Lung volume reduction coil treatment for patients with severe heterogeneous emphysema, a multicenter feasibility trial

Introduction: The Lung Volume Reduction Coil (LVRC) is a bronchoscopic device made of self-expandable nitinol wire for the treatment of emphysema. A previous single center pilot study showed safety and efficacy in severe upper-lobe emphysema. Aim: In this study we investigated the feasibility, safety and efficacy of LVRC treatment in a multicenter cohort trial design in patients with severe upper or lower lobe heterogeneous emphysema. Methods: 44 patients (23F/21M, 60yrs (±11), FEV1 29.9%pred (±6.9%), RV 249%pred (±52%), TLC 135%pred (±16%)) were bronchoscopically treated under general anesthesia using fluoroscopy with LVRCs (PneumRx, USA) in either one or two lungs (in two sequential procedures) in 10 European centers. Safety was evaluated by recording of all adverse events (AEs). Efficacy as measured by questionnaires, pulmonary function- and exercise testing will be measured at 3, 6 and 12 months post treatment. Results: 83 LVRC procedures were performed (39 bilateral, 5 unilateral). 33 patients were treated in the upper lobes and 11 in the lower lobes. The mean procedure time was 50 mins (±24), using a median of 10 coils (range 8-14) per lobe. The coil lengths used were 70mm (2x), 85mm (19x), 100mm (352x), 125mm (347x), 150mm (81x) and 175mm (25x). AEs <24hrs after the procedure were: COPD exacerbation (n=2), pneumothorax (n=1), chest pain (n=2), dyspnea (n=3), consolidation (n=1), cough (n=1), and mild hemoptysis (n=5). Conclusion: The LVRC treatment is technically feasible in both upper and lower lobe emphysema, with a good periprocedural safety profile. At the ERS conference meeting we will also be able to present the follow-up efficacy and safety data for this trial.