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Balloon Sinuplasty

Surgical techniques and instrumentation are available and are currently utilized by experienced otolaryngologists for the management of sinus disease and rhinosinusitis refractory to medical therapy.

Balloon catheter dilation is a recently introduced Food & Drug Administration (FDA) approved instrumentation that has been shown to have a role in the surgical management of sinus disease. The purpose of this revised position statement is to set forth for our members and other interested persons, the current opinion of the American Rhinologic Society (ARS) regarding balloon dilation technology and its place among the armamentaria available to otolaryngologists and their patients in dealing with sinus disease based on up-to-date scientific evidence.

Two studies describe safety and effectiveness of balloon catheter sinus dilation technology^1,2 and have appeared in peer reviewed otolaryngology literature. A third study specifically targeted at safety and outcomes of balloon catheter sinus dilation3, presented at the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) (Toronto, Canada, September 2006) was closely reviewed and accepted for publication. This prospective level 2 study indicates that the balloon catheter sinus dilation instrumentation and techniques required for dilation of sinus ostia are safe and do provide patent ostial openings over a 6 month period in the maxillary, sphenoid, and frontal sinuses.³

At this time, the American Rhinologic Society would like to clarify the present knowledge regarding this technology for its members and interested persons.

Based on currently available scientific medical evidence, endoscopic balloon dilation technology is acceptable and safe for use in the management of sinus disease.
Endoscopic balloon dilation technology is a tool, not a procedure, available to the operating surgeon at his/her discretion for the surgical management of sinus disease.
Patients who are treated with this technology may require concurrent conventional endoscopic sinus surgery especially in the ethmoid sinuses much like any surgical instrument that may be used in some parts of the sinus and not others or in combination with other technologies.
In a group of selected patients, the use of balloon catheter dilation technology alone may eliminate the need for other surgical techniques.
Endoscopic balloon catheter dilation as a tool for dilating the opening of the maxillary sphenoid, and frontal sinuses is not investigational or experimental and should not be viewed as such.

As with all surgical interventions, continuing outcome and safety data is monitored to appropriately evaluate the long-term success of balloon catheter sinus dilation technology.

With the above statement in mind, the American Rhinologic Society also endorses the AAO-HNS position statements regarding endoscopic balloon catheter dilation.⁴

references
1. Brown CL, Bolger WE, Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Annals of Otology, Rhinology & Laryngology. 115(4):293-9; discussion 300-1, 2006, April.

2. Bolger WE, Vaughn WC, Catheter based dilation of the sinus ostia: initial safety and feasibility analysis in a cadaver model. American Journal of Rhinology, 20(3):290-4, 2006, May-June.

3. Bolger WE, et al.: Safety & Outcomes of Balloon Catheter Sinusotomy: A Multi-Center 24 week Analysis in 115 Patients. Otolaryngology-Head & Neck Surgery. Accepted for publication, 2007.

4. Otolaryngology Coding Alert, March 2007, 9 (3), 19.