Mahajan Amit K, Khandhar Sandeep J
Section of Thoracic Surgery and Interventional Pulmonology, Department of Surgery, Inova Fairfax Hospital, Falls Church, USA.
J Thorac Dis. 2017 Mar;9(Suppl 2):S110-S115. doi: 10.21037/jtd.2016.12.63.
Unidirectional airway valves are devices used for the treatment of persistent air leaks (PALs) secondary to alveolar-pleural fistulas (APF) or bronchopleural fistulas (BPFs). These valves were originally developed as a non-surgical alternative to lung volume reduction surgery (LVRS) for patients with chronic obstructive pulmonary disease (COPD). Randomized trials investigating the use of valves for bronchoscopic LVRS did not lead to the Federal Drug Administration (FDA) approval, but stemming from these studies a Humanitarian Device Exemption (HDE) was granted to Spiration intrabronchial valves (IBVs) for the treatment of PALs. These valves are being increasingly utilized due to the effectiveness of IBVSs in reducing PALs, thus shortening duration of hospitalizations and minimizing the risk of hospital associated complications. The literature supporting the use of unidirectional airway valves for the bronchoscopic treatment of PALs is grounded primarily in case reports. While the current body of literature available to justify the use of unidirectional valves is limited to case series, current multicenter, randomized trials should provide further guidance regarding patient selection and effectiveness.
单向气道阀是用于治疗继发于肺泡 - 胸膜瘘（APF）或支气管胸膜瘘（BPF）的持续性漏气（PAL）的装置。这些阀门最初是作为慢性阻塞性肺疾病（COPD）患者肺减容手术（LVRS）的非手术替代方案而开发的。研究支气管镜下LVRS使用阀门的随机试验未获得美国食品药品监督管理局（FDA）的批准，但基于这些研究，一种人道主义器械豁免（HDE）被授予Spiration支气管内瓣膜（IBV）用于治疗PAL。由于IBV在减少PAL方面的有效性，这些阀门正越来越多地被使用，从而缩短住院时间并将医院相关并发症的风险降至最低。支持使用单向气道阀进行支气管镜治疗PAL的文献主要基于病例报告。虽然目前可用于证明使用单向阀合理性的文献仅限于病例系列，但当前的多中心随机试验应能为患者选择和有效性提供进一步指导。
