Endobronchial valves are synthetic devices deployed into ventilatory airways of the lung to control airflow (i.e., Spiration® IBV Valve System, The Zephyr® Endobronchial Valve System). They have been investigated for use in individuals who have prolonged broncho-pleural air leaks, as well as an alternative to lung volume reduction surgery (LVRS) in individuals with lobar hyperinflation from severe emphysema.
Endobronchial valves permit one-way air movement. During inhalation the valve is closed preventing air flow to the diseased area of the lung. The valve opens during exhalation to allow air to escape from the diseased area of the lung. When used to treat persistent air leak from the lung into the pleural space, the endobronchial valve theoretically permits less air flow across the diseased portion of the lung during inhalation aiding in air leak closure. The valve may be placed, and subsequently removed, by bronchoscopy.
Endobronchial valves have also been investigated for use in severe emphysematous COPD when peripheral lung tissue forms bullae. The diseased portions of the lung ventilate poorly, cause air trapping and hyperinflate, compressing relatively normal lung tissue. They also may rupture, causing a pneumothorax. Use of an endobronchial valve is thought to prevent hyperinflation of these bullae.
Endobronchial valves as a treatment of prolonged air leaks, chronic obstructive pulmonary disease, emphysema or any other condition/disease is considered investigational.
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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The only available data on endobronchial valves for treating air leaks are uncontrolled trials with small numbers of heterogeneous individuals. Data on the FDA-approved endobronchial valve device are particularly limited.
BlueCross BlueShield Association. Evidence Positioning System. (6:2018). Bronchial valves (7.01.128). Retrieved April 26, 2019 from https://www.evidencepositioningsystem.com/. (12 articles and/or guidelines reviewed)
Davey, C., Zoumot, Z., Jordan, S., McNulty, W., Carr, D., Hind, M., et al. (2015). Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomized controlled trial. Lancet, 386, 1066-1073. (Level 2 evidence)
Ding, M., Gao, Y., Zeng, X., Guo, Y., & Yang, J. (2017). Endobronchial one-way valves for treatment of persistent air leaks: a systematic review. Respiratory Research, 18 (1), 186. (Level 2 evidence)
Gkegkes, I., Mourtarakos, S., & Gakidis, I. (2015). Endobronchial valves in treatment of persistent air leaks: a systematic review of clinical evidence. Medical Science Monitor, 21, 432-438. (Level 2 evidence)
Klooster, K., ten Hacken, N. H., Hartman, J. E., Kerstjens, H. A., van Rikxoort, E. M, & Slebos,D. J. (2015). Endobronchial valves for emphysema without interlobar collateral ventilation. New England Journal of Medicine, 373 (24), 2325-2335. Abstract retrieved July 22, 2016 from PubMed database.
Liu, H., Xu, M., Xie, Y., Gao, J., & Ni, S. (2015). Efficacy and safety of endobronchial valves for advanced emphysema: a meta analysis. Journal of Thoracic Disease, 7 (3), 320-328. (Level 1 evidence)
National Institute for Health and Care Excellence. (2017, December). Endobronchial valve insertion to reduce lung volume in emphysema. Retrieved June 13, 2018 from www.nice.org.uk/guidance/ipg600.
National Institute for Health and Care Excellence. (2013, March). Insertion of endobronchial valves for persistent air leaks. Retrieved August 14, 2015 from www.nice.org.uk/ipg448.
Slebos, D.J., Shah, P.L., Herth, F. & Valipour, A. (2017). Endobronchial valves for endoscopic lung volume reduction: best practice recommendations from expert panel on endoscopic lung volume reduction. Respiration, 93 (2), 138-150. (Level 5 evidence)
U.S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. Listing of CDRH humanitarian device exemptions. H060002. Retrieved August 17, 2015 fromhttp://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/hdeapprovals/ucm161827.htm.
Winifred. S. Hayes, Inc. Medical Technology Directory. (2019, February). Bronchoscopically placed coils or valves for lung emphysema: A review of reviews. Retrieved April 26, 2019 from www.Hayesinc.com/subscribers. (45 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/24/2011
MOST RECENT REVIEW DATE: 5/9/2019
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