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Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

Policy

Policy Guidelines

Benefit Application

Rationale

Transesophageal Suturing (i.e., Endocinch)

Minimal data are available regarding transesophageal suturing published in peer-reviewed journals. Filipi and colleagues (1) reported on a multicenter case series of 64 patients with symptoms of gastroesophageal reflux disease (GERD). Inclusion criteria were 3 or more episodes of heartburn per week while not taking medications, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Therefore, the enrolled patients would appear to have only mild to moderate GERD-related symptoms and would not be considered candidates for a surgical procedure. At a 6-month follow-up, patients reported significant improvements in heartburn severity and frequency as well as regurgitation. Twenty-four hour pH monitoring showed improvement in number of episodes below a pH of 4 at 3 and 6 months (p < 0.0007 and 0.0002) and in percentage of total time the pH was less than 4 at 6 months (p < 0.011). Transesophageal suturing is a technically demanding procedure that requires accurate placement of plication stitches. In addition, the procedure required more than conscious sedation in 31% of patients. A repeat procedure was required in 11 patients for unknown reasons.

Swain and colleagues reported on a case series of 28 patients with GERD whose symptoms were not controlled with medical therapy and who were offered and declined open or laparoscopic antireflux surgery, or who were considered unfit for anesthesia due to concurrent illness. (2) Therefore, in this case, transesophageal suturing appears to be an alternative to surgery, not medical therapy. Pre- and postoperative assessment (at 3 months) focused on symptoms, manometry, and 24-hour ambulatory pH monitoring. There was a significant decrease in symptoms, use of proton pump inhibitors, and percentage of time when a pH of less than 4 was recorded. In addition, there was a significant increase in the length of the lower esophageal sphincter and sphincter pressure. The potential benefits of the procedure noted by the authors include easy repeatability, reversibility, short operation time, and lack of need for general anesthesia.

Mahmood and colleagues reported on another case series of 26 patients, which evaluated outcomes at 1 year. (3) The selection criteria and procedures were similar to the Filipi study, summarized here. At 1 year, the heartburn symptoms score was reduced from 19.22 at baseline to 7.5, and the regurgitation score was reduced from 2.27 to 0.86. Use of proton pump inhibitors (PPI) was reduced from 100% to 36%.

These case series were evaluated by a 2003 TEC Assessment (4), which offered the following observations and conclusions.

Since the 2003 TEC Assessment, 1 case series in children and a non-randomized comparative study comparing transesophageal suturing to laparoscopic antireflux surgery have been published. The study in children (5) showed improvement from baseline symptoms. The comparative study (6) showed that suturing was not as effective as antireflux surgery in reducing medication use. These additional studies do not provide additional evidence of the efficacy of transesophageal suturing.

Transesophageal Radiofrequency Energy Delivery to the Gastroesophageal Junction (i.e., the Stretta procedure)

The 2003 TEC Assessment (4) offered the following observations and conclusions regarding the Stretta procedure.

• Data were evaluated from 3 case series of 118, 25, and 18 patients, respectively. (7-9) All 3 studies reported improvement in symptoms and symptom-related quality of life measures. The largest study reported 12 months’ follow-up; (7) the next largest study followed patients only to 3 months; (8) and the smallest study followed up patients to 6 months. (9)
• Data were also evaluated from a single randomized trial. (10) This trial enrolled patients with symptoms at least partially responsive to proton pump inhibitors, a pH study showing abnormal acid exposure, and the usual exclusions including severe esophagitis or significant anatomic defect. The sham procedure involved balloon inflation but no needle deployment or energy delivery. A total of 64 patients were randomized, and partial or complete 6-month follow-up data were available on 56 patients.
• The results of this trial were inconsistent; although there was improvement in heartburn symptoms, quality of life, and general physical quality of life in the active treatment group compared to the sham group, there were no differences in medication usage and esophageal acid exposure. Thus in terms of the objective measures of GERD, the findings are equivocal. The large proportion of sham-treated patients successfully reducing medication use points to possible placebo effect of the procedure. In addition, data are also needed from controlled comparison with other treatment for GERD, such as Nissen fundoplication to better characterize outcomes relative to the risks involved.

Considerable interest in the Stretta procedure continues, with several reviews published since the TEC Assessment. (11, 12) However, a literature search through January 2006 did not identify any additional randomized studies. Only additional case series have been identified. In 1 such study, Houston and colleagues reported the results in 41 patients, of whom 18 had follow-up manometry and pH studies after a mean follow-up of 6 months. (13) In these patients, a significant decrease in esophageal acid exposures was found, but there was no change in lower esophageal sphincter pressure. The improvement in esophageal acid exposure in this trial contrasts the lack of improvement in the randomized trial considered in the TEC Assessment. (10)

Injection of Polymer (i.e., Enteryx procedure)

The U.S. Food and Drug Administration (FDA) approval for the Enteryx procedure was based on a prospective case series of 85 patients who had gastroesophageal reflux disease (GERD) that was controlled by medical therapy including PPIs. (14) A successful outcome was defined as elimination of PPI use or a reduction in use of PPIs by at least 50% compared to baseline usage. Therefore, the procedure was clearly designed to be an alternative to medical therapy. At 12 months, 80.3% of the study subjects met the primary outcome. While this case series reports promising results, as noted by the TEC Assessment of other transesophageal endoscopic therapies for GERD, randomized studies are required to determine treatment effectiveness. As of January 2005, this single study has remained the only published case series reporting outcomes of this procedure. In fact, as part of the postmarketing phase of FDA regulation, the FDA required a sham-controlled study. In addition, the long-term efficacy of the implant is unknown. For example, more than 40% of the subjects had greater than 25% decrease in residual implant volume at 6 and 12 months, raising concerns about the durability of the procedure. The protocol permitted reinjection of the polymer within the first 3 months of therapy; 19 of 85 patients (22%) underwent repeat injection during this period, either due to lack of effectiveness or sloughing of the implanted material. The safety and efficacy of repeat injections are unknown. Other safety concerns The chest pain resolved within 1 month in 90% of the patients, and in all patients by 3 months. A total of 20% of patients reported dysphagia.

In March 2005, Deviere and colleagues reported on a single-blind randomized controlled trial of 64 patients with GERD randomized to either Enteryx implantation or a sham procedure. (15) At 3 and 6 months’ follow-up, patients in the Enteryx group had greater reductions in PPI use and more improvement in GERD health-related quality of life heartburn scores. However, the small size and short duration of the study limit interpretation of findings. The established alternative to treating GERD is medical therapy, typically focusing on PPI therapy, which has a long track record of safety and efficacy. Given the small number of patients reported on, there are inadequate data to determine whether or not injection of a polymer is as least as good as the established alternative of medical therapy. In addition, in September 2005, Enteryx was voluntarily removed from the market due to serious adverse effects, as noted here.

Injection of Polymethylmethacrylate (PMMA) Beads

Published data regarding transesophageal submucosal implantation of PMMA consist of a case series of 10 patients with GERD who were either refractory to or dependent on proton pump inhibitors. (16) While a significant decrease in symptom scores was noted at post-treatment follow-up (time not specified), the small number of patients and lack of long-term follow-up preclude scientific analysis. As of January 2006, no additional studies had been identified evaluating this treatment option.

In recent guidelines released by the American College of Gastroenterology (17), endoscopic therapies for reflux were stated to “control symptoms in selected patients with well-documented GERD,” with level III evidence, which are trials without randomization, single group prepost, cohort, time series, or matched case-controlled studies. Medical therapy with proton pump inhibitors and antireflux surgery are endorsed with higher levels of evidence in these guidelines.

In December 2005, the Agency for Healthcare Research and Quality released a report entitled “Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease.” (18) The report findings, as follows, are consistent with the policy conclusions above:

• Data on comparative endoscopic treatments with continued (or intensified) use of PPIs are needed to better understand their efficacy compared to an established standard.
• More efficacy and safety data on new endoscopic approaches tested against a sham procedure with adequate follow-up are needed.

2007 Update

A literature search was conducted using MEDLINE through April 2007. When possible, the articles reviewed below are those that included a comparative group, i.e., were not case series.

Transesophageal Suturing

Montgomery reported on a double-blind sham study of 46 patients with GERD who required daily PPI therapy. (19) In this study, 22 patients had plication (EndoCinch) and 24 had a sham procedure. There were no statistically significant differences between groups for some key measures including acid exposure and discontinuation of PPI. Also, there were no changes in the extent of esophagitis. Also noted was a marked loss of sutures with 67% remaining at 12 months. While the sample size is small, this blinded randomized study highlights many open questions about use of this technique.

Rothstein reported on use of full-thickness plication (Plicator) with 3-month follow-up in a randomized, sham-controlled multicentered study of 159 patients with GERD requiring maintenance therapy. (20) In this short-term study, complete cessation of PPI therapy was higher among those in the treatment group than in the sham group (50% vs. 24%). Quality of life scores also improved more in the active group. The percent reduction in median percent time the pH was less than 4 was improved more in the active group (7% vs. 10%) but did not change in the sham group (10% vs. 9%). The authors noted that the single full-thickness plication normalized the distal esophageal acid contact for less than one third of the patients and was not effective in healing esophagitis. Also, radiating shoulder pain and abdominal pain were more frequent adverse events in the active treatment group (12% vs. 0% and 9% vs. 0%, respectively).

Schwartz reported on a single-center study of 60 patients with GERD; 20 patients were randomized to EndoCinch; 20 had a sham procedure; and 20 had observation. (21) At three-month follow-up; while PPI use decreased more in the active treatment group (compared to sham), there was no difference between the 2 groups in acid exposure time. Acid exposure times normalized in 29% of actively treated patients and 22% of sham patients ('p=0.71). During the 12-month follow-up, 29% of those who received suturing were retreated.

Mahmood reported on a nonrandomized contemporaneous comparative study of 27 patients receiving endoscopic plication to 24 patients having laparoscopic Nissen fundoplication (LNF). (22) Many of those receiving endoscopic procedures were referred to a gastroenterologist while those having the fundoplication were often referred directly to a surgeon. Patients had GERD symptoms requiring continuous PPI treatment; some had breakthrough symptoms on PPIs. In this small, non-randomized study, symptom control improved in both groups but was better for the LNF group. Dysphagia was more common after LNF. Ninety-one percent of LNF patients achieved normal esophageal pH compared to 48% in the endoscopic group.

Use of Radiofrequency Energy

For use of radiofrequency energy (e.g., Stretta procedure), no randomized trials were identified. Two reports with longer term follow-up of case series were reported. Noar reported on the 4-year follow-up of 109 consecutive patients who underwent the Stretta procedure for drug-refractory GERD. (23) Ninety-six of the 109 patients had results at 4 years; of these, medication use changed from 100% receiving twice daily proton-pump inhibitor therapy to 75% eliminating this medication or using it only on an as-needed basis. Quality of life scores improved. Thirteen patients required a second procedure. Reymunde reported on the 4-year follow-up of 83 consecutive patients with refractory GERD symptoms who were treated using radiofrequency energy. (24) Daily medication use dropped from 100% to 14%. Quality of life scores improved. However, long-term pH monitoring was not reported in either study. Reports with small numbers of patients describe preliminary results on use of this procedure in those who have persistent reflux symptoms following anti-reflux surgery. (25)

Injection of Polymer

Domagk reported on a European trial in which a small number of patients (N=51) with refractory GERD were randomized to either gastroplasty (EndoCinch) or polymer implantation (Enteryx) and followed up for 6 months. (26) Approximately 25% of patients in each group required retreatment during the trial. Decrease in medication use and improved quality of life scores were noted in both groups; there were no statistically significant differences between results for the 2 treatments.

Summary

An editorial accompanying the Rothstein article indicates that there is still uncertainty as to where to position endoscopic anti-reflux procedures for those with GERD, and that given the lack of data it is premature to claim superiority or even equivalence of these devices to best medical or surgical therapy. (27) Some of the unresolved issues include questions about the safety and durability of the device/treatment, lack of consistent improvement in objective measures (esophageal acid exposure) using these devices, and the lack of randomized comparative trials to best medical and best surgical therapy. The efficacy of these devices in those with highly erosive disease or hiatal hernias is unknown. Until these key issues are addressed, these devices are considered investigational; the policy statement is unchanged.

2008 Update

2009 Update
The policy was updated with a literature review using MEDLINE in June 2009. No new randomized controlled trials addressing the issues outlined above were identified. The 2008 Medical Position Statement of the American Gastroenterological Association (31) makes no recommendation for or against“the use of currently commercially available endoluminal antireflux procedures in the management of patients with an esophageal syndrome” based on insufficient evidence (Grade Insufficient).

References:

1. Filipi CJ, Lehman GA, Rothstein RI et al. Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointest Endosc 2001; 53(4):416-22.
2. Swain CP. Endoscopic suturing. Baillieres Best Pract Res Clin Gastroneterol 1999; 13(1):97-108.
3. Mahmood Z, McMahon BP, Arfin Q et al. Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up. Gut 2003; 52(1):34-9.
4. 2003 TEC Assessment: Transesophageal Endoscopic Treatment for Gastroesophageal Reflux Disease
5. Thomson M, Fritscher-Ravens A, Hall S et al. Endoluminal gastroplication in children with significant gastro-oesophageal reflux disease. Gut 2004; 53(12):1745-50.
6. Chadalavada R, Lin E, Swafford V et al. Comparative results of endoluminal gastroplasty and laparoscopic antireflux surgery for the treatment of GERD. Surg Endosc 2004; 18(2):261-5.
7. Triadafilopoulos G, DiBaise JK, Nostrant TT et al. The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc 2002; 55(2):149-56.
8. Richards WO, Scholz S, Khaitan L et al. Initial experience with the Stretta procedure for the treatment of gastroesophageal reflux disease. J Laparoendosc Adv Surg Tech A 2001; 11(5):267-73.
9. DiBaise JK, Brand RE, Quigley EM. Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: efficacy and potential mechanism of action. Am J Gastroenterol 2002; 97(4):833-42.
10. Corley DA, Katz P, Wo JM et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized sham-controlled trial. Gastroenterology 2003; 125(3):668-76.
11. Triadafilopoulos G. Stretta: an effective, minimally invasive treatment for gastroesophageal reflux disease. Am J Med 2003; 115(suppl 3A):192S-200S.
12. Vakil N, Sharma P. Review article: endoscopic treatments for gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2003; 17(12):1427-34.
13. Houston H, Khaitan L, Holzman M et al. First year experience of patients undergoing the Stretta procedure. Surg Endosc 2003; 17(3):401-4.
14. Johnson DA, Ganz R, Aisenberg J et al. Endoscopic implantation of enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial. Am J Gastroenterol 2003; 98(9):1921-30.
15. Deviere J, Costamagna G, Neuhaus H et al. Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial. Gastroenterology 2005; 128(3):532-40.
16. Feretis C, Benakis P, Dimopoulos C et al. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc 2001; 53(4):423-6.
17. DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005; 100(1):190-200.
18. Ip S, Bonis P, Tatsoni A et al. Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease. Evidence Report/Technology Assessment No. 1. (Prepared by Tufts-New England Medical Center Evidence-based Practice Center) Agency for Healthcare Research and Quality. AHRQ Publication No. 06-EHC003-EF. http://effectivehealthcare.ahrq.gov/synthesize/reports/finalGERD.cfm.
19. Montgomery M, Hakanson B, Ljungqvist O et al. Twelve months’ follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study. Scand J Gastroenterol 2006; 41(12):1382-9.
20. Rothstein R, Filipi C, Caca K et al. Endoscopic full-thickness placation for the treatment of gastroesophageal reflux disease: a randomized, sham-controlled trial. Gastroenterology 2006; 131(3):704-12.
21. Schwartz MP, Wellink H, Gooszen HG et al. Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial. Gut 2007; 56(1):20-8.
22. Mahmood Z, Byrne PJ, McMahon BP et al. Comparison of transesophageal endoscopic plication (TEP) with laparoscopic Nissen fundoplication (LNF) in treatment of uncomplicated reflux disease. Am J Gastroenterol 2006; 101(3):431-6.
23. Noar MD, Lotfi-Emran S. Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure. Gastrointest Endosc 2007; 65(3):367-72.
24. Reymunde A, Santiago N. Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up. Gastrointest Endosc 2007; 65(3):361-6.
25. McClusky DA3rd,Khaitan L, Swafford VA et al. Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) in patients with recurrent reflux after antireflux surgery: can surgery be avoided? Surg Endosc 2007; 21(7):1207-11.
26. Domagk D, Menzel J, Seidel M et al. Endoluminal gastroplasty (EndoCinch) versus endoscopic polymer implantation (Enteryx) for treatment of gastroesophageal reflux disease: 6-month results of a prospective, randomized trial. Am J Gastroenterol 2006; 101(3):422-30.
27. Shaheen NJ. The rise and fall (and rise?) of endoscopic anti-reflux procedures. Gastroenterology 2006: 131(3):952-4.
28. Thomson M, Antao B, Hall S et al. Medium-term outcomes of endoluminal gastroplication with the EndoCinch device in children. J Pediatr Gastroenterol Nutr 2008; 46(2):172-7.
29. von Renteln D, Schiefke I, Fuchs KH et al. Endoscopic full-thickness placation for the treatment of GERD by application of multiple Plicator implants: a multicenter study (with video). Gastrointest Endosc 2008 Jun 3 [Epub ahead of print].
30. Triadafilopoulos G. Endotherapy and surgery for GERD. J Clin Gastroenterol 2007; 41(6 Suppl 2):S87-96.
31. American Gastroenterological Association. Medical position statement on the management of gastroesophageal reflux disease. Available at: www.gastro.org/wmspage.cfm?parm1=4453. Last viewed June 2008.
32. Cadiere G, Buset M, Muls V et al. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg 2008; 32(8):1676-88.
33. Birk J, Pruitt R, Haber G et al. The Plicator procedure for the treatment of gastroesophageal reflux disease: a registry study. Surg Endosc 2009; 23(2):423-31.
34. Coron E, Sebille V, Cadiot G et al. Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients. Aliment Pharmacol Ther 2008; 28(9):1147-58.
35. Jafri S, Arora G, Triadafilopoulos G. What is left of the endoscopic antireflux devices? Curr Opin Gastroenterol 2009; 25(4):352-7.
36. Johnson D. Injectable treatment for GERD: the flight of the Phoenix? Gastrointest Endosc 2009; 69(2):324-6.
37. Mosler P, Aziz A, Hieston K et al. Evaluation of supplemental cautery during endoluminal gastroplication for the treatment of gastroesophageal reflux disease. Surg Endosc 2008; 22:2158-63.
38. Noar M and Noar E. Gastroparesis associated with gastroesophageal reflux disease and corresponding reflux symptoms may be corrected by radiofrequency ablation of the cardia and esophagogastric junction. Surg Endosc 2008; 22(10):2440-4.
39. Ganz R, Fallon E, Wittchow T et al. A new injectable agent for the treatment of GERD: results of the Durasphere pilot trial. Gastrointest Endosc 2009; 69(2):318-23.
40. Bonavina L, Saino G, Bona D et al. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg 2008; 12(12):2133-40.

Index

Policy History