Long‐term outcomes following impedance‐controlled radiofrequency ablation for the treatment of chronic rhinitis

Abstract

ObjectiveTo assess long‐term safety and effectiveness of a multipoint, impedance‐controlled, RF ablation device for treatment of chronic rhinitis through 12‐month follow‐up.MethodsA prospective, multicenter study. Bilateral posterior nasal nerve (PNN) ablation was performed on all participants. Assessments at 6‐, 9‐, and 12‐month visits included Visual Analog Scale Nasal Symptom Score (VAS NSS), reflective Total Nasal Symptom Score (rTNSS), mini‐Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ), and adverse events.ResultsThirty‐six participants were enrolled and 35 completed the 12‐month follow‐up. All 5 VAS NSS items demonstrated statistically significant improvement (p < .0001) over baseline at all 3 time points. The total rTNSS improved from 7.9 ± 1.8 at baseline to 4.3 ± 2.1 at 6‐months, 3.8 ± 2.4 at 9‐months, and 4.0 ± 2.1 at 12‐months (all p < .0001). At 12‐months, 91% (31/35) of participants had achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point and 80% (28/35) of the participants met the responder criteria of ≥30% reduction from baseline. The total mean mini RQLQ was reduced from 3.0 ± 1.0 at baseline to 1.4 ± 0.8 at 6‐months, 1.4 ± 1.0 at 9‐months, and 1.3 ± 0.8 at 12‐months (all p < .0001). At 12‐months, 86% (30/35) of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ. No related serious adverse events occurred during the study.ConclusionsImpedance‐controlled RF ablation of the PNN is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12‐month follow‐up.Trial RegistrationThe study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397.Level of Evidence4.