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

Abstract

Importance: Nasal valve collapse is a primary cause of nasal airway obstruction (NAO). Patients with NAO and nasal valve collapse experience a variety of symptoms that lower their quality of life, such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring.

Objective: To determine if active treatment of the nasal valve with a temperature-controlled radiofrequency (TCRF) device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months.

Design, setting, and participants: In a prospective, multicenter, single-blinded, randomized clinical trial, patients in 16 centers in the US with index procedures between August and December 2020 were assigned to TCRF device treatment of the nasal valve or a sham control procedure (no RF energy). Patients had a baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score of 55 or greater with nasal valve collapse as the primary or substantial contributor to NAO. After primary end point evaluation at 3 months, eligible patients in the sham control arm crossed over to active treatment. Data analysis was performed between April and May 2022.

Interventions: Patients were treated bilaterally with the TCRF device at 4 or fewer nonoverlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall.

Main outcomes and measures: The primary end point measure was responder rate, defined as 20% or greater reduction in NOSE Scale score or 1 or greater reduction in NOSE Scale clinical severity category.

Results: A total of 108 patients received active treatment (77 as index active treatment, 31 after crossover). The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) were women. The combined group of patients receiving active treatment had a mean baseline NOSE Scale score of 76.3 (95% CI, 73.6-79.1). At 12 months (n = 88), the responder rate was 89.8% (95% CI, 81.7%-94.5%). The NOSE Scale score improved from baseline (mean change, -44.9 [95% CI, -52.1 to -37.7]). No device/procedure-related serious adverse events were reported.

Conclusions and relevance: In this follow-up of a cohort from a randomized clinical trial, the minimally invasive TCRF device, previously demonstrated to be superior to a sham procedure, was safe and associated with improvement in symptoms of NAO through 12 months postprocedure.

Trial registration: ClinicalTrials.gov Identifier: NCT04549545.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Han reported receiving personal fees from Aerin Medical (research consultant) during the conduct of the study; and personal fees (research consultant) from Medtronic, Intersect ENT, Genentech, Sanofi Genzyme, AstraZeneca, and GlaxoSmithKline outside the submitted work. Dr Silvers reported receiving personal fees (consultant) from Aerin Medical and Intersect ENT outside the submitted work. Dr Yen reported receiving research funding from Aerin Medical during the conduct of the study; and personal fees from OptiNose US, Stryker ENT, Regeneron, Sanofi Genzyme, Genentech, Oyster Point Pharma, Neurent Medical; stock options from Cyrano Therapeutics and Sound Health; and research funding from GlaxoSmithKline, OptiNose US, Gossamer Bio, Septal Solutions, Stryker ENT, Lyra Therapeutics, Neurent Medical, AstraZeneca, and Sound Health outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Patient Disposition

ENT indicates ear, nose, and throat.

Figure 2.. Outcome Results: Responder Rate

The percentage of patients designated responders, defined as 20% or greater improvement (decrease) in Nasal Obstruction Symptom Evaluation (NOSE) Scale score or 1 or greater NOSE Scale severity category improvement from baseline. Error bars indicate 95% CIs.

Figure 3.. Outcome Results: Nasal Obstruction Symptom Evaluation (NOSE) Scale

Adjusted mean NOSE Scale score. Error bars indicate 95% CIs.

Figure 4.. Outcome Results: Nasal Obstruction Symptom Evaluation (NOSE) Scale Severity Classification System

The percentage of patients classified in ordered NOSE Scale severity categories over time. There was a shift toward lower severity categories comparing each follow-up time point with baseline.