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that keeps a continuous protective layer of mucus flowing out of the sinuses (Slack&Bates). Indications for balloon sinusplasty are somewhat similar to FESS. Balloon sinus ostial dilation (BSD) has been found to be most effective in the treatment of recurrent acute sinusitis (RARS) and chronic rhinosinusitis without nasal polyposis (CRSsNP) that has been refractory to medical therapy. Under direct vision or fluoroscopy, a thin catheter is inserted into the narrowed ostium, then a balloon is inflated under pressure to enlarge the opening by stretching the mucous membrane and creating a small bony fracture. Balloon sinuplasty has been developed as a less invasive alternative to functional endoscopic sinus surgery. Balloon sinuplasty is contraindicated in patients with polyps, eosinophilic mucosal membrane disease, sinonasal tumors, certain anatomical variants, and sinus disease with significant osteoneogenesis For adults with recurrent acute sinusitis (RARS) or chronic sinusitis unresponsive to medical management, balloon sinuplasty or balloon ostial dilation is a procedure developed over the past decade in which the frontal, sphenoid, or maxillary sinus ostium is dilated using a balloon catheter. The procedure does not include surgical removal of tissue and can be performed in the office setting under local anesthesia. A registry of 1036 adult patients who received 3276 procedures had, at an average follow-up of 40 weeks, a revision rate of 1.3%. Although 95.2% of patients improved, the authors stated Moda Health Medical Necessity Criteria Sinus Surgery Page 8/8 that the study was not prospective or controlled, and it did not provide a comparative analysis of outcomes for sinus disease categorized by clinical staging. An observational study of 82 adults (with 313 ostial dilations) found that there was significant improvement in symptom scores and medication use at 1-year follow-up. The authors noted that the study had two structural limitations: symptom scores that were dependent upon patient recall and thus subject to bias, and lack of a control group to assess for placebo effect or other variables that could confound the outcomes. An observational study of 59 adults (with 107 ostial dilations) found, at 2-year follow-up, that there was significant improvement in symptom scores, although the authors noted the potential for a self-reporting bias to contribute to the improvement in symptom scores. A single-center study of 45 consecutive patients with chronic rhinosinusitis originally scheduled to undergo functional endoscopic sinus surgery who elected balloon sinuplasty of the frontal, maxillary, or sphenoid sinuses noted a failure rate of 65%, leading to the study's early cessation. A randomized double-blind study of 32 adult patients (50 sinuses) that compared sinuplasty with or without functional endoscopic sinus surgery to a Draf 1 procedure (complete removal of the anterior ethmoid cells and uncinate process surrounding the frontal recess to the frontal ostium) found, at 12-month follow-up, that both groups had significant improvement in symptom and radiologic extent of chronic rhinosinusitis scores. Additional larger, controlled studies were recommended. Cohort studies and randomized controlled trials have shown that balloon sinuplasty can result in long-term improvement in sinus symptoms and is not inferior to functional endoscopic sinus surgery. For children with chronic sinusitis unresponsive to medical management, evidence for balloon sinuplasty is insufficient, and demonstrates an incomplete assessment of net benefit vs harm; additional research is recommended. A prospective study of 30 children (56 sinuses) with chronic rhinosinusitis who failed medical therapy and underwent balloon sinuplasty reported that 51 of 56 sinuses were successfully dilated, as validated by nasal endoscopy and fluoroscopy. No short-term or long-term postoperative results were reported. The authors concluded that although the procedure is attractive in children because there is no bone or tissue removal, there are concerns about radiation exposure during fluoroscopy. A follow-up study of 32 children, of which 24 completed the 52-week follow-up, reported that 12 patients had significant improvement in Sino-Nasal-5 scores, 7 had moderate improvement, 2 had mild improvement, 1 had no improvement, and 2 had worsening. Additional studies comparing balloon sinuplasty with other treatment modalities were recommended. An observational study of 31 pediatric patients with chronic rhinosinusitis who failed medical therapy compared balloon sinuplasty and ethmoidectomy to functional endoscopic sinus surgery and reported that, at a mean follow-up of 9 months, there was no significant difference in overall improvement in sinus symptoms. Larger, long-
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