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Late-Breaking Scientific Oral Presentations

Rhinology/Allergy

Session: Late-Breaking Scientific Orals: Rhinology and Allergy

Temperature-Controlled Radiofrequency Treatment of Patients With Nasal Airway Obstruction: Long-Term Outcomes of a Randomized Controlled Trial

Sunday, September 29, 2024

1:54 PM – 2:00 PM EDT

Location: MBCC, 222

Disclosure(s):

Stacey L. Silvers, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

David M. Yen, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Introduction: Nasal airway obstruction (NAO) is a highly prevalent condition that affects patients’ quality of life with nasal valve dysfunction often being cited as a common contributing factor. Temperature-controlled radiofrequency (TCRF) device treatment is a minimally invasive in -office procedure that has been shown to be effective in improving the symptoms of patients with NAO.

Methods: This was a long-term, prospective, multicenter, single blind, randomized controlled trial evaluating the efficacy, safety, and durability of TCRF treatment of the nasal valve in patients with severe or extreme NAO. Patients from 16 centers in the US between August and December 2020 were randomized 2:1 to receive TCRF or a sham procedure. Patients receiving sham were offered participation in a crossover treatment arm. All patients were followed through 3 years. Outcome measures included Nasal Obstruction Symptom Evaluation (NOSE) Scale, Epworth Sleepiness Scale (ESS), and adverse event. Treatment responders were defined as a ≥1 reduction in severity class or ≥20% reduction in NOSE score.

Results: Out of 108 patients who received TCRF treatment, 54 reached the 3-year follow-up timepoint. The baseline mean NOSE score was 76.3 (95%CI, 73.6 to 79.1). The 3-year NOSE score treatment effect was -49.4 [(95%CI, -56.5 to -42.4); p < 0.0001)] a 64% improvement from baseline; 88.7% (95%CI, 80.1% to 97.2%) of patients were responders. Most patients reported significant improvements in sleep posttreatment with a mean ESS score of 4.5 (95%CI, 3.4 to 5.6) at 3 years compared to 10.3 (95%CI, 9.2 to 11.4; p < 0.0001) at baseline. No serious adverse events were reported during the study.

Conclusions: Treatment with the TCRF device for nasal valve obstruction resulted in sustained improvements in nasal obstruction symptoms and sleep quality over a three-year period, without any serious adverse events. These findings support the long-term safety and efficacy of TCRF treatment for patients with nasal airway obstruction.

Presenting Author(s)

Stacey L. Silvers, MD

ENT specialist, Adjunct Professor
Madison ENT & Facial Plastic Surgery
New York, NY, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Co-Author(s)

JH

Joseph K. Han, MD

Chief of the Division of Rhinology
EVMS Otolaryngology
Virginia Beach, VA, United States

Disclosure information not submitted.
JR

Jon Rosenthal, MD

ENT and Allergy Associates of Florida, United States

Disclosure information not submitted.
CM

Chad McDuffie, MD

ENT Associates of Texas, United States

Disclosure information not submitted.
DY

David M. Yen, MD

Chief, Division of Otolaryngology — Head and Neck Surgery
St. Luke's University Health Network
Bethlehem, PA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.
NB

Nadim Bikhazi, MD

Ogden Clinic Ear Nose and Throat, United States

Disclosure information not submitted.

Senior Author(s)

Stacey L. Silvers, MD

ENT specialist, Adjunct Professor
Madison ENT & Facial Plastic Surgery
New York, NY, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.