Steven B Levine1, Theodore Truitt2, Michael Schwartz3, James Atkins4. 1. Department of Surgery, Section of Otolaryngology, Yale University School of Medicine, New Haven, Connecticut, USA. slevine@entallergymd.com 2. St Cloud Ear, Nose and Throat, St Cloud, Minnesota, USA. 3. Ear, Nose and Throat Associates of South Florida, West Palm Beach, Florida, USA. 4. Texas Sinus Center, San Antonio, Texas, USA.
Abstract
OBJECTIVES: This study evaluated in-office balloon dilation of maxillary sinus ostia and ethmoid infundibula to treat chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS). METHODS:Seventy-four patients with disease in the maxillary and anterior ethmoidsinuses on computed tomography were prospectively enrolled across 12 study centers. All procedures were performed in the office. The primary outcomes were clinical effectiveness and health-care utilization at 1 year, measured by the validated surveys Sino-Nasal Outcome Test (SNOT-20) and Rhinosinusitis Symptom Inventory (RSI). RESULTS:Dilation was successful in 69 patients (93.2%), and the average periprocedural pain level was 3.2 (scale of 0 to 10). The mean improvement on the SNOT-20 at 1 year was clinically and statistically significant (p < 0.0001), with no significant difference between the CRS and RARS patient outcomes. The treatment effect was the same in the CRS and RARS subgroups and was either "moderate" or "large" for 10 of 12 symptoms. The mean numbers of antibiotic courses (p < or = 0.001), sinus-related physician visits (p < 0.0001), and number of acute sinus infections (p < 0.001) decreased significantly in both subgroups. There were no serious device-related adverse events, and the rate of revision surgery was 5.8%. CONCLUSIONS: Stand-alone balloon dilation of the maxillary sinus ostia and ethmoid infundibula performed in the office is well tolerated and effectively treats both CRS and RARS.
RCT Entities:
OBJECTIVES: This study evaluated in-office balloon dilation of maxillary sinus ostia and ethmoid infundibula to treat chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS). METHODS: Seventy-four patients with disease in the maxillary and anterior ethmoid sinuses on computed tomography were prospectively enrolled across 12 study centers. All procedures were performed in the office. The primary outcomes were clinical effectiveness and health-care utilization at 1 year, measured by the validated surveys Sino-Nasal Outcome Test (SNOT-20) and Rhinosinusitis Symptom Inventory (RSI). RESULTS: Dilation was successful in 69 patients (93.2%), and the average periprocedural pain level was 3.2 (scale of 0 to 10). The mean improvement on the SNOT-20 at 1 year was clinically and statistically significant (p < 0.0001), with no significant difference between the CRS and RARS patient outcomes. The treatment effect was the same in the CRS and RARS subgroups and was either "moderate" or "large" for 10 of 12 symptoms. The mean numbers of antibiotic courses (p < or = 0.001), sinus-related physician visits (p < 0.0001), and number of acute sinus infections (p < 0.001) decreased significantly in both subgroups. There were no serious device-related adverse events, and the rate of revision surgery was 5.8%. CONCLUSIONS: Stand-alone balloon dilation of the maxillary sinus ostia and ethmoid infundibula performed in the office is well tolerated and effectively treats both CRS and RARS.
Authors: Elisabeth H Ference; Madeline Graber; David Conley; Rakesh K Chandra; Bruce K Tan; Charlesnika Evans; Melissa Pynnonen; Stephanie S Smith Journal: Laryngoscope Date: 2014-09-02 Impact factor: 3.325