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。
Feasibility, effectiveness, and safety of a novel cryo-balloon targeted lung denervation technique in an animal model.
机构信息
Department of Pulmonary and Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 201620, China; Department of Pulmonary and Critical Care Medicine, Shanghai East Hospital, Tongji University, Shanghai, 200120, China.
Department of Pulmonary and Critical Care Medicine, Shanghai East Hospital, Tongji University, Shanghai, 200120, China.
出版信息
Cryobiology. 2020 Apr;93:27-32. doi: 10.1016/j.cryobiol.2020.03.003. Epub 2020 Mar 9.
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.
背景与目的
靶向肺去神经术（TLD）是一种治疗 COPD 的肺部介入程序，旨在破坏肺的副交感神经传入，以减少胆碱能活性亢进的临床后果。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的冷冻球囊 TLD 系统，并评估了其可行性、安全性和有效性。
方法
在 12 只绵羊中进行了一项临床前研究，其中 4 只在 TLD 前后测试气道阻力变化，2 只测试 Hering-Breuer 反射（HBR），其余 6 只绵羊评估 28 天，以评估该程序的安全性和有效性。
结果
在 28 天的观察期后，通过组织学和生理学评估可以验证对肺的迷走神经支配的明显破坏。与传统手术相比，该手术的操作时间更短，对邻近组织的损伤最小，且无与器械相关的不良事件。
结论
新型冷冻球囊 TLD 程序是可行、安全且有效的。与传统手术相比，这种治疗系统需要更短的手术时间，对邻近组织的去神经损伤更小。
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