Skowasch Dirk, Fertl Andreas, Schwick Björn, Schäfer Harald, Hellmann Andreas, Herth Felix J F
Department of Internal Medicine II - Pneumology, University of Bonn, Bonn, Germany.
Respiration. 2016;92(2):118-26. doi: 10.1159/000448119. Epub 2016 Aug 24.
Randomized controlled trials indicate that significant lung volume reduction (ELVR) can be obtained with Zephyr® valves by occluding the target lobe in the absence of collateral ventilation, leading to relevant functional benefits in advanced emphysema patients.
To observe the long-term effects of endobronchial valve (EBV) implantation in emphysema patients screened by Chartis assessment in the context of daily pulmonology practice.
The LIVE Study is a prospective, observational, open-label, single-arm, multicenter trial conducted in Germany. 498 patients included in this interim analysis were enrolled between July 2, 2012, and September 16, 2014. The 6-month follow-up visit data were recorded for 343 patients (safety population), and complete data sets were available for 321 treated patients (efficacy population) - 56.4% male, age: 64.5 years, forced expiratory volume in 1 s (FEV1) % predicted: 31.3%, residual volume (RV) % predicted: 252%.
Efficacy results at 6 months: FEV1 (l) increased by +100 ml (+11.9%), RV (l) decreased by -0.42 liter, and the COPD Assessment Test score decreased by -3.14 points (each p < 0.0001). Safety outcomes: A total of 66 adverse events (AEs; with 50 serious AEs - SAEs) were reported in 55 patients (16%) during the hospital stay for EBV placement - pneumothorax (35 cases), chronic obstructive pulmonary disease (COPD) exacerbation (5 cases), and pneumonia (4 cases). During the subsequent 6-month follow-up window, 170 SAEs were recorded in 125 patients (36.4%), predominantly COPD exacerbation (53% of the SAEs).
The current results of this large-scale German observational study performed in the context of daily practice further demonstrates that ELVR with Zephyr® valves is an effective and well-tolerated treatment option in advanced emphysema.
随机对照试验表明，在无侧支通气的情况下，使用Zephyr®瓣膜封堵目标肺叶可实现显著的肺容积减少（ELVR），从而为晚期肺气肿患者带来相关功能益处。
在日常肺病诊疗实践中，观察经Chartis评估筛选的肺气肿患者接受支气管内瓣膜（EBV）植入的长期效果。
LIVE研究是在德国进行的一项前瞻性、观察性、开放标签、单臂、多中心试验。纳入本次中期分析的498例患者于2012年7月2日至2014年9月16日入组。记录了343例患者（安全人群）的6个月随访数据，321例接受治疗的患者（疗效人群）有完整数据集，其中男性占56.4%，年龄64.5岁，1秒用力呼气容积（FEV1）占预计值的31.3%，残气量（RV）占预计值的252%。
6个月时的疗效结果：FEV1（升）增加了100毫升（+11.9%），RV（升）减少了0.42升，慢性阻塞性肺疾病评估测试评分降低了3.14分（均p<0.0001）。安全性结果：在EBV置入住院期间，55例患者（16%）共报告了66例不良事件（AE；其中50例为严重不良事件 - SAE），包括气胸（35例）、慢性阻塞性肺疾病（COPD）加重（5例）和肺炎（4例）。在随后的6个月随访期内，125例患者（36.4%）记录了170例SAE，主要是COPD加重（占SAE的53%）。
在日常实践背景下进行的这项大规模德国观察性研究的当前结果进一步证明，使用Zephyr®瓣膜进行ELVR是晚期肺气肿一种有效且耐受性良好的治疗选择。
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