Gastric Electrical Stimulation for the Treatment of Gastroparesis and Obesity
DESCRIPTION
Gastric electrical stimulation (i.e., gastric pacing, gastric pacemaker) is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The device (i.e., Enterra™ Therapy System) consists of four components: the implanted pulse generator, two unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. The intramuscular stomach leads are implanted either laparoscopically or during a laparotomy and are connected to the pulse generator that is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters.
Gastroparesis is a chronic disorder of gastric motility characterized by delaying emptying of a solid meal. Symptoms include bloating, distension, nausea and vomiting. Severe and chronic, gastroparesis can be associated with dehydration, poor nutritional status and poor glycemic control in diabetics. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson's disease, and psychological pathology. Treatment of gastroparesis includes prokinetic agents such as cisapride and metoclopramide, and antiemetic agents such as metoclopramide, granisetron, or ondansetron. Severe cases may require enteral or total parenteral nutrition.
Gastric electrical stimulation has also been investigated for the treatment of obesity as a technique to increase a feeling of satiety with subsequent reduced food intake and weight loss. The exact mechanisms that result in changes in eating and behavior are uncertain. The mechanisms may be related to neuro-hormonal modulation and / or stomach muscle stimulation.
POLICY
Gastric electrical stimulation for the treatment of gastroparesis or obesity is considered investigational.
See also:
ADDITIONAL INFORMATION
The data is inadequate to permit scientific conclusions regarding the application of gastric electrical stimulation for the treatment of gastroparesis or obesity.
Currently, there is only one gastric electrical stimulator that has received approval from the U.S. Food and Drug Administration (FDA), the Enterra™ Therapy System (i.e., Gastric Electrical Stimulator [GES]), manufactured by Medtronic, Inc. This approval is for the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The FDA approval was given through a "humanitarian device exemption." This regulatory category was established in 1996 and only applies to devices intended to benefit less than 4,000 patients. The approval process is similar to that of a pre-market approval application (PMA), but is exempt from the effectiveness requirements of a PMA. Thus, the application is not required to provide results of scientifically valid clinical investigations, but must contain sufficient information for the FDA to determine that the device does not pose unreasonable or significant risk of illness or injury. A humanitarian use device may only be used in facilities that have an Institutional Review Board (IRB) to supervise clinical testing of the device.
SOURCES
Abell, T. L., Cutsem, E. V., Abrahamsson, H., Huizinga, J. D., Konturek, J. W., Galmiche, J. P., et al. (2002). Gastric electrical stimulation in intractable symptomatic gastroparesis. Digestion, 66, 204-212.
Abell, T., Lou, J., Tabbas, M., Batista, O., Malinowski, S., & Al-Juburi, A. (2003). Gastric electrical stimulation for gastroparesis improves nutritional parameters at short, intermediate, and long-term follow-up. Journal Parenteral Enteral Nutrition, 27, 277-281.
Abell, T., McCallum, R., Hocking, M., Koch, K., Abrahamsson, H., LeBlanc, I., et al. (2003). Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology, 125, 421-428.
Agrawal, S., Stollman, N. H., & Rogers, A. I. (1999). University of Miami Division of Clinical Pharmacology therapeutic rounds: update on diagnosis and treatment of gastroparesis. American Journal of Therapeutics, 6 (2), 97-109.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2008). Gastric electrical stimulation (7.01.73). Retrieved December 31, 2008 from BlueWeb.
Bortolotti, M. (2002). The "electrical way" to cure gastroparesis. American Journal of Gastroenterology, 97 (8), 1874-1883.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2007, December). Gastric electric stimulation for medically refractory gastroparesis. Retrieved December 31, 2008 from ECRI Institute. (14 articles and/or guidelines reviewed)
Familoni, B. O., Abell, T. L., Voeller, G., Salem, A., & Gaber, O. (1997). Electrical stimulation at a frequency higher than basal rate in human stomach. Digestive Diseases and Sciences, 42 (5), 885-891.
Forster, J., Sarosick, I., Lin, Z., Durham, S., Denton, S., Roeser, K., et al. (2003). Further experience with gastric stimulation to treat drug refractory gastroparesis. American Journal of Surgery, 186, (6), 690-695. Abstract retrieved May 12, 2005 from PubMed database.
Forster, J., Sarosiek, I., Delcore, R., Lin, Z., Raju, G. S., & McCallum, R. W. (2001). Gastric pacing is a new surgical treatment for gastroparesis. American Journal of Surgery, 182 (6), 676-681. Abstract retrieved September 24, 2002 from PubMed database.
Hayes. Medical Technology Directory. (2008, April). Gastric electrical stimulation for gastroparesis. Retrieved December 31, 2008 from www.Hayesinc.com/subscribers. (34 articles and/or guidelines reviewed)
Horowitz, M., Su, Y. C., Rayner, C. K., & Jones, K. L. (2001). Gastroparesis: prevalence, clinical significance and treatment. Canadian Journal of Gastroenterology, 15 (12), 805-813. Abstract retrieved September 24, 2002 from PubMed database.
Lin, Z., Forster, J., Sarosiek, I., & Mccallum, R. W. (2003). Treatment of gastroparesis with electrical stimulation. Digestive Diseases and Science, 48 (5), 837-848.
National Institute for Excellence (NICE). (2003). Intervention procedure overview gastroelectrical stimulation for gastroparesis. Retrieved December 31, 2008 from http://www.nice.org.uk/nicemedia/pdf/231_gastroelectrical_stimulation_for_gastroparesis%20_overview_111004.pdf.
Parkman, H. P., Hasler, W, L., & Fisher, R. S. (2004). American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology, 127 (5), 1589-1591.
Rabine, J. C., & Barnett, J. L. (2001). Management of the patient with gastroparesis. Journal of Clinical Gastroenterology, 32 (1), 11-18.
Smith, D. S., & Ferris, C. D. (2003). Current concepts in diabetic gastroparesis. Drugs, 63 (13), 1339-1358.
Tougas, G., & Huizinga, J. D. (1998). Gastric pacing as a treatment for intractable gastroparesis: shocking news? Gastroenterology, 114, 598-600.
U. S. Food and Drug Administration. (2000, March). Center for Devices and Radiological Health. Humanitarian device exemption. Retrieved January 1, 2009 at http://www.fda.gov/cdrh/pdf/h990014b.pdf.
ORIGINAL EFFECTIVE DATE: 8/10/1998
MOST RECENT REVIEW DATE: 2/12/2009
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