BlueCross BlueShield of Tennessee Medical Policy Manual

Implantable Sinus Stents and Drug-eluting Implants for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease

DESCRIPTION

Sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS). These devices maintain patency of the sinus openings and/or have been proposed for use as a local drug delivery vehicle. Traditionally postoperative ESS treatments have include saline irrigation, nasal packs, topical steroids, systemic steroids, topical decongestants, oral antibiotics, and/or follow-up surgical sinus cavity debridement.

Bioabsorbable, drug eluting implants (e.g., PROPEL™, PROPRL™ mini Sinus Implant) are intended to offer local delivery of a sustained release medication while maintaining sinus patency, as the implant slowly dissolves. Another bioresorbable product combines nasal packing and sinus stenting (e.g., MeroPack™, MeroGel®), designed for hemostasis and wound healing.

Other steroid-eluting absorbable stents can be inserted in the office setting after ESS or to treat persistent or recurrent polyposis following ESS. Reducing postoperative inflammation and maintaining patency of the sinuses are important in achieving optimal sinus drainage and recovery from surgery.

POLICY

Policies with similar titles:  Balloon Sinuplasty for the Treatment of Chronic Sinusitis

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

Long-term studies for drug-eluting sinus implants are limited, and the results of comparative studies are conflicting. The evidence for implantable drug-eluting sinus stents in those individuals that experience recurrent sinonasal polyposis is scant, and the risk of bias is very high due to unblinded outcome assessment. Therefore, these devices remain investigational.

SOURCES

American Academy of Otolaryngology – Head & Neck Surgery (2015, September) Position Statement: The use of biomaterials in sinonasal procedures. Retrieved June 12, 2017 from http://www.entnet.org.

Bangiyev, J., Govil, N., Sheyn, A., Haupert, M., and Thottam, P. (2017, January) Novel application of steroid eluting stents in choanal atresia repair: a case series. Annals of Otolaryngology, Rhinology and Laryngology; 126(1):79-82. Abstract retrieved June 12, 2017 from PubMed database.

BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2017). Implantable sinus stents for postoperative use following endoscopic sinus surgery and for recurrent sinus disease (7.01.134). Retrieved June 12, 2017 from BlueWeb. (18 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Information Service. Emerging Technology Evidence Report. (2015, February; update March 2017). Steroid-eluting implant for maintaining sinus patency after ethmoid sinus surgery. Retrieved June 12, 2017 from ECRI Institute. (92 articles and/or guidelines reviewed)

Forwith, K. D., Chandra, R. K., Yun, P. T., Miller, S. K., & Jampel, H. D. (2011). ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope, 121 (11), 2473-2480. Abstract retrieved February 23, 2016 from PubMed database.

Forwith, K. D., Han, J. K., Stolovitzky, J. P., Yen, D. M., Chandra, R. K., Karanfilov, B., Matheny, K. E. (2016). RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. International Forum of Allergy & Rhinology, 6 (6), 573-581. Abstract retrieved October 20, 2016 from PubMed database.

Han, J. K., Forwith, K. D., Smith, T. L., Kern, R. C., Brown, W. J., Miller, S. K., Ow, R. A., et al. (2014). RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. International Forum of Allergy & Rhinology, 4 (11), 861-870. (Level 1 evidence - Industry sponsored)

Huang, Z., Hwang, P., Sun Y., & Zhou, B. (2015). Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database Systematic Review, 10 (6). Abstract retrieved February 23, 2016 from PubMed database.

Janisiewicz, A. & Lee, J. T. (2015). In-office use of a steroid-eluting implant for maintenance of frontal ostial patency after revision sinus surgery. Allergy & Rhinology, 6 (1), e68-e75. (Level 4 - Independent)

Kennedy, D. W. (2012). The PROPEL™ steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Review of Respiratory Medicine, 6 (5), 493-498. Abstract retrieved October 20, 2016 from http://www.tandfonline.com/doi/full/10.1586/ers.12.53.

Marple, B. F., Smith, T. L., Han J. K., Gould, A. R., Jampel, H. D., Stambaugh, J. W., et al. (2012). Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngology - Head and Neck Surgery, 146 (6), 1004-1011. Abstract retrieved October 24, 2016 from PubMed database.

Matheny, K. E., Carter, Jr., K. B., Tseng, E. Y., & Fong, K. J. (2014). Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: a prospective case series. International Forum of Allergy & Rhinology, 4 (10), 808-815. Abstract retrieved February 23, 2016 from PubMed database.

Murr, A. H., Smith, T. L., Hwang, P. H., Bhattacharyya, N., Lanier, B. J., Stambaugh, J. W., et al. (2011). Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. International Forum of Allergy & Rhinology, 1 (1), 23-32. Abstract retrieved October 24, 2016 from http://onlinelibrary.wiley.com/doi/10.1002/alr.20020/full.

National Institute for Health and Clinical Excellence. (2016, March). Interventional procedural guidance: Corticosteroid-eluting bioabsorbable stent or spacer insertion during endoscopic sinus surgery to treat chronic rhinosinusitis. Retrieved October 20, 2016 from https://www.nice.org.uk/guidance/ipg551.

Ow, R., Groppo, E., Clutter, D., & Gawlicka, A. K. (2014). Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study. International Forum of Allergy & Rhinology, 4 (10), 816-822. Abstract retrieved October 20, 2016 from PubMed database. (Level 4 - Industry sponsored)

Rudmik, L., Mace, J., & Mechor, B. (2012). Effect of a dexamethasone Sinu-Foam™ middle meatal spacer on endoscopic sinus surgery outcomes: a randomized, double-blind, placebo-controlled trial. International Forum of Allergy & Rhinology, 2 (3), 248-251. Abstract retrieved January 8, 2013 from PubMed database.

Smith, T. L., Singh, A., Luong, A., Ow, R. A., Shotts, S. D., Sautter, N. B. (2016). Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope, Epub ahead of print July 1, 2016. Abstract retrieved October 20, 2016 from PubMed database.

U. S. Food and Drug Administration. (2008. March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072891. Retrieved February 2, 2013 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2011, August). Center for Devices and Radiological Health. Premarket approval decision P100044 (PROPEL ™). Retrieved October 20, 2016 from http://www.accessdata.fda.gov.

Wei, C. & Kennedy, D. (2012). Mometasone implant for chronic rhinosinusitis. Medical Devices: Evidence and Research. 2012 (5), 75-80. (Level 4 evidence - Industry supported)

Xu, J. J., Busato, G. M., McKnight, C., & Lee, J. M. (2016). Absorbable steroid-impregnated spacer after endoscopic sinus surgery to reduce synechiae formation. Annals of Otology, Rhinology, & Laryngology, 125 (3), 195-198. Abstract retrieved February 23, 2016 from PubMed database.

ORIGINAL EFFECTIVE DATE:  6/8/2013

MOST RECENT REVIEW DATE:  8/10/2017

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