Endoscopic GERD therapy: is enteryx the answer?: Johnson DA, Ganz R, Aisenberg J, et al., Endoscopic, deep mural implantation of enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial, Am J Gastroenterol 2003;98:250–8

In the February issue of The American Journal of Gastroenterology, Johnson et al. describe a single-armed, unblinded, prospective, controlled trial evaluating the efficacy and safety of Enteryx (Enteryx, Boston Scientific Corp., Natick, MA) implantation at or just distal to the squamocolumnar junction for the treatment of proton pump inhibitor (PPI)-responsive gastroesophageal reflux disease (GERD). To be included in the study, patients had to have heartburn and/or regurgitation with GERD confirmed by pH-metry. Additionally, symptoms had to be relieved with PPIs (defined by a GERD health-related quality-of-life [HRQL] score 20). Exclusion criteria included Barrett's epithelium, hiatal hernia > 3 cm, persistent esophagitis > grade III with administration of PPIs, and esophageal motility disorders. Patients were evaluated at eight sites, and the study reported results over a 6-month period. After an extensive baseline evaluation, enrolled patients underwent the Enteryx injection procedure while taking PPIs, and then discontinued taking PPIs on day 11 after the procedure. At that point, patients were asked to take only antacids as needed. If antacids failed to control symptoms, histamine receptor antagonists (H2RAs) were given. If H2RAs failed to control symptoms, PPIs were resumed. The primary outcome was the use of PPIs 6 months after the procedure. Additional outcomes included questionnaire results measuring GERD-related symptoms and generic health status, esophageal manometric parameters, and esophageal pH measurements. Adverse events were also recorded. A total of 85 patients were enrolled, but five were unavailable for evaluation at the 6-month visit. The remaining 80 patients were included in the analysis. After 6 months, 74% of study patients were able to eliminate PPIs, and 10% were able to reduce PPIs by more than 50%, resulting in a combined 84% “medication improved.” Most of these patients were able to discontinue all medications, with only approximately 15% requiring antacids or H2RAs. The GERD-HRQOL scores and broader quality of life scores were significantly improved at 6 months after Enteryx treatment compared with baseline scores when PPIs were not being taken. Esophageal acid exposure measured in 71 patients after Enteryx treatment was statistically improved compared with baseline scores when PPIs were not being taken in the median time at pH < 4 (supine, upright, and total) and in the total number of episodes of pH < 4. The authors also noted that 26/71 (37%) of patients normalized their pH measurement (total time). Manometry measured in 74 patients revealed that the median lower esophageal sphincter length significantly increased during the follow-up period as well, although there were no significant changes in lower esophageal sphincter pressure. There were no clinically serious adverse events that were life-threatening or required surgical intervention. Retrosternal chest pain that was mild or moderate was experienced by 91.8% of patients, and it resolved within 2 weeks in most cases. Of patients with chest pain, 69.2% used prescribed oral analgesics, and 10.3% used over-the-counter analgesics. Seventeen patients (20%) reported dysphagia, all of which resolved by 12 wk. One patient underwent two dilation procedures. Ten patients (11.8%) had low grade fevers, all of which resolved within 3 days. In accordance with the protocol, 19 patients (22%) were retreated with Enteryx injection because of inadequate relief with the initial treatment. At 6 months, 12/19 had reduced or eliminated PPIs. The authors concluded that endoscopic implantation of Enteryx is a relatively safe and efficacious treatment option for the management of GERD, and that it might offer a viable alternative to lifelong PPI drug use without the risks associated with antireflux surgery.