Medical Policy: 02.01.23
Original Effective Date: July 2001
Reviewed: October 2018
Revised: October 2018
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
More than 60 million people in United States suffer from a weakening or inappropriate relaxation of the lower esophageal sphincter, which allows movement of stomach contents into the lower esophagus, a condition known as gastroesophageal reflux disease (GERD). This has generated interest in creating minimally invasive transesophageal therapeutic alternatives to open or laparoscopic fundoplication or chronic medical therapy. The available FDA approved minimally invasive endoscopic treatments are based on a variety of technologies that involve improving the function of the lower esophageal sphincter. Three types of procedures have been investigated including Transesophageal endoscopic gastroplasty including transesophageal (or transoral) incisionless fundoplication (TIF), application of radiofrequency (RF) energy, and injection/implantation of prosthetic devices or bulking agents.
The definition of refractory gastroesophageal reflux disease (GERD) is controversial. According to most experts, patients with GERD who exhibit partial or lack of response to proton pump inhibitor (PPI) twice daily are considered to have failed PPI therapy. GERD in these patients is termed refractory GERD. However, we suggest that lack of satisfactory symptomatic response to PPI once a day should be considered a failure of PPI therapy.
Transesophageal endoscopic gastroplasty (gastroplication or fundoplication) is an outpatient procedure. During this procedure, suture(s) are placed in the lower esophageal sphincter. The sutures are designed to strengthen and lengthen the sphincter to decrease reflux. Currently, four endoscopic suturing devices have received FDA 510(k) marketing clearance for use in the treatment of GERD:
Radiofrequency energy has been used to produce submucosal thermal lesions at the gastroesophageal junction. This technique has also been referred to as the Stretta® (Mederi Therapeutics, Greenwich, CT) procedure. 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.
Submucosal injection or implantation of a prosthetic or bulking agent to enhance the volume of the lower esophageal sphincter. In one procedure, a biocompatible liquid 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. One polymer, Enteryx™, received FDA approval in 2003 through the premarket approval process for the treatment of symptomatic GERD. However, in September 2005, Boston Scientific Corporation issued a recall of Enteryx™ due to the device polymerizing shortly after injection into a spongy material that cannot be removed. Serious adverse events involved unrecognized transmural injections of Enteryx™ into structures surrounding the esophagus, potentially resulting in serious injury or death.
Another bulking agent, pyrolytic carbon-coated zirconium oxide spheres (Durasphere®), is being evaluated. Durasphere® is a bulking agent approved for treatment of urinary and fecal incontinence. Use of this product for esophageal reflux would be considered off-label use. The website of Carbon Medical Technologies states that Durasphere GR is an investigational device in the United States "intended to treat problems associated with GERD."
The Gatekeeper Reflux Repair System (Medtronic, Shoreview, MN) utilizes a soft, pliable, expandable prosthesis made of a polyacrylonitrile-based hydrogel. The prosthesis is implanted into the esophageal submucosa and with time the prosthesis absorbs water and expands, creating bulk in the region of implantation.
Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.
Barrett's esophagus is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium known as intestinal metaplasia, in response to irritation and injury caused by gastroesophageal reflux disease (GERD).
The current management of Barrett's esophagus includes treatment of GERD, and surveillance endoscopy to detect progression to high-grade dysplasia or adenocarcinoma. The findings of low-grade dysplasia typically warrants only follow-up and surveillance biopsies, whereas the findings of high-grade dysplasia or early-stage adenocarcinoma warrants mucosal ablation or resection, either endoscopic mucosal resection or esophagectomy.
Confocal laser endomicroscopy (CLE) is a device that allows in vivo microscopic imaging of cells during endoscopy. For patients undergoing screening or surveillance multiple studies have evaluated the diagnostic accuracy of CLE. While the reported sensitivity and specificity in these studies is high, it may not be sufficiently high to replace biopsy and histopathologic analysis. Several RCTs and a meta-analysis of RCTs and observational studies suggest that CLE has high accuracy for identifying dysplasia in patients with BE. The sensitivity of CLE in these studies was higher than for white-light endoscopy alone, but the specificity was not consistently higher. There are limited data comparing standard protocols using random biopsies to protocols using CLE and targeted biopsies, so data are inconclusive regarding the potential for CLE to reduce the number of biopsies in patients with BE undergoing surveillance without compromising diagnostic accuracy.
The patented PathFinderTG®/BarreGEN™ test is a molecular test intended to be used adjunctively when a definitive pathologic diagnosis cannot be made, because of inadequate specimen or equivocal histologic or cytologic findings. RedPath Integrated Pathology (Pittsburgh, PA), the test provider, states that PathFinderTG® produces mutational profiles to help physicians resolve complex diagnostic dilemmas inpatients who are at risk of cancer.
The evidence reviewed does not demonstrate that PathFinderTG® testing for prognosis of Barrett esophagus adds value to current prognostic assessments.
Guidelines released by the American College of Gastroenterology in 2013 state that the usage of current endoscopic therapy or transoral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical.
In 2018 the guideline “Endoscopic eradication therapy for patients with Barrett’s esophagus-associated dysplasia and intramucosal cancer” was published:
NCCN guidelines for esophageal cancer indicate resection is the preferred treatment choice for Barrett’s esophagus but ablative therapy such as RFA is listed as an alternative option to resection for Barrett’s esophagus with high-grade dysplasia. NCCN guidelines state that, for primary treatment, endoscopic mucosal resection or ablative therapy may be appropriate for Barrett’s esophagus associated with Tis (HGD or carcinoma in-situ). Patients with superficial T1a disease should have ablation (preferred) or esophagectomy performed following mucosal resection. For post-treatment surveillance, the guidelines state that ablation of residual flat or recurrent high-grade and low-grade dysplasia using RFA or cryoablation should be considered. Ablation of non-dysplastic Barrett’s esophagus is not recommended.
The National Institute for Health and Care Excellence (NICE) issued updated interventional procedure guidance in 2013 on endoscopic radiofrequency treatment for GERD, concluding: “The evidence on the safety of endoscopic radiofrequency ablation for gastro-esophageal reflux disease is adequate in the short and medium term but there is uncertainty about longer term outcomes. With regard to efficacy, there is evidence of symptomatic relief but objective evidence on reduction of reflux is inconclusive. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.” The reviewing committee noted “concern on the part of some specialists about the possibility that symptoms may improve as a result of denervation caused by the procedure; if that were the case then failure to recognize and treat reflux might lead to complications in the long term.”
SAGES considers RF treatment an appropriate therapy for patients being treated for GERD who are 18 years of age or older; who have had symptoms of heartburn, regurgitation, or both for six months or more; and who have been partially or completely responsive to anti-secretory pharmacologic therapy.
The 2008 Medical Position Statement of the American Gastroenterological Association 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.
ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus includes the following recommendations:
At this time, other key gastroenterological societies (American Gastroenterological Association and American Society of Gastrointestinal Endoscopy) do not have any guidelines or position statements endorsing laser ablation, argon plasma ablation or electrocoagulation as a treatment for Barrett's esophagus. Current literature consists primarily of uncontrolled studies with small group sizes, with only a limited number of randomized controlled trials comparing treatments for Barrett's esophagus. While these endoscopic techniques are promising in terms of treating Barrett's esophagus, few long-term results are available. In 2010, the National Institute for Health and Clinical Excellence (NICE) issued a clinical guideline for "Ablative therapy for the treatment of Barrett's esophagus." For ablative therapies, they concluded to "not use argon plasma coagulation, laser ablation or multipolar electrocoagulation alone, or in combination with each other, unless part of a clinical trial." The authors of a Cochrane review in 2010 concluded that ablative therapies have a role in the management of Barrett's esophagus, however; "more clinical trial data and in particular randomized controlled trials are required to assess whether or not the cancer risk is reduced in routine clinical practice."
Most studies of endoscopic therapy have only limited follow-up information of a relatively small number of patients. Thus, the durability of these technologies beyond 1–2 years remains unclear. Short-term and long-term safety issues are unresolved, but serious adverse events led to the voluntary withdrawal of Enteryx by the manufacturer in September 2005 and suspension of the Gatekeeper clinical program in late 2005. While newer devices and improvements in endoscopic antireflux techniques may yield better and more durable treatment outcomes, current data suggest that there are no definite indications for endoscopic therapy for GERD at this time. Both practitioners and patients need to be aware of the limitations in the evidence that exist with these devices at present.
In high-grade dysplasia, abnormal changes are seen in many of the cells and there is an abnormal growth pattern of the cells. Low-grade dysplasia means that there are some abnormal changes seen in the tissue sample but the changes do not involve most of the cells, and the growth pattern of the cells is still normal. “Indefinite for dysplasia” simply means that the pathologist is not certain whether changes seen in the tissue are caused by dysplasia. Other conditions, such as inflammation or swelling of the esophageal lining, can make cells appear dysplastic when they may not be.
Transesophageal endoscopic gastroplasty is considered investigational as a treatment of gastroesophageal reflux disease (e.g., Endocinch™, NDO Plicator™, Medigus Ultrasonic Surgical Endostapler (MUSE™ System) or EsophysX™/EsophyX2 HD procedures). This includes transoral incisionless fundoplication.
Transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction (i.e., the Stretta procedure) is considered investigational as a treatment of gastroesophageal reflux disease.
Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., biocompatible liquid polymer, plexiglass implantation/PMMA polymethylmethacrylate beads, zirconium oxide spheres, Durasphere) is considered investigational as a treatment of gastroesophageal reflux disease
Magnetic esophageal ring implant (LINX) for the treatment of GERD is investigational because the safety and/or effectiveness of this service cannot be established.
Reza Band Upper Esophageal Sphincter Assist Device is considered investigational for the treatment of Gastroesophageal Reflux Disease.
Roux-en-Y Gastric Bypass (RYGBP) (open or laparoscopic) for the treatment of Gastroesophageal Reflux Disease is considered investigational.
Radiofrequency ablation may be considered medically necessary for the treatment of Barrett's esophagus with high-grade dysplasia.
Radiofrequency ablation may be considered medically necessary for the treatment of Barrett's esophagus with low-grade dysplasia when the initial diagnosis of low-grade dysplasia is confirmed by two physicians (a physician and a pathologist).
Radiofrequency ablation is considered investigational for treatment of Barrett's esophagus in the absence of dysplasia.
Cryoablation is considered is considered investigational for Barrett's esophagus, with or without dysplasia.
Argon plasma coagulation, electrocoagulation and laser ablation are considered investigational for the treatment of Barrett's esophagus.
Confocal Laser Endomicroscopy is considered investigational at this time the evidence is not sufficient to conclude that CLE improves outcomes when used as an adjunct to endoscopy.
Molecular testing using the PathFinderTG® system, now called BarreGEN, is considered investigational for all indications. The evidence is insufficient to determine the effects of the technology on health outcomes.
There is insufficient evidence at present to establish the safety and efficacy of these procedures, particularly in the long term. Some of the unresolved issues include questions about the safety and durability of the device/treatment, and lack of consistent improvement in objective measures (esophageal acid exposure) using these devices. Laparoscopic Nissen fundoplication is considered the gold standard surgical intervention for individuals with GERD. Evidence for newer endoluminal and laparoscopic therapies is limited in quality and quantity and concerns remain about the safety and long-term effectiveness of many of these procedures. Well-designed RCTs and comparative studies with longer follow-up time are needed in order to better assess the safety and effectiveness of these interventions. Well-designed trials should use standardized outcome measures to examine whether subjective improvement, such as discontinuation of medication therapy and GERD-HRQL scores, is supported by objective improvement, such as esophageal acid exposure.
In regards to the magnetic esophageal ring implant, the FDA has required a 5-year follow-up on the subjects in the pivotal study, as well as a post-approval study and a randomized trial is in progress that will compare treatment with the magnetic esophageal ring and treatment with double-dose proton pump inhibitors. Randomized comparisons of magnetic sphincter augmentation with Nissen fundoplication are also needed to evaluate the relative risk-benefit of the magnetic esophageal ring versus the current gold standard. All studies available are using historical controls which are invalid for comparitive studies. While several studies provided long-term outcomes, both of them had limitations, including high drop out rates. Moreover, they do not address the critical issues that comparisons of LINX with either fundoplication or comparisons with medical therapy are needed. A recent systematic review and meta-analysis concluded the validity of many of the primary outcomes was decreased due to their subjective nature and lack of clear medical definition. The long-term implications of reversal of the LINX remain unknown.
There is no evidence that the use of ablation in Barret’s esophagus without dysplasia is necessary in preventing progression to cancer. Surveillance without ablation is recommended.
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