Sinus Balloon Catheterization Position Statement

Sinus balloon catheterization is a surgical technique by which dilation of a paranasal sinus ostium is accomplished through use of a balloon catheter.  The procedure involves insertion of a balloon dilation catheter over a guide-wire which has been positioned within the involved paranasal sinus under the direction of endoscopy and fluoroscopy.  Inflation of the balloon results in dilation of the targeted ostium. 

The current body of evidence regarding safety as it relates to balloon catheter dilation of the paranasal sinuses has been supportive.  Evidence regarding indications for use, efficacy, and long-term results remain pending.  While this technology may hold potential for future expanded uses, at the present time sinus balloon catheterization may be indicated for selected cases of rhinosinusitis without polyposis involving the frontal,  sphenoid or maxillary sinuses either in conjunction with or in place of conventional instrumentation. Further, inflammatory disease of the ethmoid sinuses, which constitutes the most commonly involved site of paranasal sinus disease, still requires the use of conventional surgical instrumentation when surgery is indicated.

The American Academy of Otolaryngology-Head and Neck Surgery recognizes the value of introducing new technologies to those currently available to Otolaryngologists and their patients, as well as the importance of supporting and encouraging research intended to establish outcomes, ensure safety, and determine indications of such technologies.  Based upon current available evidence, sinus balloon catheterization may hold a potential role as an adjunct to currently accepted treatments for diagnosis and treatment of selected diseases that involve the paranasal sinuses.

Bibliography

• Brown CL, Bolger WE, Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. [See comment]. [Journal Article. Randomized Controlled Trial] Annals of Otology, Rhinology & Laryngology. 115(4):293-9; discussion 300-1, 2006 Apr.
• Bolger WE, Vaughan WC, Catheter-based dilation of the sinus ostia: initial safety and feasibility analysis in a cadaver model. [Journal Article. Research Support, Non-U.S. Gov't] American Journal of Rhinology. 20(3):290-4, 2006 May-Jun.
• http://www.fda.gov/cdrh/pdf6/K061903.pdf

Adopted 3/5/07

Guidelines are not a substitute for the experience and judgment of a physician and are developed to enhance the physicians' ability to practice evidence-based medicine.

Important Notice

The American Academy of Otolaryngology-Head and Neck Surgery, Inc. and Foundation (AAO-HNS/F) Policy Statements are guidelines only. In no sense do they represent a standard of care. The applicability of an indicator for a procedure, and/or of the process or outcome criteria, must be determined by the responsible physician in light of all the circumstances presented by the individual patient. Adherence to these guidelines will not ensure successful treatment in every situation. The AAO-HNS emphasizes that these policies should not be deemed inclusive of all proper treatment decisions or methods of care, nor exclusive of other treatment decisions or methods of care reasonably directed to obtaining the same results.