Catheter-based dilation of the sinus ostia: initial safety and feasibility analysis in a cadaver model.

BACKGROUND: Over the past 20 years, many patients have benefited from endoscopic sinus surgery and its ability to relieve sinus obstruction. However, problems still occur with surgery, thereby leaving room for innovation. Recently, catheter-based technology has provided new options for treating cardiac, vascular, and urologic diseases. We speculated that catheter technology also might offer new treatment options for sinusitis patients. The purpose of this investigation was to explore the feasibility and safety of catheter-based technology to relieve sinus ostial obstruction.

METHODS: Anatomic models and human cadaver specimens were used initially to design and iterate catheters to open sinus ostial drainage pathways. Thereafter, the safety of balloon-catheter dilation was evaluated in six human cadaver heads. CT scan obtained before and after catheter ostial dilation was analyzed for evidence of catheter-induced trauma. Dilated ostia also were examined by endoscopy and gross anatomic dissection for unwanted catheter-induced trauma.

RESULTS: Catheters successfully dilated 31 of 31 ostia, including 9 maxillary, 11 sphenoid, and 11 frontal ostia/recesses. CT scan, endoscopy, and gross anatomic dissection revealed that such dilation did not cause trauma to surrounding structures such as the orbit or skull base. Mucosal trauma imparted by catheter dilation appeared to be less than that normally seen with standard endoscopic instruments.

CONCLUSION: This initial study suggests that catheter technology can be used to dilate sinus ostia safely. Mucosal preservation and ease of use make catheters an attractive minimally invasive treatment strategy. Additional testing in patients is indicated to gain additional safety information and to explore the usefulness of catheter-based technology.