Saccomanno Jacopo, Kilic Lara, Sgarbossa Thomas, Neumann Konrad, Stanzel Franz, Holland Angelique, Grah Christian, Gesierich Wolfgang, Krist Joanna, Ficker Joachim H, Eggeling Stephan, Andreas Stefan, Schmidt Bernd, Eisenmann Stephan, Schwick Björn, Franke Karl-Josef, Fertl Andreas, Witzenrath Martin, Hübner Ralf-Harto
Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité - Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
ERJ Open Res. 2025 Jan 13;11(1). doi: 10.1183/23120541.00410-2024. eCollection 2025 Jan.
Data regarding the effectiveness and safety of endoscopic lung volume reduction with valves (ELVR) in emphysema patients with a very low 6-min walk test (6MWT) are limited. Patients with severe emphysema and very low exercise capacity, as indicated by a 6MWT ≤140 m, are often excluded from clinical studies on ELVR, assuming limited therapeutic benefits and increased complication risk.
This study utilised data from the Lungenemphysemregister e.V., a large German national multi-centre prospective open-label clinical trial, and aimed to assess the outcomes of ELVR in patients with a baseline 6MWT ≤140 m and dyspnoea primarily attributed to hyperinflation.
54 patients with a baseline 6MWT ≤140 m and 365 patients with a baseline 6MWT between 140 and 450 m were included in the study. Baseline characteristics were representative for patients with advanced lung emphysema. Patients with a 6MWT ≤140 m at baseline had a lower forced expiratory volume in 1 s and diffusing capacity of the lung for carbon monoxide and higher symptom burden. In the 3-month follow-up, patients of both groups showed statistically significant improvements in lung function parameters, exercise capacity and quality of life parameters compared to baseline. Patients with a 6MWT ≤140 m at baseline showed significantly more 6MWT improvement compared to patients with baseline 6MWT between 140 and 450 m. Moreover, complication rates were similar in both groups.
In summary, the data indicate that ELVR may be an effective and safe treatment for emphysema patients with a very low 6MWT of ≤140 m if very limited exercise capacity is predominately caused by lung emphysema. Therefore future studies should include emphysema patients with a very low 6MWT.
关于阀门式内镜肺减容术(ELVR)在6分钟步行试验(6MWT)结果极低的肺气肿患者中的有效性和安全性的数据有限。6MWT≤140米表明患有严重肺气肿且运动能力极低的患者通常被排除在ELVR临床研究之外,因为假定其治疗益处有限且并发症风险增加。
本研究利用了德国全国性大型多中心前瞻性开放标签临床试验Lungenemphysemregister e.V.的数据,旨在评估基线6MWT≤140米且呼吸困难主要归因于肺过度充气的患者接受ELVR的结果。
本研究纳入了54例基线6MWT≤140米的患者和365例基线6MWT在140至450米之间的患者。基线特征代表了晚期肺气肿患者。基线6MWT≤140米的患者一秒用力呼气量和肺一氧化碳弥散量较低,症状负担较重。在3个月的随访中,与基线相比,两组患者的肺功能参数、运动能力和生活质量参数均有统计学显著改善。基线6MWT≤140米的患者与基线6MWT在140至450米之间的患者相比,6MWT改善更为显著。此外,两组的并发症发生率相似。
总之,数据表明,如果运动能力极其有限主要是由肺气肿引起的,那么ELVR对于6MWT≤140米的极低水平的肺气肿患者可能是一种有效且安全的治疗方法。因此,未来的研究应纳入6MWT极低的肺气肿患者。