Impact of endobronchial valves on patient reported outcomes in severe emphysema

Abstract

Introduction: Bronchoscopic Lung Volume Reduction (BLVR) with the Zephyr® Valve improves lung function, exercise tolerance and quality of life in hyperinflated emphysema patients with little to no collateral ventilation (CV). Here we report further analysis of the impact of BLVR on patient reported outcomes (PROs) in the LIBERATE Study. Methods: 190 severe heterogeneous emphysema subjects were randomized 2:1 (Zephyr Valve to Standard of Care (SOC)) at 24 centers. Subjects were 53% female and had mean forced expiratory volume (FEV1) 27.4% predicted; Residual Volume 225% predicted; St George’s Respiratory Questionnaire (SGRQ) score of 54.5; and COPD Assessment Test (CAT) score of 19.2. Improvements in the total and individual domain scores of the SGRQ, total and individual questions of the CAT and the Focal and individual component scores of the Transitional Dyspnea Index (TDI) at 12-months from baseline were compared between the Zephyr Valve and SOC groups. Results: All three PROs showed statistically significant and clinically meaningful improvements in Zephyr Valve patients compared to SoC patients (SGRQ, -7.05 points; CAT, -3.1 points; TDI Focal score, 4.3 points). The improvement in the SGRQ was driven by the “Impacts” and “Activity” domains (p Conclusion: Data from the LIBERATE trial demonstrates that the Zephyr Valve significantly improves multidimensional measures of dyspnea and quality of life.