Standalone Balloon Dilation versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multicenter, Randomized, Controlled Trial

Abstract

Balloon dilation is noninferior to FESS for symptom improvement and superior to FESS for postoperative debridements in patients with maxillary and anterior ethmoid disease. Balloon dilation is an effective treatment in patients with uncomplicated CRS who meet the criteria for medically necessary FESS.

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

“…Results of the final study cohort of 135 patients in the REMODEL trial, with follow‐up from 1 to 2 years postprocedure, are consistent with the earlier reports from a smaller cohort of patients . Improvements in sinus symptoms after balloon dilation are maintained over a 2‐year time period and are similar to the improvements observed with FESS.…”

“…The REMODEL trial was a multicenter, randomized controlled trial comparing the outcomes of standalone balloon sinus dilation performed in the office setting versus standard FESS done in an operating room. The trial was statistically powered, with a minimum of 36 patients per arm needed to provide 90% power to detect a change of 0.8 in mean 20‐item Sino‐Nasal Outcomes Test (SNOT‐20) score . In total, 61 patients underwent treatment with FESS and 74 with balloon dilation.…”

“…Balloon dilation of sinus ostia has been studied in randomized controlled trials with comparison to standard functional endoscopic sinus surgery (FESS). Previous reports of the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long‐term follow‐up) randomized trial of standalone balloon sinus dilation versus FESS provided results for the first 92 treated patients, exceeding the 72 patients required to statistically evaluate the primary endpoints . Total enrollment in REMODEL included 135 patients who were treated with one of the two interventions.…”

Long-term follow-up after ESS and balloon sinuplasty: Comparison of symptom reduction and patient satisfaction

“…Cutler et al [13] had a revision rate of 2.0% after 6-months follow-up, and Levine et al [19] had a rate of 5.8% after 1-year follow-up. Our revision rate of 14% needs to be established by other studies with equal follow-up time.…”

“…The disadvantages of the procedure are the lack of knowledge of its long-term effect, the high costs of the disposable instruments, and its technical limitations in ethmoidal area or in removal of atypical mucosa [9]. Several uncontrolled and controlled studies have suggested balloon sinuplasty to be a safe and effective method [6,7,[10][11][12][13]. However, the limitations of these studies are the heterogeneity of patients and procedures as well as short follow-up time, which makes the conclusions difficult to draw.…”