Safety and Feasibility of the Lung Volume Reduction Reverser System in Patients with Severe Emphysema: A First-in-Human Pilot Study.

INTRODUCTION

Endoscopic lung volume reduction with coils is a symptomatic treatment approach for patients with severe pulmonary emphysema and positive collateral ventilation. In this study, we evaluated the safety and feasibility of the new Lung Volume Reduction Reverser (LVR-R) system.

METHODS

Prospective, nonrandomized, exploratory, single-center, first-in-man study in 15 patients with chronic obstructive pulmonary disease (COPD) and severe emphysema. Most affected lung lobes were treated sequentially with the LVR-R coils from May 2019 to JUL 2022. Pulmonary function, 6-min walking distance (6-MWD), questionnaires and adverse events were recorded from baseline to 1-year post-procedure. Computer tomography was acquired at baseline and 6 months.

RESULTS

A total of 28 procedures were performed, in which 10 (n = 22, 78.6%), 9 (n = 2, 7.1%), or 8 (n = 4, 14.3%) LVR-R coils were implanted, predominantly in the upper lobes (n = 26/28, 92.86%). Two patients refused a second treatment, one of whom refused follow-ups. Adverse events at 3 months included severe pneumonia and/or COPD exacerbations (n = 7), ventilatory failure (n = 2) and 1 pneumothorax requiring thoracic drainage. Mild hemoptysis occurred in 18 and mild pneumonia and/or COPD exacerbations in 9 patients. Overall, neither FEV1, residual volume, 6-MWD, CAT nor mMRC improved within 1-year (n.s. all). In 2 patients, response in FEV1 >500 mL occurred.

CONCLUSION

In this severely diseased and small patient cohort, LVR-R implantation was technically feasible. The complication rate was similar to other coil studies and requires a careful pre-procedure benefit-risk evaluation. Two of fourteen bilaterally treated individuals demonstrated a notable improvement in lung function.