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Steroid‐eluting sinus implant for in‐office treatment of recurrent nasal polyposis: a prospective, multicenter study
Author(s) -
Lavigne François,
Miller Steven K.,
Gould Andrew R.,
Lanier Brent J.,
Romett J. Lewis
Publication year - 2014
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.21309
Subject(s) - medicine , implant , surgery , mometasone furoate , nasal polyps , prospective cohort study , functional endoscopic sinus surgery , refractory (planetary science) , adverse effect , ethmoid sinus , sinus (botany) , chronic rhinosinusitis , sinusitis , corticosteroid , physics , botany , astrobiology , biology , genus
Background Treatment options for chronic rhinosinusitis with recurrent polyposis (CRSwNP) after endoscopic sinus surgery (ESS) are limited, and include frequent use of systemic steroids and revision surgery. A bioabsorbable, steroid‐eluting implant was studied for its ability to dilate sinuses obstructed by polyps and provide localized, controlled steroid delivery to reestablish sinus patency. This study assessed the initial feasibility, safety, and efficacy of steroid‐eluting implants placed in the office setting in patients who were candidates for revision ESS. Methods Prospective, multicenter study enrolling 12 patients who had prior ESS but experienced recurrent polyposis refractory to medical therapy. Implants were placed bilaterally under topical anesthesia in‐office. Follow‐up through 6 months included endoscopic grading, patient‐reported outcomes (22‐item Sino‐Nasal Outcomes Test [SNOT‐22]) and need for revision ESS. Results Implants were successfully inserted in 21 of 24 (88%) ethmoid sinuses, resulting in 11 evaluable patients. No serious adverse events occurred. Within 1 month, mean bilateral polyp grade was reduced from 4.5 at baseline to 2.3 ( p = 0.008) and sustained through 6 months (2.33; p = 0.008). Mean SNOT‐22 score was significantly improved from 2.19 at baseline to 0.90 within 1 month ( p = 0.001) and sustained to 6 months (1.03; p = 0.012). Sixty‐four percent of patients were no longer revision ESS candidates at 6 months. Conclusion The study provided initial clinical evidence of the feasibility, safety, and efficacy of in‐office steroid‐eluting implant placement in CRS patients with recurrent polyposis after ESS. Although further studies are needed, the results suggest this therapy may provide a safe and effective, office‐based option for the treatment of obstructive polyposis.