Transesophageal 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 transesophageal therapeutic alternative to open or laparoscopic fundoplication or chronic medical therapy. Four different types of procedures have been investigated.
Transesophageal endoscopic gastroplasty (or gastroplication) is an outpatient procedure that takes about 30-35 minutes and does not require general anesthesia. In the procedure, sutures are placed in the lower esophageal sphincter. The sutures are designed to strengthen and lengthen the sphincter to decrease reflux. Currently there are three endoscopic suturing devices for use in the treatment of GERD:
The EndoCinch™ (manufactured by CR Bard) for partial-thickness plication
The Plicator™ System (manufactured by Ethicon Endo-Surgery) for full-thickness placation
Esophy X™ (manufactured by EndoGastric Solutions) for full-thickness plication
Radiofrequency energy has also been used to produce submucosal thermal lesions at the gastroesophageal junction (e.g., Stretta™). Specifically, radiofrequency energy is applied through 4 electrodes inserted into the esophageal wall at multiple sites both above and below the squamocolumnar junction. 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.
Implantation of a polymer (e.g., Enteryx™) has also been investigated. Specifically, a biocompatible polymer is injected into the lower esophageal sphincter. On contact with the tissue, the polymer precipitates into a spongy mass. The mechanism of action in reducing reflux is not precisely known. This polymer, Enteryx™, received FDA approval in 2003 for the treatment of symptomatic gastroesophageal reflux disease. In 2005, the manufacturer initiated a voluntary recall of the procedure kit and the FDA issued notification to physicians to discontinue its use.
Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated. The purpose is to increase tissue thickness at the gastroesophageal junction, thereby narrowing the lower esophageal sphincter and reducing gastroesophageal reflux disease.
POLICY
Transesophageal endoscopic gastroplasty (e.g., Bard EndoCinch™ Suturing System, Plicator™ System, EsophyX) for the treatment of gastroesophageal reflux disease is considered investigational.
Transesophageal radiofrequency (e.g., Stretta™) for the treatment of gastroesophageal reflux disease is considered investigational.
Endoscopic submucosal implantation of a biocompatible polymer (e.g., Enteryx™) for the treatment of gastroesophageal reflux disease is considered investigational.
Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds for the treatment of gastroesophageal reflux disease is considered investigational.
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ADDITIONAL INFORMATION
There is a lack of evidence to support the long term safety and efficacy of these procedures.
SOURCES
American Gastroenterological Association Institute. (2008). American Gastroenterological Association medical position statement on the management of gastroesophageal reflux disease. Gastroenterology, 135, 1383-1391.
American Society for Gastrointestinal Endoscopy. (2007). Role of endoscopy in the management of GERD. Retrieved September 15, 2009 from http://www.asge.org/assets/0/78/86/39A574DC-1EA9-4175-BE3D-8E21E5EA764F.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2010). Transesophageal endoscopic therapies for gastroesophageal reflux disease (2.01.38). Retrieved August 1, 2010 from BlueWeb. (51 articles and/or guidelines reviewed)
Cadier, G. B., Buset, M., Muls, V., Rajan, A., Rosch, T., Eckardt, A. J., et al. (2008). Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World Journal of Surgery, 32, 1676-1688.
Winifred S. Hayes, Inc. Medical Technology Directory. (2007, October). Endoscopic therapy for gastroesophageal reflux disease. Retrieved September 15, 2009 from www.Hayesinc.com/subscribers. (75 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. (2008, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K073671. Retrieved February, 15, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K073671.pdf.
U. S. Food and Drug Administration. (2009, May). Medical devices. Advice for patients with ENTERYX® for gastroesophageal reflux disease (1st advisory). Retrieved September 15, 2009 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064748.htm.
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 http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092400.pdf.
Wisconsin Physicians Service Insurance Corporation. (2011, April). Local Coverage Determination (LCD) for endoscopic treatment of GERD (L30473). Retrieved August 1, 2011 from http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=30473&ContrId=47&ver=8&ContrVer=1&Date=05%2f01%2f2011&DocID=L30473&bc=iAAAAAgAAAAA&.
ORIGINAL EFFECTIVE DATE: 1/1/2001
MOST RECENT REVIEW DATE: 10/13/2011
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