Baroreflex Stimulation Devices
DESCRIPTION
Baroreflex stimulation devices (e.g., Barostim neo® Legacy System, Barostim Therapy®, Barostim Neo System) 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.
POLICY
The use of baroreflex stimulation implanted devices is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
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ADDITIONAL INFORMATION
In 2014, the Barostim neo® Legacy System (CVRx, Minneapolis, MN) received a humanitarian device exemption from the FDA for use in individuals with treatment-resistant hypertension who received Rheos® Carotid Sinus leads as part of the Rheos pivotal trial and were considered responders in that trial. In November 2015, CVRx received expedited access pathway (EAP) designation from the FDA for Barostim Therapy® to treat heart failure. The Barostim Neo® System received FDA clearance in 2019 via the Premarket Approval (PMA) clearance pathway.
SOURCES
American College of Cardiology and American Heart Association. (2018, June). 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Retrieved 6/3/2022 from https://www.professional.heart.org/en/guidelines-and-statements.
American Heart Association, American College of Cardiology and Heart Failure Society of America. (2022, May). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Retrieved July 14, 2023 from https://www.ahajournals.org/doi/epub/10.1161/CIR.0000000000001063.
Babar, N., & Giedrimiene, D. (2022). Updates on baroreflex activation therapy and vagus nerve stimulation for treatment of heart failure with reduced ejection fraction. Cardiology research, 13 (1), 11–17. (Level 1 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (6:2023). Baroreflex stimulation devices (8.01.57). Retrieved July 13, 2023 from www.bcbsaoca.com/eps/. (16 articles and/or guidelines reviewed)
Cai, G., Guo, K., Zhang, D., & Qin, S. (2020). The efficacy of baroreflex activation therapy for heart failure. A meta-analysis of randomized controlled trials. Medicine, 99 (45): e22951. (Level 1 evidence)
Chunbin, W., Fu, S., & Jing, H. (2018). Efficacy and safety of baroreflex activation therapy for treatment of resistant hypertension: a systematic review and meta-analysis. Clinical and Experimental Hypertension, 40 (6), 501-508. Abstract retrieved October 22, 2018 from PubMed database.
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., & Lobo, M. (2016). Device-based therapy for hypertension. Current Hypersion Report, 18 (61). (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., et 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).
Winifred S. Hayes, Inc. Evolving Evidence Review. (2022, November). Barostim Neo System for Treatment of Heart Failure. Retrieved July 14, 2023 from www.Hayesinc.com/subscribers. (28 articles and/or guidelines reviewed)
Zile, M. R., Lindenfeld, J., Weaver, F. A., Zannad, F., Galle, E., Rogers, T., & Abraham, W. T. (2020). Baroreflex activation therapy in patients with heart failure with reduced ejection fraction. Journal of the American College of Cardiology, 76 (1), 1-13. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 8/9/2008
MOST RECENT REVIEW DATE: 8/10/2023
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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