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Position Statement: Drug-Eluting Sinus Implants

Position Statement: Drug-Eluting Sinus Implants

The American Academy of Otolaryngology-Head and Neck Surgery supports the use of drug-eluting implants in the management of mucosal inflammation of the paranasal sinuses. Drug-eluting implants serve as a vehicle for the topical delivery of corticosteroid therapies into the sinonasal cavities, thereby decreasing tissue inflammation, relieving obstruction of sinuses, and improving the sinonasal symptoms and quality of life of affected patients.

Multiple studies have demonstrated the efficacy and safety of drug-eluting implants in controlling sinonasal inflammation. Clinical evidence regarding the use of drug-eluting implants after sinus surgery has particularly shown enhanced wound healing through the reduction of both scar formation and anatomic obstruction1-9. Additional studies have specifically highlighted the utility of drug-eluting implants in previously opened sinus cavities to decrease mucosal inflammation and improve associated patient-reported outcomes10. Furthermore, drug-eluting implants in the paranasal sinuses have been found to reduce the use of systemic corticosteroids, which are associated with undesired adverse effects, including elevations in blood glucose, bone demineralization, cataracts, and mood alterations11.

The American Academy of Otolaryngology-Head and Neck Surgery thus considers drug-eluting implants in the paranasal sinuses as a proven and effective therapeutic option for mucosal inflammation.

References1-11

  1. Forwith KD, Chandra RK, Yun PT, Miller SK, Jampel HD. ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope. Nov 2011;121(11):2473-80. doi:10.1002/lary.22228
  2. Forwith KD, Han JK, Stolovitzky JP, et al. 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. Int Forum Allergy Rhinol. Jun 2016;6(6):573-81. doi:10.1002/alr.21741
  3. Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. Nov 2014;4(11):861-70. doi:10.1002/alr.21426
  4. Huang Z, Zhou B, Wang D, et al. Comparison of Bioabsorbable Steroid-Eluting Sinus Stents Versus Nasopore After Endoscopic Sinus Surgery: A Multicenter, Randomized, Controlled, Single-Blinded Clinical Trial. Ear Nose Throat J. May 2022;101(4):260-267. doi:10.1177/0145561320947632
  5. Hwang CS, Al Sharhan SS, Kim BR, et al. Randomized controlled trial of steroid-soaked absorbable calcium alginate nasal packing following endoscopic sinus surgery. Laryngoscope. Feb 2018;128(2):311-316. doi:10.1002/lary.26871
  6. Marple BF, Smith TL, Han JK, et al. Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngol Head Neck Surg. Jun 2012;146(6):1004-11. doi:10.1177/0194599811435968
  7. Murr AH, Smith TL, Hwang PH, et al. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. Jan-Feb 2011;1(1):23-32. doi:10.1002/alr.20020
  8. Singh A, Luong AU, Fong KJ, et al. Bioabsorbable steroid-releasing implants in the frontal sinus ostia: a pooled analysis. Int Forum Allergy Rhinol. Feb 2019;9(2):131-139. doi:10.1002/alr.22238
  9. Smith TL, Singh A, Luong A, et al. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. Dec 2016;126(12):2659-2664. doi:10.1002/lary.26140
  10. Kern RC, Stolovitzky JP, Silvers SL, et al. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. Apr 2018;8(4):471-481. doi:10.1002/alr.22084
  11. Dautremont JF, Mechor B, Rudmik L. The role of immediate postoperative systemic corticosteroids when utilizing a steroid-eluting spacer following sinus surgery. Otolaryngol Head Neck Surg. Apr 2014;150(4):689-95. doi:10.1177/0194599814521373

 

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