title: Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema.
abstract: BACKGROUND
  The lung volume reduction coil (LVR-coil), a new experimental device to achieve lung volume reduction by bronchoscopy in patients with severe emphysema, works in a manner unaffected by collateral airflow. We investigated the safety and efficacy of LVR-coil treatment in patients with heterogeneous emphysema.
  
  
  METHODS
  In this prospective cohort pilot study, patients were treated bronchoscopically with Nitinol LVR-coils under fluoroscopic guidance in either one procedure or two sequential procedures. Follow-up tests included the St. George Respiratory Questionnaire (SGRQ), pulmonary function testing, and the 6-min walk test (6MWT).
  
  
  RESULTS
  Twenty-eight LVR-coil procedures were performed in 16 patients (baseline FEV₁, 28% [± 7.6%] predicted). Four patients were treated in one lung, and 12 patients were treated in both lungs. A median of 10 (5-12) coils was placed per lung in 36.5 (20-60) min. Adverse events (AEs) rated as possibly related to either the device or the procedure < 30 days after treatment were pneumothorax (n ± 1), pneumonia (n ± 2), COPD exacerbation (n ± 6), chest pain (n ± 4), and mild (< 5 mL) hemoptysis (n ± 21). From 30 days to 6 months, the AEs that occurred were pneumonia (n ± 3) and COPD exacerbation (n ± 14). All events resolved with standard care. Six months after LVR-coil treatment, there were significant improvements in SGRQ (-14.9 points [± 12.1 points, with 11 patients improving by > 4 points]), FEV₁ (+14.9% ± 17.0%), FVC (+13.4% ± 12.9%), residual volume (-11.4% ± 9.0%), and 6MWT (+84.4 ± 73.4 m), all P < .005.
  
  
  CONCLUSIONS
  LVR-coil treatment is a promising technique for the treatment of patients with severe heterogeneous emphysema. The treatment is technically feasible and results in significant improvements in pulmonary function, exercise capacity, and quality of life, with an acceptable safety profile.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.:NCT01220908; URL: www.clinicaltrials.gov
authors: Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Electronic address: d.j.slebos@long.umcg.nl.
authors: Dirk-Jan
authors: DJ
authors: Slebos
authors: Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors: Karin
authors: K
authors: Klooster
authors: Department of Pulmonary, Critical Care and Sleep Medicine, St. Elizabeth Medical Center/Tufts University School of Medicine, Boston, MA.
authors: Armin
authors: A
authors: Ernst
authors: Department of Pneumology and Critical Care Medicine, Thoraxklinik, Heidelberg, Germany.
authors: Felix J F
authors: FJF
authors: Herth
authors: Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors: Huib A M
authors: HAM
authors: Kerstjens
mesh_terms: D000368:Aged; D001999:Bronchoscopy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D002637:Chest Pain / Q000453:epidemiology / Q000209:etiology; D004646:Emphysema / Q000601:surgery*; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006469:Hemoptysis / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011013:Pneumonectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D011014:Pneumonia / Q000453:epidemiology / Q000209:etiology; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome