Drug-Eluting Implants

 ARS POSITION STATEMENT ON DRUG-ELUTING IMPLANTS
September 14, 2016

The American Rhinologic Society endorses the utilization of drug-eluting implants into the sinus cavities. Results in sinus surgery are often dependent on proper healing of the sinus cavity and the reduction of inflammation. Furthermore, reduction of polyp burden and inflammation can result in a decrease in the use of oral medications as well as delaying the time until revision surgery.
There have been a number of well-controlled studies on drug-eluting implants in the paranasal sinuses, specifically implants that release steroids to the local tissues. These studies have demonstrated improvement of patient outcomes by reducing inflammation, decreasing scarring and middle turbinate lateralization and limiting the need for oral steroids.
The American Rhinologic Society thus feels strongly that drug-eluting implants are not investigational and should be available to our patients, when selected by the physician, in order to maximize outcomes.


References:
Bleier BS, Kofonow JM, Hashmi N, Chennupati SK, Cohen NA. Antibiotic eluting chitosan glycerophosphate implant in the setting of acute bacterial sinusitis: a rabbit model. Am J Rhinol Allergy. 2010 Mar-Apr;24(2):129-32. doi: 10.2500/ajra.2010.24.3439. PMID: 20338111.

Campbell RG, Kennedy DW. What is new and promising with drug-eluting stents in sinus surgery? Curr Opin Otolaryngol Head Neck Surg. 2014;22(1):2-7.

Cho KS et al. State-of-the-art biomaterials in the nasal cavity: hemostats and spacers following sinus surgery. Otorinolaringologia. 2013;63(3):111-121.
Engle, RD, Neel, GS, Rosen, J, Kenning, TJ, and Pinheiro-Neto, CD. Draf iib and iii frontal sinusotomy in cystic fibrosis patients. Journal of Neurological Surgery, Part B: Skull Base. 2014;75.

Forwith KD, Chandra RK, Yun PT, Miller SK, Jampel HD. ADVANCE: a multi-site trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope. 2011; 121:2473–2480.

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. Intl Forum Allergy Rhinol. 2016.

Han JK, Marple BF, Smith TL, et. al. Effect of Steroid-Releasing Sinus Implants on Post-Operative Medical and Surgical Interventions: An efficacy meta-analysis. Intl Forum Allergy & Rhinol. 2012; 2:271-279.

Han J, Forwith K, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Intl Forum Allergy Rhinol. 2014 Sep 29.

Janisiewicz A and Lee JT. In-office use of a steroid-eluting implant for maintenance of frontal ostial patency after revision sinus surgery. Allergy Rhinol 6:1-8, 2015.

Kennedy DW. The PROPEL steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Rev. Respir. Med. 6(5)(2012).

Lai SK, Suk JS, Pace A, Wang YY, Yang M, Mert O, Chen J, Kim J, Hanes J. Drug carrier nanoparticles that penetrate human chronic rhinosinusitis mucus. Biomaterials. 2011 Sep;32(26):6285-90. doi: 10.1016/j.biomaterials.2011.05.008. Epub 2011 Jun 12.
PMID: 21665271

Lavigne F, et. al. Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study. Intl Forum Allergy & Rhinol. 2014 May;4(5):381-9.

Lee JT and Han JK. Sinus implants for chronic rhinosinusitis: technology evaluation. Expert Opin. Drug Deliv. (2013) 10(12).

Li PM, Downie D, Hwang PH. Controlled steroid delivery via bioabsorbable stent: safety and performance in a rabbit model. Am J Rhinol Allergy. 2009; 23(6):591-596.

Marple BF, Smith TL, et al. ADVANCE II: A prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngol Head Neck Surg. 2012; 146(6): 1004–1011.

Matheny K, Carter K, et al. Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: A prospective case series. Intl Forum Allergy Rhinol. 2014; 4: 808-815.

Matheny K. Bioabsorbable steroid-releasing sinus implants in the frontal and maxillary sinuses: 2-year follow-up. Allergy Rhinol 6:e118 –e121, 2015; doi: 10.2500/ar.2015.6.0117.

Murr AH, Smith TL, Hwang PH, et al. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. 2011; 1:23–32.

Ow R, Groppo E, Clutter D, et al. Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study. Intl Forum Allergy Rhinol. 2014; 3:1-7.

Parikh A, et al. Drug-Eluting Nasal Implants: Formulation, Characterization, Clinical Applications and challenges. Pharmaceutics. 2014; 6, 249-267.

Ramakrishnan VR, Kennedy DW. Advances in the surgical management of chronic sinusitis and nasal polyps. Current Allergy and Asthma Reports. 2011; 11(3):220-229.

Rizzo J, Rudmik L, Mallow P, Palli S. Budget impact analysis of bioabsorbable drug-eluting sinus implants following endoscopic sinus surgery. Journal of Medical Economics, 2016. DOI: 10.1080/ 13696998.2016.1176577

Rudmik L and Smith TL. Evidence-Based Practice: Postoperative Care in Endoscopic Sinus Surgery. Otolaryngol Clin N Am; 45 (2012) 1019-1032.

Rudmik L and Smith TL. Economic Evaluation of a Steroid-Eluting Sinus Implant following Endoscopic Sinus Surgery for Chronic Rhinosinusitis. Otolaryngol Head Neck Surg. 2014 May5;151(2):359-366.

Torres, L, Shaari, CM, and Ghalili, A. Maintaining favorable middle turbinate position after endoscopic sinus surgery. Otolaryngology - Head and Neck Surgery. 2014;151(1):253.

Wei CC, Kennedy DW. Mometasone implant for chronic rhinosinusitis. Medical Devices: Evidence and Research. 2012; 5:75–80.




Revised 09/15/2016
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