Aiming to investigate long-term efficacy and safety (three years post treatment), this was an extension of a previous multicentre, prospective, single-blinded, randomised controlled trial that investigated the effectiveness and safety of temperature-controlled radiofrequency treatment (TCRF) to the nasal valve (NV) in treating severe to extreme nasal obstruction. The primary study had included 118 patients from 16 otolaryngologic clinics and academic centres in United States of America. Participants were randomised to active treatment or a sham arm. The active treatment procedure involved administration of local anaesthesia, TCRF treatment of the NV bilaterally to the nasal mucosa at the junction of the upper and lower lateral cartilage of the lateral nasal wall using the VivAer® ARC stylus (Aerin Medical), with up to four non-overlapping applications and no retreatment allowed. Key inclusion criteria: 18–85 years, seeking treatment for nasal obstruction; a baseline Nasal Obstruction Symptom Evaluation (NOSE) score ≥55, nasal valve collapse as the primary or significant contributor to the nasal obstruction, a positive response to a temporary nasal dilation measure such as the modified Cottle manoeuvre, and patient dissatisfaction with medical management. Key exclusion criteria: prior surgery of the lateral nasal wall; a severe case of septal deviation, turbinate hypertrophy, polyps or ptotic nose tip believed to be the primary contributor to the nasal obstruction symptoms and warranting surgical intervention. Of 73 patients in the combined active treatment group in the primary study, 55 agreed to participate in this three-year extended follow-up study. Results showed that there was a sustained benefit with a responder rate of 87% at three years, consistent with earlier findings. Treatment responders defined as a ≥20% reduction (improvement) in total NOSE score or ≥1 NOSE severity category improvement compared to baseline. NOSE score improved from baseline and was sustained through three years (64.6% improvement). There were significant improvements in all five subcomponents of the NOSE score through three years. The mechanism of NV collapse did not appear to affect NOSE scores. TCRF significantly improved mean Epworth Sleepiness Scale (ESS) scores at three years (4.5 vs. 10.3). For most participants (91.8%), medication usage remained the same or had been reduced or discontinued at three years. No additional adverse events were reported in the interval after six months through three years. No serious adverse events at any time point. They conclude that TCRF treatment for NV obstruction resulted in sustained improvements in nasal obstruction symptoms and sleep quality over a three-year period without any serious adverse effects.
Temperature-controlled radiofrequency treatment of the nasal valve confers sustained benefit
Reviewed by Richard (Wei Chern) Gan
Temperature-Controlled Radiofrequency Treatment of the Nasal Valve in Patients With Nasal Obstruction: Long-Term Outcome.
CONTRIBUTOR
Richard (Wei Chern) Gan
Hull University Teaching Hospitals NHS Trust, UK.
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