Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study.
BACKGROUND
A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial.


METHODS
Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm.


RESULTS
The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation.


CONCLUSIONS
The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.
Cadière
Guy-Bernard
GB
Department of Digestive Surgery, Centre Hospitalier Universitaire St. Pierre, 322 rue Haute, Brussels 1000, Belgium. Guy-Bernard_CADIERE@stpierre-bru.be
Buset
Michel
M
Muls
Vinciane
V
Rajan
Amin
A
Rösch
Thomas
T
Eckardt
Alexander J
AJ
Weerts
Joseph
J
Bastens
Boris
B
Costamagna
Guido
G
Marchese
Michele
M
Louis
Hubert
H
Mana
Fazia
F
Sermon
Filip
F
Gawlicka
Anna K
AK
Daniel
Michael A
MA
Devière
Jacques
J
D000328:Adult; D000368:Aged; D002908:Chronic Disease; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D005260:Female; D018662:Fundoplication / Q000295:instrumentation / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D016896:Treatment Outcome