Supplementary Material for: A Multicenter Pilot Study of a Bronchial Valve for the Treatment of Severe Emphysema

<i>Background:</i> 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. <i>Objective:</i> To study the safety and effectiveness of the IBV® Valve for the treatment of severe emphysema. <i>Methods:</i> A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs. <i>Results:</i> 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. FEV₁, 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. <i>Conclusion:</i> Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.

<i>背景：</i>慢性阻塞性肺疾病（Chronic obstructive pulmonary disease, COPD）影响全球数百万人群，且可供选择的治疗手段十分有限。针对合并肺气肿的重度COPD患者，外科手术治疗仅对经过严格筛选的人群有效。若能开发微创的肺气肿治疗方案，或可降低并发症发生率，提升患者的治疗接受度。<i>目标：</i>评估IBV®瓣膜（IBV® Valve）治疗重度肺气肿的安全性与有效性。<i>方法：</i>本多中心研究纳入91例存在重度气道阻塞、肺过度充气且以上叶（upper lobe, UL）为主的肺气肿患者，经双侧支气管途径向病变上叶置入609枚支气管瓣膜。<i>结果：</i>瓣膜精准放置于目标气道，技术成功率达99.7%，未出现瓣膜移位或侵蚀情况。本研究无手术相关死亡病例，术后30天并发症发生率与死亡率分别为5.5%与1.1%。气胸是最常见的严重设备相关并发症，主要发生于单叶肺所有节段（尤其是左上叶）被完全封堵的场景。研究观察到健康相关生活质量（health-related quality of life, HRQL）出现极具统计学意义的改善：术后6个月的平均变化值为-8.2±16.2（均值±标准差）。HRQL改善与治疗肺叶的体积缩小（平均缩小294±427ml，p=0.007）相关，且未出现可见的肺不张。一秒用力呼气容积（FEV₁）、运动试验结果与肺总量未发生显著改变，但通气分布出现比例性重塑：吸入气量被重新分配至未接受治疗的肺叶。结合肺灌注扫描结果，该现象提示非上叶肺实质的通气与灌注匹配情况得到改善。<i>结论：</i>支气管瓣膜治疗肺气肿具有多种作用机制，安全性良好，可显著改善多数患者的生活质量。