title: 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.
abstract: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer-term outcomes.
  
  
  
  A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in-office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six-month follow-up included endoscopic grading and patient-reported outcomes.
  
  
  
  At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2-fold improvement in mean nasal obstruction/congestion score (-1.06 ± 1.4 vs -0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2-fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients.
  
  
  
  The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population.
authors.affiliation: Advanced ENT and Allergy, Louisville, KY.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Forwith
authors.affiliation: Divisions of Rhinology and Endoscopic Sinus-Skull Base Surgery and Allergy, Eastern Virginia Medical School, Norfolk, VA.
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Han
authors.affiliation: ENT of Georgia, Atlanta, GA.
authors.forename: J Pablo
authors.initials: JP
authors.lastname: Stolovitzky
authors.affiliation: Bethlehem Ear, Nose and Throat Associates, Bethlehem, PA.
authors.forename: David M
authors.initials: DM
authors.lastname: Yen
authors.affiliation: Rhinology, Sinus and Skull Base Surgery, Department of Otolaryngology, Vanderbilt University, Nashville, TN.
authors.forename: Rakesh K
authors.initials: RK
authors.lastname: Chandra
authors.affiliation: Department of Otolaryngology, Ohio State University, Ohio Sinus Institute, Dublin, OH.
authors.forename: Boris
authors.initials: B
authors.lastname: Karanfilov
authors.affiliation: Collin County Ear Nose and Throat, Frisco, TX.
authors.forename: Keith E
authors.initials: KE
authors.lastname: Matheny
authors.affiliation: Clinical Affairs, Intersect ENT, Menlo Park, CA.
authors.forename: James W
authors.initials: JW
authors.lastname: Stambaugh
authors.affiliation: Clinical Affairs, Intersect ENT, Menlo Park, CA.
authors.forename: Anna K
authors.initials: AK
authors.lastname: Gawlicka
mesh_terms: D020341:Absorbable Implants; D000553:Ambulatory Care; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002908:Chronic Disease; D004724:Endoscopy; D006801:Humans; D000068656:Mometasone Furoate / Q000008:administration & dosage* / Q000627:therapeutic use; D009298:Nasal Polyps / Q000188:drug therapy* / Q000601:surgery; D010256:Paranasal Sinuses / Q000601:surgery; D000071066:Patient Reported Outcome Measures; D012008:Recurrence; D012086:Reoperation; D012220:Rhinitis / Q000188:drug therapy* / Q000601:surgery; D012852:Sinusitis / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000068656:Mometasone Furoate
keywords: CRSwNP; bioabsorbable; chronic sinusitis; corticosteroid; implant; inflammation; nasal polyps; refractory; revision ESS; stent