Background Emphysema is a hallmark of end stage COPD and endoscopic lung volume reduction is a therapeutic approach against symptomatic burden. In this prospective, nonrandomized, exploratory, single center, first-in-man study we aimed to evaluate the safety and feasibility of the novel CinensesTM Lung Volume Reduction Reverser (LVR-R) system.
Methods In 14 patients with severe emphysema (?/?:8/6, age: 65±6years, 43±18pack years), the most affected lobes were treated bilateally and sequentially with the LVR-R system. In total, 27 procedures were performed in which 10 (n=21, 78.8%), 9 (n=2, 7.4%) or 8 (n=4, 14.8%) LVR-Rs per lobe were implanted. 26 procedures involved both upper lobes, 1 a lower lobe. Pulmonary function, 6MWD, mMRC dyspnea scale, CAT score and complications were recorded from baseline to 1 year post procedure. 8 patients underwent all tests.
Results Compared to baseline, neither FEV1 (28.0.0±6.7 vs 30.0±5.7%, ns), residual volume (247.0±27.2 vs 241.1±27.2%, ns), 6MWD (353.6±63.8 vs 288.5±137.0m, ns), CAT (23.3±8.1 vs 22.9±6.1 points, ns) nor mMRC (2,8±1.0 vs 2.3±0.9 points, ns) improved one year after treatment. Complications included pneumonia requiring iv antibiotics (n=17 in 9 patients), severe COPD exacerbations (n=7 in 5 patients), 1 pneumothorax requiring draining, ventilatory failure necessitating non-invasive ventilation (3 patients) and severe hemoptysis (n=4 in 3 patients). Mild self-limiting haemoptysis occurred in 11 and mild pneumonia or COPD exacerbations in 9 patients.
Conclusion LVR-R implantation had no significant clinical benefit but was associated with numerous severe complications in our study.