BlueCross BlueShield of Tennessee Medical Policy Manual

Baroreflex Stimulation Devices

DESCRIPTION

Baroreflex stimulation devices (e.g. Barostim neo® Legacy System, Barostim Therapy®) provide electrical stimulation of the baroreceptors in the carotid arteries using an implanted device. Baroreflex stimulation devices are being investigated as an alternative treatment for resistant hypertension and heart failure. Baroreceptors are pressure sensors contained within the walls of the carotid arteries.  They are part of the autonomic nervous system that regulates basic physiologic functions such as heart rate and blood pressure.  When these receptors are stretched, as occurs with increases in blood pressure, the baroreflex is activated resulting in various physiologic changes, including slowed heart rate and lower blood pressure.

The use of baroreflex stimulation devices (also known as baroreflex activation therapy) is a proposed alternative treatment for resistant hypertension and heart failure. Both hypertension and heart failure are relatively common conditions, and are initially treated with medications and lifestyle changes.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

In 2014, the Barostim neo® Legacy System (CVRx, Minneapolis, MN) received a humanitarian device exemption (HDE) from the FDA for treatment-resistant hypertension who received Rheos® Carotid Sinus leads as part of the Rheos pivotal trial and were considered responders in that trial. November 2015, CVRx received expedited access pathway (EAP) designation from FDA for Barostim Therapy® to treat heart failure.

SOURCES 

Bakris, G., Nadim, M., Haller, H., Lovett, E., Schafer, J., & Bisognano, J. (2012). Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. Journal of the American Society of Hypertension, 6 (2), 152-158. Abstract retrieved December 30, 2016 from PubMed database.

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 2 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017). Baroreflex stimulation devices (8.01.57). Retrieved October 23, 2017 from BlueWeb. (11 articles and/or guidelines reviewed)

Hoppe, U. C., Brandt, M. C, Wachter, R., Beige, J., Rump, L. C., Kroon, A. A., et al. (2012). Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: Results from the Barostim neo trial. Journal of the American Society of Hypertension, 6 (4), 270-276. (Level 4 evidence)

Iliescu, R., Tudorancea, I., & Lohmeier, T. E. (2014). Baroreflex activation: from mechanisms to therapy for cardiovascular disease.  Current Hypertension Reports, 16 (8), 453-469. (Level 4 evidence)

National Institute for Health and Care Excellence. (2015, October). Implanting a baroreceptor stimulation device for resistant hypertension. Retrieved March 7, 2016 from www.nice.org.uk.

Ng, F., Saxena, M., Mahfoud, F., Pathak, A., and Lobo, M. (2016, July) Device-based therapy for hypertension. Current Hypersion Report, 18 (61), epub. (Level 2 evidence)

U.S. Food and Drug Administration. (2013, December) Center for Devices and Radiologic Health. Humanitarian device exemption H130007 (Barostim neo® Legacy System). Retrieved October 23, 2017 from http://www.acessdata.gda.gov.

Weaver, F., Abraham, W., Little, W., Butter, C., Ducharme, A., Halbach, M., er al. (2016) Surgical experience and long-term results of baroreflex activation therapy for heart failure with reduced  ejection fraction. Seminars in Thoracic and Cardiovascular Surgery, 28 (2), 320-329. (Level 3 evidence)

ORIGINAL EFFECTIVE DATE:  8/9/2008

MOST RECENT REVIEW DATE:  12/14/2017

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