Late Breaking Abstract - Endobronchial Valves for Severe Emphysema – 12-month Results of the EMPROVE Trial

We report 12-month endpoint results of the EMPROVE study, a multicenter, randomized controlled trial that assessed safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in patients with severe emphysema. 172 subjects with hyperinflation and severe dyspnea without interlobar collateral ventilation determined by HCRT were randomized (2:1) to either treatment (SVS valves and medical management, N=113) or control (medical management alone, N=59). Target lobe treatment, based on high resolution computed tomography (HRCT) was 70% upper lobe and 30% lower lobe resulting in a mean target lobe volume reduction of 53%. Lung function, disease specific health status and dyspnea scores reached statistical and clinically meaningful difference between the study groups. Mean ±95% Bayesian Credible Interval, PP = Posterior Probability; SGRQ – St. George’s Respiratory Questionnaire, mMRC – Modified Medical Research Council dyspnea score. Through 12-months, 16.9% of control group patients had thoracic serious adverse events compared to 38.9% of the treatment group. Early onset pneumothorax rate (14.2%), a recognized marker for target lobe volume reduction was the main adverse event in the treatment group. This study demonstrates that selecting patients for bronchoscopic lung volume reduction by HRCT assessment results in durable effectiveness through 12 months.