In‐office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: a randomized, placebo‐controlled study

Abstract

BackgroundA limited number of studies have demonstrated symptomatic improvement for recurrent acute rhinosinusitis (RARS) patients after endoscopic sinus surgery. In this randomized, controlled study we evaluated 24‐week outcomes for balloon sinus dilation (BSD) performed in‐office (IO) with medical management (MM) as compared with MM only for RARS patients.MethodsAdults diagnosed with RARS were randomized to groups with BSD plus MM (n = 29) or MM alone (n = 30). Patients who received MM alone also received a sham BSD‐IO procedure to blind them to group assignment. Patients were followed to 48 weeks posttreatment. The primary outcome was the difference between arms in change in Chronic Sinusitis Survey (CSS) score from baseline to 24 weeks. Secondary endpoints included comparisons of Rhinosinusitis Disability Index (RSDI) score, medication usage, medical care visits, and sinus infections.ResultsChange in patient‐reported quality of life (QOL), as measured by the CSS total score from baseline to 24 weeks, was significantly greater in the BSD plus MM group compared with the MM‐only group (37.3 ± 24.4 [n = 26] vs 21.8 ± 29.0 [n = 27]; p = 0.0424).ConclusionBSD plus MM proved superior to MM alone in enhancing QOL for RARS patients. BSD plus MM should be considered as a viable treatment option for properly diagnosed RARS patients.

International consensus statement on allergy and rhinology: rhinosinusitis 2021

“…Current guidelines delineate a role for BSD in RARS, although CT imaging is required showing evidence of ostial occlusion and mucosal thickening 510 . The first randomized, placebo‐controlled, unblinded trial showed that patients who received in‐office BSD and medical management for RARS (n = 29), compared to patients receiving in‐office sham procedure and medical management (n = 30), reported significant improvements in CSS and RSDI scores at 8 and 24 weeks follow‐up 511 . BSD also significantly reduced mean number of sinus infections at 24 weeks follow‐up.…”

“…Nonetheless, the REMODEL study provides level 1 evidence that BCD may be a potential treatment option for patients with limited disease involving the maxillary and/or anterior ethmoid sinuses, where appropriate medical therapy has failed. A recent randomized, placebo‐controlled trial in patients with RARS showed BCD plus medical management proved superior to medical management alone further potentially supporting its role in minimal diseased states 511 …”

Qualität in der chirurgischen Therapie chronisch entzündlicher Erkrankungen der Nasennebenhöhlen

“…If surgery for RARS is performed, maxillary sinus surgery and anterior ethmoidectomy are the most common procedures [308,317,318]. Balloon sinuplasty also shows positive effects on QoL and number of acute infections [319]. After sinus surgery, there is a significant reduction of the number of acute infections.…”

“…Compared to medical therapy, surgical treatment leads to a greater improvement of the disease-specific quality of life in the SNOT-22 [308]. Patients under medical treatment often change to a surgical approach in the further course (33-76 %) [308,319]. There is often a deterioration of QoL prior to this change [308].…”

Analysis of Sinus Balloon Catheter Dilation Providers Based on Medicare Provider Utilization and Payment Data

“…1,2 Prospective studies have shown that BCD is noninferior to endoscopic sinus surgery (ESS) for improving symptoms and quality of life in adult and pediatric patients with chronic rhinosinusitis (CRS). [3][4][5][6][7] However, issues with these findings have been raised regarding sample size and obvious discrepancies in disease severity. 8 Proper comparison of BCD and ESS has been challenging, as patients undergoing BCD usually have lower disease burden.…”