title: A Long-Term Follow-Up Investigation of Endobronchial Valves in Emphysema (the LIVE Study): Study Protocol and Six-Month Interim Analysis Results of a Prospective Five-Year Observational Study.
abstract: BACKGROUND
  Randomized controlled trials indicate that significant lung volume reduction (ELVR) can be obtained with Zephyr® valves by occluding the target lobe in the absence of collateral ventilation, leading to relevant functional benefits in advanced emphysema patients.
  
  
  OBJECTIVE
  To observe the long-term effects of endobronchial valve (EBV) implantation in emphysema patients screened by Chartis assessment in the context of daily pulmonology practice.
  
  
  METHODS
  The LIVE Study is a prospective, observational, open-label, single-arm, multicenter trial conducted in Germany. 498 patients included in this interim analysis were enrolled between July 2, 2012, and September 16, 2014. The 6-month follow-up visit data were recorded for 343 patients (safety population), and complete data sets were available for 321 treated patients (efficacy population) - 56.4% male, age: 64.5 years, forced expiratory volume in 1 s (FEV1) % predicted: 31.3%, residual volume (RV) % predicted: 252%.
  
  
  RESULTS
  Efficacy results at 6 months: FEV1 (l) increased by +100 ml (+11.9%), RV (l) decreased by -0.42 liter, and the COPD Assessment Test score decreased by -3.14 points (each p < 0.0001). Safety outcomes: A total of 66 adverse events (AEs; with 50 serious AEs - SAEs) were reported in 55 patients (16%) during the hospital stay for EBV placement - pneumothorax (35 cases), chronic obstructive pulmonary disease (COPD) exacerbation (5 cases), and pneumonia (4 cases). During the subsequent 6-month follow-up window, 170 SAEs were recorded in 125 patients (36.4%), predominantly COPD exacerbation (53% of the SAEs).
  
  
  CONCLUSIONS
  The current results of this large-scale German observational study performed in the context of daily practice further demonstrates that ELVR with Zephyr® valves is an effective and well-tolerated treatment option in advanced emphysema.
authors: Department of Internal Medicine II - Pneumology, University of Bonn, Bonn, Germany.
authors: Dirk
authors: D
authors: Skowasch
authors: Andreas
authors: A
authors: Fertl
authors: Björn
authors: B
authors: Schwick
authors: Harald
authors: H
authors: Schäfer
authors: Andreas
authors: A
authors: Hellmann
authors: Felix J F
authors: FJ
authors: Herth
mesh_terms: D000368:Aged; D001999:Bronchoscopy / Q000009:adverse effects / Q000295:instrumentation*; D004646:Emphysema / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects / Q000706:statistics & numerical data*