“Nasal valve collapse is recognized as a primary cause of nasal airway obstruction (NAO),” Joseph K. Han, MD, and colleagues wrote in JAMA Otolaryngology-Head and Neck Surgery. “Treatment options for nasal valve collapse include external/internal nasal dilators, surgical functional rhinoplasty and/or nasal valve repair, and bioabsorbable graft techniques. Temperature-controlled radiofrequency (TCRF) device treatment on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall has previously been shown to improve the symptoms of nasal valve collapse and NAO through 2-year follow-up.”
Study Protocol & Overall Results
For the study, Dr. Han and colleagues sought to confirm the efficacy of TCRF. “Originally, this study was initiated to compare the safety and efficacy of the temperature-controlled radiofrequency device against a sham control,” Dr. Han explains. “It was the first randomized controlled clinical trial [RCT] of its kind. The 3-month RCT demonstrated the superiority of the TCRF 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 TCRF device treatment for 12 months.”
The cohort follow-up utilized results from a prospective RCT with a sham procedure control arm that was blinded to patients. 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. Primary outcome instruments included the Nasal Obstruction Symptom Evaluation (NOSE) Scale and the Epworth Sleepiness Scale.
The 119 participants were randomly assigned, resulting in 77 receiving active treatment and 40 in the sham control arm; 117 were included in the 3-month analysis. After the unblinding, 31 patients were eligible for crossover to active treatment; of these, two patients were found to be ineligible during trial monitoring but were included in data analysis.
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% to 91.3%) at 3 months, 91.0% (95% CI,
83.8% to 95.2%) at 6 months, and 89.8% (95% CI, 81.7% to 94.5%) at 12 months (Figure).
‘Excellent Responder Rate’ at 3 Months
“TCRF treatment was associated with a durable reduction in NAO symptoms through 12 months,” Dr. Han says. “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 resulted in fewer complaints of daytime sleepiness.”
In addition, “an excellent responder rate at 3 months (86%) remained high (90%) through 12 months,” he noted. “It is nice to be able to provide options for patients regarding the treatment of NAO due to nasal valve collapse.”
Future research should evaluate whether the treatment “will have a sustained effect for longer than 12 months,” according to Dr. Han.