Gastroesophageal reflux disease (GERD) is a clinical condition that can lead to esophagitis, esophageal strictures, aspiration, pneumonia, vocal cord inflammation, pulmonary dysfunction, Barrett esophagus, and esophageal cancer among others. Forty-four percent of the general population has some reflux and up to 10% of the population has daily reflux symptoms.^1,2 Several factors have been known to contribute to GERD including LES function, hiatal hernias, esophageal dysmotility, and gastric delayed emptying. Surgical correction of reflux disease has demonstrated improvement in patient symptoms, correction of some pulmonary dysfunction, and may have a role in reducing the incidence of esophageal cancer.³ The most common surgical approach today is the laparoscopic Nissen fundoplication (Chapter 39), although other approaches such as the Toupet (Chapter 40) and the transthoracic Belsey (Chapter 38) procedures also have been utilized. Endoscopic treatment for reflux, however, has lagged both in terms of efficacy and durability. We review the attempted endoscopic approaches and the future outlook of endoscopic antireflux surgery.

Most endoscopic therapies have focused on trying to increase the resistance at the gastroesophageal (GE) junction.

The Stretta system uses radiofrequency ablation of the GE junction. This method utilizes a flexible catheter with a balloon. Four electrodes are placed into the surrounding tissue at the level of the LES. The probes reach the level of the submucosa and radiofrequency energy is applied, elevating the submucosal temperature to 85°C whereas a cold water infusion in the balloon keeps the mucosal temperature at 50°C. The procedure is repeated. The energy creates thermal lesions in the submucosa which cause scarring and tightening around the LES. In essence, a stricture is created at the LES, increasing resistance at the GE junction. Unfortunately, a randomized sham trial did not demonstrate any difference in any objective measure of reflux in these patients, although some did report a reduction in heartburn symptoms.⁴

Additional studies, to date, all have been characterized by short-term follow-ups of 6 to 12 months, small numbers of patients, and variable improvements in objective symptoms.⁵ Aziz et al.⁶ in 2010 reported on 30 patients with improvement in health-related quality-of-life (HRQL) scores, LES pressure, and pH scores of those patients off medication, although some patients experienced some delayed gastric emptying. Coron et al.⁷ in 2008 demonstrated that 18 of 20 patients were able to stop proton pump inhibitor (PPI) use, although there was no change in esophageal acid exposure.

One prospective nonrandomized comparison of the Stretta system with laparoscopic fundoplication demonstrated a superior outcome with the laparoscopic procedure. Patients in both groups had improvement of their quality of life and symptoms, but only 58% of patients in the Stretta group were able to discontinue medication compared to 97% of patients following the laparoscopic procedure, despite the fact that the Stretta group patients had less severe disease.⁸

Bard Endocinch and the NDO Plication System use sutures placed with a proprietary device to tighten the LES. Although some studies have demonstrated some efficacy, there have been concerns about its durability. Schwartz conducted a double-blind randomized sham-controlled trial with the Endocinch that demonstrated less PPI in the treatment group (65%) compared to the observation group (0%), but there was no difference in esophageal acid exposure in the treatment group versus the sham group.⁹ Montgomery et al.,¹⁰ in a randomized placebo controlled trial, likewise determined that there was no difference in esophageal acid exposure at 3 and 12 months.

With regard to the plication system, results have been more promising. A randomized single blind prospective multicenter trial in 2006 did demonstrate greater cessation of PPI treatment in the treatment arm compared to sham (50% vs. 20%, p = 0.002) and with greater improvement in esophageal pH compared to sham.¹¹ von Renteln in 2009 demonstrated 63% of patients had symptomatic improvement.¹² Daily PPI use was eliminated in 69% of patients at 12 months. Khajanchee performed a meta-analysis of 266 patients that demonstrated a decreased in DeMeester score with 32% of patients resulting in a normal range. However, the company lost funding, and the device is no longer available.¹³

Injection of inert products into the LES also has been tried. Plexiglas, Gatekeeper Reflux Repair System, and the Enteryx are some of the products in this category. Plexiglas inserted polymethylmethacrylate (PMMA) into the submucosa of the LES to decrease transient relaxation of the sphincter. Enteryx injected 8% ethylene vinyl alcohol in dimethyl sulfoxide and micronized tantalum powder into the muscular layer of the LES.¹⁴ The compound hardened after injection. This procedure was associated with serious complications including injection into the mediastinum, embolization to the kidney, pericarditis, and aortoesophageal fistula, which resulted in withdrawal from the market. The Gatekeeper used a soft, pliable, biocompatible, hydrophilic prosthesis into the submucosa of the LES. Upon insertion, it absorbs water and expands, creating bulk and decreasing compliance of the LES. A randomized sham-controlled blinded multicenter study demonstrated no improvement in outcomes at 6 months.¹⁵ This, too, was withdrawn from the market.

Endoscopic Partial Fundoplication

The most recent entry into the endoscopic antireflux therapy is the EsophyX device by endogastric solutions. The goal of this device is to produce a 270-degree partial fundoplication. A large tubular device is placed over the endoscope and through the mouth into the esophagus. Once in the stomach, the end of the device is advanced and the tip closed such that it is facing the GE junction. A helical device is anchored to the Z-line. Using this anchor, the GE junction is then pulled into the open device and closed. The gastric fundus is approximated to the distal intra-abdominal lumen by the device. Two stylets are used to deploy two polypropylene H-shaped fasteners that are supposed to traverse from the gastric mucosa to the esophageal mucosa, thereby securing the shape. The device is opened and then rotated, and the sequence repeated until fasteners are placed from the posterior lesser curvature to the anterior lesser curvature and an omega-shaped 270-degree wrap is formed, ideally of 2 cm length. Small hiatal hernias can also reportedly be reduced by using suction traction on the device.