BlueCross BlueShield of Tennessee Medical Policy Manual

Laparoscopic and Endoscopic Therapies for Gastroesophageal Reflux (GERD)

DESCRIPTION

Due in part to the prevalence of gastroesophageal reflux disease (GERD), there has been interest in creating a minimally invasive alternative to the standard treatments of open or laparoscopic fundoplication (Nissen) or chronic pharmaceutical therapy. This policy addresses several different types of emerging minimally invasive procedures:

Standard treatments for gastroesophageal reflux (GERD) are not addressed in this policy.

  1. Transesophageal endoscopic gastroplasty, also referred to as gastroplication, fundoplication, and transoral incisionless fundoplication (TIF), is a procedure where sutures are placed in the lower esophageal sphincter. The sutures are proposed to strengthen and lengthen the sphincter to decrease reflux. Products approved for marketing by the FDA include EsophyX® and Medigus SRS Endoscopic Stapling System (MUSE).

  2. Radiofrequency energy has been proposed as a treatment option to produce submucosal thermal lesions at the gastroesophageal junction (e.g. Stretta™). The mechanism of action of the thermal lesions is not precisely known but may be related to ablation of the nerve pathways responsible for sphincter relaxation or may induce a tissue tightening effect related to heat-induced collagen contraction.

  3. Submucosal implantation of a prosthesis (e.g., Gatekeeper™ Reflux Repair System) or injection of a bulking agent (e.g., polymethylmethacrylate beads, zirconium oxide spheres) to enhance the volume of the lower esophageal sphincter has also been proposed.

  4. A ringed magnetic bead sphincter augmentation device (e.g. LINX® Reflux Management System) placed laparoscopically has been proposed as a treatment for GERD. The magnetic attraction between the beads purportedly helps the Lower Esophageal Sphincter (LES) resist opening to gastric pressures, preventing reflux from the stomach into the esophagus. Swallowing forces temporary breaks in the magnetic bond, allowing food and liquid to pass normally into the stomach. Magnetic attraction closes the LES immediately after swallowing, purportedly restoring the barrier to reflux.

POLICY

See also:  Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Peroral Endoscopic Myotomy (POEM)

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

There remains a lack of high quality evidence to support the procedures addressed within this policy. There is a need for large randomized controlled trials with long-term outcomes comparing these procedures to currently accepted treatments.

SOURCES

Agency for Healthcare Research and Quality. (2011, September). Comparative effectiveness of management strategies for gastroesophageal reflux disease: an update. Retrieved May 9, 2013 from http://www.effectivehealthcare.ahrq.gov. 

American College of Gastroenterology. (2013, March). Guidelines for the diagnosis and management of gastroesophageal reflux disease. Retrieved March 17, 2014 from the National Guideline Clearinghouse (NGC: 009639).

American Gastroenterological Association. (2016, April). Technology coverage statement on minimally invasive surgical options for gastroesophageal reflux disease. Retrieved January 18, 2017 from https://www.gastro.org.

American Society for Gastrointestinal Endoscopy. (2015). Guideline: The role of endoscopy in the management of GERD. Retrieved March 2, 2017 from http://www.giejournal.org.

American Society of General Surgeons. (2009). Position statement: transoral fundoplication. Retrieved March 2, 2017 from https://theasgs.org.

American Society of General Surgeons. (2014). LINX statement of support from ASGS. Retrieved January 11, 2018 from https://theasgs.org.

Asti, E., Bonitta, G., Lovece, A., Lazzari, V., & Bonavina, L. (2016). Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation. Medicine, 95 (30), e4366. (Level 2 evidence)

Bell, R., Barnes, W., Carter, B., Sewell, R., Mavrelis, P., and Ihde, G., et al.  (2014). Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. The American Surgeon, 80 (11), 1093-1105. (Level 3 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2017). Transesophageal endoscopic therapies for gastroesophageal reflux disease (2.01.38). Retrieved January 9, 2018 from BlueWeb. (39 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2017). Magnetic esophageal ring to treat gastroesophageal reflux (7.01.137). Retrieved January 9, 2018 from BlueWeb. (20 articles and/or guidelines reviewed)

Bonavina, L., Saino, G., Lipham, J. C., & DeMeester, T. R. (2013). LINX®  reflux management system in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux.Therapeutic Advances in Gastroenterology, 6 (4), 261-268. (Level 2 evidence)

Danalioglu, A., Cipe, G., Toydemir, T., Kocaman, O., Ince, A.T., Muslumanoglu, M., & Senturk, H. (2014). Endoscopic stapling in comparison to laparoscopic fundoplication for the treatment of gastroesophageal reflux disease. Digestive Endoscopy, 26 (1), 37-42. Abstract retrieved January 12, 2018 from PubMed database.

Dughera, L., Rotondano, G., DeCento, M., Cassolino, P, & Cisaro, F. (2014). Durability of Stretta radiofrequency treatment for GERD: results of an 8-year follow-up. Gastroenterology Research and Practice, DOI:10.1155/2014/531907. (Level 2 evidence)

ECRI Institute. Emerging Technology Evidence Report. (2017, July). Magnetic sphincter augmentation (LINX reflux management system) for treating gastroesophageal reflux disease. Retrieved January 10, 2018 from ECRI Institute. (108 articles and/or guidelines reviewed)

European Association of Endoscopic Surgery (EAES). (2014). EAES recommendations for the management of gastroesophageal reflux disease. Retrieved January 12, 2018 from Surgical Endoscopy, 28 (6), 1753-1773. 

Franciosa, M., Triadafilopoulos, G, and Mashimo, H. (2013). Stretta radiofrequency treatment for GERD: a safe and effective modality. Gastroenterology Research and Practice. Vol 2013, Article ID 783815. (Level 2 evidence)

Ganz, R., Peters, J., Horgan, S., Bemelman, W., Dunst, C.., Edmundowicz, S., et al. (2013). Esophageal sphincter device for gastroesophageal reflux disease. New England Journal of Medicine, 368 (8), 719-727. (Level 3 evidence)

Huang, X., Chen, S., Zhao, H., Zeng, X., Lian, J, Tseng, Y., & Chen, J. (2017). Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis. Surgical Endoscopy, 31 (3), 1032-1044. Abstract retrieved January 12, 2018 from PubMed database.

Hunter, J., Kahrilas, P., Bell, R., Wilson, E., Trad, K., Dolan, J., et al. (2015). Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology, 148, 324-333. (Level 2 evidence)

Kim, H., Kwon, C., Kessler, W., Selzer, D., McNulty, G., Bapaye, A., et al. (2016). Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device. Surgical Endoscopy, 30, 3402-3408. (Level 3 evidence)

National Institute for Health and Clinical Excellence (NICE). (2012, September). Laparoscopic insertion of a magnetic bead band for gastro-esophageal reflux disease. Retrieved August 28, 2014 from http://www.nice.org.

National Institute for Health and Clinical Excellence. (2011, July). Endoluminal gastroplication for gastro-oesphageal reflux disease. Retrieved May 9, 2013 from http://www.nice.org.

National Institute for Health and Clinical Excellence. (NICE). (2013, August). Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease. Retrieved January 11, 2018 from http://www.nice.org.

National Institute for Health and Clinical Excellence. (NICE). (2004, April; last updated January 2012). Endoscopic injection of bulking agents for gastro-oesophageal reflux disease. Retrieved January 11, 2018 from http://www.nice.org.

Sheu, E.G., Nau, P., Nath, B., Kuo, B., & Rattner, D.W. (2015). A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surgical Endoscopy, 29 (3), 505-509. Abstract retrieved January 9, 2018 from PubMed database.

Smith, C.D., Ganz, R.A., Lipham, J.C., Bell, R.C., & Rattner, D.W. (2017). Lower esophageal sphincter augmentation for gastroesophageal reflux disease: the safety of a modern implant. Journal of laparoendoscopic & advanced surgical techniques, 27 (6), 586-591. Abstract retrieved January 10, 2018 from PubMed database.

Society of American Gastrointestinal and Endoscopic Surgeons. (2017, March). SAGES technology and value assessment committee (TAVAC) safety and effectiveness analysis: LINX® Reflux Management System. Retrieved January 9, 2018 from http://www.sages.org.

Society of American Gastrointestinal Endoscopic Surgeons (SAGES). (2017, May). Clinical Spotlight Review: Endoluminal treatments for gastroesophageal reflux disease (GERD). Retrieved January 10, 2018 from https://www.sages.org.

Stefanidis, G., Viazis, N., Kotsikoros, N., Tsoukalas, N., Lala, E., Theocharis, L., et al. (2017). Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy. Disease of the Esophagus, 30 (3), 1-8. (Level 4 evidence)

Trad, K., Fox, M., Simoni, G., Shughoury, A., Mavrelis, P., Raza, M., et al. (2016). Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm. Surgical endoscopy. DOI 10.1007/s00464-016-5252-8. (Level 3 evidence)

U. S. Food and Drug Administration. (2000, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K000245. Retrieved August 29, 2014 from www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2009, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database, K092400. Retrieved February 15, 2011 from www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2012, March). PMA Pre-Market Approval Database. P100049 (LINX™). Retrieved September 2, 2014 from www.accessdata.fda.gov. 

U.S. Food and Drug Administration. (2012, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120299. Retrieved January 11, 2018 from www.accessdta.fda.gov.

Warren, H.F., Reynolds, J.L., Lipham, J.C., Zehetner, J., Bildzukewicz, N. A., Taiganides, P. A., et al. (2016). Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease. Surgical Endoscopy, 30 (8), 3289-3296. Abstract retrieved January 9, 2018 from PubMed database.

Wendling, M.R., Melvin, W.S., & Perry, K.A. (2013). Impact of transoral incisionless fundoplication (TIF) on subjective and objective GERD indices: a systematic review of the published literature. Surgical Endoscopy, 27 (10), 3735-3761. Abstract retrieved March 2, 2017 from PubMed database.

Wilson, E., Barnes, W., Mavrelis, P., Carter, B., Bell, R., Sewell, R., (2014). The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience. Surgical Laparoscopic, Endoscopic & Percutaneous Techniques, 24 (1), 36-46. Abstract retrieved March 2, 2017 from PubMed database.

Winifred S. Hayes, Inc. Medical Technology Directory. (2017, December). Comparative Effectiveness review. Endoscopic therapy for gastroesophageal reflux disease. Retrieved January 11, 2018 from www.Hayesinc.com/subscribers.  (106 articles and/or guidelines reviewed)

Wisconsin Physician Services. (2018, January). LCD for Endoscopic Treatment of GERD (L34659). Retrieved January 10, 2018 from https://www.cms.gov.

Zhang, H., Dong, D., Liu, Z., He, S., Hu, L., & Lv, Y. (2016). Revaluation of the efficacy of magnetic sphincter augmentation for treating gastroesophageal reflux disease. Surgical Endoscopy, 30 (9), 3684-3690. Abstract retrieved January 10, 2018 from PubMed database.

ORIGINAL EFFECTIVE DATE:  1/1/2001

MOST RECENT REVIEW DATE:  2/8/2018

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