BlueCross BlueShield of Tennessee Medical Policy Manual

Balloon Ostial Dilation for Treatment of Chronic Sinusitis

DESCRIPTION

Balloon ostial dilation (also known as balloon sinuplasty™) is proposed as an alternative to traditional endoscopic sinus surgery (ESS) for individuals with chronic sinusitis who fail medical management.  The procedure involves inflating a balloon in the sinus ostium to stretch the opening.  This procedure can be performed as a stand-alone procedure or as an adjunctive procedure to functional endoscopic sinus surgery (FESS).

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.

Note: This policy does not address FESS (functional endoscopic sinus surgery).

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Well-designed studies in peer-reviewed journals continue to be lacking.  Evidence is needed from randomized trials to demonstrate an improvement in outcomes for individuals treated with balloon ostial dilation. More information is needed to determine which individuals and which sinuses benefit from the balloon technique as an adjunct to FESS and which individuals should receive standard approaches.  Therefore, it is unknown if this technology leads to improved treatment or better health outcomes.

SOURCES

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. 

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. Medical Policy Reference Manual. (5:2017). Balloon ostial dilation for treatment of chronic sinusitis (7.01.105). Retrieved August 16, 2017 from BlueWeb. (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). (2008, September). Balloon catheter dilation of paranasal sinus ostia for 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. Retrieved January 20, 2010 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2009, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091681. Retrieved August 6, 2012 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) Balloon sinuplasty for treatment of chronic rhinosinusitis. Retrieved August 16, 2017 from www.hayesinc.com. (46 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  10/14/2006

MOST RECENT REVIEW DATE:  9/14/2017

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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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