Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial

Abstract

Background: Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature-controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single-arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control).

Methods: In a prospective, multicenter, single-blinded, randomized controlled trial (RCT), patients were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a ≥20% reduction in Nasal Obstruction Symptom Evaluation (NOSE)-scale score or ≥1 reduction in clinical severity category.

Results: At baseline, patients had a mean NOSE-scale score of 76.7 (95% confidence interval [CI], 73.8 to 79.5) and 78.8 (95% CI, 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%-93.7%] vs 42.5% [95% CI, 28.5%-57.8%]; p < 0.001). The active treatment arm had a significantly greater decrease in NOSE-scale score (mean, -42.3 [95% CI, -47.6 to -37.1] vs -16.8 [95% CI, -26.3 to -7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved.

Conclusion: This RCT shows temperature-controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short-term follow-up.

Keywords: NOSE scale; nasal congestion; nasal obstruction; nasal valve; nasal valve collapse; radiofrequency; randomized controlled trial.

Conflict of interest statement

S.L.S.: research consultant for Aerin Medical and Intersect ENT; D.M.Y.: research funding for Aerin Medical, and research funding, speaker, and consultant for Stryker; J.K.H.: research consultant for Aerin Medical, Medtronic, Intersect ENT, Genentech, Sanofi Genzyme, AstraZeneca, and GlaxoSmithKline.

© 2021 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.

Figures

FIGURE 1

Patients were treated bilaterally with the stylus at up to 4 non‐overlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage of the lateral nasal wall, as indicated

FIGURE 2

Enrollment, treatment arm allocations, and follow‐up through 3 months postprocedure

FIGURE 3

Primary endpoint at 3 months postprocedure: the proportion of patients with ≥20% improvement (decrease) in NOSE‐scale score or ≥1 NOSE scale severity category improvement from baseline. Active treatment with a temperature‐controlled RF energy device was superior to the sham‐control procedure (p < 0.001). Bars indicate 95% confidence intervals

FIGURE 4

The distribution in NOSE‐scale severity classifications at 3 months in the active treatment and sham‐control arms. NOSE‐scale score ranges included in the categories were: extreme (80‐100); severe (55‐75); moderate (30‐50); mild (5‐25); and no problems (0‐5). All patients were classified as extreme or severe at baseline (46.8% extreme and 53.2% severe in the active treatment arm and 52.5% extreme and 47.5% severe in the sham‐control arm; p = 0.556 based on a comparison of the distribution of the ordered classifications in each arm using a generalized linear model). At 3 months, the difference in distribution of the ordered classifications was significantly different (p < 0.001). NOSE = Nasal Obstruction Symptom Evaluation

FIGURE 5

Change in NOSE‐scale component scores from baseline through 3 months postprocedure in the active treatment arm and sham‐control arm. Bars indicate 95% confidence intervals. ***p < 0.001 comparing changes in the active treatment arm vs sham‐control arm. NOSE = Nasal Obstruction Symptom Evaluation