BlueCross BlueShield of Tennessee Medical Policy Manual

Minimally Invasive Procedures for Weight Loss

DESCRIPTION

Minimally invasive procedures involving a various gastrointestinal devices are being investigated for individuals who are morbidly obese, have regained weight following weight loss surgery and/or have diabetes.

One gastrointestinal device, an implantable sleeve (e.g., the EndoBarrier® Gastrointestinal Liner) is an impermeable fluoropolymer sleeve that will allow partially digested food leaving the stomach to move through the gastrointestinal tract without mixing with digestive enzymes or allowing nutrients to be absorbed through the intestinal walls. A catheter-based delivery system using fluoroscopy imaging is advanced through the esophagus into the stomach and then into the small intestine while the individual is under general anesthesia. The sleeve is deployed through the catheter, anchored within the duodenal bulb with a self-expanding stent that has proximally and distally placed barbs. The barbs penetrate into the muscle wall stabilizing the sleeve and then the catheter is removed. After the procedure, a 60 mL bolus of contrast fluid is injected to confirm sleeve positioning. The device can be removed endoscopically by using the sleeve drawstrings to collapse and retract the anchor stent barbs.

Another technique is a restrictive bariatric procedure also known as laparoscopic greater curve plication or total vertical gastric plication. In this procedure the stomach is accessed endoscopically and numerous pleats or imbrications are created to reduce the volume of the gastric cavity. The pleats are sutured or stapled in place (e.g. EndoCinch™, StomaphyX™, EsophyX™, NDO Plicator™).

POLICY

See also:

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Data is lacking from of peer published evidence-based, well-designed studies and non-industry based randomized controlled trials to determine whether the use of these minimally invasive procedures improve net health outcomes.

There is a lack of evidence regarding the safety and efficacy to support the use of the EndoBarrier® Gastrointestinal Liner technology.

Currently, the EndoBarrier® Gastrointestinal Liner is approved in Europe and Australia, with several studies under way in Brazil, Chile and the Netherlands. However at this time, the U. S. Food and Drug Administration has not granted any 510(k) approvals in the United States for the EndoBarrier® Gastrointestinal Liner technology.

Endoscopic pleating devices have received FDA clearance for use in the treatment of gastroesophageal reflux.

SOURCES

American Society for Gastrointestinal Endoscopy/ American Society for Metabolic and Bariatric Surgery Task Force on Endoscopic Bariatric Therapy, Ginsberg, G. G., Chand, B., Cote, G. A., Dallal, R. M., Edmundowicz, S. A., et al. (2011). A pathway to endoscopic bariatric therapies. Gastrointestinal Endoscopy, 74 (5), 943-953.

American Society for Metabolic and Bariatric Surgery. (2011). Policy statement on gastric plication. Retrieved November 25, 2013 from https://s3.amazonaws.com/publicASMBS/GuidelinesStatements/PolicyStatment/Rev_Gastric+Plication+Statement_10.06.11.pdf

American Society for Metabolic and Bariatric Surgery. (2009). Position statement on emerging endosurgical interventions for the treatment of obesity, Surgery for Obesity and Related Diseases. 5 (2009), 297-298.

de Moura, E. G., Martins, B. C., Lopes, G. S., Orso, I. R., de Oliverira, S. L., Galvao Neto, M. P., et al. (2012). Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technology & Therapeutics, 14 (12), 183-189. (Level 2 Evidence - Industry sponsored)

ECRI Institute, Health Technology Forecast. (2013). Endoluminal sleeve for preoperative weight loss or treating obesity. Retrieved November 25, 2013 from https://members2.ecri.org/Components/Forecast/Documents/IssueFiles/10971.pdf

Gersin, K., Rothstein, R., Rosenthal, R., Stefanidis, D., Deal, S., Kuwada, T., et al. (2010). Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates. Gastrointestinal Endoscopy, 71 (6), 976-982. (Level 2 Evidence - Industry sponsored)

Gersin, K., Keller, J., Stefanidis, D., Simms, C., Abraham, D., Deal, S., et al. (2007). Duodenal-jejunal bypass sleeve: A totally endoscopic device for the treatment of morbid obesity. Surgical Innovation, 14 (4), 275-278.

National Institute for Health and Clinical Excellence. (2012, November). Laparoscopic gastric plication for the treatment of severe obesity. Retrieved November 25, 2013 from http://guidance.nice.org.uk/ipg432/publicinfo/pdf/English.

Ramos, A., Neto, M, Galvao, M., Evangelista, L., Campos, J., & Ferraz, A. (2010). Laparoscopic greater curvature plication: Initial results of an alternative restrictive bariatric procedure. Obesity Surgery, 2010 (20), 913-918. (Level 4 Evidence – Industry supported)

Rodriquez, L., Reves, E., Fagalde, P., Oltra, M. S., Saba, J., Aylwin, C. G., et al. (2009). Pilot clinical: Study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes. Diabetes Technology & Therapeutics, 11 (11), 725-732. (Level 2 Evidence - Industry sponsored)

Ryou, M., Ryan, M., & Thompson, C. (2011). Current status of endoluminal bariatric procedures for primary and revision indications. Gastrointestinal Endoscopy Clinics of North America, 21 (2), 315-333.

Schouten ,R., Rijs, C., Bouvy, N., Hameeteman, W., Koek, G., Janssen, I., Greve, J., et al. (2010). A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Annals of Surgery, 251 (2), 236-243. (Level 2 Evidence - Industry sponsored)

Stylopoulos, N., & Aguirre, V. (2009). Mechanisms of bariatric surgery and implications for the development of endoluminal therapies for obesity. Gastrointestinal Endoscopy, 70 (6), 1167-1175.

Talebpour, M., & Amoli, B. (2007). Laparoscopic total gastric vertical plication in morbid obesity. Journal of Laparoscopic and Advanced Surgical Techniques, 17 (6), 793-798.

U. S. Food and Drug Administration. (2007. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071553. Retrieved November 25, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/k071553.pdf.

U. S. Food and Drug Administration. (2012, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120147. Retrieved November 25, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf12/k120147.pdf.

Verdam, F., Schouten, R., Greve, J., Koek, G., & Bouvy, N. (2012). An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery. Journal of Obesity, 2012 (epub).

ORIGINAL EFFECTIVE DATE:  9/9/2012

MOST RECENT REVIEW DATE:  1/9/2014

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