Sustained health-related quality of life in patients with severe heterogenous emphysema treated with spiration valve system at 24-month follow-up (EMPROVE)

Abstract

<b>Background:</b> COPD&nbsp;impairs the physiological and structural function of the lungs and negatively impacts physical performance. Patients with emphysema&nbsp;typically have significant impairments in daily activities and a reduced quality&nbsp;of life. <b>Objective:</b> We assessed health-related quality of life at the 24-month followup in patients with severe heterogeneous emphysema treated with the Spiration Valve&nbsp;System (SVS) versus optimal medical managment (Control) in EMPROVE. <b>Methods:</b> EMPROVE was a prospective, mulitcenter, randomized controlled trial. Patients were randomized in a 2:1 allocation to SVS treatment (n=97) or Control (n=44). Disease-targeted measures of health-related quality of life were determined using the St. George9s Respiratory Questionnaire (SGRQ), the modified Medical Research Council dyspnea&nbsp;scale (mMRC) and the COPD Assessment Test (CAT) at 1, 3, 6,12 and 24 months. <b>Results:</b> The SVS-treated group demosntrated significant improvements in SGRQ (p=0.037) at 24 months with a mean change of -6.5 points, with a similar improvement in CAT&nbsp;(−2.6 points for the SVS treatment and Control groups, respectively, p=0.048). Dyspena also improved post SVS treament compared to the Control&nbsp;group with a mean reduction of -0.6 points in the mMRC Dyspena Scale, yielding a significant difference between groups (p=0.0012). <b>Conclusion:</b> Our results&nbsp;from the EMPROVE&nbsp;trial demonstrate&nbsp;that SVS&nbsp;treatment provides a sustained clinically significant benefit in health-related quality of life in patients with severe heterogeneous emphysema.