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GERD treatments review

Stretta tops the bill in review of GERD treatments

The review critically assessed each endoscopic technique, although the Angelchik silicone prosthesis, Linx LES magnetic ring augmentation and EndoStim electric stimulator were not included in the review

In a critical assessment of endoscopic techniques for gastro-oesophageal reflux disease (GERD) published in the Journal of Clinical Gastroenterology, Stretta radiofrequency technology (Mederi Therapeutics) was deemed “effective, safe and durable with 15 years of worldwide use”. Newer therapies such as endoscopic plication and suturing (Endo-Cinch, Plicator System, EsophyX, MUSE), were said to have demonstrated “mixed outcomes and are more cumbersome.” The review’s authors, Dr Wai-Kit Lo and Hiroshi Mashimo, said that additional research was required to “tailor the newer treatments to specific patient subgroups, with special consideration of the risks and benefits of these techniques relative to laparoscopic surgery.”

In the paper, ‘Critical Assessment of Endoscopic Techniques for Gastroesophageal Reflux Disease.’, GERD is said to be prevalent in 10% to 28% of adults in western countries, and that its management is based on medical therapy (primarily proton pump inhibitor, PPI) or surgical fundoplication. However, more recently endoscopic treatment modalities have emerged that could improve the 40% of patients that report incomplete or unsatisfactory response to PPIs or surgery. Therefore, the review critically assessed each endoscopic technique, although the Angelchik silicone prosthesis, Linx LES magnetic ring augmentation and EndoStim electric stimulator were not included in the review.

Stretta

Stretta radiofrequency technology, approved in 2000 by the FDA for the treatment of GERD symptoms, uses a transoral specialised balloon catheter system to deliver radiofrequency energy to the lower oesophageal sphincter (LES) with the aim of increased LES thickness and thereby controlling reflux activity. Due to its longevity on the market, the Stretta device has long-term outcomes data, compared to its endoscopic rivals.

The papers authors state that a review of the clinical data shows “a significant improvement in subjective reflux symptom scores in those undergoing Stretta treatment”. Furthermore, they note that a subgroup analyses of demonstrated improvements in objective measures of acid reflux following Stretta, including DeMeester score (44.37±93 to 28.53±33.4, p=0.0074, over 13.1 months in 267 patients across seven studies), and oesophageal acid exposure (10.29±17.8 to 6.51±12.5%, p=0.0003, over 11.9 months in 364 patients across 11 studies). The long-term durability of Stretta has also been confirmed in studies that reported improvements in reflux symptom scores and decreased PPI dependence (continued at eight and ten years after initial therapy).

In addition, in a review by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for endoscopic treatment of GERD in 2013, Stretta was given the highest recommendation by the Society.

In summary, the researchers said “…a wealth of research has demonstrated the safety, efficacy, durability, and repeatability of Stretta radiofrequency treatment. Most important, it does not preclude alternative treatments including medical, surgical or repeat radiofrequency treatments, and may also provide potential treatment for patients who have failed fundoplication. Stretta is likely the least expensive alternative to medical therapy. This technique should be considered a viable complement or alternative to medical and surgical treatment of GERD symptoms.”

Newer technologies

A review of the newer endoscopic therapies included the EndoCinch endoluminal gastroplication (CR Bard), endoscopic full-thickness plication using the Plicator System (Ethicon Endo-Surgery), and transoral incisionless fundoplication (TIF) including EsophyX (EndoGastric Solutions) and MUSE technologies (Medigus).

EndoCinch places threaded sutures at the GE junction, effectively cinching the junction to enhance the barrier to reflux and early research showed safety and efficacy of the procedure up to two years. Moreover, a randomised, sham-controlled study demonstrated improvement in reflux scores, however, a re-assessment of the same patient cohort at four years revealed 80%PPI dependence and 64% treatment failure. It is thought that suture loss at 12 to 18 months was the likely cause and therefore the authors stated that improvements in the durability of the sutures maybe be required (CR Bard has now since discontinued the device).

The Plicator System for transmural suturing at the GE junction is designed to create at least one pleat at the gastric cardia to increase the anatomic barrier to reflux. A randomised, sham-controlled study reported improvements in oesophageal acid exposure, reflux symptoms and PPI dependence – outcomes that were confirmed out to five years. In a comparison with radiofrequency ablation, plication resulted in greater improvement in regurgitation symptoms, although both techniques otherwise resulted in similar outcomes.

Transoral Incisionless Fundoplication (TIF) using the MUSE device uses a surgical endostapler with ultrasound guidance and standard staples. The authors said that initial six-month follow-up data for MUSE “are promising, although the presence of two early severe adverse events including esophageal leak and postprocedural upper gastrointestinal bleeding necessitated changes to the procedure protocol and to the device. Questions about safety and long-term durability of symptom relief remain.

The EsophyX device reconstructs the gastro-oesophageal valve, restoring its competency and re-establishing the barrier to reflux. The device has undergone several modifications to more closely replicate laparoscopic fundoplication. A randomised study of 63 patients, TIF vs. PPI therapy reported a greater reduction in reflux symptoms and PPI dependence at six-month follow-up in the TIF arm. Three-year follow-up data from a multi-centre prospective study found symptom relief, healing of erosive esophagitis and PPI cessation “remained stable”. However, the review found that some smaller observational studies have “mixed findings”. Nevertheless, a systematic review (including 15 studies) reported overall improvement in reflux symptoms scores.

EsophyX device reconstructs the gastro-oesophageal valve, restoring its competency and re-establishing the barrier to reflux

Overall, the review authors said that endoscopic plication and suturing “suffer from poor therapeutic durability.. lack of long-term data and questions about safety and mixed results with a few cases requiring subsequent surgical revision…Although there may be a role for these procedures in select patient populations, such as those with elevated surgical risks or who prefer a less invasive approach, further study is needed to identify the most appropriate subjects for device application.”

Injections

In a review of materials that are injected or implanted into the GE junction to create an anatomic barrier to reflux, the authors report that these treatments have had a poor record of efficacy and safety, demonstrated by the fact that Enteryx (Boston Scientific) and Gatekeeper (Medtronic) were with recalled or withdrawn, respectively.

Plexiglas is an injection of polymethylmethacrylate (PMMA) beads that has been used in one small study to treat GERD in humans, it has not been approved for endoluminal injection for GERD management.

Durasphere (Carbon Medical Technologies) is an injectable agent comprised of carbon-coated beads suspended in a water-based gel, but is not approved for injection at the GE junction for reflux treatment.

In summary the authors state that in regard to safety and efficacy, injectables have demonstrated poor outcomes with particular concern about accidental injection or injury to adjacent structures. “Further research is needed before these technologies can be considered viable treatment options for GERD,” they add.

“With many different options of varying success and market duration, national gastroenterological societies have struggled to clarify the role of these advanced recommendation for application of any of these procedures comes from the SAGES consortium, specifically in the use of Stretta as an alternative to surgical management….More recent guidelines published by the American Society for Gastrointestinal Endoscopy recommend Stretta and TIF in select patients with uncomplicated GERD after reviewing more traditional treatment options,” the authors write.

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