Stretta Radiofrequency Treatment for GERD: A Safe and Effective Modality

To the Editor: We read with interest your guidelines for the diagnosis and management of GERD published this month in the American Journal of Gastroenterology ( 1 ). We are responding to the statements in those guidelines claiming that endoscopic therapies “ have not demonstrated long-term effi cacy ” in improving pH and decreasing antirefl ux therapy use and incorrectly dismisses all modalities as “ removed from US market place. ” Although some of the endoscopic therapies have not proven useful, including injectable that were withdrawn from the market, radiofrequency energy application to the lower esophageal sphincter using Stretta (Mederi Th erapeutics) has the longest experience as a safe and eff ective method in the treatment of GERD. Several studies have shown a decrease in esophageal acid exposure aft er Stretta. Arts et al. ( 2 ) followed 13 patients over 6 months and all patients underwent repeated pH monitoring 6 months aft er the procedure. One measurement was technically inadequate and not interpretable. In the evaluable patients, esophageal pH monitoring was signicantly improved, from 11.6 % ± 1.6 % to 8.5 % ± 1.8 % of the time at pH < 4 ( P < 0.05). Normalization of the pH monitoring ( < 4 % of the time at pH < 4) occurred in only three patients. Th e DeMeester score showed a similar improvement, from 46.8 ± 7.3 to 35.6 ± 6.7 ( P = 0.01) ( 2 ). Aziz et al. ( 2 ) showed similar results from their prospective randomized sham study of 36 patients, which showed signifi cant reduction in esophageal acid 12 months ( 7 ). Dughera et al. ( 8 ) reported similar results in 48-month follow-up data for 56 out of 69 patients who were treated with Stretta. Radiofrequency treatment signifi cantly improved heartburn scores, GERD-related quality of life scores, and general quality of life scores at 24 and 48 months in 52 out of 56 patients (92.8 % ). At 48 months, 41 out of 56 patients (72.3 % ) were completely off PPIs. Morbidity was minimal, except for one patient who developed transient gastroparesis. We believe that there is a suffi cient body of literature to support that Stretta is a safe and eff ective alternative to treatment of GERD and that the statement “ the usage of current endoscopic therapy or trans oral incisionless fundoplication cannot be recom mended as an alternative to medical or traditional surgical therapies ” , is inaccurate and misleading. Th is statement ignores the numerous published randomized studies with long duration of follow up and a recently published meta-analysis, but cites a SAGES web-based survey by Urbach and colleagues ( 9 ) based on a Delphi process of collecting anonymous opinions from online surveys. Th e review is also inconsistent with more recent and strong recommendation (assessed as 4-plus quality of evidence) from SAGES based on literature review ( 10 ). We believe that recommendations should be based on sound evidence such as randomized clinical trials rather than by anonymous opinions.


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The American Journal of GASTROENTEROLOGY VOLUME 108 | OCTOBER 2013 www.amjgastro.com

LETTERS TO THE EDITOR
To the Editor: We read with interest your guidelines for the diagnosis and management of GERD published this month in the American Journal of Gastroenterology ( 1 ). We are responding to the statements in those guidelines claiming that endoscopic therapies " have not demonstrated long-term effi cacy " in improving pH and decreasing antirefl ux therapy use and incorrectly dismisses all modalities as " removed from US market place. " Although some of the endoscopic therapies have not proven useful, including injectable that were withdrawn from the market, radiofrequency energy application to the lower esophageal sphincter using Stretta (Mederi Th erapeutics) has the longest experience as a safe and eff ective method in the treatment of GERD. Several studies have shown a decrease in esophageal acid exposure aft er Stretta. Arts et al. ( 2 ) followed 13 patients over 6 months and all patients underwent repeated pH monitoring 6 months aft er the procedure. One measurement was technically inadequate and not interpretable. In the evaluable patients, esophageal pH monitoring was signicantly improved, from 11.6 % ± 1.6 % to 8.5 % ± 1.8 % of the time at pH < 4 ( P < 0.05). Normalization of the pH monitoring ( < 4 % of the time at pH < 4) occurred in only three patients. Th e DeMeester score showed a similar improvement, from 46.8 ± 7.3 to 35.6 ± 6.7 ( P = 0.01) ( 2 ). Aziz et al. ( 2 ) showed similar results from their prospective randomized sham study of 36 patients, which showed signifi cant reduction in esophageal acid 12 months ( 7 We believe that there is a suffi cient body of literature to support that Stretta is a safe and eff ective alternative to treatment of GERD and that the statement " the usage of current endoscopic therapy or trans oral incisionless fundoplication cannot be recom mended as an alternative to medical or traditional surgical therapies " , is inaccurate and misleading. Th is statement ignores the numerous published randomized studies with long duration of follow up and a recently published meta-analysis, but cites a SAGES web-based survey by Urbach and colleagues ( 9 ) based on a Delphi process of collecting anonymous opinions from online surveys. Th e review is also inconsistent with more recent and strong recommendation (assessed as 4-plus quality of evidence) from SAGES based on literature review ( 10 ). We believe that recommendations should be based on sound evidence such as randomized clinical trials rather than by anonymous opinions. . Th e esophageal acid exposure was reported in 11 studies comprising of 364 patients over a mean follow-up period of 11.9 months. Esophageal acid exposure decreased from a mean of 10.29 % ± 17.8 % to 6.51 % ± 12.5 % ( P = 0.0003) ( 4 ). High frequency of transient lower esophageal sphincter relaxations (TLESRs) is now appreciated as the most common underlying mechanism of GERD ( 5 ), and Arts et al. ( 2 ) proposes that the noted reduction in TLESR aft er Stretta may explain the improvement in refl ux episodes.

CONFLICT OF INTEREST
In addition, Stretta has proven eff ective at decreasing acid refl ux medication use. Th ere have been several studies showing a signifi cant decrease in medication use aft er Stretta. Triadafi lopoulos et al. ( 6 ) conducted a nonrandomized, prospective, multicenter study that included 118 patients treated with Stretta for GERD. Follow-up information was available for 94 patients (80 % ) at 12 months; the proportion of patients requiring proton-pump inhibitors (PPIs) fell from 88 % to 30 % . Th ere was also an improvement in quality of life scores and reduction in esophageal acid exposure ( 6 ). In another trial by Liu et al.  option for the management of refractory gastro-esophageal refl ux disease (GERD), the delivery of radiofrequency energy to the gastro-esophageal junction (Stretta). Th is endoscopic therapy is safe, eff ective, durable, and repeatable if necessary and serves an unmet need for many GERD suff erers ( 2 ). Refractory GERD implies clinically signifi cant impairment of quality of life due to episodes of refl ux while on proton pump inhibitor (PPI) therapy. Approximately a third of patients with GERD are resistant or partial responders to PPIs and they represent a major clinical challenge for practicing gastroenterologists today ( 3 ). Potential underlying mechanisms include persistence of acid or weakly acidic refl ux, as these drugs do not address an incompetent sphincter, esophageal mucosal hypersensitivity, or psychological factors ( 4 ). Consequently, some patients seek alternative treatments (endoscopic or surgical) if their quality of life is compromised ( 5 ).
Stretta is a valuable option for such refractory patients who are not willing to undergo anti-refl ux surgery. Potential candidates for Stretta would be those who have persistent heartburn and / or regurgitation despite PPI use (refractory GERD), patients with GERD who are symptomatic because they cannot tolerate PPIs, those who desire to stop drug therapy and those who do not wish anti-refl ux surgery, or are poor surgical candidates. In contrast, patients with refractory GERD who have large sliding hiatal hernia ( > 3 cm long) or very low sphincter pressure ( < 5 mm Hg) are not appropriate candidates ( 6 ).
Several studies have shown signifi cant reduction of esophageal acid exposure but not consistent normalization esophageal acid exposure aft er Stretta. In a recent metaanalysis reporting 11 studies comprising 364 patients over a mean follow-up period of 11.9 months, esophageal acid exposure decreased from a mean of 10.29 % ± 17.8 % to 6.51 % ± 12.5 % ( P = 0.0003; ( 7 )). However, refractory GERD symptoms may not always refl ect the acidity of the refl uxate but may be due to increased refl uxate volume, esophageal distensibility, and individual sensitivity to acid ( 8 -9 ). Indeed, visceral analgesics, such as a tricyclic antidepressants, selective serotonin uptake inhibi-tors, or trazodone, are used as adjunctive tools in the management of PPI-refractory GERD patients. Stretta could be eff ective in decreasing esophageal sensitivity to acid. Th is has been suggested by controlled clinical trials showing improvement of symptoms and decrease in PPI use despite the lack of normalization of esophageal acid exposure, as well as experimentally, by decreasing esophageal infl ammation and sensitivity to acid perfusion (Bernstein ' s test) ( 10 ).
Stretta also decreases gastro-esophageal junction compliance, which in turn contributes to symptomatic benefi t by decreasing refl uxate volume ( 11 ). Th erefore, Stretta may be considered as an endoscopic pain modulator and should be considered in patients with refractory symptoms despite PPIs, as well as in patients with hypersensitive esophagus and functional heartburn ( 4 ). Further, it does not preclude any other alternative (repeat Stretta, PPI addition or fundoplication) and is the least expensive alternative to medical therapy. Today more than ever, clinicians will benefi t from the addition of Stretta to the treatment armamentarium for their GERD patient.