BACKGROUND AND OBJECTIVE Targeted lung denervation (TLD) is a pulmonary interventional procedure for COPD that aims to disrupt parasympathetic nerve input to the lung to reduce the clinical consequences of cholinergic hyperactivity. TLD has been proven to be a safe procedure and effectively alleviate symptoms and reduce the onset of exacerbation. In the present study, we developed a novel cryo-balloon TLD system and evaluated its feasibility, safety, and effectiveness. METHODS A preclinical study was performed on twelve sheep, four were tested for airway resistance alterations before and after TLD, two were tested for the Hering-Breuer reflex (HBR) and the remaining six sheep were evaluated for 28 days to assess the safety and effectiveness of the procedure. RESULTS After an observation period of 28 days, significant disruption of vagal innervation to the lung could be validated by both histological and physiological assessments. The operation time was shorter than traditional procedure, with minimal adjacent tissue injury and no device-related adverse events. CONCLUSIONS The novel cryo-balloon TLD procedure was feasible, safe, and effective. In comparison with the traditional procedure, this treatment system required shorter operation time and caused less denervation-induced damage to adjacent tissues.

中文翻译：

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一种新型冷冻球囊靶向肺去神经支配技术在动物模型中的可行性、有效性和安全性

背景和目的靶向肺去神经支配术 (TLD) 是一种针对 COPD 的肺部介入手术，旨在阻断副交感神经对肺部的输入，以减少胆碱能亢进的临床后果。TLD 已被证明是一种安全的程序，可有效缓解症状并减少恶化的发生。在本研究中，我们开发了一种新型冷冻气球 TLD 系统并评估了其可行性、安全性和有效性。方法 对 12 只羊进行了临床前研究，其中 4 只在 TLD 前后进行了气道阻力变化测试，2 只进行了 Hering-Breuer 反射 (HBR) 测试，其余 6 只羊进行了 28 天的评估以评估安全性和有效性的程序。结果 经过 28 天的观察期，肺迷走神经支配的显着破坏可以通过组织学和生理学评估来验证。手术时间比传统手术短，邻近组织损伤最小，无器械相关不良事件。结论 新型冷冻球囊 TLD 程序可行、安全且有效。与传统手术相比，该治疗系统所需的手术时间更短，对邻近组织的神经支配损伤更小。