Arschang Valipour1, Dirk-Jan Slebos2, Felix Herth3, Kaid Darwiche4, Manfred Wagner5, Joachim H Ficker5, Christoph Petermann6, Ralf-Harto Hubner7, Franz Stanzel8, Ralf Eberhardt3. 1. 1 Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner Spital, Vienna, Austria. 2. 2 Department of Pulmonary Diseases, University of Groningen, and University Medical Center Groningen, Groningen, the Netherlands. 3. 3 Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany. 4. 4 Department of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Clinic Essen, Essen, Germany. 5. 5 Department of Respiratory Medicine, Allergology and Sleep Medicine, General Hospital Nuernberg, and Paracelsus Medical University, Nuremberg, Germany. 6. 6 Lungenabteilung, Thoraxzentrum Hamburg, Asklepios Klinik, Hamburg, Germany. 7. 7 Charité Campus Virchow-Klinikum, Berlin, Germany; and. 8. 8 Lungenklinik Hemer, Hemer, Germany.
Abstract
RATIONALE: Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema. OBJECTIVES: To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system. METHODS: Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George's Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction. MEASUREMENTS AND MAIN RESULTS:Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV1 from baseline was 13.7 ± 28.2% in the EBV group and -3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, -8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. -17.34 ± 52.8 m). Target lobe volume reduction at 3 months was -1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves. CONCLUSIONS:EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.
RCT Entities:
RATIONALE: Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema. OBJECTIVES: To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system. METHODS: Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George's Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction. MEASUREMENTS AND MAIN RESULTS: Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV1 from baseline was 13.7 ± 28.2% in the EBV group and -3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, -8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. -17.34 ± 52.8 m). Target lobe volume reduction at 3 months was -1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves. CONCLUSIONS:EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.
Authors: Wassim W Labaki; Carlos H Martinez; Fernando J Martinez; Craig J Galbán; Brian D Ross; George R Washko; R Graham Barr; Elizabeth A Regan; Harvey O Coxson; Eric A Hoffman; John D Newell; Douglas Curran-Everett; James C Hogg; James D Crapo; David A Lynch; Ella A Kazerooni; MeiLan K Han Journal: Am J Respir Crit Care Med Date: 2017-12-01 Impact factor: 21.405