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

Abstract

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 C50% 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. Conclusion 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 G.

Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX

“…Initial screening assessment was conducted without discontinuation of PPIs and consisted of the nine-question GERD health-related quality-of-life (GERD-HRQL) [22], 24-hour ambulatory pH-metry [23,24], upper GI endoscopy, esophageal biopsy, esophageal manometry, medical history, and GERD medication usage as described previously [19,20]. In addition, we assessed each patient's ability to consume foods and beverages commonly associated with triggering GERD symptoms, such as citrus, strawberries, tomatoes, chocolate, fatty foods, deep-fried foods, spicy foods, carbonated drinks, tea, coffee, caffeinated drinks, and alcohol [25].…”

“…The TIF procedure was performed under general anesthesia with nasal or transoral intubation and following the standard TIF 1 protocol [19,20,26]. The device was inserted transorally into the esophagus with the patient in the left-lateral position.…”

“…The long-term durability of TIFs was evaluated by comparing their geometric aspects, including valve length, defined as the length (in centimeters) from the apex of the fundus to the valve lip [27], circumference, defined as the distance in degrees between the two most distant points of esophagogastric valve, as well as Hill grade [28] and adherence to the endoscope through the duration of the study using published and unpublished data from the same study [19]. A global assessment of all outcome measures was performed for each patient to determine the long-term effectiveness of TIF in curing GERD [20]. Patients were considered ''cured'' if they had no more heartburn or regurgitation, eliminated esophagitis and hiatal hernia, and discontinued all usage of PPIs.…”

“…Patients (n = 14, 50% female) available at 2 years had a median age of 34 (range, 23-55) years and a median BMI of 22 (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31) kg/m 2 . Patients had suffered from GERD for a median of 10 (range, 3-15) years and were on continuous daily PPI therapy for a median of 6 (range, 2-13) years before undergoing TIF.…”

“…Two clinical trials demonstrated the safety and effectiveness of TIF in treating patients with chronic GERD at 1 year [19,20]. This study reports the 2-year follow-up results from the feasibility study that evaluated the safety and durability of TIF.…”