Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial.

Autor: Takashima M; The Department of Otolaryngology-Head and Neck Surgery, Houston Methodist Hospital, Houston, Texas, USA., Stolovitzky JP; The Department of Otolaryngology, Emory University School of Medicine, Atlanta, Georgia, USA., Ow RA; Sacramento Ear Nose and Throat Medical and Surgical Group, Roseville, California, USA., Silvers SL; Madison ENT & Facial Plastic Surgery, New York, New York, USA., McDuffie CM; Ear, Nose, and Throat Associates of Texas, McKinney, Texas, USA., Dean M; Ear & Sinus Institute, Fort Worth, Texas, USA.; Department of Otolaryngology-Head and Neck Surgery, Texas Tech Health Science Center, Lubbock, Texas, USA.; Otorhinologic Research Institute, Dallas, Texas, USA., Sedaghat AR; Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Tajudeen BA; Department of Otorhinolaryngology-Head and Neck Surgery, Rush University Medical Center, Chicago, Illinois, USA.
Jazyk: angličtina
Zdroj: International forum of allergy & rhinology [Int Forum Allergy Rhinol] 2024 Jul; Vol. 14 (7), pp. 1182-1194. Date of Electronic Publication: 2024 Jan 24.
DOI: 10.1002/alr.23315
Abstrakt: Background: Minimally invasive temperature-controlled radiofrequency (TCRF) ablation of the posterior nasal nerve (PNN) demonstrated a significant larger treatment effect on the symptom burden of chronic rhinitis patients than a sham control (no energy delivery) at the 3-month primary endpoint of this trial.
Methods: Two-year posttreatment outcomes for patients treated in a prospective, multicenter, patient-blinded randomized controlled trial were determined by combining the index active treatment-arm and index control-arm crossover patients into a single group (after the primary endpoint) to evaluate the treatment effect durability and long-term effects on concomitant chronic rhinitis medication usage.
Results: The mean baseline reflective total nasal symptom score (rTNSS) was 8.2 (95% confidence interval [CI], 7.9-8.6; N = 104). At 2 years (N = 79), the mean change in rTNSS was -5.3 (95% CI, -5.8 to -4.8; p < 0.001; 64.6% improvement). The 2-year responder rate (≥30% improvement in rTNSS) was 87.3% (95% CI, 78.0-93.8). All four components of the rTNSS (rhinorrhea, congestion, sneezing, and nasal itching) showed significant improvement over baseline, with rhinorrhea and congestion showing the most improvement. Postnasal drip and cough symptoms were also significantly improved. At 2 years, 81.0% (95% CI, 70.6-89.0) reported a minimal clinically important difference of ≥0.4-point improvement in the mini-rhinoconjunctivitis quality of life questionnaire score. Of 56 patients using chronic rhinitis medications at baseline, 25 of 56 (44.6%) either stopped all medication use (7/56 [12.5%]) or stopped/decreased (18/56 [32.1%]) use of ≥1 medication class at 2 years. No serious adverse events related to the device/procedure were reported over 2 years. To determine the potential effect of patients who left the trial over 2 years on the responder rate, the responder statuses of the 14 patients with follow-up data who were lost to follow-up/withdrew/died were imputed by the last observation carried forward and the responder statuses of all nine patients who had an additional nasal procedure were imputed to nonresponder, resulting in a 2-year responder rate of 79.4% (95% CI, 70.3-86.8).
Conclusion: TCRF ablation of the PNN is safe and resulted in a significant and sustained reduction in chronic rhinitis symptom burden through 2 years and a substantial reduction in concomitant medication burden.
(© 2024 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.)
Databáze: MEDLINE
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