Sustained Clinical Benefits of Spiration Valve System in Severe Emphysema Patients: 24-Month Follow-Up of EMPROVE.

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Annals of the American Thoracic Society


RATIONALE: Follow-up of emphysema patients treated with endobronchial valves is limited to 3-12 months after treatment in prior reports. To date, no comparative data exist between treatment and controls with a longer follow-up.

OBJECTIVE: To assess the durability of the Spiration® Valve System (SVS) in patients with severe heterogeneous emphysema over a 24-month period.

METHODS: EMPROVE, a multicenter, randomized controlled trial, presents a rigorous comparison between treatment and control groups for up to 24 months. Lung function, respiratory symptoms, and quality-of-life (QOL) measures were assessed.

RESULTS: A significant improvement in forced expiratory volume in 1 second was maintained at 24 months in the SVS treatment vs. control group. Similarly, significant improvements were maintained in several QOL measures, including St. George's Respiratory Questionnaire and the COPD Assessment Test. Patients in the SVS treatment group experienced significantly less dyspnea than those in the control group, as indicated by the modified Medical Research Council Dyspnea Scale score. Adverse events at 24 months did not significantly differ between the SVS treatment and control groups. Acute COPD exacerbation rates in the SVS treatment and control groups were 13.7% (14/102) and 15.6% (7/45), respectively. Pneumothorax rates in the SVS treatment and control groups were 1.0% (1/102) and 0.0% (0/45), respectively.

CONCLUSIONS: SVS treatment resulted in statistically significant and clinically meaningful durable improvements in lung function, respiratory symptoms, and QOL, as well as a statistically significant reduction in dyspnea, for at least 24 months, while maintaining an acceptable safety profile.

CLINICAL TRIAL REGISTRATION: NCT01812447 Primary Source of Funding: This study was funded by Olympus Corporation.





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