Balloon and Self-Expanding Absorptive Ostial Dilation for Treatment of Chronic Sinusitis
Balloon ostial dilation, also known as balloon sinuplasty, (e.g. Relieva™, Relieva Spin Sinus Dilation System®, Relieva Seeker Balloon Sinuplasty System®, NuVent™ EM Balloon Sinus Dilation System, NuVent™, Ventera™ Sinus Dilation System EM) can be an alternative to traditional endoscopic sinus surgery (ESS) for selected individuals with chronic rhinosinusitis who have failed medical management. The procedure involves inflating a balloon delivered via a disposable catheter in the sinus ostium to stretch the opening, thereby allowing drainage of the treated sinus and a resolution or reduction of symptoms.
Chronic rhinosinusitis (CRS) is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months. Symptoms of congestion often accompany the nasal discharge. There also may be mild pain and/or headache. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae, although symptoms vary considerably because of the location and shape of these sinus ostia.
Self-expanding absorptive ostial dilation devices (e.g., SinuSys Vent-OS™) have been proposed as an additional treatment for maxillary sinus ostia. However, the safety and effectiveness of these devices is uncertain and has not been established in clinical studies.
Note: This policy does not address functional endoscopic sinus surgery; for that criteria refer to Functional Endoscopic Sinus Surgery (FESS) Ambulatory Care Guideline (ACG).
Balloon ostial dilation (balloon sinuplasty) for treatment of chronic sinusitis may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Self-expanding absorptive sinus ostial dilation for the treatment of any sinus condition is considered investigational.
Balloon ostial dilation (i.e., balloon sinuplasty) for treatment of chronic sinusitis may be considered medically appropriate when ALL of the following are met:
Sinusitis confined to the paranasal sinuses without adjacent involvement of neurologic, soft tissue, or bony structures
No evidence of sinonasal polyposis
Sinusitis as documented by ANY ONE of the following:
Four or more acute rhinosinusitis episodes (defined as four weeks or less in duration) within one year
Chronic sinusitis (defined as twelve weeks or more in duration)
Diagnostic work up that includes a computed tomography (CT) scan in each of the sinuses being considered for treatment that demonstrates ANY ONE of the following:
mucosal thickening >3 millimeters
air fluid levels
Symptoms persist despite attempts with ALL of the following medical therapies:
Allergy testing followed by appropriate environmental controls and pharmacotherapy (e.g., antihistamines, intranasal corticosteroids, leukotriene antagonists)
Antibiotic therapy for at least four (4) consecutive weeks
Trial of inhaled steroids
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.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Based on a large number of low-quality but consistent studies balloon sinuplasty appears to be a safe and effective treatment for chronic sinusitis in adults with the effects durable for up to two years. Self-expanding absorptive devices for ostial dilation have no clinical studies to support their use.
Abreua, C., Balsalobrec, L., Pascotoc, G., Pozzobonc, M., Fuchsb, S., and Stamm, A. (2014) Effectiveness of balloon sinuplasty in patients with chronic rhinosinusitis without polyposis. Brazilian Journal of Otorhinolaryngology, 86(6), 470-75. (Level 4 evidence)
American Academy of Otolaryngology - Head and Neck Surgery. (2014). Clinical consensus statement: pediatric chronic rhinosinusitis. Retrieved August 4, 2016 from http://www.entnet.org .
American Academy of Otolaryngology - Head and Neck Surgery. (2015). Clinical practice guideline (update): adult sinusitis executive summary. Retrieved September 14, 2015 from http://oto.sagepub.com.
American Academy of Otolaryngology - Head and Neck Surgery. (2017, March). Position statement: dilation of sinuses, any method (e.g., balloon, etc.). Retrieved February 20, 2018 from http://www.entnet.org.
Bikahzi, N., Light, J., Truitt, T., Schwartz, M., & Cuter, J. (2014) Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up. American Journal of Rhinology & Allergy, 28 (4), 323-329. (Level 3 evidence - Industry sponsored)
BlueCross BlueShield Association. Evidence Positioning System. (2:2018). Balloon ostial dilation for treatment of chronic sinusitis (7.01.105). Retrieved December 10, 2018 from http://www.evidencepositioningsystem.com . (37 articles and/or guidelines reviewed)
Chandra, R. K., Kern, R. C., Cutler, J. L., Welch, K. C., & Russell, P. T. (2015). REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. The Laryngoscope, 126, 44-50. (Level 1 evidence - Industry sponsored)
ECRI Institute. Emerging Technology Evidence Report. (2016, July). Standalone balloon sinus dilation for treating chronic rhinosinusitis in adults. Retrieved August 4, 2016 from ECRI Institute. (139 articles and/or guidelines reviewed)
Gould, J., Alexander, I., Tomkin, E. & Brodner, D. (2014). In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. American Journal of Rhinology & Allergy, 28 (2), 156-163. (Level 3 evidence)
Koskinen, A., Myller, J., Mattila, P., Penttilӓ, M., Silvola, J., Alastalo, I., et al. (2016). Long-term follow-up after ESS and balloon sinuplasty: Comparison of symptom reduction and patient satisfaction. Acta Otolaryngolica, 136 (5), 532-536. Abstract retrieved August 5, 2016 from PubMed database.
National Institute for Health and Clinical Excellence (NICE). (2016, December). Medical technologies guidance XprESS multi sinus dilation system for treating chronic sinusitis. Retrieved August 16, 2017 from http://www.nice.org.uk.
Payne, S. C., Stolovitzky, P., Mehendale, N., Matheny, K., Brown, W., Rieder, A., et al. (2016). Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study. American Journal of Rhinology & Allergy, 30, 279-286. (Level 1 evidence - Industry sponsored)
Sikand, A., Silvers, S., Pasha, R., Shikani, A., Karanfilov, B., Harfe, D., et al. (2015). Office-based balloon sinus dilation. 1-year follow-up of a prospective, multicenter study. Annals of Otology, Rhinology & Laryngology, 124 (8), 630-637. Abstract retrieved August 5, 2016 from PubMed database.
Technology Evaluation Center. (2013, April). Balloon sinus ostial dilation for the treatment of chronic rhinosinusitis. (Vol. 27, No. 9). Retrieved February 18, 2014 from http://www.bcbs.com (27 articles and/or guidelines reviewed)
Thottam, P. J., Kieu, M. C., Barazi, R. A., Saraiya, S., Dworkin, J. P., & Belenky, W. M. (2013). FESS versus balloon sinuplasty as long-term treatment for pediatric chronic rhinosinusitis: A 2-year postoperative analysis. Otolaryngology - Head and Neck Surgery, 149 (2), suppl P130. Abstract retrieved August 4, 2016 from PubMed database.
U. S. Food and Drug Administration. (2008, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K073041(Relieva™). Retrieved January 20, 2010 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2010, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K102003. Retrieved August 6, 2012 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, September, last update search October 2018) Balloon sinuplasty for treatment of chronic rhinosinusitis. Retrieved December 10, 2018 from www.hayesinc.com (68 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 10/14/2006
MOST RECENT REVIEW DATE: 2/14/2019
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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