Clinical Consensus Statement: Balloon Dilation of the Sinuses

Abstract

Objective To develop a clinical consensus statement on the use of sinus ostial dilation (SOD) of the paranasal sinuses. Methods An expert panel of otolaryngologists was assembled to represent general otolaryngology and relevant subspecialty societies. The target population is adults 18 years or older with chronic or recurrent rhinosinusitis (with or without nasal polyps, with or without prior sinus surgery) for whom SOD is being recommended, defined as endoscopic use of a balloon device to enlarge or open the outflow tracts of the maxillary, frontal, or sphenoid sinuses, as a standalone procedure or with endoscopic surgery. A modified Delphi method was used to distill expert opinion into clinical statements that met a standardized definition of consensus. Results After 3 iterative Delphi method surveys, 13 statements met the standardized definition of consensus while 45 statements did not. The clinical statements were grouped into 3 categories for presentation and discussion: (1) patient criteria, (2) perioperative considerations, and (3) outcomes. Strong consensus was obtained for not performing SOD in patients without sinonasal symptoms or positive findings on computed tomography (CT) in patients with symptoms only of headache or sleep apnea without criteria for sinusitis. In addition, strong consensus was met that CT scan of the sinuses was necessary before performing SOD and that surgeons need to understand and abide by regulations set forth by the US Food and Drug Administration if they choose to reuse/reprocess devices. Conclusion Expert panel consensus may provide helpful information for the otolaryngologist considering the use of SOD for the management of patients with a diagnosis of rhinosinusitis. This panel reached consensus on a number of statements that defined the use of SOD as inappropriate in the management of a variety of symptoms or diseases in the absence of underlying sinusitis. When patients meet the definition of chronic sinusitis as confirmed by CT scan, SOD of the sinuses can be indicated and/or effective in certain scenarios. Additional consensus statements regarding proper setting and safeguards for performing the procedure are described.

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

“…The 2018 AAO-HNS Clinical Consensus Statement on BCD was a necessary intervention to reduce possible over-or undertreatment of CRS in certain US regions and ensure appropriate patient selection for the procedure. 29 Information on how many patients underwent BCD in each region is not available, but our analysis still suggests regional differences in BCD usage. These data regarding provider characteristics should be interpreted with caution, as we did not perform multivariable analysis to reduce the chance of bias and/or confounders.…”

The use of balloon dilation in revision sinus surgery

“…The use of BSD in the revision setting was addressed in the recent clinical consensus statement regarding sinus ostial dilation. Experts reached near‐consensus for the statement that there is a role for balloon dilation in patients who have had previous sinus surgery 23 . Nonetheless, the relatively prevalent use of BSD in revision surgery needs to be further investigated, because there is very little evidence in the literature that BSD is effective in this setting.…”

Preoperative Management of Chronic Rhinosinusitis Prior to Office Balloon Sinus Dilation: A 2011–2014 MarketScan® Analysis

“…This possibility was addressed by the recent clinical consensus statement published by the American Academy of Otolaryngology, in which an expert panel reached “near consensus” on the statement that BSD can be considered for patients with limited disease prior to FESS. 15 Finally, higher physician reimbursement may play a factor in this difference. Regardless of the reasons, differences in practice patterns raise the concern for overuse and suggest the need for more evidence regarding indications and optimal medical therapy.…”