Introduction: Bronchoscopic lung volume reduction with endobronchial valves is an established therapy for selected patients with severe heterogeneous emphysema. The PulmValve is a novel lobar endobronchial valve, designed to achieve occlusion with larger-diameter valves. We present here its first-in-human exploratory experience. Case Series: Six male patients underwent successful lobar valve implantation, with a median of one valve per treated lobe. No intraprocedural complications, device malfunctions, or valve migration were observed during follow-up. Four serious adverse events occurred, including one hydropneumothorax, one acute exacerbation of COPD, one pulmonary infection in a non-treated lobe, and one sudden cardiac death. The fatal event was adjudicated as possibly unrelated. Early improvement in dyspnea was noted in most patients. Compared to baseline, at 3 months, forced expiratory volume in 1 second (FEV1) improved by 80 mL (30 to 310) and residual volume (RV) decreased by 200 mL (-890 to 430), accompanied by 6-minute walk test (6MWT) increased by 34 m (-34 to 71) and St. George's Respiratory Questionnaire (SGRQ) score dropped by 16 points (-4 to 23). At 6 months, pulmonary function changes were variable, while exercise capacity and symptom scores remained improved in selected cases. Conclusion: In this exploratory first-in-human case series, lobar PulmValve implantation was technically feasible and generated descriptive clinical signals. Larger controlled studies are required to define safety, durability, and clinical efficacy.
Chen et al. (Mon,) studied this question.