Sgarbossa Thomas, Borchers Philipp, Saccomanno Jacopo, Ahrens Katharina, Wüstefeld Hannah Friederike, Pappe Eva, Wuelfing Uta, Klein Ulrich, Witzenrath Martin, Stanzel Franz, Grah Christian, Hübner Ralf-Harto
Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Klinik Havelhöhe, Clinic for Internal Medicine and Pneumology, Berlin, Germany.
Respiration. 2025;104(4):281-289. doi: 10.1159/000542806. Epub 2024 Nov 25.
Endoscopic lung volume reduction (ELVR) with valves is an effective intervention in patients with severe lung emphysema. Two types of valves are established in clinical practice: Zephyr endobronchial valves (EBVs) and Spiration Valve System (SVS). We aimed to compare outcomes and the safety associated with these two types of one-way valves.
Data were collected from three German lung emphysema centers as part of a prospective observational study focusing on lung volume reduction. Two groups were formed based on valve types. In both groups, lung function (FEV1, RV, diffusion capacity of the lung for carbon monoxide, pCO2), 6-min walking distance (6MWD), quality of life (SGRQ, mMRC, CAT), and complication rate were recorded at baseline and at follow-up 3 to 6 months later.
A total of 54 patients were treated with SVS valves and 99 patients with EBV. There were no significant differences between both groups at baseline. Notably, both types of valves exhibited significant enhancements in lung function and quality of life. Interestingly, there were no significant differences in the median change of all measured parameters for both groups, suggesting comparable improvements in EBV and SVS. Pneumothorax was the most common complication for both valve types. The incidence of adverse events did not differ significantly between groups.
Our study suggests that both types of valves are safe and effective in the treatment of severe lung emphysema. We recommend choosing the valve type based on individual bronchial anatomy. However, further randomized studies are needed to confirm our results.
使用瓣膜进行内镜下肺减容术（ELVR）是重度肺气肿患者的一种有效干预措施。临床实践中已确立了两种类型的瓣膜：泽弗尔支气管内瓣膜（EBV）和吸气瓣膜系统（SVS）。我们旨在比较这两种单向瓣膜的疗效及安全性。
作为一项聚焦于肺减容术的前瞻性观察性研究的一部分，从三个德国肺气肿中心收集数据。根据瓣膜类型分为两组。两组均在基线时以及3至6个月后的随访时记录肺功能（第一秒用力呼气容积、残气量、肺一氧化碳弥散量、二氧化碳分压）、6分钟步行距离（6MWD）、生活质量（圣乔治呼吸问卷、改良英国医学研究委员会呼吸困难量表、慢性阻塞性肺疾病评估测试）和并发症发生率。
共有54例患者接受了SVS瓣膜治疗，99例患者接受了EBV治疗。两组在基线时无显著差异。值得注意的是，两种类型的瓣膜在肺功能和生活质量方面均有显著改善。有趣的是，两组所有测量参数的中位数变化无显著差异，表明EBV和SVS的改善效果相当。气胸是两种瓣膜类型最常见的并发症。两组不良事件的发生率无显著差异。
我们的研究表明，两种类型的瓣膜在治疗重度肺气肿方面均安全有效。我们建议根据个体支气管解剖结构选择瓣膜类型。然而，需要进一步的随机研究来证实我们的结果。
