title: Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients.
abstract: BACKGROUND
  Balloon sinus dilation (BSD) is an increasingly used tool in endoscopic sinus surgery (ESS). The tissue-sparing nature of the instrumentation allows for properly selected patients to undergo office-based procedures under local anesthesia.
  
  
  METHODS
  This was an Institutional Review Board (IRB)-approved, prospective, 14-center trial. Patients (n = 203) requiring ESS for medically refractory chronic sinusitis underwent transnasal BSD treatment in an office setting under local anesthesia. Safety, tolerability, technical success, clinical efficacy (20-item Sino-Nasal Outcome Test [SNOT-20]), and radiographic outcome (Lund-Mackay [LMK] score) of ESS with BSD in the office setting were assessed. Subjects were followed at 2, 8, and 24 weeks.
  
  
  RESULTS
  A total of 552 sinuses were dilated in 203 patients: 47.6% maxillaries, 45.5% frontals, and 6.9% sphenoids. Seventy-seven patients were revisions of prior ESS. The mean number of sinuses dilated per subject was 2.7. Technical dilation success was 93.3%, 90.5%, and 93.7% for maxillary, sphenoid, and frontal sinuses, respectively. SNOT-20 and LMK computed tomography (CT) scoring showed statistically significant improvement at 24 weeks (p < 0.0001) and clinically significant improvement in quality of life. The procedure was reported as tolerable or highly tolerable by 82.3% of patients. There were 0.15 postoperative debridements per patient and the majority returned to normal activity within 48 hours. One (0.5%) procedure-related adverse event related to periorbital swelling was reported, which spontaneously resolved shortly after the procedure without further sequelae.
  
  
  CONCLUSIONS
  Performance of ESS with BSD in the office under local anesthesia is feasible, well-tolerated, safe, and effective. Twenty-four week follow-up demonstrates clinical and statistical improvement in patient quality of life and radiographic outcomes.
authors.affiliation: Ohio Sinus Institute, Dublin, OH 43016, USA. bk@ohiosinus.com
authors.forename: Boris
authors.initials: B
authors.lastname: Karanfilov
authors.forename: Stacey
authors.initials: S
authors.lastname: Silvers
authors.forename: Raza
authors.initials: R
authors.lastname: Pasha
authors.forename: Ashley
authors.initials: A
authors.lastname: Sikand
authors.forename: Alan
authors.initials: A
authors.lastname: Shikani
authors.forename: Michael
authors.initials: M
authors.lastname: Sillers
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D002908:Chronic Disease; D018572:Disease-Free Survival; D004724:Endoscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010256:Paranasal Sinuses / Q000601:surgery*; D011788:Quality of Life; D012852:Sinusitis / Q000175:diagnosis / Q000601:surgery*; D011795:Surveys and Questionnaires; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult