Sinus & Respiratory Disease Center

To report outcomes for subjects undergoing balloon dilation in either the operating room (OR) or the clinic and define criteria to identify suitable candidates for local anesthesia procedures. Subjects with medically refractory chronic rhinosinusitis (CRS) underwent de novo surgery via transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum. Concomitant nasal or endoscopic sinus surgeries were contraindicated. Technical success, surgical parameters, and long-term outcomes were evaluated through 12-month follow-up. Seventy-one subjects underwent balloon dilation and 94% completed follow-up through 12 months. A total of 132 maxillary ostia were targeted for treatment and 129 were successfully dilated (98%). Almost one-half (33) of the procedures were performed in the OR under local anesthesia with intravenous sedation. Average balloon procedure times for unilateral and bilateral treatment were 28.3 ± 21.1 and 40.2 ± 17.7 minutes, respectively. Thirty-three ostial dilations in 19 subjects were attempted in the clinic. Each ostium was successfully accessed and ballooned under local anesthesia. Patient tolerance was very good with an average self-reported pain level of 2.7 (2 = hurts a little bit) out of 10. Each subject was discharged within 2 hours of the procedure and there was no postoperative bleeding. Symptomatic improvement of the clinic subgroup at 3, 6, and 12 months postprocedure was statistically significant (p ≤ 0.0012) and clinically meaningful and similar in magnitude to improvement seen across all subjects regardless of site of service. Transantral balloon dilation can be performed safely in the clinic and operative settings with symptom improvement sustained through 1 year.

Although multiple clinical trials have demonstrated that balloon dilation of sinus ostia in patients diagnosed with chronic rhinosinusitis (CRS) results in sustained symptomatic improvement, less data are available to measure the effects of sinusitis on worker productivity. The objective of our research was to analyze work and activity impairment before and after transantral, endoscopically-guided balloon dilation of the maxillary sinus ostia and ethmoid infundibulum. Subjects diagnosed with CRS and computed tomography (CT) evidence of disease in the maxillary sinuses alone, or maxillary and anterior ethmoid sinuses, completed the Work Productivity and Activity Impairment (WPAI) questionnaire and the Work Limitation Questionnaire (WLQ) before treatment and at 3, 6, and 12 months postprocedure. A total of 56 subjects were enrolled and 53 completed the 1-year follow-up. The lost productivity composite score computed from the WLQ improved by 73% (9.0 to 2.4; p < 0.0001) at 1-year follow-up whereas lost productivity at work as measured by the WPAI improved by approximately 76% (38.3 to 9.2; p < 0.0001) 12 months after treatment. These results indicate that sinus-related health problems impose a substantial burden on work productivity and physical/mental activity levels. Treatment of CRS by dilating the maxillary sinus ostium and ethmoid infundibulum can significantly improve quality of life (QOL) and work productivity.

A multicenter study (BREATHE I - Entellus Medical, Inc.) was performed to assess the safety and outcomes of a new, less invasive system that uses direct endoscopic visualization to facilitate balloon dilation of the maxillary sinus ostia and ethmoid infundibulum. General anesthesia was avoided in most subjects to assess feasibility of performing transantral ostial dilatation in an office setting. Subjects with chronic rhinosinusitis of the maxillary sinuses alone or maxillary and anterior ethmoid sinuses underwent baseline evaluation including CT imaging and symptom assessment using the Sino-Nasal Outcome Test (SNOT 20). Subjects underwent transantral balloon dilation and follow-up evaluation at 1 week, 3 months, and 6 months post-procedure. Thirty subjects were treated at three centers. Fifty-five of 58 maxillary ostia were successfully treated for a procedural completion rate of 94.8%. Ninety-seven percent of the procedures were completed under local anesthesia with or without minimal intravenous sedation. There were no device-related serious adverse events or unanticipated adverse device effects. The mean overall SNOT 20 score at baseline was 2.9 +/- 1.0. Mean overall SNOT 20 scores at 1-week, 3-month, and 6-month follow-up were 0.8 +/- 0.8, 0.7 +/- 0.8, and 0.8 +/- 0.9 respectively. Patency at 3-months as confirmed by CT imaging was 95.8%. These results indicate that transantral balloon dilation of the ostiomeatal complex under local anesthesia appears to be a safe technique for managing isolated maxillary or maxillary and anterior ethmoid sinusitis and can potentially be performed safely in an office setting.