Bivort Dorian, Blondeel Astrid, Geysen Hannelore, Vandervelde Christelle M, Coolen Johan, Ceulemans Laurens J, Dooms Christophe, Janssens Wim, Everaerts Stephanie
Clinical Department of Pulmonary Diseases, University Hospitals Leuven, Leuven, Belgium.
Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.
Int J Chron Obstruct Pulmon Dis. 2025 Mar 25;20:799-810. doi: 10.2147/COPD.S509468. eCollection 2025.
Bronchoscopic lung volume reduction (BLVR) using one-way endobronchial valves (EBV) is a minimally invasive treatment for patients with advanced emphysema and severe hyperinflation. While several randomized controlled trials have demonstrated improvements in lung function, exercise performance, and quality of life, information on long-term outcomes of BLVR outside clinical trial settings are limited.
This study provides real-world data with a follow-up of up to two years, incorporating the BODE index (Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity Index), as part of the follow-up assessments.
Data were collected for all patients treated with BLVR at the University Hospitals of Leuven, Belgium, including lung function parameters, 6-minute walking distance, respiratory questionnaires, and the BODE index at intervals of 3, 6, 12, and 24 months. A composite outcome combining FEV1 (forced expiratory volume in 1 second), 6MWD (6-minute walk distance), and SGRQ (St. George's Respiratory Questionnaire) was used to evaluate the overall impact of BLVR. Mixed model analyses were performed.
All outcome parameters, including FEV1, residual volume (RV), 6MWD, modified Medical Research Council (mMRC) and SGRQ exhibited significant improvement up to 1 year of treatment. RV and mMRC maintained statistical significance compared to baseline at the 2-year follow-up. The BODE index as well, revealed a significant improvement persisting up to 2 years of treatment. Response rate for the composite outcome was 86% (44/51) at one year and 71% (17/24) at 2 years follow-up.
Follow-up data of a real-world setting show maintained benefits of bronchoscopic lung volume reduction with endobronchial valves up to 2 years after treatment, for patients of whom the valves are still in situ. A potential survival benefit of BLVR, based on BODE, and high response rate on the composite outcome was present, in patients who remained in follow-up.
使用单向支气管内瓣膜(EBV)进行支气管镜肺减容术(BLVR)是治疗晚期肺气肿和严重肺过度充气患者的一种微创治疗方法。虽然多项随机对照试验已证明肺功能、运动能力和生活质量有所改善,但关于临床试验环境之外BLVR长期结果的信息有限。
本研究提供了长达两年随访的真实世界数据,将BODE指数(体重指数、气流阻塞、呼吸困难和运动能力指数)纳入随访评估。
收集了比利时鲁汶大学医院所有接受BLVR治疗患者的数据,包括肺功能参数、6分钟步行距离、呼吸问卷以及在3、6、12和24个月时的BODE指数。使用结合第一秒用力呼气量(FEV1)、6分钟步行距离(6MWD)和圣乔治呼吸问卷(SGRQ)的综合结果来评估BLVR的总体影响。进行了混合模型分析。
所有结果参数,包括FEV1、残气量(RV)、6MWD、改良医学研究委员会(mMRC)评分和SGRQ,在治疗1年内均有显著改善。与基线相比,在2年随访时RV和mMRC评分仍具有统计学意义。BODE指数在治疗2年内也持续显著改善。综合结果的缓解率在1年时为86%(44/51),在2年随访时为71%(17/24)。
真实世界环境的随访数据显示,对于瓣膜仍在位的患者,支气管镜肺减容术使用支气管内瓣膜治疗后长达2年仍保持益处。基于BODE指数,BLVR对仍在随访的患者存在潜在的生存益处,且综合结果的缓解率较高。