Nasal valve therapy with a temperature-controlled radiofrequency device is safe: JAMA

USA: Treatment of the nasal valve with a temperature-controlled radiofrequency device was linked to a consistent reduction in nasal airway congestion symptoms over the course of a year, states a study published in JAMA Otolaryngology-Head and Neck Surgery.

Nasal airway obstruction is known to be mostly caused by nasal valve collapse (NAO). The symptoms of nasal valve collapse and NAO have been demonstrated to improve with temperature-controlled radiofrequency (TCRF) device therapy The method is less invasive, eliminates implanting a foreign body that could protrude, and might provide an option for some patients who either choose to forgo surgery or may not be ideal surgical candidates.

"The overall decline in the use of medications and/or mechanical aids is positive, despite the fact that this research was not intended to investigate changes in medication use, they added.

The researchers aimed to comprehend whether active therapy of the nasal valve with a temperature-controlled radiofrequency (TCRF) device—previously shown to be superior to a sham surgery at 3 months—was secure and connected to long-lasting reductions in NAO symptoms through 12 months.

From August 2020 to December 2020, 119 patients were randomly assigned in 2:1 ratio to either active treatment or a sham procedure at one of 16 U.S. research locations. The average patient age was 48.5 years old, 61% of them were women, and 89% were white. The NOSE Scale score was required to be less than 55, with nasal valve collapse being the main cause of nasal airway obstruction. Three months later, when the primary outcome was evaluated, eligible control patients could switch to active treatment (31 of the 41 sham patients crossed over). At the intersection of the upper and lower lateral cartilage on the lateral nasal wall, patients received bilateral treatment with the TCRF device (VivAer System) at four or fewer nonoverlapping locations on the nasal mucosa.

Key findings of the study:

• The mean baseline NOSE Scale score for the entire group of patients undergoing active treatment was 76.3 which at 12 months had decreased by 44.9.
• Based on a 20% or higher reduction in NOSE Scale score or a 1 or greater reduction in the NOSE Scale clinical severity category, 89.8% of the 108 patients with nasal airway obstruction who received TCRF-based sessions were designated responders at 12 months.
• At three months, the active-treatment arm had a responder rate that was much greater than the sham arm (88.3% vs. 42.5%). By month 12, there had been a mean drop of 4.8 on the Epworth Sleepiness Scale. An average improvement of 7.4 on the 0-to-24 scale was observed in those who were identified as having extreme daytime drowsiness.

"There were no significant adverse events connected to the device and/or technique, which demonstrates the excellent long-term safety profile of the TCRF device therapy of the nasal valve", the authors wrote.

The researchers concluded that the minimally invasive TCRF device, which had previously been shown to be preferable to a sham operation, was secure and linked to remission in NAO symptoms up to 12 months after the procedure.

REFERENCE

Han JK, Silvers SL, Rosenthal JN, McDuffie CM, Yen DM. Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction. JAMA Otolaryngol Head Neck Surg. Published online September 01, 2022. doi:10.1001/jamaoto.2022.2293