University of Pennsylvania Medical Center, Philadelphia, PA 19104-4283, USA.
Respiration. 2010;79(3):222-33. doi: 10.1159/000259318. Epub 2009 Nov 17.
Chronic obstructive pulmonary disease (COPD) affects millions of people and has limited treatment options. Surgical treatments for severe COPD with emphysema are effective for highly selected patients. A minimally invasive method for treating emphysema could decrease morbidity and increase acceptance by patients.
To study the safety and effectiveness of the IBV(R) Valve for the treatment of severe emphysema.
A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs.
Valves were placed in desired airways with 99.7% technical success and no migration or erosion. There were no procedure-related deaths and 30-day morbidity and mortality were 5.5 and 1.1%, respectively. Pneumothorax was the most frequent serious device-related complication and primarily occurred when all segments of a lobe, especially the left UL, were occluded. Highly significant health-related quality of life (HRQL) improvement (-8.2 +/- 16.2, mean +/- SD change at 6 months) was observed. HRQL improvement was associated with a decreased volume (mean -294 +/- 427 ml, p = 0.007) in the treated lobes without visible atelectasis. FEV(1), exercise tests, and total lung volume were not changed but there was a proportional shift, a redirection of inspired volume to the untreated lobes. Combined with perfusion scan changes, this suggests that there is improved ventilation and perfusion matching in non-UL lung parenchyma.
Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.
慢性阻塞性肺疾病（COPD）影响了数以百万计的人，并且治疗选择有限。对于严重肺气肿的 COPD 手术治疗对高度选择的患者有效。一种治疗肺气肿的微创方法可以降低发病率并提高患者的接受度。
研究 IBV（R）阀治疗严重肺气肿的安全性和有效性。
一项多中心研究对 91 例严重阻塞、过度充气和上叶（UL）为主的肺气肿患者进行了治疗，共放置了 609 个支气管瓣到 UL 双侧。
以 99.7%的技术成功率将瓣膜放置在预期的气道中，无迁移或侵蚀。没有与程序相关的死亡，30 天发病率和死亡率分别为 5.5%和 1.1%。气胸是最常见的严重与器械相关的并发症，主要发生在一个肺叶的所有节段，特别是左 UL 被阻塞时。观察到与健康相关的生活质量（HRQL）显著改善（-8.2 +/- 16.2，6 个月时的平均 +/- SD 变化）。HRQL 的改善与治疗肺叶中体积的显著减少（平均 -294 +/- 427 ml，p = 0.007）相关，而没有可见的肺不张。FEV（1）、运动试验和总肺容量没有改变，但存在比例变化，即向未治疗的肺叶重新定向吸入量。结合灌注扫描变化，这表明未处理的肺实质中通气和灌注的匹配得到了改善。
支气管瓣治疗肺气肿具有多种作用机制和可接受的安全性，可显著提高大多数患者的生活质量。
