Endolumenal Fundoplication With EsophyX: The Initial North American Experience

Abstract

EsophyX is a novel endolumenal therapeutic option for the treatment of gastroesophageal reflux disease (GERD). The device is passed into the stomach, where it deploys a series of full-thickness fasteners to create a neogastroesophageal valve. The objective of this study was to demonstrate the safety and characterize the effectiveness of this approach in the initial North American experience. This is a retrospective study of consecutive patients with GERD who had undergone endolumenal fundoplication with the EsophyX device. At follow-up, proton pump inhibitor usage was elicited and 2 validated questionnaires were administered measuring GERD health-related quality of life (range 0-50) and symptom severity (range 0-72). In limited preliminary evaluation, the initial North American experience with endolumenal fundoplication using the EsophyX device is that it appears to be safe and provides moderate effectiveness in treating the symptoms of GERD. Further studies comparing this technique with conventional medical and surgical therapies are necessary.

Randomized Controlled Trial of Transoral Incisionless Fundoplication Vs. Proton Pump Inhibitors for Treatment of Gastroesophageal Reflux Disease

“…Th is symptom-free period may be induced by initial placebo eff ects, but considering objective outcomes in GERD control, it is more likely explained by an initially well-functioning TIF procedures. In the 18 studies, with a total of a composite 728 patients, 50 cases (7%) of revisional laparoscopic fundoplication have been reported (31)(32)(33)(34)(35)(36)(37)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63)(64)(65).…”

Transoral Incisionless Fundoplication 2.0 Procedure Using EsophyX™ for Gastroesophageal Reflux Disease

“…11 Several clinical studies have evaluated the safety and efficacy of transoral fundoplication in patients with chronic GERD. [12][13][14][15][16][17] There has been a wide range of results reported for the TIF procedure, with rates of PPI cessation ranging from 25% to 83% within various studies (Table 1). We evaluated the efficacy and safety of the TIF 2.0 procedure as a substitute for a laparoscopic fundoplication in our centers.…”

Transoral incisionless fundoplication for gastroesophageal reflux disease in an unselected patient population

“…Our technique, modeled after that of Cadière et al [9], has been described elsewhere [8]. Briefly, the patient is placed in the left lateral decubitus position after undergoing nasotracheal intubation.…”

“…We first published our initial experience with EsophyX for eight patients in 2008 [8]. This current study aimed to investigate further the safety and efficacy of EsophyX in a larger patient population.…”