HCC 4, Suite 6200, Los Angeles, CA 90033.
E-mail address: John.Lipham@med.usc.edu

Thorac Surg Clin 28 (2018) 521–526

https://doi.org/10.1016/j.thorsurg.2018.07.003
1547-4127/18/Ó 2018 Elsevier Inc. All rights reserved.
Downloaded for Anonymous User (n/a) at Bezmialem Vakif University from ClinicalKey.com by Elsevier on January 03,
2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
522 Tatum & Lipham

The diagnosis of reflux disease requires several increasing the pressure of the LES through the cre-
key diagnostic studies. We routinely use 4 diag- ation of a gastric fundoplication of the distal
nostic studies. An upper endoscopy (EGD) is key esophagus. These tasks may be accomplished
to rule out malignant or anatomic defects of the by multiple approaches.
esophagus or stomach as well as to visualize the
distal esophagus and facilitates biopsy of poten- Thoracic Approach
tially metaplastic or dysplastic tissue. While con-
The primary benefit of the thoracic approach is
ducting the EGD, the second test, a pH study is
that it allows virgin access to the gastroesopha-
facilitated when a detachable 48-hour to 96-hour
geal junction (GEJ) in patients having undergone
pH probe is left on the esophageal wall providing
multiple or complicated prior abdominal surgeries.
a measurement of esophageal acid exposure.
The trans-thoracic fundoplication is accomplished
We primarily use the video esophagogram (VEG)
through a thoracotomy or video-assisted thoraco-
to assess motility of the esophagus and as the
scopic surgery via the left chest. In this procedure,
most sensitive study to diagnose and assess the
the mid to distal esophagus is mobilized, hiatal
size of hiatal hernia, particularly those that are
hernia is reduced, a partial 270 fundoplication is
small.4 The fourth routine study is esophageal
performed, and the hiatus is closed. An esopha-
manometry to formally characterize esophageal
geal lengthening procedure may occasionally be
motility. Rarely, a symptomatic patient will have
required.
symptoms consistent with reflux or other esopha-
geal dysmotility disorder, which results in equiv-
Open Abdominal Approach
ocal or negative DeMeester score, in which case
we pursue impedance studies, particularly in With the proliferation of complex laparoscopic
cases in which we suspect alkaline reflux. In pa- skills, rarely is an open approach to fundoplication
tients with questionable motility on VEG or indicated outside of the complex reoperation with
manometry, we advocate partial fundoplication. prohibitive adhesive disease, on occasion of an
Patients with nausea and vomiting as the predom- indication for fundoplication coexisting with an in-
inant symptoms merit a nuclear medicine gastric dependent indication for laparotomy or in a patient
emptying study to assess for gastroparesis. Fail- who will not tolerate laparoscopy.
ure to adequately diagnose poor gastric emptying
or an occult esophageal motility disorder can Laparoscopic Abdominal Approach
result in disastrous outcomes for the patient and
The preferred and most common approach to
surgeon.
accomplishing both primary and redo fundoplica-
In patients with a DeMeester score of greater
tion is the laparoscopic approach. Not only does
than 14.72, anatomically normal EGD without can-
a laparoscopic approach result in less pain, but it
cer, and a VEG with adequate motility, we offer a
facilitates earlier return to function and discharge
complete fundoplication or magnetic sphincter
and is more economical.6 The real benefit of lapa-
augmentation. In patients with impaired motility
roscopic surgery is that it allows better and more
we offer a partial fundoplication, preferentially the
complete visualization of the hiatus, GEJ, and pos-
posterior 270 wrap. As discussed later, in the
terior mediastinum than an open abdominal or
most complex patients we consider a Roux-en-Y
thoracic approach. The CO2 pneumoperitoneum
procedure.
also aids in the reduction of the hiatal hernia
from the thorax, and if the pleura are violated dur-
FUNDOPLICATION ing hernia reduction, the resulting pneumothorax
rarely if ever requires a painful tube thoracostomy.
GERD is a result of an incompetent LES that re-
Any of the variety of anterior or posterior partial or
sults in transient or basal low LES tone.5 This
complete anterior fundoplication procedures may
incompetence is primarily the result of a weak
be accomplished by this approach depending on
lower esophageal smooth muscle tone, and is
motility, associated anatomy, and procedures
contributed to by a laxity of the diaphragmatic
and surgeon or patient preference.
crural or a hiatal hernia.2,3 The object of the fundo-
plication, regardless of approach or degree is to
Robotic Fundoplication
restore competence of the LES while still allowing
successful bolus transport into the stomach. Although a robotic approach to fundoplication has
A fundoplication procedure requires the been described, we have not found a place for it
reduction of any hiatal hernia, tightening of the dia- in the practice of an advanced laparoscopic sur-
phragmatic crura, return of an appropriate length geon. Indications and limitations parallel those of
of esophagus into the abdominal cavity, and laparoscopy.

Downloaded for Anonymous User (n/a) at Bezmialem Vakif University from ClinicalKey.com by Elsevier on January 03,
2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
 Extraluminal Approaches to GERD 523

Redo Antireflux Surgery efficacy.9,10 The larger trial is multicenter and

multinational with 44 patients followed to 6 months
Redo antireflux surgery is frequently considered in
with incidence of pH <4.0 reduced from 10.0% to
the face of a disrupted or failed gastric fundoplica-
3.8% after 3 months and to 4.4% at 6 months
tion or recurrent hiatal hernia. The same diagnostic
(P 5 .0001). Complications have been reported,
studies as indicated for first-time surgery are indi-
including bowel injury during placement, and
cated before a second or redo fundoplication sur-
erosion and dysphagia in cases of simultaneous
gery, particularly if a significant amount of time
hiatal hernia repair.10
has passed. Operative notes from the previous sur-
The EndoStim may in time prove to be a
geries are helpful, as they can describe if any and
reasonable therapy in patients with impaired
what type of mesh may have been placed at the hi-
motility, inability to tolerate a prolonged or major
atus. Serious consideration of referral to an experi-
operation, or other contraindication for alternative
enced foregut surgical specialist should be
antireflux surgery or as a less invasive therapy for
considered by those who are not familiar with the
patients not desiring more invasive antireflux sur-
difficulty of redo surgery at the hiatus and in any pa-
gery who demonstrate only a partial response to
tient who had prior mesh placement at the hiatus.
pharmacologic therapy.11 Studies are not avail-
able on long-term efficacy, impact on metaplasia,
DIVERTING PROCEDURES FOR THE or the rate of recurrence of a hiatal hernia repaired
TREATMENT OF REFLUX DISEASE at the time of implantation. We would advise
The Roux-en-Y gastric bypass (RYGB) treats caution in the implantation of this device in the
GERD through a different strategy than proced- setting of simultaneous hiatal hernia repair
ures augmenting the GEJ. Rather than retarding (Box 1, Fig. 1).
the reflux of caustic enteric and gastric secretions,
the RYGB diverts the secretions from their origin
Box 1
into the more distal enteric tract. RYGB should Enrollment criteria for ongoing EndoStim
be considered in several population of patients: device trial (NCT02749071)
(1) those with a body mass index of greater than
35 kg/m2 owing to their high rates (31%) of failure Inclusion criteria
after fundoplication surgery,7 (2) those with very  Age 22 to 75
poor or absent esophageal motility, (3) those pre-
 Gastroesophageal reflux disease (GERD)
viously having complicated fundoplication surgery symptoms of 6 months duration that are not
not amenable to redo, and (4) those with a history completely treated with medical therapy
of sleeve gastrectomy with intractable reflux.
 Documented symptomatic improvement on
medical therapy
ELECTRICAL AUGMENTATION OF THE LOWER
ESOPHAGEAL SPHINCTER  Documented excessive esophageal acid expo-
sure off of medical therapy
Currently undergoing Food and Drug Administra-  Esophagitis  Los Angeles Grade B
tion (FDA) trials after approval in Europe and South
 Adequate esophageal body contraction
America is the EndoStim System (EndoStim, amplitude (>30 mm Hg for 30% of swallows
St. Louis, MO). This device consists of a and 30% peristaltic contraction on high-
pacemaker-type generator that is implanted in a resolution manometry, or 30% peristaltic
subcutaneous pocket in the abdominal wall with contraction with distal contractile index >450
2 implantable bipolar electrodes that are sutured  Suitable surgical candidates
superficially through the muscular layer of the
distal esophagus approximately 1 cm apart. The Key exclusion criteria
device generates a periodic electrical charge be-  Previous procedure for GERD
tween the electrodes, stimulating the LES and
 Hiatal hernia >3 cm as determined by
increasing resting sphincter tone.8 The device endoscopy
can be programmed by the physician in clinic, as
would be a cardiac pacemaker device. The device  Esophageal stricture or significant dysmotility
battery is expected to last between 7 and 10 years Data from EndoStim Inc. An investigation on the En-
depending on device type and use, at which time doStim lower esophageal sphincter (LES) stimulation
the battery may be changed during an outpatient system for the treatment of reflux. In U.S. National
Library of Medicine, Clinicaltrial.gov. Available at:
surgical procedure. https://clinicaltrials.gov/ct2/show/NCT02749071/. Ac-
Two trials have been published on the system. cessed January 26, 2018.
Results of the 2 published trials show similar

Downloaded for Anonymous User (n/a) at Bezmialem Vakif University from ClinicalKey.com by Elsevier on January 03,
2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
524 Tatum & Lipham

outcome after MSA implantation is dysphagia. In

initial studies, the preoperative dysphagia rate
was 6%. Postoperatively the rates of dysphagia
in the immediate postoperative, 1-year, and
5-year time points was 68%,11%, and 5%,
respectively. In this study 19 (19%) of 100 patients
required dilatation during the postoperative year.16
We believe that the incidence of dysphagia can
be minimized through careful attention to not under-
sizing the device at time of implantation and careful
patient selection, with a mind to the fact that pa-
tients with prominent atypical symptoms, particu-
larly nausea and vomiting or laryngeal/pharyngeal
symptoms, especially those with a potential psychi-
atric component, should be considered carefully
and preoperative studies examined strictly before
consideration of MSA implantation in the face of
any concern. However, the duration of most
Fig. 1. EndosStim generator with leads attached. dysphagia is short and with thorough preoperative
Figure illustrating placement of leads 1 cm apart at counseling, well tolerated by most patients. It is
the GEJ. (Ó2018 EndoGastric Solutions, Inc. Redmond, important to make it clear to patients that for several
WA, USA.) days to weeks after surgery they will predictably
experience mild dysphagia that typically resolves.
MAGNETIC SPHINCTER AUGMENTATION There is also growing evidence that the MSA de-
DEVICE vice can be successfully used simultaneously in
the treatment of hiatal hernia of at least 7 cm in
The magnetic sphincter augmentation device size. We recently published a study of 47 patients
(MSA) is indicated as an alternative to the complete with 89% follow-up at 19 months with 89% of pa-
gastric (Nissen) fundoplication. The device consists tients remaining off pharmacologic therapy and
of a band of rare earth magnets that are encased in only a 4.3% recurrence rate.17 Further study on
titanium, each of which is connected with a discon- the success and safety of the MSA in more com-
tinuous segment of titanium wire to the adjacent plex situations, including implantation at the time
beads. When closed around the GEJ, the MSA de- of large hiatal hernia repair, after failed fundoplica-
vice increases the yield pressure of the LES/GEJ tion with intact wrap, and in patients with reflux
preventing pathologic reflux while still allowing the following sleeve gastrectomy is needed, and
passage of solid or liquid bolus without inducting ongoing by our group and others (Box 2, Fig. 2).
dysphagia and allowing the retrograde passage of
gas and vomit, preventing gas-bloat or intractable Box 2
retching sometimes so troublesome to those having Indications and contraindication for LINX
undergone complete fundoplication. magnetic sphincter augmentation
Studies on the initial cohort of patients in a multi-
Indications
center trial seeking FDA device approval showed
excellent outcomes after MSA device implanta-  Patients who seek an alternative to contin-
tion; 93% of patients will reduce proton pump in- uous medical acid suppression therapy to
treat the symptoms of GERD.
hibitor dosing by at least 50%, and decrease in
esophagitis from 40% to 12% with high patient Key contraindications
satisfaction.12 Follow-up of this cohort at 5 years  Allergy to titanium, stainless steel, ferrous
with 85% (85/100) continued to show cessation metals, or nickel
or significant reduction (>50%) in 90% of pa-
 Likely or known need for MRI scan in a
tients.12 There was also a significant reduction in
machine of greater than 0.7 to 1.5 T depend-
the prevalence and significance of esophagitis. ing on generation of magnetic sphincter
The placement of a foreign body in any part of augmentation device
the body, particularly near soft tissue is a proposal
requiring careful consideration. Device erosion has Data from Torax Medical Inc. Indication, safety and
warnings [Linx]. In: Commercial Linx Web site.
been rare in initial studies at 0.2%, and was 0.1% Available at: http://www.linxforlife.com/abridged-
in the analysis of the first 1000 cases reported statement. Accessed January 26, 2018.
in the literature.13–15 The primary concerning

Downloaded for Anonymous User (n/a) at Bezmialem Vakif University from ClinicalKey.com by Elsevier on January 03,
2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
 Extraluminal Approaches to GERD 525

gastro-oesophageal reflux disease (GORD) in

adults. Cochrane Database Syst Rev 2015;(11):
1–53.
2. Mittal RK, Balaban DH. The esophagogastric junc-
tion. N Engl J Med 1997;13:924–32.
3. Kahrilas PH, Lin S, Chen J, et al. The effect of hiatus
hernia on gastro-oesophageal junction pressure.
Gut 1999;4:476–82.
4. Tatum JM, Samakar K, Bowdish ME, et al. Videoeso-
phagography vs. endoscopy for prediction of
intraoperative hiatal hernia size. Am Surg 2018;
84(3):387–91.
5. Holloway RH, Dent J. Pathophysiology of
gastroesophageal reflux. Lower esophageal
sphincter dysfunction in gastroesophageal reflux
disease. Gastroenterol Clin North Am 1990;19:
517–35.
6. Richards KF, Fisher KS, Flores JH, et al. Laparo-
scopic Nissen fundoplication: cost, morbidity, and
Fig. 2. The LINX device consists of a variable number outcomes compared with open surgery. Surg Lapa-
of titanium beads each encasing a rare earth magnet. rosc Endosc 1996;2:140–3.
The device provides dynamic and static augmentation 7. Perex AR, Moncure AC, Rattner DW. Obesity
of the LES yield. (Courtesy of Torax Medical, Shore- adversely affects the outcome of antireflux surgery.
view, MN. Available at: http://www.linxforlife. Surg Endosc 2001;9:986–9.
com/dist/images/linx-device-full-closed-grey.jpg; with 8. Crowell MD. Implanted electrical devices and
permission.)
gastroesophageal reflux disease: an effective
approach to treatment. Expert Rev Gastroenterol
SUMMARY
Hepatol 2013;3:189–91.
A multitude of extraluminal therapies exist for 9. Rodriguez L, Rodriquez P, Gomex B, et al. Long-
GERD. The choice of the correct procedure term results of electrical stimulation of the lower
should depend as much on the surgeon’s exper- esophageal sphincter for the treatment of gastro-
tise as patient preference. In a patient with no esophageal reflux disease. Endoscopy 2015;8:
prior surgical intervention, the gold standard re- 595–604.
mains a fundoplication. In these straightforward 10. Kappelle WF, Bredenoord AJ, Conchillo JM, et al.
patients there is now sufficient evidence to Electrical stimulation therapy of the lower esopha-
recommend an MSA if placed by a surgeon with geal sphincter for refractory gatro-oesophageal re-
experience in the procedure as well as its postop- flux disease—interm results of an international
erative management. The MSA offers similar multicenter trial. Aliment Pharmacol Ther 2015;5:
reflux control when compared with the Nissen 614–25.
with the added benefit of retained ability to vomit 11. Soffer E, Rodriquez L, Rordriguez P, et al. Effect
and belch with the potential for better long-term of electrical stimulation of the lower esophageal
(10 yr1) results; however, this has yet to be sphincter in gastroesophageal reflux disease
shown. The Toupet procedure remains a viable patients refractory to proton pump inhibitors.
option for both those with or without impaired World J Gastrointest Pharmacol Ther 2016;1:
esophageal motility. 145–55.
Looking to the future, we suspect that the Endo- 12. Ganz RA, Peters JH, Horgan S, et al. Esophageal
Stim may find a place in the treatment of GERD; sphincter device for gastroesophageal reflux dis-
what that place is remains unclear at the present ease. N Engl J Med 2013;368:719–27.
time. An area of growing interest is the treatment 13. Lipham JC, Taiganides PA, Louie BE, et al. Safety
of GERD following sleeve gastrectomy. We believe analysis of first 1000 patients treated with mag-
that the MSA device may prove of particular utility netic sphincter augmentation for gastroesopha-
in this clinical situation, as may revision to RYGB. geal reflux disease. Dis Esophagus 2015;4:
305–11.
14. Bielefeldt K. Adverse events after implantation of a
REFERENCES
magnetic sphincter augmentation device for gastro-
1. Garg SK, Gurusamy KS. Laparoscopic fundopli- esophageal reflux. Clin Gastroenterol Hepatol 2016;
cation surgery versus medical management for 10:1507–8.

Downloaded for Anonymous User (n/a) at Bezmialem Vakif University from ClinicalKey.com by Elsevier on January 03,
2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
526 Tatum & Lipham

15. Asti E, Siboni S, Lazzari V, et al. Removal of the mag- gastroesophageal reflux. Clin Gastroenterol Hepatol
netic sphincter augmentation device. Ann Surg 2016;5:671–7.
2016;265:941–5. 17. Rona KA, Tatum JM, Zehetner J. Hiatal hernia recur-
16. Ganz RA, Edmundowicz SA, Taiganides PA, et al. rence following magnetic sphincter augmentation
Long-term outcomes of patients receiving a and posterior cruroplasty: intermediate-term out-
magnetic sphincter augmentation device for comes. Surg Endosc 2018;32(7):3374–9.

Downloaded for Anonymous User (n/a) at Bezmialem Vakif University from ClinicalKey.com by Elsevier on January 03,
2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.