LCD L34553: Stretta Procedure

Abstract

Gastroesophageal reflux disease (GERD) is defined by the presence of chronic symptoms or mucosal damage caused by an abnormal reflux of gastric contents into the esophagus. GERD may be caused by a weakness in the lower esophageal sphincter (LES), the presence of a hiatal hernia (HH), transient LES relaxation, alterations in the gastroesophageal pressure gradient, and esophageal factors such as poor clearance and changes in motility. Heartburn (pyrosis) and regurgitation, the most common and highly specific symptoms of GERD, may be experienced alone or in combination after eating a meal. Severe complications of GERD include the development of strictures, erosive esophagitis, and Barrett’s esophagus.

The Stretta system (Mederi Therapeutics Inc., Greenwich, Connecticut) is a radiofrequency (RF) treatment for GERD. The system, including its specialized catheters and RF generators were originally cleared by the United States (U.S.) Food and Drug Administration (FDA) for use in 2000 and was issued an updated clearance on the RF generator in 2011 . The transoral Stretta catheter system uses a proprietary algorithmic application of low power (5 Watts) RF energy and generates low tissue temperatures (65°C to 85°C) during a series of 1-minute treatment cycles. The endoluminal Stretta therapy remodels (thickens) the musculature of the LES and gastric cardia. Clinical results demonstrate that the Stretta RF 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 of the sphincter.

Limitations

An extensive literature review documented the following information:

The results show that RF treatment significantly improved heartburn scores and produced significant improvements in quality of life (QOL) as measured by the GERD Health-Related Quality of Life (GERD-HRQL) scale and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. Esophageal acid exposure decreased but did not normalize, and while the procedure did not significantly increase LES pressure, there was a trend toward improvement.

More than 30 peer reviewed studies, including randomized, controlled studies, a comprehensive meta-analysis and multiple prospective clinical trials have documented the safety and efficacy of the Stretta procedure. Durable treatment outcomes to at least 120 months have been demonstrated. In multiple studies, significant reduction or elimination of medications used to treat the symptoms of GERD, as well as improvement in GERD QOL and symptom scores have been demonstrated. Stretta may be recommended as an appropriate therapeutic option for patients with chronic GERD who meet current indications and patient selection criteria and choose endoluminal therapy over the gold standard of laparoscopic fundoplication (Noar, et al. 2014).

Those criteria include:

• Adult patients (age ≥ 18) with symptoms of chronic GERD, heartburn, regurgitation, or both for ≥ 6 months who have been partially or completely refractory to antisecretory pharmacologic therapy.

• Adult patients who do not wish to continue long-term medication use or are not appropriate surgical candidates or do not wish to undergo surgery if there were a less invasive treatment option available.

The procedure has not been studied and should not be applied in treating patients with severe esophagitis, hiatal hernias > 2 cm, long segment Barrett’s esophagus, dysphagia, or those with a history of autoimmune disease, collagen vascular disease, and/or coagulation disorders.

A systematic review and meta-analysis to determine the efficacy of Stretta for the treatment of GERD was performed. Randomized controlled trials (RCTs) and cohort studies evaluating the Stretta for treatment of GERD were included in the analysis, with the search spanning from database inception to May 2016. The analysis included 28 studies (4 RCTs, 23 cohort studies, 1 registry study). Pooled results found that Stretta decreased (i.e., improved) mean health-related QOL score by -14.6 (95% CI, -16.48 to 12.73; P<0.001). Pooled mean heartburn standardized score was also decreased by Stretta group by -1.53 (95% CI, -1.97 to 1.09; P<0.001). Following Stretta, only 49% of patients who used proton-pump inhibitors (PPIs) at baseline still needed medication at follow-up (P<0.001). Reductions in the incidence of erosive esophagitis (24%; P<0.001) and esophageal acid exposure (mean of -3.01 [95% CI, -3.72 to -2.30]; P<0.001) also occurred with Stretta treatment. However, LES basal pressure was nonsignificantly increased following Stretta therapy by a mean of 1.73 (95% CI, -0.29 to 3.74) mm Hg. The authors concluded that subjective and objective clinical outcomes are improved by the Stretta procedure, and the procedure should be considered as an alternative for the management of GERD (Fass, et al. 2017).