title: Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema.
abstract: OBJECTIVE
  Bronchoscopic lung volume reduction coil (LVR-coil) treatment has been shown to be safe and clinically effective in patients with severe emphysema in the short term; however, long-term safety and effectiveness has not been evaluated. The aim of this study was to investigate the long-term safety and effectiveness of LVR-coil treatment in patients with severe emphysema.
  
  
  METHODS
  Thirty-eight patients with severe emphysema (median age is 59 years, forced expiratory volume in 1 s is 27% predicted) who were treated in LVR-coil clinical trials were invited for a voluntary annual visit. Safety was evaluated by chest X-ray and recording of adverse events and by efficacy by pulmonary function testing, 6-min walk distance (6MWD) and questionnaires.
  
  
  RESULTS
  Thirty-five patients visited the hospital 1 year, 27 patients 2 years and 22 patients 3 years following coil placement. No coil migrations were observed on X-rays. At 1-year follow-up, all clinical outcomes significantly improved compared with baseline. At 2 years, residual volume % pred, modified Medical Research Council (mMRC) and the SGRQ score were still significantly improved. At 3 years, a significant improvement in mMRC score remained, with 40% of the patients reaching the 6MWD minimal important difference, and 59% for the St George's Respiratory Questionnaire (SGRQ) minimal important difference.
  
  
  CONCLUSIONS
  Follow-up of the patients treated with LVR-coils in our pilot studies showed that the coil treatment is safe with no late pneumothoraces, coil migrations or unexpected adverse events. Clinical benefit gradually declines over time; at 3 years post-treatment, around 50% of the patients maintained improvement in 6MWD, SGRQ and mMRC.
  
  
  BACKGROUND
  NCT01220908 and NCT01328899 registered at ClinicalTrials.gov.
authors.affiliation: Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Jorine E
authors.initials: JE
authors.lastname: Hartman
authors.forename: Karin
authors.initials: K
authors.lastname: Klooster
authors.forename: Kiki
authors.initials: K
authors.lastname: Gortzak
authors.forename: Nick H T
authors.initials: NH
authors.lastname: ten Hacken
authors.forename: Dirk-Jan
authors.initials: DJ
authors.lastname: Slebos
mesh_terms: D000368:Aged; D001999:Bronchoscopy / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D008176:Lung Volume Measurements; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011656:Pulmonary Emphysema / Q000503:physiopathology* / Q000628:therapy*; D012115:Residual Volume; D011795:Surveys and Questionnaires; D013997:Time Factors
keywords: bronchoscopy and interventional technique; clinical respiratory medicine; coil; emphysema; long-term follow-up