Bronchoscopic Lung Volume Reduction with Zephyr Valves: The French Real-world Experience

<bold>Background:</bold> BLVR with Zephyr valves (ZV) is a treatment option for patients with severe emphysema. Prospectively collected real-world data in France needed for health authorities and confirm RCT findings. <bold>Objective:</bold> Evaluate safety and effectiveness of the ZV treatment of patients with severe emphysema across treating centers in France with varying level of experience. <bold>Methods:</bold> Multi-center, single-arm, prospective registry at 11 centers. ZV placement performed per standard of care in France. <bold>Results:</bold> 154 patients (51% male; baseline mean±SD: Post-BD FEV1 29.6%±8.8; RV 251%±55 pred.) with a CV- target lobe enrolled. 93% had ZV placement during 2 procedures and 7% in a single procedure; median of 5 valves placed. Mean TLVR at 45days was -1.01L±0.74 with 79.9% of patients achieving ≥350ml reduction. At 12months, 48.4% patients were FEV1 responders (≥12% improvement); mean changes from baseline to 6- and 12-months respectively were: FEV1 +18.0%, +15.3%; RV −0.49L, −0.28L; SGRQ -8.8pts, -6.4pts; and 6MWD +24m, +25m. SAEs (>3%) in the treatment period (0 to 45days post-ZV), longer term (46days to 12months) include pneumothorax (11.0%, 5.0%) and COPD exacerbations (5.2%, 12.9%), respectively. Five (3.2%) deaths occurred. <bold>Conclusion:</bold> French real-world data of ZV benefits in severe emphysema patients is consistent with prior studies with clinically meaningful reduction in hyperinflation, improvements in lung function, exercise capacity and quality of life. In this single arm study, the pneumothorax rate after staged ZV implantation was consistent with recent retrospective published studies and appear to be lower than previously reported in RCTs, whereas the average number of valves placed was higher.