Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study

• Published in: World journal of surgery 2008-08, Vol.32 (8), p.1676-1688
• Main Authors: Cadière, Guy-Bernard, Buset, Michel, Muls, Vinciane, Rajan, Amin, Rösch, Thomas, Eckardt, Alexander J., Weerts, Joseph, Bastens, Boris, Costamagna, Guido, Marchese, Michele, Louis, Hubert, Mana, Fazia, Sermon, Filip, Gawlicka, Anna K., Daniel, Michael A., Devière, Jacques
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Adult; Aged; Antireflux Surgery; Biological and medical sciences; Cardiac Surgery; Chronic Disease; Endoscopy, Gastrointestinal - methods; Esophagitis; Female; Fundoplication - instrumentation; Fundoplication - methods; Gastroesophageal Reflux - surgery; General aspects; General Surgery; Hiatal Hernia; Humans; Lower Esophageal Sphincter; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Postoperative Complications; Prospective Studies; Proton Pump Inhibition Therapy; Surgery; Thoracic Surgery; Treatment Outcome; Vascular Surgery
• ISSN: 0364-2313; 1432-2323
• DOI: 10.1007/s00268-008-9594-9

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° (160°–300°). 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 ≥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