title: Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study.
abstract: 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.
  
  
  
  To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system.
  
  
  
  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.
  
  
  
  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 FEV1from 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.
  
  
  
  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: 1 Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner Spital, Vienna, Austria.
authors: Arschang
authors: A
authors: Valipour
authors: 2 Department of Pulmonary Diseases, University of Groningen, and University Medical Center Groningen, Groningen, the Netherlands.
authors: Dirk-Jan
authors: DJ
authors: Slebos
authors: 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.
authors: Felix
authors: F
authors: Herth
authors: 4 Department of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Clinic Essen, Essen, Germany.
authors: Kaid
authors: K
authors: Darwiche
authors: 5 Department of Respiratory Medicine, Allergology and Sleep Medicine, General Hospital Nuernberg, and Paracelsus Medical University, Nuremberg, Germany.
authors: Manfred
authors: M
authors: Wagner
authors: 5 Department of Respiratory Medicine, Allergology and Sleep Medicine, General Hospital Nuernberg, and Paracelsus Medical University, Nuremberg, Germany.
authors: Joachim H
authors: JH
authors: Ficker
authors: 6 Lungenabteilung, Thoraxzentrum Hamburg, Asklepios Klinik, Hamburg, Germany.
authors: Christoph
authors: C
authors: Petermann
authors: 7 Charité Campus Virchow-Klinikum, Berlin, Germany; and.
authors: Ralf-Harto
authors: RH
authors: Hubner
authors: 8 Lungenklinik Hemer, Hemer, Germany.
authors: Franz
authors: F
authors: Stanzel
authors: 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.
authors: Ralf
authors: R
authors: Eberhardt
mesh_terms: D001980:Bronchi / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D018592:Cross-Over Studies; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000379:methods; D011030:Pneumothorax / Q000209:etiology; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects; D011656:Pulmonary Emphysema / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D014057:Tomography, X-Ray Computed
keywords: collateral ventilation; endobronchial valve; homogeneous emphysema; lobar occlusion; lung volume reduction