Objective: To assess long-term safety and effectiveness of a multipoint, impedance-controlled, RF ablation device for treatment of chronic rhinitis through 12-month follow-up. Methods: A 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. Results: Thirty-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. Conclusions: mpedance-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.
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Second Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R ChinaSecond Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R China
Li, Rui-bin
Zhang, Ji-dong
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Second Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R ChinaSecond Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R China
Zhang, Ji-dong
Cui, Xiao-ran
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Second Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R ChinaSecond Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R China
Cui, Xiao-ran
Cui, Wei
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Second Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R ChinaSecond Hosp Hebei Med Univ, Dept Cardiol, 215 West Heping Rd, Shijiazhuang 050000, Hebei, Peoples R China
机构:
Hofstra Univ, Zucker Sch Med, ENT & Allergy Associates, 18 E48th St,2nd Floor, New York, NY 10017 USA
Hofstra Univ, Zucker Sch Med, Dept Otolaryngol, 18 E48th St,2nd Floor, New York, NY 10017 USAHofstra Univ, Zucker Sch Med, ENT & Allergy Associates, 18 E48th St,2nd Floor, New York, NY 10017 USA
Jacobowitz, Ofer
Ehmer, Dale
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ENT Associates Texas, Plano, TX USAHofstra Univ, Zucker Sch Med, ENT & Allergy Associates, 18 E48th St,2nd Floor, New York, NY 10017 USA
Ehmer, Dale
Lanier, Brent
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Cent Calif Ear Nose & Throat, Fresno, CA USAHofstra Univ, Zucker Sch Med, ENT & Allergy Associates, 18 E48th St,2nd Floor, New York, NY 10017 USA
Lanier, Brent
Scurry, William
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Piedmont Ear Nose & Throat Associates, Winston Salem, NC USAHofstra Univ, Zucker Sch Med, ENT & Allergy Associates, 18 E48th St,2nd Floor, New York, NY 10017 USA
Scurry, William
Davis, Bryan
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Colorado ENT & Allergy, Colorado Springs, CO USAHofstra Univ, Zucker Sch Med, ENT & Allergy Associates, 18 E48th St,2nd Floor, New York, NY 10017 USA
机构:
Department of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Wei Yang
Kun Yan
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Department of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Kun Yan
Gong-Xiong Wu
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Research Division,Joslin Diabetes Center,Harvard Medical School,Boston,MA 02215,United States
Department of Cardiovascular,The Second Hospital Affiliated to Guangzhou Medical University,Guangzhou Institute of Cardiovascular DiseaseDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Gong-Xiong Wu
Wei Wu
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Department of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Wei Wu
Ying Fu
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Department of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Ying Fu
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Jung-Chieh Lee
Zhong-Yi Zhang
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Department of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Zhong-Yi Zhang
Song Wang
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Department of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Song Wang
Min-Hua Chen
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Department of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteDepartment of Ultrasound,Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute