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7 Novel Endoscopic Antireux Procedures: Do They Have aRole inPatients
Fig. 7.8 Retrograde view of the displaced fundoplication, revealing laxity around the shaft of the
endoscope. This is not amenable to endoscopic repair and a revisional surgery is needed
113
7.2.5 Obesity
Patients with morbid obesity have been excluded from EART trials and data on
efcacy and safety are scant. In general, if a patient with GERD is a candidate
for anti-obesity surgery, the performance of Roux-en-Y bypass is the best surgical option. Sleeve gastrectomy is less likely to be associated with complete control of GERD symptoms, but if such symptoms occur postoperatively,
radiofrequency therapy of EGJ is feasible and effective [11]. Regardless of the
choice of invasive therapy, endoscopic or surgical, peri-operative morbidity is
high in obese patients and needs to be considered and balanced against the
anticipated gains.
7.2.6 Extra-Esophageal Symptoms
The efcacy of EART in controlling extra-esophageal symptoms—particularly if
such symptoms occur in the absence of typical GERD—has not been adequately
explored and more data is needed. Non-cardiac chest pain, cough, asthma, recurrent
hoarseness and dental erosions, are less responsive to pharmacologic, endoscopic or
surgical interventions. Prior proof that GERD is inducing such symptoms is
generally advised in order to maximize gains.
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7.3 Endoscopic Anti-Reux Therapies (EART)
Currently, there are four EART options available for patients with GERD.
Radiofrequency therapy of GEJ (Stretta) used for over 15years has the best longterm data [12]. The transoral fundoplication (TF) device creates molding of the GEJ
through endoscopic placement of polypropylene suture material; its short-term efcacy and safety have been recently demonstrated in controlled clinical trials. The
MUSE™ endoscopic stapling system is a recent technique that creates an endoscopic partial fundoplication under ultrasound guidance, but clinical data is still
scant. More recently, the use of conventional endoscopic dissection tools to perform
anti-reux mucosectomy (ARMS) has been reported from Japan [13].
The presence of a sliding hiatal hernia plays an important role when selecting
EART. Since Stretta treats the intrinsic LES muscle without interfering with the
crural diaphragm element of the anti-reux mechanism, the dissociation of the two
in the setting of a hernia longer than 2cm serves as a contraindication for the procedure since the treated area will remain above the diaphragm, possibly creating an
acid pocket effect (Fig.7.9). Radiofrequency therapy may be most helpful in those
with TLESR as the cause of their reux. The same is probably true for ARMS,
although we do not have enough information on this issue. Since they create a partial valvular structure at the GEJ, both TF and MUSE may be feasible and effective
in patients with <3 cm hernias that, during the procedure, can be stretched and
mobilized aborally, but more data will be needed on their durability in such patients.
Fig. 7.9 Antegrade view
of a <2cm sliding hiatal
hernia that could be treated
with EART
7 Novel Endoscopic Antireux Procedures: Do They Have aRole inPatients
115
Since many open and controlled studies and recent reviews have addressed the
safety, efcacy and durability of EART, the discussion below focuses on the specifics of these procedures in patients with Hill grades I and II and sliding hiatal hernias
<3cm. It is with such understanding that a balanced decision towards endoscopic or
surgical therapy can be made, aiming at optimizing clinical outcomes, particularly
in the long-term.
7.3.1 Radiofrequency Treatment oftheEGJ (Stretta)
Radiofrequency energy delivery to the EGJ muscle (Stretta) has been used extensively and has long-term data (10years) (Fig.7.10) [14]. In general, Stretta is most
effective in patients without hiatal hernia; its mechanism of action is mostly driven
by enhancement of the lower esophageal sphincter (LES) tone and reduction of
transient LES relaxations [15]. The presence of a hiatal hernia >2cm is a contraindication to the performance of Stretta, hence feasibility and efcacy studies on
patients with signicant (>3cm) hiatal hernia are lacking. In the rst randomized,
sham-controlled trial, patients (40% with hiatal hernia <2cm) who were treated
with Stretta had signicantly improved symptoms and quality of life scores without
improvement seen in the sham group. Stretta reduced PPI usage by 46% compared
to 29% in the sham group [16]. In another prospective, randomized, double-blinded,
sham-controlled trial, patients with hiatal hernia <2 cm were treated with either
a
Fig. 7.10 (a) Stretta catheter. Upon ination of the balloon, the four needles are impregnated into
the muscle of the EGJ prior to radiofrequency application
b
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G. Triadalopoulos
ab
Fig. 7.11 (a) Endoscopic view of the EGJ immediately after Stretta, revealing the white mucosal
markings where the radiofrequency treatment was administered at the level of the EGJ and cardia.
(b) Retrograde view of the cardia in the same patient 2months afterwards revealing a Hill grade I
appearance. The endoscope is snug around the tissues of the cardia
Stretta once, Stretta twice, or with a sham procedure. At 12months there was a
signicant symptom improvement in both active treatments, but not the sham group.
LES pressures and pH improved in both the single- and double-treatment groups,
with non-signicant changes seen in the sham group [17] (Fig.7.11).
7.3.2 Transoral Fundoplication (TF)
Trans-oral, incisionless fundoplication (TF) treats GERD by creating a fullthickness esophago-gastric plication using trans-mural fasteners (Fig.7.12) and a
large number of studies over the past several years have validated its safety and
effectiveness. TF can ll the “therapeutic gap” that exists between PPI and laparoscopic fundoplication but TF cannot effectively close a signicant hiatal hernia. In
the earliest TF study [18], upper endoscopy was performed before and after the
procedure in order to grade esophagitis and to exclude Barrett’s esophagus. A hiatal
hernia was diagnosed when the Z-line was above the diaphragmatic pinch caused by
external compression by the crus or when a herniation was visible on the retroexed
endoscopic view. Hiatal hernias (<3cm) were present in 13 patients (76%) and they
were all reduced and remained reduced in 62% of cases.
The recent randomized study of 44 patients (22 TF and 22 sham) excluded
patients with body mass index (BMI) >35, Hill grade IV, and hiatal hernia >3cm
[19]. Based on their data, the authors concluded that ideal TF candidates would be
patients with persistent GERD symptoms and with the following anatomic
7 Novel Endoscopic Antireux Procedures: Do They Have aRole inPatients
117
Fig. 7.12 (Top ) Retrograde endoscopic appearance of the cardia before and after TF. (Bottom).
Diagrammatic representation of the transmural fasteners, creating the partial fundoplication affect
characteristics: (i) hiatal hernia <2 cm without an enlarged hiatus; (ii) normal
esophageal motility; (iii) abnormal ambulatory pH or evidence of reux esophagitis
on endoscopy or biopsy; (iv) Hill grade II–III at the GEJ.
In a prospective randomized trial, of patients poorly responsive to PPI therapy,
high-resolution esophageal manometry conrmed the absence of esophageal motor
dysfunction, endoscopy was performed to grade the appearance of the anti-reux
barrier (Hill grade), to conrm the absence of long segment Barrett’s esophagus,
and to grade esophagitis, if present. Cine-esophagography was performed to conrm the absence of hiatal hernia or a hiatal hernia ≤2cm in length. There were no
patients with larger hernias [5].
Similarly, another controlled study of TF included only highly selected GERD
patients with a small (≤2cm) hiatal hernia [20]. The authors of another study with
TF considered preoperative endoscopy as mandatory to determine the diaphragmatic hiatus, and the greatest transverse dimension of the hiatus under full gastric
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G. Triadalopoulos
distension [21]. They claimed that only a hiatal hernia <2.5cm long can be fully
reduced below the diaphragm, while a plication performed in a hiatus with a transverse dimension >3.0cm can end up in the thorax, which reduces the efcacy of the
newly created valve. In that series, hiatal hernia, even <2.5 cm and ineffective
esophageal motility increased the risk of symptomatic recurrence. In another study,
patients were required to have Hill grades II, III, or IV, while patients with a hiatal
hernia >3cm, esophageal motility disorders, diverticula, strictures, previous gastroesophageal surgery, or Barrett’s esophagus were excluded. Fifteen patients (55%)
had hernia <2cm [22].
7.3.3 MUSE
The MUSE™ endoscopic stapling system creates an endoscopic partial fundoplication (Fig.7.13). The MUSE endoscope is inserted and advanced into the stomach
and retroexed, pulling it back to the correct stapling level above the GEJ.Tissue is
then stapled under ultrasonographic gap nder. The procedure is repeated circumferentially to form a 180° fundoplication.
A multi-center, prospective study evaluated 69 patients; no patients with sliding
hiatal hernia >3cm were enrolled. During general anesthesia all patients were ventilated with a PEEP setting of 5mmHg; if a hernia was still evident, PEEP was
gradually increased to 10mmHg until the hernia was reduced and the procedure
was performed. Of the 66 patients who completed follow-up 6months after the
procedure, the GERD-HRQL score improved by >50% off PPI in 73% of patients
and 64.6% were no longer using daily PPIs. The proportions of patients with an
unacceptable Hill Grade (>2) dropped dramatically after the procedure. There were
two severe adverse events (empyema and gastrointestinal bleeding) requiring intervention [23]. Larger randomized studies and registry trials with longer periods of
follow up will be required.
Fig. 7.13 Diagrammatic
representation of the
MUSE device, creating the
partial fundoplication
affect
7 Novel Endoscopic Antireux Procedures: Do They Have aRole inPatients
119
7.3.4 Anti-Reux Mucosectomy (ARMS)
ARMS is performed using endoscopic mucosal resection (EMR) and endoscopic
submucosal dissection (ESD) of the distal 1cm of the esophagus and proximal 2cm
of the stomach, with the resection length at the cardia measured in retroexion
(Fig. 7.14). The presence of a sliding hiatal hernia is a contraindication for
ARMS.The procedure is preferably performed along the lesser curve of the stomach, thus preserving a sharp mucosal valve at gastric cardia. In one study, GERD
symptoms, pH as well as bile reux scores improved signicantly after the procedure. In two cases of total circumferential resection, repeat balloon dilation was
necessary to control distal esophageal stricture. In all cases, PPI therapy was
stopped. Larger studies with long-term follow up will be needed [24].
a
c
b
d
Fig. 7.14 Endoscopic follow up of circumferential anti-reux mucosectomy (ARMS) (retroexed
views). (a) Immediately after ARMS showing a 2cm-wide gastric cardia mucosa that was circumferentially resected by cap-endoscopic mucosal resection. (b) Appearance at 3years, a tight gastroesophageal junction revealing convergence of three gastric folds along the gastric lesser curve. (c)
More than 10years after circumferential ARMS shows an appearance that is similar to (b). (d)
Forward view of the EGJ >10years after circumferential ARMS. Chromoendoscopy with Lugol’s
solution demonstrates well-stained squamous epithelium, with neither recurrence of esophagitis
nor Barrett’s esophagus (Reproduced from ref. [24])
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G. Triadalopoulos
7.4 Conclusions
The clinical and phenotypic complexity of GERD requires that a detailed, multimodality diagnostic evaluation prior to decision-making for EART or surgical therapies. Each of the four currently available endoscopic modalities has unique features
and limitations, particularly in regards to hiatal hernia size. A tailored and individualized selection has to be based on symptoms, clinical presentation, proper disease
denition, therapeutic objectives, and available local endoscopic and surgical expertise. As these novel endoscopic and laparoscopic technologies evolve and mature
and long-term data becomes available, decision-making will remain in ux but best
done at multi-disciplinary esophageal centers of excellence.
What Is the Current Knowledge and What Future Direction
Is Required
• GERD is a more complex and multifactorial disease than previously
thought and results from imbalance between several offensive and protective factors
• Reux hypersensitivity is increasingly recognized and add-on therapies
may be required
• Precision GERD management requires several key questions to be
addressed
• Although gastric acid hypersecretion is not a pathogenetic factor in GERD,
acid inhibition is the mainstay of GERD therapy.
• When acid inhibition fails, laparoscopic anti-reux surgery with or without
hernia repair is the best-validated option.
• Not all patients with GERD are suitable candidates for endoscopic antireux therapy
• The effectiveness and adverse effects of all new endoscopic treatment
modalities must be investigated in randomized controlled and comparative
efcacy trials
Compliance with Ethical Standards Conict of Interest: The author has equity position with
Mederi Therapeutics, C2 Therapeutics and EndoStim.
Human and Animal Rights and Informed Consent: This article does not contain any studies with
human or animal subjects performed by the author.
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