Patients with a collapsed nasal valve experienced remission after treatment with temperature-controlled radiofrequency (TCRF), according to a prospective sham-controlled trial.
In 108 patients with nasal airway obstruction receiving TCRF-based therapy, a 20% or more reduction in score according to the Nasal Obstruction Symptom Evaluation (NOSE) scale or 1 by Norfolk East The researchers, led by Joseph Han, MD, of the Medical College of Virginia, reported reduced or greater clinical severity categories on the NOSE scale.
Mean baseline NOSE scale score was 76.3 (95% CI 73.6-79.1) in the active treatment group, which decreased by 44.9 (95% CI -52.1 to -37.7) at 12 months .
“The treatment effect was durable, with patients experiencing a reduction in [nasal airway obstruction] symptoms 3 to 12 months postoperatively,” the authors wrote in JAMA ENT – Head and Neck Surgery . “The long-term safety profile of the TCRF device for the treatment of nasal valves was excellent; there were no serious adverse events related to the device and/or procedure.”
Nasal patient Han and colleagues explained that due to nasal congestion, Symptoms such as headaches, sleep disturbances, daytime sleepiness and snoring, airway obstruction and nasal valve collapse can reduce quality of life. Minimally invasive TCRF treatment is performed in the office and does not generate aerosols above background levels. It works by heating the tissue, resulting in a tightening effect of the submucosa of the lateral nasal wall. The active treatment group had a higher response rate at 3 months compared with the sham group (88.3% vs 42.5%). Treatment, eg, on the Epworth Sleepiness Scale, reduced a mean reduction of 4.8 (95% CI -6.0 to -3.7) by month 12. They noted that this effect was more pronounced among those classified as having excessive daytime sleepiness, with a mean improvement of 7.4 (95% CI -9.1 to -5.8) on a scale of 0 to 24.
The use of at least one class of drugs (antihistamines, decongestants) or mechanical nasal aids (nasal strips) was reduced or stopped in two-thirds of patients treated with TCRF, they said.
As for how their results compare to other data, the authors cite a meta-analysis showing a composite reduction in NOSE scale scores of 49 (>6 months) and 43 (6-12 months) ) ) after functional rhinoplasty. A separate trial of bioabsorbable implant-based therapy for dynamic nasal valve collapse reported an 85.2% response rate and a reduction in NOSE scale score of 41 from baseline.
Their study was completed at the 16-year US center from August 2020 to December 2020, and a total of 119 patients were randomized 2:1 to active treatment or sham treatment. The mean age of the patients was 48.5 years, 61% were female, and 89% were white. Inclusion criteria were NOSE Scale score ≥55 and nasal valve collapse was the main cause of nasal airway obstruction. The primary endpoint was assessment at 3 months, when eligible control patients were able to cross over to active treatment (31 of 41 sham patients).
Patients received bilateral treatment with a TCRF device (VivAer system) in four or fewer non-overlapping areas on the nasal mucosa at the junction of the superior and inferior lateral cartilages of the lateral nasal wall.
In terms of adverse events, one author said the patient experienced a “mild vasovagal response” during the procedure. Two patients reported epistaxis, one of which was a severe case 26 days postoperatively, but “it resolved within 48 hours by nasal packing and was thought to be associated with removal of the nasal scab.”
Study limitations included the fact that drug use was not guided by the protocol and could lead to potential confounders. In addition, only patients with nasal airway obstruction caused by nasal valve collapse were included, which may limit generalizability. Finally, the patient population is not racially/ethically diverse.
James Lopilato is a staff writer for Medpage Today. He covers a variety of topics currently being explored in medical scientific research.
This study was funded by Aerin Medical.
Han discloses relationships with Aerin, Medtronic, Intersect ENT, Genentech, Sanofi/Genzyme, AstraZeneca and GSK. Co-authors disclosed multiple relationships with industry, including Aerin.