An expensive radiofrequency ablation technique known as Stretta does not benefit patients with gastroesophageal reflux disease (GERD), researchers report in the June issue of Clinical Gastroenterology and Hepatology. In a meta-analysis of randomized controlled studies, Seth Lipka et al found no evidence that Stretta normalized esophageal pH values, augmented lower esophageal sphincter (LES) pressure, increased health-related quality of life, or allowed patients to stop taking proton pump inhibitors (PPIs).
GERD is characterized by symptoms or complications from the reflux of gastric contents into the esophagus. It is usually treated with lifestyle modification and anti-reflux medications. However almost half of patients do not respond to PPI therapy.
A radiofrequency ablation technique known as Stretta uses a catheter to deliver radiofrequency energy to the LES, muscle, and gastric cardia. Some clinical studies found that Stretta significantly reduced tissue compliance and transient LES relaxations, as well as increased LES wall thickness due to muscle growth.
However, Stretta is expensive, its effects are irreversible, and it has the potential to cause serious adverse events. Due to these factors and conflicting results from randomized controlled trials, Seth Lipka et al performed a systematic review and meta-analysis of evidence from clinical trials to assess the efficacy of Stretta for the management of GERD.
In an analysis of data from 4 randomized controlled trials, on a total of 153 patients, Lipka et al found the overall quality of evidence to be very low. They also observed significant heterogeneity among the studies analyzed.
Overall, their results showed no beneficial effect of the Stretta procedure for any of the outcomes reported in these studies.
Their pooled results showed no difference between Stretta and sham surgery or PPIs in patients with GERD for mean percentage of time with a pH less than 4 (over a 24 hr time period), LES pressure, ability to stop taking PPIs, or health-related quality of life.
The US Food and Drug Administration (FDA) cleared Stretta for use in patients with GERD in 2000, and the procedure has been recommended by the Society of American Gastrointestinal and Endoscopic Surgeons. However, this recommendation was not based on a meta-analysis of data from the most recent randomized controlled trials.
To assess the risks associated with the Stretta procedure, Lipka et al assessed the FDA’s Manufacturer and User Facility Device Experience database. They found Stretta to have been associated with cases of pneumonia, gastroparesis, esophageal perforation, cardiac arrest, and at least 4 deaths.
Lipka et al. state that more studies are needed to gain a better understanding of the mechanisms for Stretta as a potential anti-reflux device. These should include before and after treatment studies that measure transient LES relaxation using high-resolution manometry, as well as impedance-pH tests to assess changes in the frequency of acid and weak acid reflux and the proximal extent of these reflux episodes. They also should include measures of LES compliance using functional lumen imaging probe technology.
Members of the Society of American Gastrointestinal and Endoscopic Surgeons wrote in a letter to the journal that they disagree with the methodology used and the conclusions reached iby Lipka et al and continue to support the Stetta procedure for treating GERD in carefully selected patients.