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 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.

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 esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.

Fig. 1

Usage and dosage of proton pump inhibitors. TIF: transoral incisionless fundoplication

Fig. 2

Hill grade distribution of the valves

Fig. 3

Resting pressure of lower esophageal sphincter (LES) determined by manometry before and after the EsophyX-TIF procedure

Fig. 4

Endoscopic images of gastroesophageal valves from two patients who had Hill grade IV valves, esophagitis A, and a 2 cm hiatal hernia before TIF. At 6 and 12 months post-TIF both patients had Hill grade I valves, no hiatal hernia, and no esophagitis

Fig. 5

Study population divided into three groups depending on the degree of cure from gastroesophageal reflux disease (GERD) based on the long-term clinical effectiveness of EsophyX-TIF. Cured: patients demonstrated clinically significant alleviation of their symptoms and discontinued their usage of proton pump inhibitor (PPI) therapy. Improved: patients required only occasional PPI therapy and had reduced heartburn. Ongoing GERD: patients showed no alleviation of their symptoms and required daily usage of PPIs. Among the cured patients, 24% were “completely cured” of GERD based on total elimination of heartburn and regurgitation, completely healed esophagitis, reduced hiatal hernia, and normalized or significantly reduced esophageal acid exposure