An evaluation to confirm the safety and efficacy of balloon sinuplasty in the paranasal sinuses was performed. This study of 115 patients investigates paranasal balloon catheter devices that represent a recently developed suite of small, flexible tools that enable surgeons to endoscopically create an opening in a patients blocked or narrowed sinus ostia while maximizing tissue preservation and minimizing iatrogenic mucosal injury.
Initial evidence of the safety and effectiveness of balloon catheter sinusotomy has been encouraging. The 24-week results of the prospective multicenter CLEAR study revealed a favorable safety profile with zero adverse events, durability of patency in 98% of observed ostia, and significant improvement in patient symptoms. One year after surgery, the impressive ostial patency and symptom improvement results remained durable. Also, there was significant resolution of disease by CT examination.
In addition, safety and effectiveness have also been assessed in a large-scale, world registry of 1036 patients, in which there were no serious adverse events and 96% of patients reported symptom improvement with less frequency and severity of infections after an average follow- up of 40 weeks.
In a comparative study of endoscopic sinus surgeries with and without balloon catheters, patients receiving balloons experienced significantly greater improvement in sinus symptoms, quality of life, and patient satisfaction at an equivalent (primary cases) or lower cost (revision cases) relative to a comparable group of patients who had not received balloon catheter sinusotomy after a follow-up of 12 weeks.
Longer-term outcome data for balloon catheter sinusotomy will provide meaningful insight into the durability of the clinical results previously reported. The purpose of this study is to evaluate the long-term subjective and objective clinical outcomes for patients receiving balloon catheter sinusotomy by extending the follow-up period of the original CLEAR study to two years postsurgery.