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

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.

Keywords: Balloon sinus dilation; chronic rhinosinusitis; endoscopic sinus surgery; long-term outcomes; meta-analysis; randomized controlled trial.

© 2015 The American Laryngological, Rhinological and Otological Society, Inc.

Figures

Figure 1
Figure 1
REMODEL trial: SNOT‐20 overall scores by treatment arm for all treated patients by follow‐up period. FESS = functional endoscopic sinus surgery; SNOT‐20 = 20‐item Sino‐Nasal Outcomes Test; REMODEL = randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long‐term follow‐up.
Figure 2
Figure 2
Meta‐analysis of standalone balloon dilation studies: random effects model for mean SNOT‐20 overall score and subscale scores over time. SNOT‐20 = 20‐item Sino‐Nasal Outcomes Test.
Figure 3
Figure 3
Meta‐analysis of standalone balloon dilation studies: random effects model for Work Limitations Questionnaire (WLQ) over time.
Figure 4
Figure 4
Mean SNOT‐20 overall scores for standalone balloon dilation studies included in meta‐analysis and REMODEL FESS arm. FESS = functional endoscopic sinus surgery; SNOT‐20 = 20‐item Sino‐Nasal Outcomes Test.

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