title: Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Otolaryngology, Centre hospitalier de l'Université de Montréal (CHUM), Hôpital Notre-Dame, Montréal, Québec, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Lavigne
authors.forename: Steven K
authors.initials: SK
authors.lastname: Miller
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Gould
authors.forename: Brent J
authors.initials: BJ
authors.lastname: Lanier
authors.forename: J Lewis
authors.initials: JL
authors.lastname: Romett
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D004724:Endoscopy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009298:Nasal Polyps / Q000628:therapy*; D010256:Paranasal Sinuses / Q000187:drug effects / Q000601:surgery*; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000706:statistics & numerical data; D019919:Prosthesis Implantation; D012008:Recurrence; D012220:Rhinitis / Q000628:therapy*; D012852:Sinusitis / Q000628:therapy*; D013256:Steroids / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D013256:Steroids
keywords: FESS; bioabsorbable; corticosteroid; drug-eluting implant; functional endoscopic sinus surgery; inflammation; mometasone furoate; nasal congestion; nasal polyps; sinusitis