SAGES provides 'strong recommendation' for endoluminal GERD therapies

A clinical review approved by the Society of American Gastrointestinal and Endoscopic Surgeons’ Board of Governors provided strong recommendations for the use of endoluminal treatments for GERD, including Esophyx and Stretta therapies.

“Since numerous, quality studies and vast literature accumulation have arisen since the previous SAGES publication [a 2013 review], the SAGES Guidelines Committee decided to update its recommendations on these techniques,” according to the report.

The committee performed a systematic literature review in July 2016, and used the GRADE system to assess the quality of evidence and strength of their subsequent recommendations.

Transoral incisionless fundoplication

Esophyx (EndoGastric Solutions), originally cleared by the FDA in 2007, is an endoscopic device used to perform transoral incisionless fundoplication (TIF), which aims to reconstruct the gastroesophageal valve and restore its barrier function to prevent reflux in patients with GERD. The initial TIF 1.0 technique is no longer recommended, so the report evaluated the current TIF 2.0 technique.

Since SAGES previous report, five randomized controlled trials, two systematic reviews, one meta-analysis and eight observational studies on TIF have been published.

Among patients included in four of the RCTs, TIF patients more often achieved response at 6 months compared with controls treated with PPIs (66% vs. 30.5%; RR = 2.44; 95% CI, 1.25-4.79).

“Compared with PPI treatment, TIF has clearly demonstrated to be more effective in controlling patient GERD symptoms 6 months post-procedure,” the committee wrote. No RCT to date has compared TIF with surgical fundoplication, “but preliminary evidence suggests that the latter can be used safely after TIF failure,” they noted.
Further, TIF resulted in improved esophageal acid exposure time compared with sham controls (P = .02), and similar esophageal acid exposure time compared with patients on PPIs. TIF patients also had fewer total reflux episodes compared with those on PPIs (P < .00001), but a similar incidence of acid reflux episodes.

Between 45% and 86% of patients were satisfied with the procedure after a mean of 6 months. Serious adverse events occurred in 2.4% of a total of 781 patients included in 16 studies, including perforations, post-procedural bleeding, pneumothorax and severe epigastric pain.

“Based on existing evidence, TIF can be performed with an acceptable safety risk in appropriately selected patients,” the committee concluded. “The procedure leads to better control of GERD symptoms compared with PPI treatment in the short term (6 months), but appears to lose effectiveness during longer term follow-up and is associated with moderate patient satisfaction scores. Objective GERD measures improve similarly after TIF 2.0 compared with PPI.”

Radiofrequency therapy

Stretta radiofrequency therapy (Mederi Therapeutics), approved by the FDA in 2000, uses low power, low temperature radiofrequency energy to reduce GERD symptoms by remodeling the lower esophageal sphincter.

While no new RCTs have been published since the last SAGES review, two new systematic reviews and meta-analyses and four new observational studies have been published.

Pooled results from the most recent systematic review and meta-analysis representing 2,468 patients showed Stretta improved health-related quality of life (P < .001) and heartburn (P < .001), and half of PPI users were able to stop using PPIs after treatment with Stretta (P < .001). Stretta also reduced the incidence of erosive esophagitis by 24% (P < .001) and reduced esophageal acid exposure (P < .001), and while it did increase lower esophageal sphincter basal pressure, this did not reach statistical significance.

“Compared to fundoplication, Stretta is less effective for GERD symptom control but has fewer complications,” the committee wrote, with a complication rate of 0.12%, most of which were minor, according to one meta-analysis.

“The effectiveness of the procedure diminishes some over time, but persistent effects have been described up to 10 years after the procedure in appropriately selected patients with GERD,” the committee concluded. “Stretta is more effective than PPI, but less so than fundoplication [and] is safe in adults and has a short learning curve.” – by Adam Leitenberger

Disclosures: Healio Gastroenterology was unable to confirm the review authors’ relevant financial disclosures at the time of publication.

A clinical review approved by the Society of American Gastrointestinal and Endoscopic Surgeons’ Board of Governors provided strong recommendations for the use of endoluminal treatments for GERD, including Esophyx and Stretta therapies.

“Since numerous, quality studies and vast literature accumulation have arisen since the previous SAGES publication [a 2013 review], the SAGES Guidelines Committee decided to update its recommendations on these techniques,” according to the report.

The committee performed a systematic literature review in July 2016, and used the GRADE system to assess the quality of evidence and strength of their subsequent recommendations.

Transoral incisionless fundoplication

Esophyx (EndoGastric Solutions), originally cleared by the FDA in 2007, is an endoscopic device used to perform transoral incisionless fundoplication (TIF), which aims to reconstruct the gastroesophageal valve and restore its barrier function to prevent reflux in patients with GERD. The initial TIF 1.0 technique is no longer recommended, so the report evaluated the current TIF 2.0 technique.

Since SAGES previous report, five randomized controlled trials, two systematic reviews, one meta-analysis and eight observational studies on TIF have been published.

Among patients included in four of the RCTs, TIF patients more often achieved response at 6 months compared with controls treated with PPIs (66% vs. 30.5%; RR = 2.44; 95% CI, 1.25-4.79).

“Compared with PPI treatment, TIF has clearly demonstrated to be more effective in controlling patient GERD symptoms 6 months post-procedure,” the committee wrote. No RCT to date has compared TIF with surgical fundoplication, “but preliminary evidence suggests that the latter can be used safely after TIF failure,” they noted.
Further, TIF resulted in improved esophageal acid exposure time compared with sham controls (P = .02), and similar esophageal acid exposure time compared with patients on PPIs. TIF patients also had fewer total reflux episodes compared with those on PPIs (P < .00001), but a similar incidence of acid reflux episodes.

Between 45% and 86% of patients were satisfied with the procedure after a mean of 6 months. Serious adverse events occurred in 2.4% of a total of 781 patients included in 16 studies, including perforations, post-procedural bleeding, pneumothorax and severe epigastric pain.

“Based on existing evidence, TIF can be performed with an acceptable safety risk in appropriately selected patients,” the committee concluded. “The procedure leads to better control of GERD symptoms compared with PPI treatment in the short term (6 months), but appears to lose effectiveness during longer term follow-up and is associated with moderate patient satisfaction scores. Objective GERD measures improve similarly after TIF 2.0 compared with PPI.”

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Radiofrequency therapy

Stretta radiofrequency therapy (Mederi Therapeutics), approved by the FDA in 2000, uses low power, low temperature radiofrequency energy to reduce GERD symptoms by remodeling the lower esophageal sphincter.

While no new RCTs have been published since the last SAGES review, two new systematic reviews and meta-analyses and four new observational studies have been published.

Pooled results from the most recent systematic review and meta-analysis representing 2,468 patients showed Stretta improved health-related quality of life (P < .001) and heartburn (P < .001), and half of PPI users were able to stop using PPIs after treatment with Stretta (P < .001). Stretta also reduced the incidence of erosive esophagitis by 24% (P < .001) and reduced esophageal acid exposure (P < .001), and while it did increase lower esophageal sphincter basal pressure, this did not reach statistical significance.

“Compared to fundoplication, Stretta is less effective for GERD symptom control but has fewer complications,” the committee wrote, with a complication rate of 0.12%, most of which were minor, according to one meta-analysis.

“The effectiveness of the procedure diminishes some over time, but persistent effects have been described up to 10 years after the procedure in appropriately selected patients with GERD,” the committee concluded. “Stretta is more effective than PPI, but less so than fundoplication [and] is safe in adults and has a short learning curve.” – by Adam Leitenberger

Disclosures: Healio Gastroenterology was unable to confirm the review authors’ relevant financial disclosures at the time of publication.