Twelve‐month outcomes following temperature‐controlled radiofrequency treatment of the septal swell body for nasal airway obstruction

Abstract

BackgroundImproved nasal airway obstruction (NAO) symptoms were reported at 3 months following temperature‐controlled radiofrequency (TCRF) treatment of the septal swell body (SSB). This report provides results from assessments of the long‐term safety and efficacy of TCRF treatment of SSB hypertrophy to treat NAO through 12 months posttreatment.MethodsThis prospective, multicenter, long‐term, open‐label study was conducted in nine centers within the United States and included patients with severe/extreme NAO attributed to SSB hypertrophy. Outcome measures included assessments of Nasal Obstruction Symptom Evaluation Score (NOSE), Numeric Rating Scale (NRS) ease‐of‐breathing, patient satisfaction, and adverse events at 6 and 12 months.ResultsOf the 70 patients treated, 65 and 62 patients completed the 6‐ and 12‐month follow‐up assessments. Compared to baseline, there was a 67.5% decrease in adjusted mean NOSE scores at 6 months (mean change −49.6, 95% confidence interval [CI] −54.8 to −44.4; p < 0.001) and a 65.4% decrease at 12 months (mean change −48.1, 95% CI −53.7 to −42.5); p < 0.001), which is consistent with previously published 3‐month results. A 62.0% and 62.5% improvement compared to baseline was observed in the NRS ease‐of‐breathing score at 6 and 12 months, respectively (p < 0.001). No serious adverse were reported overall and no new device‐ or procedure‐related adverse events were reported in the interval between 3 and 12 months posttreatment.ConclusionTCRF treatment of SSB hypertrophy has a significant and durable effect on improving the symptoms of NAO and health‐related quality of life in patients with symptoms of nasal obstruction and congestion through 12 months postprocedure.