Yao William C, Ow Randall, Sillers Michael J, Nachlas Nathan E, Johnson Curtis D, Ehmer Dale, Pritikin Jordan, Barham Henry P
Department of Otorhinolaryngology-Head and Neck Surgery McGovern Medical School at the University of Texas Health Science Center Houston Texas USA.
Sacramento Ear, Nose and Throat Medical and Surgical Group Roseville California USA.
OTO Open. 2025 Apr 7;9(2):e70111. doi: 10.1002/oto2.70111. eCollection 2025 Apr-Jun.
To evaluate the long-term safety and effectiveness of temperature-controlled radiofrequency (TCRF) treatment of nasal valve collapse (NVC) in patients with nasal airway obstruction (NAO).
This is an extended follow-up from a prospective, multicenter, single-arm study. The initial study included participants from 12 sites across the United States who were followed for 24 months and additionally agreed to participate in the extended 36-month follow-up.
Procedure was performed in-office with an in-person follow-up at 3 months and subsequent follow-up assessment remotely.
Participants received TCRF treatment of only the nasal valve and participated in the extended 36-month follow-up. The effect of TCRF treatment was determined by analyzing changes in nasal obstruction symptom evaluation (NOSE) score at each follow-up compared to the baseline.
Of the 122 participants in the primary study, 66 participated in the extended 36-month follow-up. Compared to baseline, there was a 52.6% decrease in the NOSE score at 36 months (mean change -45.3 [95% CI -52.3 to -38.3]; < .001), and 83.3% of the participants met the criteria for treatment response at 36 months, as defined by the study endpoint. Post hoc sensitivity analysis of the treatment response for all participants from the time of enrollment was 73.9%. No device or procedure-related adverse events or serious adverse events were reported in the interval between 24 and 36 months.
TCRF treatment of only the nasal valve resulted in significant and durable improvement in NAO symptoms through 36 months in participants with NAO due to NVC.
评估温控射频（TCRF）治疗鼻气道阻塞（NAO）患者鼻瓣膜塌陷（NVC）的长期安全性和有效性。
这是一项前瞻性、多中心、单臂研究的延长随访。初始研究纳入了来自美国12个地点的参与者，对其进行了24个月的随访，这些参与者另外还同意参与延长至36个月的随访。
手术在门诊进行，3个月时进行面对面随访，后续随访评估通过远程方式进行。
参与者仅接受鼻瓣膜的TCRF治疗，并参与延长至36个月的随访。通过分析每次随访时与基线相比鼻阻塞症状评估（NOSE）评分的变化来确定TCRF治疗的效果。
在初步研究的122名参与者中，66名参与了延长至36个月的随访。与基线相比，36个月时NOSE评分下降了52.6%（平均变化-45.3 [95% CI -52.3至-38.3]；P <.001），并且83.3%的参与者在36个月时达到了研究终点所定义的治疗反应标准。对所有参与者从入组时起的治疗反应进行的事后敏感性分析为73.9%。在24至36个月期间未报告与设备或手术相关的不良事件或严重不良事件。
对于因NVC导致NAO的参与者，仅对鼻瓣膜进行TCRF治疗在36个月内使NAO症状得到了显著且持久的改善。
