title: A randomized study of endobronchial valves for advanced emphysema.
abstract: BACKGROUND
  Endobronchial valves that allow air to escape from a pulmonary lobe but not enter it can induce a reduction in lobar volume that may thereby improve lung function and exercise tolerance in patients with pulmonary hyperinflation related to advanced emphysema.
  
  
  METHODS
  We compared the safety and efficacy of endobronchial-valve therapy in patients with heterogeneous emphysema versus standard medical care. Efficacy end points were percent changes in the forced expiratory volume in 1 second (FEV1) and the 6-minute walk test on intention-to-treat analysis. We assessed safety on the basis of the rate of a composite of six major complications.
  
  
  RESULTS
  Of 321 enrolled patients, 220 were randomly assigned to receive endobronchial valves (EBV group) and 101 to receive standard medical care (control group). At 6 months, there was an increase of 4.3% in the FEV1 in the EBV group (an increase of 1.0 percentage point in the percent of the predicted value), as compared with a decrease of 2.5% in the control group (a decrease of 0.9 percentage point in the percent of the predicted value). Thus, there was a mean between-group difference of 6.8% in the FEV1 (P=0.005). Roughly similar between-group differences were observed for the 6-minute walk test. At 12 months, the rate of the complications composite was 10.3% in the EBV group versus 4.6% in the control group (P=0.17). At 90 days, in the EBV group, as compared with the control group, there were increased rates of exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization (7.9% vs. 1.1%, P=0.03) and hemoptysis (6.1% vs. 0%, P=0.01). The rate of pneumonia in the target lobe in the EBV group was 4.2% at 12 months. Greater radiographic evidence of emphysema heterogeneity and fissure completeness was associated with an enhanced response to treatment.
  
  
  CONCLUSIONS
  Endobronchial-valve treatment for advanced heterogeneous emphysema induced modest improvements in lung function, exercise tolerance, and symptoms at the cost of more frequent exacerbations of COPD, pneumonia, and hemoptysis after implantation. (Funded by Pulmonx; ClinicalTrials.gov number, NCT00129584.)
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA. sciurbafc@upmc.edu
authors.forename: Frank C
authors.initials: FC
authors.lastname: Sciurba
authors.forename: Armin
authors.initials: A
authors.lastname: Ernst
authors.forename: Felix J F
authors.initials: FJ
authors.lastname: Herth
authors.forename: Charlie
authors.initials: C
authors.lastname: Strange
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Criner
authors.forename: Charles H
authors.initials: CH
authors.lastname: Marquette
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Kovitz
authors.forename: Richard P
authors.initials: RP
authors.lastname: Chiacchierini
authors.forename: Jonathan
authors.initials: J
authors.lastname: Goldin
authors.forename: Geoffrey
authors.initials: G
authors.lastname: McLennan
mesh_terms: D000328:Adult; D000368:Aged; D019072:Antibiotic Prophylaxis; D001993:Bronchodilator Agents / Q000627:therapeutic use; D001999:Bronchoscopy; D017079:Exercise Tolerance; D005541:Forced Expiratory Volume; D006801:Humans; D008875:Middle Aged; D011013:Pneumonectomy / Q000379:methods; D016016:Proportional Hazards Models; D019736:Prostheses and Implants; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications; D011656:Pulmonary Emphysema / Q000150:complications / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D012143:Respiratory Physiological Phenomena
chemical_list: D001993:Bronchodilator Agents