Reh Douglas D, Lay Kristopher, Davis Greg, Dubin Marc G, Yen David M, O'Malley Ellen M, Sillers Michael
Centers for Advanced ENT Care Baltimore Maryland USA.
Alabama Nasal and Sinus Center Birmingham Alabama USA.
Laryngoscope Investig Otolaryngol. 2024 Jun 4;9(3):e1286. doi: 10.1002/lio2.1286. eCollection 2024 Jun.
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.
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.
Thirty-six participants were enrolled and 35 completed the 12-month follow-up. All 5 VAS NSS items demonstrated statistically significant improvement ( < .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 < .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 < .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.
Impedance-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.
The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397.
通过12个月的随访,评估一种多点、阻抗控制的射频消融设备治疗慢性鼻炎的长期安全性和有效性。
一项前瞻性、多中心研究。对所有参与者进行双侧鼻后神经(PNN)消融。在6个月、9个月和12个月随访时的评估包括视觉模拟量表鼻症状评分(VAS NSS)、反射性总鼻症状评分(rTNSS)、小型鼻结膜炎生活质量问卷(mini RQLQ)以及不良事件。
36名参与者入组,35名完成了12个月的随访。所有5项VAS NSS指标在所有3个时间点均显示出相较于基线有统计学显著改善(<0.0001)。rTNSS总分从基线时的7.9±1.8改善至6个月时的4.3±2.1、9个月时的3.8±2.4以及12个月时的4.0±2.1(均<0.0001)。在12个月时,91%(31/35)的参与者实现了自基线降低≥1分的最小临床重要差异(MCID),80%(28/35)的参与者达到了自基线降低≥30%的应答标准。mini RQLQ总平均分从基线时的3.0±1.0降至6个月时的1.4±0.8、9个月时的1.4±1.0以及12个月时的1.3±0.8(均<0.0001)。在12个月时,86%(30/35)的参与者实现了mini RQLQ自基线降低≥0.4分的MCID。研究期间未发生相关严重不良事件。
PNN的阻抗控制射频消融是安全的,并且通过12个月的随访,在鼻炎症状和生活质量方面带来了持久、显著的改善。
该研究在www.clinicaltrials.gov注册,唯一标识符为NCT05324397。
4级。