PMID- 27580428
OWN - NLM
STAT- MEDLINE
DCOM- 20170707
LR  - 20220408
IS  - 1535-4970 (Electronic)
IS  - 1073-449X (Linking)
VI  - 194
IP  - 9
DP  - 2016 Nov 1
TI  - Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from 
      the IMPACT Study.
PG  - 1073-1082
AB  - 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 FEV(1) (liters) at 3 months relative to baseline in the EBV group 
      versus the SoC group. Secondary outcomes included changes in FEV(1), 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]; FEV(1), % 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 FEV(1) 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.
FAU - Valipour, Arschang
AU  - Valipour A
AD  - 1 Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner 
      Spital, Vienna, Austria.
FAU - Slebos, Dirk-Jan
AU  - Slebos DJ
AD  - 2 Department of Pulmonary Diseases, University of Groningen, and University 
      Medical Center Groningen, Groningen, the Netherlands.
FAU - Herth, Felix
AU  - Herth F
AD  - 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.
FAU - Darwiche, Kaid
AU  - Darwiche K
AD  - 4 Department of Interventional Pneumology, Ruhrlandklinik, West German Lung 
      Center, University Clinic Essen, Essen, Germany.
FAU - Wagner, Manfred
AU  - Wagner M
AD  - 5 Department of Respiratory Medicine, Allergology and Sleep Medicine, General 
      Hospital Nuernberg, and Paracelsus Medical University, Nuremberg, Germany.
FAU - Ficker, Joachim H
AU  - Ficker JH
AD  - 5 Department of Respiratory Medicine, Allergology and Sleep Medicine, General 
      Hospital Nuernberg, and Paracelsus Medical University, Nuremberg, Germany.
FAU - Petermann, Christoph
AU  - Petermann C
AD  - 6 Lungenabteilung, Thoraxzentrum Hamburg, Asklepios Klinik, Hamburg, Germany.
FAU - Hubner, Ralf-Harto
AU  - Hubner RH
AD  - 7 Charite Campus Virchow-Klinikum, Berlin, Germany; and.
FAU - Stanzel, Franz
AU  - Stanzel F
AD  - 8 Lungenklinik Hemer, Hemer, Germany.
FAU - Eberhardt, Ralf
AU  - Eberhardt R
AD  - 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.
CN  - IMPACT Study Team
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
SB  - IM
CIN - Am J Respir Crit Care Med. 2016 Nov 1;194(9):1039-1040. PMID: 27797610
MH  - Bronchi/diagnostic imaging/pathology/*surgery
MH  - Cross-Over Studies
MH  - Female
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pneumonectomy/methods
MH  - Pneumothorax/etiology
MH  - Prospective Studies
MH  - *Prostheses and Implants/adverse effects
MH  - Pulmonary Emphysema/diagnostic imaging/pathology/*surgery
MH  - Tomography, X-Ray Computed
OTO - NOTNLM
OT  - collateral ventilation
OT  - endobronchial valve
OT  - homogeneous emphysema
OT  - lobar occlusion
OT  - lung volume reduction
EDAT- 2016/11/01 06:00
MHDA- 2017/07/08 06:00
CRDT- 2016/09/01 06:00
PHST- 2016/11/01 06:00 [pubmed]
PHST- 2017/07/08 06:00 [medline]
PHST- 2016/09/01 06:00 [entrez]
AID - 10.1164/rccm.201607-1383OC [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 2016 Nov 1;194(9):1073-1082. doi: 
      10.1164/rccm.201607-1383OC.