An update on endobronchial valve therapy for severe emphysema: real world data and special indications.

Tadashi Sakaguchi, Jorine E Hartman, Dirk-Jan Slebos
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Abstract

Introduction: Bronchoscopic lung volume reduction (BLVR) using one-way endobronchial valves (EBV) is a guideline therapy for patients with severe emphysema without interlobar collateral ventilation, based on solid results from multiple randomized clinical trials (RCTs). However, whether its efficacy and safety in real-world clinical settings are comparable to those observed in RCTs has not been fully investigated. Additionally, recent reports on EBV therapy have focused on specialized populations (e.g. very low FEV1, very low DLCO) that were not represented in the RCTs.

Areas covered: We have summarized the efficacy and safety of the publications on BLVR with EBVs in real-world settings and in specialized populations, and have discussed these findings in relation to the RCTs data.

Expert opinion: The benefits of BLVR with EBVs have effectively translated into real-world clinical practice with a tolerable safety profile. These benefits and acceptable safety profile were also observed in specialized populations not fully represented in RCTs. We believe it is crucial to establish a nationwide registry in each country to keep track of outcome for quality and consistency, and to have a multidisciplinary COPD team discussion in each treating institution to keep on ensuring the successful clinical practice of BLVR with EBVs.

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严重肺气肿的支气管内瓣膜治疗最新进展:真实世界的数据和特殊适应症。
简介:根据多项随机临床试验(RCT)的可靠结果,使用单向支气管内瓣膜(EBV)的支气管镜肺容积缩小术(BLVR)是针对无叶间侧支通气的严重肺气肿患者的指导疗法。然而,其在实际临床环境中的疗效和安全性是否与随机临床试验中观察到的疗效和安全性相当,尚未得到充分研究。此外,最近关于 EBV 治疗的报道主要集中在一些特殊人群(如 FEV1 很低、DLCO 很低),而这些人群在 RCT 中并不常见:我们总结了在现实世界和特殊人群中使用 EBVs 进行 BLVR 的有效性和安全性,并结合 RCT 数据讨论了这些发现:专家意见:使用 EBVs 进行 BLVR 的益处已有效转化为现实世界中的临床实践,其安全性是可以接受的。这些益处和可接受的安全性在研究性临床试验中未充分体现的特殊人群中也得到了观察。我们认为,至关重要的是在每个国家建立一个全国范围的登记处,以跟踪结果的质量和一致性,并在每个治疗机构开展多学科 COPD 团队讨论,以继续确保使用 EBVs 进行 BLVR 的临床实践取得成功。
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