title: Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial.
abstract: BACKGROUND
  The lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial in patients with severe emphysema.
  
  
  METHODS
  Patients were treated in 11 centres. Safety was evaluated by recording all adverse events, efficacy by the St George's Respiratory Questionnaire (SGRQ) as primary endpoint, and pulmonary function testing, modified Medical Research Council dyspnoea score (mMRC) and 6-min walk distance (6MWD) up to 12 months after the final treatment.
  
  
  RESULTS
  Sixty patients (60.9 ± 7.5 years, forced expiratory volume in 1 s (FEV(1)) 30.2 ± 6.3% pred) were bronchoscopically treated with coils (55 bilateral, 5 unilateral), with a median of 10 (range 5-15) coils per lobe. Within 30 days post-treatment, seven chronic obstructive pulmonary disease exacerbations (6.1%), six pneumonias (5.2%), four pneumothoraces (3.5%) and one haemoptysis (0.9%) occurred as serious adverse events. At 6 and 12 months, respectively, ΔSGRQ was -12.1±12.9 and -11.1±13.3 points, Δ6MWD was +29.7±74.1 m and +51.4±76 m, ΔFEV(1) was +0.11±0.20 L and +0.11±0.30 L, and ΔRV (residual volume) was -0.65±0.90 L and -0.71±0.81 L (all p<0.01). Post hoc analyses showed significant responses for SGRQ, 6MWD and RV in patients with both heterogeneous and homogeneous emphysema.
  
  
  CONCLUSIONS
  LVR coil treatment results in significant clinical improvements in patients with severe emphysema, with a good safety profile and sustained results for up to 1 year.
  
  
  BACKGROUND
  NCT01328899.
authors.affiliation: Department of Pulmonary Medicine, University Hospital of Reims, Reims, France.
authors.forename: Gaëtan
authors.initials: G
authors.lastname: Deslee
authors.affiliation: Department of Pulmonary diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Karin
authors.initials: K
authors.lastname: Klooster
authors.affiliation: Krankenhaus vom Roten Kreuz, Stuttgart, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Hetzel
authors.affiliation: Lungenklinik, Hemer, Germany.
authors.forename: Franz
authors.initials: F
authors.lastname: Stanzel
authors.affiliation: Department of Pulmonary Medicine, University Hospital of Strasbourg, Strasbourg, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Kessler
authors.affiliation: Department of Pulmonary Medicine, University Hospital of Nice, Nice, France.
authors.forename: Charles-Hugo
authors.initials: CH
authors.lastname: Marquette
authors.affiliation: Campus Charité Mitte, Berlin, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Witt
authors.affiliation: Donaustauf Hospital, Center for Pneumology, Donaustauf, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Blaas
authors.affiliation: Asklepios-Fachkliniken Munich-Gauting, Comprehensive Pneumology Center Munich, Gauting, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Gesierich
authors.affiliation: Department of Pneumology and Critical Care Medicine, Thoraxklinik, Translational Lung Research Center Heidelberg, University of Heidelberg, Heidelberg, Germany.
authors.forename: Felix J F
authors.initials: FJ
authors.lastname: Herth
authors.affiliation: University Hospital, Tübingen, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Hetzel
authors.affiliation: Diagnostic Image Analysis Group, Department of Radiology, Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands.
authors.forename: Eva M
authors.initials: EM
authors.lastname: van Rikxoort
authors.affiliation: Department of Pulmonary diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Dirk-Jan
authors.initials: DJ
authors.lastname: Slebos
mesh_terms: D000328:Adult; D001999:Bronchoscopy / Q000379:methods*; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000295:instrumentation*; D011446:Prospective Studies; D011656:Pulmonary Emphysema / Q000175:diagnosis / Q000601:surgery*; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: Bronchoscopy; Emphysema