Nasal airway obstruction (NAO) can lead to nasal congestion, sleeping disorders, snoring, headache, daytime sleepiness, and additional symptoms that can negatively impact quality of life. NAO is primarily caused by nasal valve collapse, which can be treated with internal/external nasal dilators, surgical/functional rhinoplasty, and/or bioabsorbable graft techniques.
TCRF Device Treatment
Another treatment option available for nasal valve collapse is temperature-controlled radiofrequency (TCRF) device treatment, which is applied to the nasal mucosa at the intersection of the upper and lower lateral cartilage on the lateral nasal wall. TCRF device treatment causes tissue-tightening effects within the submucosal layer of the lateral nasal wall.
A recent study by Joseph K. Han, MD, and colleagues sought to confirm the efficacy of TCRF. As explained by Dr. Han, “Originally, this study was initiated to compare the safety and efficacy of the temperature-controlled radiofrequency device [ie, VivAer® Device] against a sham control. It was the first randomized controlled clinical trial [RCT] of its kind. The 3-month RCT demonstrated the superiority of the temperature-controlled radiofrequency device treatment over sham control for the treatment of nasal airway obstruction due to nasal valve collapse. We wanted to track the longer-term safety and efficacy results for all patients receiving temperature-controlled radiofrequency device treatment for 12 months.”
The study was a cohort follow-up of a prospective, patient single-blinded RCT with a sham procedure control arm. Patients who participated in the sham control arm were able to cross over after the 3-month follow-up if they were eligible for inclusion. Therefore, the study had three arms: index active treatment, index sham control, and crossover active treatment. The first two arms were determined via a web-based randomization module. Exclusion criteria included prior surgery of the lateral nasal wall and a severe case of septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip that was believed to contribute to nasal obstruction symptoms. The Nasal Obstruction Symptom Evaluation (NOSE) Scale and the Epworth Sleepiness Scale were used as the primary outcome instruments.
The 119 patient participants were randomized with 77 placed in active treatment and 40 placed in sham control; a total of 117 were included in the 3-month analysis. After the unblinding, 31 patients were eligible for crossover into active treatment; of these, two of the patients were found to be ineligible during trial monitoring but were included in data analysis.
Significant Response Rate
The combined active group’s mean baseline NOSE Scale score was 76.3 (95% CI, 73.6-79.1). The rate of response for the combined active group was 86.0% (95% CI, 78.2%-91.3%) at 3 months; 91.0% (95% CI, 83.8%-95.2%) at 6 months, and 89.8% (95% CI, 81.7%-94.5%) at 12 months.
Dr. Han points out that “The most important findings of this study include:
- TCRF treatment was associated with a durable reduction in NAO symptoms through 12 months; this benefit was seen in both static and dynamic nasal valve collapse.
- Improvement was seen in all symptoms of NAO including trouble breathing through the nose, congestion, blockage/obstruction, nasal breathing impacting sleep, and exercise.
- For patients with excessive daytime sleepiness as measured by the Epworth Sleepiness Scale, treatment with TCRF device treatment resulted in fewer complaints of daytime sleepiness.
- An excellent responder rate at 3 months (86%) remained high (90%) through 12 months.”
Dr. Han believes that future research should be “evaluating if the treatment will have sustained effect longer than 12 months.” He also shared that “It is nice to be able to provide options for patients regarding the treatment of nasal airway obstruction due to nasal valve collapse.”