Abstract：
BACKGROUND: Targeting the parasympathetic nervous system innervating the airway with pharmacologic products has been proved to improve the clinical outcomes of severe asthma. Bronchial cryo-denervation (BCD) is a novel non-pharmacologic treatment for severe asthma using an endobronchial cryo-balloon administered via bronchoscopy to denervate parasympathetic pulmonary nerves. Preclinical studies have demonstrated that BCD significantly disrupted vagal innervation in the lung.
METHODS: A total of 15 patients with severe asthma were enrolled in this prospective, single-center pilot study. Patients underwent bifurcated BCD treatment at a 30-day interval after baseline assessment. Follow-up through 12 months included assessment of adverse events, technical feasibility, and changes in pulmonary function; asthma control questionnaire-7 (ACQ-7); and asthma control test (ACT).
RESULTS: BCD was performed on all 15 severe asthma patients, with technical feasibility of 96.7%. There were no device-related and 2 procedure-related serious adverse events through 12 months, which resolved without sequelae. The most frequent nonserious procedure-related adverse event was increased cough in 60% (9 of 15) patients. Pulmonary function remained unchanged, and significant improvements from baseline ACQ-7 (mean, -1.19, p = 0.0032) and ACT (mean, 3.18, p = 0.0011) scores were observed since the first month\'s follow-up after a single lung airway treatment, with similar trends till the end of the 12-month follow-up.
CONCLUSIONS: This study provides the first clinical evidence of the safety, feasibility, and initial efficacy of BCD in patients with severe asthma.
METHODS: A total of 15 patients with severe asthma were enrolled in this prospective, single-center pilot study. Patients underwent bifurcated BCD treatment at a 30-day interval after baseline assessment. Follow-up through 12 months included assessment of adverse events, technical feasibility, and changes in pulmonary function; asthma control questionnaire-7 (ACQ-7); and asthma control test (ACT).
RESULTS: BCD was performed on all 15 severe asthma patients, with technical feasibility of 96.7%. There were no device-related and 2 procedure-related serious adverse events through 12 months, which resolved without sequelae. The most frequent nonserious procedure-related adverse event was increased cough in 60% (9 of 15) patients. Pulmonary function remained unchanged, and significant improvements from baseline ACQ-7 (mean, -1.19, p = 0.0032) and ACT (mean, 3.18, p = 0.0011) scores were observed since the first month\'s follow-up after a single lung airway treatment, with similar trends till the end of the 12-month follow-up.
CONCLUSIONS: This study provides the first clinical evidence of the safety, feasibility, and initial efficacy of BCD in patients with severe asthma.
摘要：
背景：用药物靶向支配气道的副交感神经系统已被证明可以改善严重哮喘的临床预后。支气管冷冻去神经（BCD）是一种新型的用于严重哮喘的非药物治疗方法，该方法使用通过支气管镜给药的支气管内冷冻球囊去神经副交感神经肺神经。临床前研究表明，BCD显着破坏了肺中迷走神经的神经支配。
方法：本次前瞻性研究共纳入15例重度哮喘患者，单中心试点研究。患者在基线评估后30天间隔接受分叉BCD治疗。12个月的随访包括不良事件的评估，技术可行性,和肺功能的变化；哮喘控制问卷-7（ACQ-7）；和哮喘控制测试（ACT）。
结果：对所有15名重度哮喘患者进行了BCD，技术可行性为96.7%。在12个月内，没有发生与设备相关的严重不良事件和2起与手术相关的严重不良事件。没有后遗症。最常见的非严重手术相关不良事件是60％（15人中有9人）的咳嗽增加。肺功能保持不变,与基线ACQ-7相比有显著改善(平均值，-1.19，p=0.0032)和ACT(平均值，自单肺气道治疗后第一个月随访以来，观察到3.18，p=0.0011）评分，在12个月的随访结束之前，趋势相似。
结论：这项研究提供了第一个安全性的临床证据，可行性,和BCD在重症哮喘患者中的初始疗效。
方法：本次前瞻性研究共纳入15例重度哮喘患者，单中心试点研究。患者在基线评估后30天间隔接受分叉BCD治疗。12个月的随访包括不良事件的评估，技术可行性,和肺功能的变化；哮喘控制问卷-7（ACQ-7）；和哮喘控制测试（ACT）。
结果：对所有15名重度哮喘患者进行了BCD，技术可行性为96.7%。在12个月内，没有发生与设备相关的严重不良事件和2起与手术相关的严重不良事件。没有后遗症。最常见的非严重手术相关不良事件是60％（15人中有9人）的咳嗽增加。肺功能保持不变,与基线ACQ-7相比有显著改善(平均值，-1.19，p=0.0032)和ACT(平均值，自单肺气道治疗后第一个月随访以来，观察到3.18，p=0.0011）评分，在12个月的随访结束之前，趋势相似。
结论：这项研究提供了第一个安全性的临床证据，可行性,和BCD在重症哮喘患者中的初始疗效。
