title: REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies.
abstract: OBJECTIVE
  To provide the final results from the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long-term follow-up) full-study cohorts and perform meta-analyses of standalone balloon sinus dilation studies to explore long-term outcomes in a large patient sample.
  
  
  METHODS
  Randomized controlled trial and meta-analysis.
  
  
  METHODS
  Final outcomes from the REMODEL randomized trial, including a larger cohort of 135 patients treated with functional endoscopic sinus surgery (FESS) or in-office balloon dilation, were evaluated. One hundred thirty patients had 12-month data, 66 had 18-month data, and 25 had 24-month data. In addition, a meta-analysis evaluated outcomes from six studies including 358 standalone balloon dilation patients with up to 24 months follow-up.
  
  
  RESULTS
  Outcomes out to 2 years from the REMODEL full-study cohort are consistent with 6-month and 12-month outcomes. In the meta-analysis of standalone balloon dilation studies, technical success is 97.5%, and mean 20-item Sino-Nasal Outcomes Test scores are significantly and clinically improved at all time points (P < .0001). There are significant reductions (P < .0001) in work/school days missed, homebound days, physician/nurse visits, acute infections, and antibiotic prescriptions. Mean recovery time is 1.4 days. Comparison of 12-month symptom improvements and revision rates between the REMODEL FESS arm (n = 59), REMODEL balloon dilation arm (n = 71), and pooled single-arm standalone balloon dilation studies (n = 243) demonstrated no statistical difference.
  
  
  CONCLUSIONS
  All outcomes are comparable between FESS and balloon dilation at all time points from 6 months to 24 months. Balloon dilation produces faster recovery, less postoperative pain, and fewer debridements than FESS. There is significant, durable benefit in a large series of 358 patients undergoing standalone balloon dilation.
authors.affiliation: Department of Otolaryngology, Vanderbilt University School of Medicine, Nashville, Tennessee.
authors.forename: Rakesh K
authors.initials: RK
authors.lastname: Chandra
authors.affiliation: Department of Otolaryngology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Kern
authors.affiliation: Associates of Otolaryngology, Denver, Colorado, U.S.A.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Cutler
authors.affiliation: Department of Otolaryngology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.|Associates of Otolaryngology, Denver, Colorado, U.S.A.
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Welch
authors.affiliation: Department of Otolaryngology, Vanderbilt University School of Medicine, Nashville, Tennessee.
authors.forename: Paul T
authors.initials: PT
authors.lastname: Russell
mesh_terms: D000328:Adult; D002404:Catheterization / Q000379:methods*; D004724:Endoscopy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008443:Maxillary Sinus; D015201:Meta-Analysis as Topic; D012220:Rhinitis / Q000628:therapy*; D012852:Sinusitis / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Balloon sinus dilation; chronic rhinosinusitis; endoscopic sinus surgery; long-term outcomes; meta-analysis; randomized controlled trial