Department of Research and Development, Ciro, Horn, The Netherlands.
NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands.
Respiration. 2022;101(5):476-484. doi: 10.1159/000520885. Epub 2021 Dec 22.
Bronchoscopic lung volume reduction (BLVR) using 1-way endobronchial valves (EBV) has become a guideline treatment in patients with advanced emphysema. Evidence from this minimally invasive treatment derives mainly from well-designed controlled trials conducted in high-volume specialized intervention centres. Little is known about real-life outcome data in hospitals setting up this novel treatment and which favourable conditions are required for a continuous successful program.
In this study, we aim to evaluate the eligibility rate for BLVR and whether the implementation of BLVR in our academic hospital is feasible and yields clinically significant outcomes.
A retrospective evaluation of patients treated with EBV between January 2016 and August 2019 was conducted. COPD assessment test (CAT), forced expiratory volume in 1 s (FEV1), residual volume (RV), and 6-min walking test (6MWT) were measured at baseline and 3 months after intervention. Paired sample t tests were performed to compare means before and after intervention.
Of 350 subjects screened, 283 (81%) were not suitable for intervention mostly due to lack of a target lobe. The remaining 67 subjects (19%) underwent bronchoscopic assessment, and if suitable, valves were placed in the same session. In total, 55 subjects (16%) were treated with EBV of which 10 did not have complete follow-up: 6 subjects had their valves removed because of severe pneumothorax (n = 2) or lack of benefit (n = 4) and the remaining 4 had missing follow-up data. Finally, 45 patients had complete follow-up at 3 months and showed an average change ± SD in CAT -4 ± 6 points, FEV1 +190 ± 140 mL, RV -770 ± 790 mL, and +37 ± 65 m on the 6MWT (all p < 0.001). After 1-year follow-up, 34 (76%) subjects had their EBV in situ.
Implementing BLVR with EBV is feasible and effective. Only 16% of screened patients were eligible, indicating that this intervention is only applicable in a small subset of highly selected subjects with advanced emphysema, and therefore a high volume of COPD patients is essential for a sustainable BLVR program.
使用单向支气管镜肺减容术(BLVR)治疗晚期肺气肿患者已成为一项指南推荐的治疗方法。这种微创治疗的证据主要来自在大容量专业介入中心进行的精心设计的对照试验。对于在医院中开展这种新型治疗的实际结果数据,以及需要哪些有利条件才能实现持续成功的项目,人们知之甚少。
本研究旨在评估 BLVR 的入选率,以及在我们的学术医院实施 BLVR 是否可行并产生有临床意义的结果。
对 2016 年 1 月至 2019 年 8 月期间接受 EBV 治疗的患者进行回顾性评估。在干预前和干预后 3 个月分别测量 COPD 评估测试(CAT)、1 秒用力呼气量(FEV1)、残气量(RV)和 6 分钟步行试验(6MWT)。采用配对样本 t 检验比较干预前后的平均值。
在 350 名筛选的患者中,283 名(81%)因缺乏目标肺叶而不适合干预。其余 67 名(19%)患者接受了支气管镜评估,如果适合,将在同一时段放置阀门。共有 55 名(16%)患者接受了 EBV 治疗,其中 10 名患者未完成完整随访:6 名患者因严重气胸(n=2)或无获益(n=4)而移除阀门,其余 4 名患者则未完成随访。最后,45 名患者在 3 个月时完成了完整随访,CAT 平均变化±标准差为-4±6 分,FEV1+190±140mL,RV-770±790mL,6MWT 增加+37±65m(均 p<0.001)。在 1 年随访后,34 名(76%)患者的 EBV 仍在位。
实施带有 EBV 的 BLVR 是可行且有效的。仅有 16%的筛选患者符合入选标准,这表明这种干预措施仅适用于一小部分高度选择的晚期肺气肿患者,因此,大量 COPD 患者是可持续 BLVR 项目的关键。