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.

Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction

“…For context, primary end point analysis at 3 months previously showed a greater responder rate of 88.3% (95% CI, 79.2%-93.7%) in the index active treatment arm vs 42.5% (95% CI, 28.5%-57.8%) in the index sham control arm. 14 The NOSE Scale score of the combined active treatment group improved from baseline at all follow-up time points: an adjusted mean change of −40.9 (95% CI, −47.3 to −34.6), −43.2 (95% CI, −50.1 to −36.3), and −44.9 (95% CI, −52.1 to −37.7) at 3, 6, and 12 months, respectively (Figure 3; eTable 2 in Supplement 2). These data represent 53.6%, 56.6%, and 58.8% improvement in NOSE Scale score from baseline at 3, 6, and 12 months, respectively.…”

“…Secondary end point analysis at 3 months previously showed a greater mean change in NOSE Scale score from baseline of −42.3 (95% CI, −47.6 to −37.1) in the index active treatment arm vs −16.8 (95% CI, −26.3 to −7.2) in the sham control arm. 14 In the combined active treatment group, 106 (98.1%) patients were classified as having extreme or severe obstruction at baseline based on the NOSE Scale severity classification system. 16 At 3 months after active treatment and thereafter, there was a shift toward lower severity categories comparing each follow-up time point with baseline (Figure 4; eTable 3 in Supplement 2).…”

“…A 3-month report on this randomized clinical trial (RCT) demonstrated the superiority of a minimally invasive TCRF device over a sham control procedure for the treatment of nasal valve collapse and NAO. 14 Here, 12-month outcomes of all patients who underwent active TCRF device treatment of the nasal valve are reported-a combination of patients in the index active treatment arm and patients in the index sham control arm who were eligible and elected to crossover to active treatment after primary end point analysis.…”

Minimally Invasive Nasal Valve Treatment

“…26 A multi-center, industry-funded, randomized, controlled trial supports the conclusions from the initial cohort study. 27 Adverse events reported in these studies were generally mild and included congestion, swelling, discomfort, and crusting. 24,27,28 Intranasal crusting and generalized soreness of the nose lasting several weeks is expected after the procedure and the patient should be counseled regarding this.…”

“…27 Adverse events reported in these studies were generally mild and included congestion, swelling, discomfort, and crusting. 24,27,28 Intranasal crusting and generalized soreness of the nose lasting several weeks is expected after the procedure and the patient should be counseled regarding this. Although not described in the previous articles, the radiofrequency device has been used to reduce nasal septal swell bodies to further improve nasal obstruction.…”