By Maureen Sullivan
Two endoluminal treatments for gastroesophageal reflux disease (GERD) were the subject of a recent assessment by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Published in February, the clinical spotlight review recommended Stretta (Mederi Therapeutics), a radiofrequency therapy, as an appropriate option for patients who meet certain indications for GERD. However, the review committee found insufficient evidence to recommend EsophyX (EndoGastric Solutions), a device used for transoral incisionless fundoplication, as a treatment option.
The process entailed a comprehensive review and analysis of the available literature on the topic. The clinical evidence to support Stretta achieved the highest possible grade (++++) of SAGES’ four-tier grading system and was conferred a “strong” recommendation.
“It is extremely gratifying to have a scientific analysis of the overwhelming body of clinical evidence supporting Stretta issued by an esteemed organization such as SAGES,” said Will Rutan, CEO of Mederi Therapeutics, in a statement. “The grade of ‘strong’ indicates that no further studies are necessary to validate Stretta as a safe and effective treatment for GERD.”
The Stretta system treats GERD using radiofrequency ablation to remodel the musculature of the lower esophageal sphincter (LES) and gastric cardia (figure). According to the review, clinical studies show that the treatment results in “significant reductions in tissue compliance and transient LES relaxations. These mechanisms act to restore the natural barrier function of the LES as well as to significantly reduce spontaneous regurgitation caused by transient inappropriate relaxations to the sphincter.”
In its literature review, SAGES cited four randomized controlled studies, a meta-analysis, multiple prospective trials and more than 30 peer-reviewed studies that supported the efficacy and safety of Stretta. They found that treatment outcomes lasted at least 48 months and led to a significant reduction or elimination of the medications required to treat GERD and improvements in quality of life, as measured by the GERD Health-Related Quality of Life scale and Quality of Life in Reflux and Dyspepsia questionnaire.
Stretta was recommended as a treatment option for patients over the age of 18 years who have experienced symptoms of regurgitation or heartburn (or both) for more than six months and who have been “partially or completely responsive to antisecretory pharmacologic therapy.”
As the SAGES review made clear, making recommendations on a particular therapy does not exclude other options that may be better suited to a particular patient’s needs:
“[The recommendations] indicate the preferable, but not necessarily the only acceptable approaches, due to the complexity of the health care environment.” This point was reiterated in a press release by Mederi Therapeutics, which stated that “Stretta therapy does not preclude further steps with more invasive procedures, if indicated.”
Furthermore, Stretta is not approved for use in pediatric patients, either by its manufacturer or the FDA, and SAGES did not recommend it for treating patients with severe esophagitis, hiatal hernias greater than 2 cm in length, long-segment Barrett’s esophagus, dysphagia or for those with a history of autoimmune disease, collagen vascular disease and/or coagulation disorders.
Asked to comment, Ronnie Fass, MD, director of gastroenterology and hepatology and head of the Esophageal and Swallowing Center at MetroHealth Medical Center in Cleveland, said, “From the data we currently have … this technique seems to work, as long as the correct patient population is selected for treatment. Stretta can be done successfully by practicing gastroenterologists because it is not as complicated as EsophyX. Still, the patient population that undergoes Stretta should be carefully selected and [should be made aware] that it is nonreversible.”
In its review of EsophyX, SAGES assigned a low (++) quality-of-evidence rating and a “weak” recommendation, as it concluded that not enough long-term data were available to support its use and several studies reported mixed results including “disappointing outcomes” and “significant untoward events.”
“I agree with the recommendation,” Dr. Fass said. “They were cautious because of a lack of long-term trials. One problem with previous endoscopic treatments for GERD that aren’t on the market anymore is that they didn’t demonstrate long-term efficacy.”
EsophyX is based on the technique of transoral incisionless fundoplication, which was first approved by the FDA in 2007. Once the device is placed endoscopically, it is deployed in the stomach and “used to create a full-thickness plication secured by H-shaped fasteners made from polypropylene.” The device underwent a number of revisions: The first technique used the TIF1 device that created a gastrogastric wrap at the gastroesophageal junction; according to the review, “critics likened it to a slipped fundoplication.” The TIF2 device was subsequently developed to more closely replicate laparoscopic fundoplication.
The SAGES review stated that “in short-term follow-up, from six months to two years, EsophyX may be effective in patients with a hiatal hernia of 2 cm with typical or atypical GERD,” but long-term studies are needed to “further evaluate device and technique safety.”
“This type of technique should not filter down too quickly to practicing gastroenterologists or surgeons,” Dr. Fass said. “It is better that it stays in expert hands, for example, esophageal centers, which will ensure that those who receive these types of procedures are going to be properly evaluated, that they are the right candidates. [The health care professionals] who should be involved are those who have expertise and do enough of these procedures on a regular basis to keep their skills at a level that will ensure long-term efficacy and prevent future complications.”