REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies

Rakesh K. Chandra*, Robert C. Kern, Jeffrey L. Cutler, Kevin C. Welch, Paul T. Russell

*Corresponding author for this work

Research output: Contribution to journalArticle

23 Scopus citations

Abstract

Objectives/Hypothesis 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. Study Design 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.

Original languageEnglish (US)
Pages (from-to)44-50
Number of pages7
JournalLaryngoscope
Volume126
Issue number1
DOIs
StatePublished - Jan 1 2016

Keywords

  • Balloon sinus dilation
  • chronic rhinosinusitis
  • endoscopic sinus surgery
  • long-term outcomes
  • meta-analysis
  • randomized controlled trial

ASJC Scopus subject areas

  • Otorhinolaryngology

Fingerprint Dive into the research topics of 'REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies'. Together they form a unique fingerprint.

  • Cite this