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Endoluminal GERD treatments

CSR on endoluminal GERD treatments (Stretta therapy)

The new CSR addresses the evidence around Stretta and Esophyx, as well as provide evidence-based answers to the following clinically relevant questions that were developed by the SAGES Guidelines Committee using the PICOD methodology

The SAGES’ CSR Guideline statement on two endoscopic treatments for the treatment of gastroesophageal reflux disease (GERD), also reviewed the transoral Stretta catheter system (Mederi Therapeutics) delivers radiofrequency (RF) energy around the lower aesophageal sphincter (LES) by forcing radially placed needles on a balloon into the area multiple times and at multiple levels (Figure 1).

Figure 1: Stretta device

It uses a proprietary algorithmic application of low power (5 Watts) RF energy that heat tissue (65°C to 85°C) during a series of one- minute treatment cycles. Stretta therapy leads to remodelling of the musculature of the LES and gastric cardia. The mechanism of action is believed to be related to decreased sensitivity to acid, decreased compliance of the LES or increased pressure of the LES (Figure 2). The FDA originally cleared Stretta for use in 2000 and issued an updated clearance on the RF generator in 2011.

Figure 2: Stretta therapy delivers low power, low temperature radiofrequency energy to remodel the valve known as the lower oesophageal sphincter (LES) at the junction of the oesophagus and the stomach. (Credit: PRNewsFoto/Mederi Therapeutics Inc.)

Under moderate sedation, the procedure is typically accomplished in less than an hour. Patients can return to home within a few hours and to work and normal activities within 24 hours, making Stretta an attractive option for the treatment of GERD.

Since the introduction of Stretta in clinical practice, numerous studies have reported on its outcomes. A systematic literature search of the available evidence revealed 117 papers on Stretta. Since the publication of the prior SAGES report on endoluminal techniques, two new systematic reviews and meta-analyses, four new observational studies reporting longer term follow up results, but no new randomised controlled trials have been published. These studies provide a clearer picture of the clinical effectiveness and safety of the procedure.

Of the two available, recent systematic reviews and meta-analyses that have analysed the existing literature on Stretta, one has included both randomised and observational studies similar to a prior systematic review that was included in our previous report and one analysed only the 4 existing randomized trials. This difference in inclusion criteria has led to fairly disparate conclusions of these studies.

In patients with GERD, one study did not demonstrate a difference between Stretta and sham or management with PPI for the outcomes of mean (%) time the pH was less than 4 over a 24-hour time course, lower esophageal sphincter pressure (LESP), ability to stop PPIs, or health related quality of life (HRQOL).

Nevertheless, all these outcomes except for the mean (%) time the pH was less than 4 over a 24-hour period, were in favour of Stretta and approached, but did not reach statistical significance. The small sample size, which analysed only 153 patients, is the main limitation of the meta-analysis. Recent studies have also argued that observational studies should be pooled with randomized trials during meta-analyses.

The most recent systematic review and meta-analysis included studies from a variety of geographic locations and institutions and provides a generalizable picture of the effectiveness of Stretta. The meta-analysis analyzed outcomes of 2,468 patients from 4 randomised and 24 observational studies who had undergone the Stretta procedure with an (unweighted) mean follow up time of 25.4 [14.0, 36.7] months.

The pooled results showed that the Stretta procedure reduced (improved) the health-related quality of life score by -14.6 [-16.48, -12.73] (P<0.001) and reduced the pooled heartburn standardized score by -1.53 [-1.97, -1.09] (P<0.001). After Stretta treatment, half of the patients using PPIs at baseline required PPIs at follow-up (P<0.001). The Stretta treatment reduced the incidence of erosive esophagitis by 24% (P<0.001) and reduced oesophageal acid exposure by a mean of -3.01 [-3.72, -2.30] (P<0.001). On the other hand, lower oesophageal sphincter basal pressure was increased post Stretta therapy by a mean of 1.73 [-0.29, 3.74] mmHg, but this change was not statistically significant (P=NS).

Using a Markov model to assess the long-term cost effectiveness of therapies such as PPI, Stretta, EsophyX and laparoscopic Nissen fundoplication for GERD, it was demonstrated that assuming a PPI cost of $234 over 6 months ($39 per month), PPI, Stretta and laparoscopic Nissen fundoplication were the most cost-effective options over a 30- year time period. When the PPI cost, however, exceeded $90 per month, medical therapy was no longer cost effective.

Compared to fundoplication, Stretta is less effective for GERD symptom control but has fewer complications. Stretta has also been applied to the treatment of GERD after prior anti-reflux surgery or after bariatric surgery with promising results. Few papers have also reported Stretta application to paediatric patients with reported improvements in GERD symptoms.

It is also important to note that in most of the trials, Stretta was used in patients with less than severe esophagitis and with <2cm hiatal hernias. As described previously, although Stretta improves the majority of GERD indices, it does not often lead to their normalization.

One meta-analysis identified 23 complications in 2,468 reported cases, for an incidence of 0.93%. Most of the identified complications were minor and included small erosions (0.36%) or lacerations (0.28%) of the mucosa and rarely prolonged gastroparesis (0.12%), pneumonia, bleeding ulcer, or mediastinitis (for all 0.04%). No mortalities have been reported.

Another meta-analysis assessed the FDA Manufacturer and User Facility Device Experience database for reported complications related to Stretta. They identified 21 reported adverse events such as pneumonia, gastroparesis, oesophageal perforation, and cardiac arrest, resulting in several hospitalizations, some permanent damages, and 4 deaths. It was, however, unclear whether these complications were solely related to the procedure and what the total number of procedures was that these complications originated from. At the time of the publication, an estimated 20,000 Stretta procedures had been performed globally,25 which would bring the MAUDE complication incidence to less than 1%.

The majority of published studies about Stretta have a short follow-up period (up to 12 months). While none of the 4 published RCTs report outcomes beyond 12 months, several observational studies do, with the longest available follow up duration being 10 years. The latter study prospectively assessed 217 patients with medically refractory GERD before Stretta. The primary outcome of normalization of GERD- health-related quality of life (GERD-HRQL) was achieved in 72% of patients (95% confidence interval 65-79) 10 years after the Stretta procedure.

In addition, the same authors reported that a 50% or greater reduction in PPI use occurred in 64% of patients, (41% eliminating PPIs entirely), and a 60% or greater increase in satisfaction occurred in 54% of patients. The study also showed that pre-existing Barrett’s metaplasia regressed in 85% of biopsied patients. Further, in a comparative cohort study of 125 patients who had undergone Stretta or laparoscopic Toupet fundoplication, both groups achieved similar independence from PPI treatment at 3 years follow up (68% vs 72%, respectively; p=ns), but the fundoplication was superior in the control of typical reflux symptoms and reduced the rate of reoperation (12% vs 0%, respectively; p=0.006).

All available cohort studies with follow up longer than 4 years indicate that the effectiveness of the procedure persists in the long term, to a degree somewhat less than that achieved initially. One of these studies, however, suggested that the best results are achieved in select patients with less severe GERD at baseline.

Few articles have reported on the learning curve of the Stretta procedure. In terms of time taken to complete Stretta, the reported learning curve appears to be less than 5 cases. Further, the technique itself does not appear to affect procedural outcomes as long as the application guidelines are followed.

Based on existing evidence, The CSR concluded that “Stretta significantly improves health related quality of life score, heartburn scores, the incidence of esophagitis, and oesophageal acid exposure in patients with GERD, but does not increase lower oesophageal sphincter basal pressure. In addition, it decreases the use of PPI by approximately 50%. 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. Stretta is more effective than PPI, but less so than fundoplication. Stretta is safe in adults and has a short learning curve. (Level of evidence +++, strong recommendation).”

Please click here to access part 1 (Esophyx) of the CSR

To review the review statement, please click here

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