Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025
Temperature-Controlled Radiofrequency Treatment of the Nasal Valve in Patients With Nasal Obstruction: Long-Term Outcomes.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Han Joseph K, Rosenthal Jon N, McDuffie Chad M, Yen David M, Bikhazi Nadim B, Kakarlapudi Venkata Vasu, Silvers Stacey L
Аннотация
OBJECTIVE: To evaluate the efficacy, safety, and durability of temperature-controlled radiofrequency (TCRF) treatment of the nasal valve in patients with severe or extreme nasal airway obstruction (NAO).
STUDY DESIGN: A long-term, prospective, multicenter, single-blind, randomized controlled trial.
SETTING: Sixteen otolaryngologic clinics and academic centers.
METHODS: Patients received TCRF treatment on the lateral nasal valve. All patients were followed through 3 years. Outcome measures included the Nasal Obstruction Symptom Evaluation (NOSE) Scale, Epworth Sleepiness Scale (ESS), and adverse events (AEs). Treatment responders were defined as a ≥1 reduction in severity class or ≥20% reduction in NOSE score.
RESULTS: Out of 108 patients who received TCRF treatment, 54 reached the 3-year follow-up timepoint. The baseline mean NOSE score was 76.3 (95% confidence interval [CI], 73.6 to 79.1). The 3-year NOSE score treatment effect was -49.4 ([95% CI, -56.5 to -42.4]; P < .001) a 64.7% improvement from baseline; 88.7% of patients were responders. Most patients reported significant improvements in sleep post-treatment with a mean ESS score of 4.5 (95% CI, 3.4 to 5.7) at 3 years compared to 10.3 (95% CI, 9.2 to 11.4) at baseline.
CONCLUSION: Treatment with the TCRF device for nasal valve obstruction resulted in sustained improvements in nasal obstruction symptoms and sleep quality over a 3-year period without any serious AEs. These findings support the long-term benefits and sustained improvements in symptoms in patients with NAO.
STUDY DESIGN: A long-term, prospective, multicenter, single-blind, randomized controlled trial.
SETTING: Sixteen otolaryngologic clinics and academic centers.
METHODS: Patients received TCRF treatment on the lateral nasal valve. All patients were followed through 3 years. Outcome measures included the Nasal Obstruction Symptom Evaluation (NOSE) Scale, Epworth Sleepiness Scale (ESS), and adverse events (AEs). Treatment responders were defined as a ≥1 reduction in severity class or ≥20% reduction in NOSE score.
RESULTS: Out of 108 patients who received TCRF treatment, 54 reached the 3-year follow-up timepoint. The baseline mean NOSE score was 76.3 (95% confidence interval [CI], 73.6 to 79.1). The 3-year NOSE score treatment effect was -49.4 ([95% CI, -56.5 to -42.4]; P < .001) a 64.7% improvement from baseline; 88.7% of patients were responders. Most patients reported significant improvements in sleep post-treatment with a mean ESS score of 4.5 (95% CI, 3.4 to 5.7) at 3 years compared to 10.3 (95% CI, 9.2 to 11.4) at baseline.
CONCLUSION: Treatment with the TCRF device for nasal valve obstruction resulted in sustained improvements in nasal obstruction symptoms and sleep quality over a 3-year period without any serious AEs. These findings support the long-term benefits and sustained improvements in symptoms in patients with NAO.