Medical Review - Experimental/Investigational

Endoscopic gastroplasty for gastroesophageal reflux disease (GERD) and weight reduction

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 procedures have been investigated:

Transesophageal endoscopic gastroplasty (or gastroplication) is an outpatient procedure 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 in order to decrease reflux. The EndoCinch (CR Bard) is a device that has been approved by the U.S. Food and Drug Administration (FDA) for use in endoscopic suturing and has been investigated as a device used in endoscopic gastroplasty.

Radiofrequency energy has been used to produce submucosal thermal lesions at the gastroesophageal junction. (This technique has also been referred to as the Stretta® procedure.) Specifically, radiofrequency energy is applied through four 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 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 through the Premarket Approval (PMA) process for the treatment of symptomatic gastroesophageal reflux disease.

Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated as a treatment of GERD.

Policy
The following transesophageal endoscopic therapies are considered experimental/investigational for all indications, including but not limited to gastroesophageal reflux disease and weight reduction due to the lack of long-term studies:

1. Transesophageal endoscopic gastroplasty (i.e., the Endocinch procedure)
2. Transesophageal radiofrequency energy to create submucosal thermal lesions of the gastroesophageal junction (i.e., the Stretta® procedure)
3. Endoscopic submucosal implantation of a biocompatible polymer (i.e., Enteryx)
4. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds

CPT Codes
43257
0008T
0133T

Determined by the Surgery Liaison committee at the 08-21-02 and 08-18-04 meetings and approved by the Medical Advisory Committee in November 2002 and November 2004.  January 1, 2006, added CPT code 0133T.

(Web updated 4/2006)

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