Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation

Abstract

Endoscopic sinus surgery (ESS) is an effective option for managing patients in whom medical therapy for rhinosinusitis fails. However, ESS is not always successful, and serious complications can occur. New techniques and instrumentation that improve outcomes and reduce complications would be seriously welcomed. Innovative catheter-based technology has improved treatment of several conditions such as coronary artery disease, peripheral vascular disease, and stroke. Recently, catheter devices have been developed for the paranasal sinuses. Cadaver studies confirm the potential use of these devices in rhinosinusitis. The objective of this investigation was to ascertain the feasibility and safety of these newly developed devices in performing catheter-based dilation of sinus ostia and recesses in patients with rhinosinusitis. A nonrandomized prospective cohort of 10 ESS candidates was offered treatment with a new technique of balloon catheter dilation of targeted sinus ostia. The frontal, maxillary, and sphenoid sinuses were considered appropriate for this innovative catheter-based technology. The primary study end points were intraoperative procedural success and absence of adverse events. A total of 18 sinus ostial regions were successfully catheterized and dilated, including 10 maxillary, 5 sphenoid, and 3 frontal recesses. No adverse events occurred. Mucosal trauma and bleeding appeared to be less with catheter dilation than is typically observed with ESS techniques. Dilation of sinus ostial regions via balloon catheter-based technology appears to be relatively safe and feasible. Larger multicenter clinical trials are now warranted to further establish safety and to determine the role of this new technique.