Baroreflex Stimulation Devices
DESCRIPTION
Baroreflex stimulation devices (e.g., Rheos® Hypertension system) are being investigated to provide baroreflex activation therapy® (BAT®) which refers to electrical stimulation of the baroreceptors in the carotid arteries by means of an implanted device. Activation of the baroreflex causes inhibition of the sympathetic nervous system, resulting in a variety of physiologic changes including slowed heart rate and decreased blood pressure. The stimulation devices consist of three components:
An implantable pulse generator, which controls and delivers the electrical energy. This is implanted subcutaneously beneath the collarbone by minimally invasive surgery.
Carotid sinus leads, which are thin wires with electrical contacts that are place in contact with the carotid baroreceptors. They conduct the electrical energy from the pulse generator to the baroreceptors.
The programmer system, which is an external device that allows clinicians to turn the system on and off and regulate the electrical signal delivered to the baroreceptors.
Note: Previously titled: Hypertension Therapy Using Low Level Electrical Stimulation.
POLICY
The use of baroreflex stimulation implanted devices is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
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ADDITIONAL INFORMATION
According to the U.S. Food and Drug Administration (FDA), there are no approvals for the baroreflex stimulation devices.
The lack of well-designed, randomized controlled trials with long-term follow-up are not available and published studies provide little evidence of safety and efficacy of the baroreflex stimulation devices.
SOURCES
Acelajado, M. C., & Calhoun, D. A. (2010). Resistant hypertension, secondary hypertension, and hypertensive crises: Diagnostic evaluation and treatment. Cardiology Clinics, 28 (4), 639-654.
Bisognano, J. D., Bakris, G., Nadim, M. K., Sanchez, L., Kroon, A. A., et al. (2011). Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: Results from the double-blind, randomized, placebo-controlled Rheos Pivotal trial. Journal of the American College of Cardiology, 58 (7), 765-773. (Level 1 Evidence - Industry sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2011). Baroreflex stimulation devices (8.01.57). Retrieved October 6, 2011 from BlueWeb. (5 articles and/or guidelines reviewed)
Heusser, K., Tank, J., Engeli, S., Diedrich, A., Menne, J., Eckert, S., et al. (2010). Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension, 55 (3), 619-626. (Level 4 Evidence - Industry sponsored)
Lobodzinski, S. S. (2010). An implantable device for treatment of drug resistant hypertension. Cardiology Journal, 17 (1), 100-103.
Mancia, G., Parati, G., & Zanchetti, A. (2010). Electrical carotid baroreceptor stimulation in resistant hypertension. Hypertension, 55 (3), 607-609.
Mohaupt, M., Schmidli, J. & Luft, F.C. (2007). Management of uncontrollable hypertension with a carotid sinus stimulation device. Hypertension, 50 (5), 825-828.
Papademtriou, V., Doumas, M., Faselis, C., Tsioufis, C., Douma, S., Gkaliagkousi, E., et al. (2011). Carotid baroreceptor stimulation for the treatment of resistant hypertension. International Journal of Hypertension, 2011, 1-5.
Scheffers, I. J., Kroon, A. A., Schmidli, J., Jordan, J., Tordoir, J. J., Mohaupt, M. G., et al. (2010). Novel baroreflex activation therapy in resistant hypertension: Results of a European multi-center feasibility study. Journal of the American College of Cardiology, 56 (15), 1254-1258. (Level 2 Evidence - Industry sponsored)
Schmidli, J., Savolainen, H., Eckstein, F., Irwin, E., Peters, T., Martin, R., et al. (2007). Acute device-based blood pressure reduction: Electrical activation of the carotid baroreflex in patients undergoing elective carotid surgery. Vascular, 15 (2), 63-69. (Level 3 Evidence - Industry sponsored)
Tordoir, J. H., Scheffers, I., Schmidli, J., Savolainen, H., Liebeskind, U., Hansky, B., et al. (2007). An implantable carotid sinus baroreflex activating system: Surgical technique and short-term outcome from a multi-center feasibility trial for the treatment of resistant hypertension. European Journal of Vascular and Endovascular Surgery, 33 (4), 414-421. (Level 2 Evidence - Industry sponsored)
Wustmann, K., Kucera, J.P., Scheffers, I., Mohaupt, M., Kroon, A.A., de Leeuw, P.W., et al. (2009). Effects of chronic baroreceptor stimulation on the autonomic cardiovascular regulation in patients with drug-resistant arterial hypertension. Hypertension, 54 (3), 530-536. (Level 4 Evidence - Industry sponsored)
ORIGINAL EFFECTIVE DATE: 8/9/2008
MOST RECENT REVIEW DATE: 12/8/2011
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