by James Lopilato, Staff Writer, MedPage Today September 1, 2022

Patients with collapsed nasal valves found relief after treatment with temperature-controlled radiofrequency (TCRF), according to a prospective, sham-controlled trial.

Among 108 patients with nasal airway obstruction who got TCRF-based sessions, 89.8% (95% CI 81.7-94.5) were deemed responders at 12 months, based on a 20% or greater reduction in Nasal Obstruction Symptom Evaluation (NOSE) Scale score or a 1 or greater reduction in NOSE Scale clinical severity category, reported researchers led by Joseph Han, MD, of the Eastern Virginia Medical School in Norfolk.

Mean baseline NOSE Scale score in the active-treatment group was 76.3 (95% CI 73.6-79.1), which was reduced by 44.9 (95% CI -52.1 to -37.7) at 12 months.

"The treatment effect was durable, and patients exhibited a reduction in the symptoms of [nasal airway obstruction] from 3 through 12 months postprocedure," the authors stated in JAMA Otolaryngology-Head & Neck Surgery. "The long-term safety profile of TCRF device treatment of the nasal valve is excellent; there were no serious adverse events with a relationship to the device and/or procedure."

Patients with nasal airway obstruction and nasal valve collapse experience a lower quality of life due to symptoms such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring, Han and colleagues explained. The minimally invasive TCRF treatment is performed in-office, and does not produce aerosol above background levels. It works by warming tissue, leading to a tightening effect in the submucosal layer of the lateral nasal wall.

Findings from the current analysis build upon the primary results of the trial, which showed a significantly higher responder rate at 3 months for the active-treatment arm versus the sham arm (88.3% vs 42.5%).

With the longer follow-up, Han's group also reported other benefits with TCRF treatment, such as a mean reduction of 4.8 (95% CI -6.0 to -3.7) by month 12 on the Epworth Sleepiness Scale. They noted that the effect was even more pronounced among those who were classified as having excessive daytime sleepiness, with individuals in this category seeing a mean improvement of 7.4 (95% CI -9.1 to -5.8) on the 0-to-24 scale.

And the use of at least one class of medication (antihistamines, decongestants) or mechanical nasal aid (nasal strips) decreased or stopped among two-thirds of patients who got TCRF treatment, they said.

As for how their results stack up against other data, the authors cited meta-analyses showing pooled reductions in NOSE Scale score of 49 (>6 months) and 43 (6-12 months) after functional rhinoplasty. A separate trial with a bioabsorbable implant-based treatment for dynamic nasal valve collapse reported an 85.2% responder rate and a reduction in NOSE Scale score from baseline of 41.

Their study was done at 16 U.S. centers from August 2020 to December 2020 with 119 patients randomized 2:1 to active treatment or sham. Mean patient age was 48.5 years, 61% were women, and 89% were white. Inclusion criteria were a NOSE Scale score ≥55, with nasal valve collapse as the primary contributor to nasal airway obstruction. The primary endpoint was evaluation at 3 months, at which time eligible control patients were able to crossover to active treatment (31 of the 41 sham patients crossed over).

Patients were treated bilaterally with the TCRF device (VivAer System) at four or fewer nonoverlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall.

In terms of adverse events, one patient experienced "a mild vasovagal reaction intraprocedure," the authors said. Two patients reported nasal bleeding, one of which was a severe case that occurred 26 days postprocedure, but "it resolved within 48 hours with nasal packing and was thought to be related to nasal scab removal."

Study limitations included the fact that medication use was not directed by the protocol and could have led to potentially confounding factors. Also, only patients with nasal airway obstruction caused by nasal valve collapse were included, which may limit generalizability. Finally, the patient population was not an ethnically/racially diverse one.

James Lopilato is a staff writer for Medpage Today. He covers a variety of topics being explored in current medical science research.

The study was funded by Aerin Medical.

Han disclosed relationships with Aerin, Medtronic, Intersect ENT, Genentech, Sanofi/Genzyme, AstraZeneca, and GSK. Co-authors disclosed multiple relationships with industry, including Aerin.

JAMA Otolaryngology -- Head & Neck Surgery

Source Reference: Han JK, et al "Outcomes 12 months after temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction" JAMA Otolaryngol Head Neck Surg 2022; DOI: 10.1001/jamaoto.2022.2293.

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