Patients who selected sinus surgery in which BSD instruments were used on the peripheral sinuses demonstrated significantly greater improvements in quality of life compared with those who elected ongoing MM. These results were achieved through office-based procedures with the patient under local anesthesia in the majority of patients.
Background Chronic rhinosinusitis (CRS) is a devastating disease affecting nearly 30 million people in the United States. An interim analysis of data from the present study suggested that, in patients who had previously failed medical therapy, balloon sinus dilation (BSD) plus medical management (MM) provides a significant improvement in the quality of life (QOL) at 24 weeks postprocedure compared to MM alone. Objective The primary objective of this final analysis was to evaluate the durability of treatment effects through the 52-week follow-up. Methods Adults aged 19 and older with CRS who had failed MM elected either BSD plus MM or continued MM. Patients were evaluated at 2 (BSD arm only), 12, 24, and 52 weeks posttreatment. Balloon dilations were performed either as an office-based procedure under local anesthesia or in the operating room per physicians' and patients' discretion. The primary end point was change in patient-reported QOL as measured by Chronic Sinusitis Survey (CSS) total score from baseline to the 24-week follow-up. Secondary outcomes including changes in CSS, Rhinosinusitis Disability Index (RSDI), and Sino-Nasal Outcome Test (SNOT) total and subscores, sinus medication usage, missed days of work/school, number of medical care visits, and sinus infections from baseline to the 52-week follow-up are reported here within. Results BSD led to sustained greater improvements in self-reported QOL using the CSS and RSDI total scores with a trend toward improvement in the SNOT-20 total score from baseline to the 52-week follow-up compared to continued MM. There were no changes in medication usage apart from nasal steroid usage for which the MM cohort had an increase in usage. There were no device-related serious adverse events. Conclusion The current analysis highlights the safety, effectiveness, and durability of BSD in CRS patients aged 19 and older who had previously failed MM.
known medical diagnoses. The most frequent complaint (50%) was shortness of breath, followed by change in voice, throat tightening, or choking sensation, coughing, throat clearing, excess saliva, globus, and swallowing complaints. The most common related medical diagnosis was GERD (42%), followed by asthma and allergies. Several patients had undergone prior surgeries, laryngeal trauma, illness, or severe emotional stress around time of onset. A laryngoscopic examination revealed hyperkinetic laryngeal behaviors in 38% of patients. Although 26% of patients had complained of dysphagia or globus, only 1 patient had documented pharyngeal dysphagia. Similarly, less than half of those patients who complained of globus actually had GERD. Finally, behavorial therapy was recommended for 80% of patients.Conclusions: ILS includes several behaviorally based disorders manifested as hyperfunctional laryngeal dysfunction. It is critical that ILS be recognized so that patients receive appropriate evaluation and treatment.
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