Assessment of efficacy and safety of endoscopic lung volume reduction with one-way valves in patients with a very low FEV 1 .

Introduction: Endoscopic lung volume reduction (ELVR) with one-way valves produces beneficial outcomes in patients with severe emphysema. Evidence on the efficacy remains unclear in patients with a very low forced expiratory volume in 1 s (FEV ₁ ) (≤20% predicted). We aim to compare clinical outcomes of ELVR, in relation to the FEV ₁ restriction.
Methods: All data originated from the German Lung Emphysema Registry (Lungenemphysem Register), which is a prospective multicentric observational study for patients with severe emphysema after lung volume reduction. Two groups were formed at baseline: FEV ₁ ≤20% pred and FEV ₁ 21-45% pred. Pulmonary function tests (FEV ₁ , residual volume, partial pressure of carbon dioxide), training capacity (6-min walk distance (6MWD)), quality of life (modified Medical Research Council dyspnoea scale (mMRC), COPD Assessment Test (CAT), St George's Respiratory Questionnaire (SGRQ)) and adverse events were assessed and compared at baseline and after 3 and 6 months.
Results: 33 patients with FEV ₁ ≤20% pred and 265 patients with FEV ₁ 21-45% pred were analysed. After ELVR, an increase in FEV ₁ was observed in both groups (both p<0.001). The mMRC and CAT scores, and 6MWD improved in both groups (all p<0.05). The SGRQ score improved significantly in the FEV ₁ 21-45% pred group, and by trend in the FEV ₁ ≤20% pred group. Pneumothorax was the most frequent complication within the first 90 days in both groups (FEV ₁ ≤20% pred: 7.7% versus FEV ₁ 21-45% pred: 22.1%; p=0.624). No deaths occurred in the FEV ₁ ≤20% pred group up to 6 months.
Conclusion: Our study highlights the potential efficacy of one-way valves, even in patients with very low FEV ₁ , as these patients experienced significant improvements in FEV ₁ , 6MWD and quality of life. No death was reported, suggesting a good safety profile, even in these high-risk patients.
Competing Interests: Conflict of interest: S. Eisenmann reports receiving grants or contracts from DFG, outside the submitted work; consulting fees from Acceleron, AstraZeneca and Sanofi Genzyme, outside the submitted work; payment for expert testimony for Nanovation, outside the submitted work; support for attending meetings and/or travel from Boehringer Ingelheim and Sanofi Genzyme, outside the submitted work. Conflict of interest: M. Witzenrath reports grants or contracts from Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, Deutsche Gesellschaft für Pneumologie, European Respiratory Society, Marie Curie Foundation, Else Kröner Fresenius Stiftung, Capnetz Stiftung, Bayer Health Care, Biotest and Pantherna, outside the submitted work; consulting fees from Insmed, Pantherna, Pherecydes, Aptarion, GlaxoSmithKline, Inflarx and Biotest, outside the submitted work; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Insmed, Chiesi, Novartis, Teva, Actelion, Boehringer Ingelheim, GlaxoSmithKline, Biotest and Bayer Health Care, outside the submitted work; patents issued EPO 12181535.1 (IL-27 for modulation of immune response in acute lung injury), WO/2010/094491 (Means for inhibiting the expression of Ang-2), DE 102020116249.9 (Camostat/Niclosamide cotreatment in SARS-CoV-2 infected human lung cells) and PCT/EP2021/075627 (New medical use of cystic fibrosis transmembrane conductance regulator (CFTR) modulators), outside the submitted work. Conflict of interest: A. Holland reports being a board member of Lungenemphysemregister e.V., outside the submitted work. Conflict of interest: W. Gesierich reports lectures fees from PulmonX GmbH, outside the submitted work. Conflict of interest: R-H. Hübner reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Pulmonx, Olympus and AstraZeneca, outside the submitted work; participation on a data safety monitoring board or advisory board for Bento Study (sponsor: IHF GmbH – Institut für Herzinfarktforschung), outside the submitted work; leadership or fiduciary role in other board, society, committee or advocacy group for Head of Lungenemphysem Register e.V., outside the submitted work. Conflict of interest: The remaining authors have nothing to disclose.
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