LATE-BREAKING ABSTRACT: A multicenter, prospective, randomized, controlled trial of endobronchial valve therapy vs standard of care in homogeneous emphysema (IMPACT)

Abstract

Background: Endobronchial valve (EBV) therapy improves lung function, exercise capacity and quality of life in patients with advanced heterogeneous emphysema. Limited data exist on the use of EBV in patients with homogeneous emphysema. Aims and Objectives: Evaluate effectiveness of EBV placement in patients with severe homogeneous emphysema. Methods: Prospective multicenter RCT enrolled 183 patients with hyperinflation (FEV 1 ≤45% pred., RV ≥200% pred.), and severe homogeneous emphysema, confirmed by quantitative HRCT and perfusion scan. 93 patients ([male]/[female]:36/57; mean age: 63.8y) with negative collateral ventilation (assessed by Chartis System) were randomized to either unilateral complete EBV treatment (Zephyr valves; n=43) or standard medical care (SoC; n=50) at 8 centres. The primary end point was ΔFEV 1 % at 90 days. Secondary endpoints were pulmonary function tests (PFT), 6-Minute-Walk-Distance (6MWD), SGRQ (St. Georges Respiratory Questionnaire), and safety. Results: Outcome measures for ITT population at 90 days were: Serious adverse events (EBV vs SoC patients) included: pneumothorax 25.6% vs 0% and COPD exacerbation 18.6% vs 12.0%. There were no deaths in the EBV group and 2 deaths in the SoC group. Conclusion: EBV treatment resulted in clinically and statistically significant improvements in pulmonary function, exercise capacity and quality of life in patients with severe homogenous emphysema and negative collateral ventilation.