Late Breaking Abstract - Preliminary Safety and Efficacy of PulmValve Endobronchial Valve in Treating Severe Heterogeneous Emphysema: A First-in-Human Study

<bold>Background:</bold> Endobronchial valves is a recognized treatment for emphysema. Key challenges were the technical complexity of upper lobe implantation and the number of valves required. PulmValve (MedTecX, Shanghai, China), a novel endobronchial valve aims to address these issues. <bold>Objective:</bold> This study evaluated the preliminary safety and efficacy of PulmValve in patients with severe emphysema. <bold>Method:</bold> This First-in-Human, prospective study enrolled patients with severe heterogeneous emphysema in the first affiliated hospital of Guangzhou medical university between January and December 2023 for PulmValve implantation. The primary endpoint was safety, with feasibility and efficacy as secondary endpoints. <bold>Results:</bold> Five patients (aged 58–77 years) with severe heterogeneous emphysema and no collateral ventilation (fissure integrity >90%), were included. Baseline FEV1 was 0.926±0.312 L, 6-minute walk test (6MWT) was 305.60±31.80 m, and SGRQ score was 52.35±14.50. Totally 6 PulmValves were successfully implanted in 5 patients with a mean procedure time of 4.047±2.127 minutes. One patient experienced pneumothorax within 3 days, and another had AECOPD within 4 weeks, both patients fully recovered after appropriate treatment. After 3 months, FEV1 increased by 0.132±0.103 L (p=0.045), 6MWT improved by 34.06±43.07 m (p=0.152), and SGRQ score decreased by 13.14±10.23 points (p=0.045). <bold>Conclusion:</bold> The application of PulmValve can treat heterogeneous emphysema by implanting only 1-2 endobronchial valves in a relatively short procedure time, demonstrating preliminary safety, feasibility, and efficacy. Larger, long-term studies are needed to confirm these promising results.