Outcomes and Complications of Balloon and Conventional Functional Endoscopic Sinus Surgery.

Background: Since the Food and Drug Administration approval of balloon sinuplasty (BSP) in 2005, no nationally representative population-based studies have examined the outcomes and adverse events of BSP. Objective: To assess the rates of complications and revision surgery in patients who received BSP, functional endoscopic sinus surgery (FESS), or a hybrid procedure. Methods: Using one of the nation's largest commercial insurance databases, we conducted a retrospective cohort study of pediatric and adult patients diagnosed with chronic rhinosinusitis between 2011 and 2014 who underwent BSP, conventional FESS, or a hybrid procedure. The primary outcomes were surgical complication and revision rates within 6 months of initial surgery. Results: A total of 16,040 patients who underwent sinus surgery were included. Overall, 2,851 patients underwent BSP, 11,955 underwent conventional FESS, and 1 234 underwent a hybrid procedure. BSP surgery was more likely to have been performed in an office setting (86.53%) compared to FESS (0.74%). The complication rate was 5.26% for BSP and 7.35% for conventional FESS. Revision rates were 7.89% for BSP, 16.85% for FESS, and 15.15% for a hybrid procedure. Conclusion: Despite the low overall risk, major complications occur with BSP including cerebrospinal fluid leak, pneumocephalus, orbital complications, and severe bleeding. Otolaryngologists should discuss these risks with their patients. Prospective studies are still needed to compare outcomes of BSP with those of FESS.