Endobronchial valve treatment in patients with severe emphysema due to alpha-1 antitrypsin deficiency

Abstract

Alpha-1 Antitrypsin Deficiency (AATD) an inherited disorder raises the risk for lung disease and often leads to emphysema. We report on the 6 & 12-month results of the AATD arm of the EMPROVE study. 20 AATD subjects on optimal medical management with hyperinflation, severe dyspnea were treated with SVS valves at 12 centers. Target lobe selection was done using high resolution computed tomography. Targeted lobe was a lower lobe in 85% and an upper lobe in 15% of patients. A mean of 4.4 valves per patient were used to isolate the target lobe, with an average procedure time of 20 minutes. Results are presented as baseline and mean changes in FEV1, Target Lobe Volume (TLV), disease specific quality of life measures – St. George’s Respiratory Questionnaire (SGRQ), modified Medical Research Council dyspnea score (mMRC), and COPD Assessment Test (CAT) and exercise capacity measured by 6-minute walk distance (6MWD). Changes at 6 and 12 months are shown in table 1. Through 12-months, there was one death. Most frequent serious adverse events were COPD exacerbation (15%), pneumonia (15%) and pneumothorax (20%). Implantation of the SVS in AATD patients with severe emphysema provides clinically meaningful improvements in FEV1, target lobe volume reduction quality of life parameters and exercise capacity, with an acceptable safety profile.