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New GERD Guidelines Focus on Endoluminal Treatments

Radiofrequency therapy, Stretta, gets ‘thumbs up’ (Feb. 11)

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has issued new guidelines focusing on two endoluminal treatments for gastroesophageal reflux disease (GERD): EsophyX (Endogastric Solutions) and Stretta (Mederi Therapeutics).

Fundoplication is a surgical procedure in which the gastric fundus (upper part) of the stomach is wrapped, or plicated, around the lower end of the esophagus and stitched in place, reinforcing the closing function of the lower esophageal sphincter. Once deployed in the stomach using an endoscopic approach, the EsophyX device reportedly creates an incisionless fundoplication using polypropylene fasteners.

According to the new guidelines, numerous published studies have reported significant adverse events with the EsophyX device, and clinical results have been mixed. Moreover, the device has undergone multiple revisions, and the procedure’s surgical technique has evolved as well.

No long-term clinical data are available for EsophyX. In short-term follow-up (from 6 months to 2 years), EsophyX may be effective in patients with a hiatal hernia with typical and atypical GERD, the guidelines say, but additional studies are needed to define optimal techniques, to determine the most appropriate patient-selection criteria, and to further evaluate the safety of ExophyX and its surgical technique. The device is given only a “weak” recommendation.

The guidelines' authors, however, have a positive opinion of the Stretta transoral catheter system, which uses radiofrequency to remodel the musculature of the lower esophageal sphincter (LES) and the gastric cardia.

According to the guidelines, more than 30 peer-reviewed studies have documented the safety and efficacy of the Stretta procedure. Treatment outcomes lasting at least 48 months have been demonstrated, with significant reductions in or elimination of medications used to treat GERD symptoms, well as improvements in GERD-related quality-of-life and symptom scores.

The new guidelines give Stretta a “strong” recommendation as a therapeutic option for patients with GERD who meet current indications and patient-selection criteria and who choose endoluminal therapy over laparoscopic fundoplication.

Source: SAGES; February 11, 2013.

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