title: Characterization of outcomes 1 year after endoscopic thermal vapor ablation for patients with heterogeneous emphysema.
abstract: BACKGROUND
  Endoscopic lung volume reduction has been developed as a therapeutic option for advanced emphysema. Six-month results following treatment with endoscopic thermal vapor ablation (InterVapor; Uptake Medical, Tustin, CA) were described previously, and here we report observations from the 12-month assessment.
  
  
  METHODS
  Two multicenter, international, single-arm trials of InterVapor (unilateral upper lobe treatment) in patients with upper lobe predominant emphysema were conducted.
  
  
  METHODS
  forced expiratory volume in 1 second (FEV(1)) 15%-45% predicted, residual volume > 150%, total lung capacity > 100%, 6-minute walk distance (6MWD) > 140 m, and diffusing capacity for carbon monoxide > 20% predicted. Efficacy endpoints: spirometry, body plethysmography, lung volumes by high-resolution computed tomography, St George's Respiratory Questionnaire, modified Medical Research Council dyspnea scale, and 6MWD. All adverse events were collected and independently adjudicated.
  
  
  RESULTS
  Forty four patients were treated at a mean (standard deviation) age of 63 (5.6) years, FEV(1) 0.86 mL (0.25 mL) (n = 22 men and 22 women). Mean (standard deviation) changes from baseline at 12 months were: FEV(1) 86.2 mL (173.8 mL), St George's Respiratory Questionnaire -11.0 (14.0) units, treated lobar volume from high-resolution computed tomography -751.8 mL (653.9 mL), residual volume -302.8 mL (775.6 mL), 6MWD 18.5 m (63.7 m), and modified Medical Research Council dyspnea scale score -0.83 (0.97) (P < 0.05 for all except 6MWD). Improvements were numerically larger at 6 versus 12 months. GOLD stage III and IV patients had similar outcomes at 6 months; however, improvements relative to baseline were numerically higher in GOLD stage IV patients. Larger improvements were observed in patients with higher heterogeneity. In total, 39 serious adverse events were reported in 23 patients with 10 events in 8 patients between 6 and 12 months.
  
  
  CONCLUSIONS
  Unilateral lobar InterVapor treatment of heterogeneous emphysema improved lung function and health outcomes 1 year following treatment. The magnitude of improvement was larger at 6 months compared to 12 months. Improvements relative to baseline continue to be exhibited at 12 months despite the expected disease related decline over time.
authors.affiliation: Department of Pneumology and Critical Care Medicine, Thoraxklinik Heidelberg, German Center for Lung Research, University of Heidelberg, Heidelberg, Germany. felix.herth@thoraxklinik-heidelberg.de
authors.forename: Felix J F
authors.initials: FJ
authors.lastname: Herth
authors.forename: Armin
authors.initials: A
authors.lastname: Ernst
authors.forename: Kimberly M
authors.initials: KM
authors.lastname: Baker
authors.forename: Jim J
authors.initials: JJ
authors.lastname: Egan
authors.forename: Mark H
authors.initials: MH
authors.lastname: Gotfried
authors.forename: Peter
authors.initials: P
authors.lastname: Hopkins
authors.forename: Franz
authors.initials: F
authors.lastname: Stanzel
authors.forename: Arschang
authors.initials: A
authors.lastname: Valipour
authors.forename: Manfred
authors.initials: M
authors.lastname: Wagner
authors.forename: Christian
authors.initials: C
authors.lastname: Witt
authors.forename: Steven
authors.initials: S
authors.lastname: Kesten
authors.forename: Gregory
authors.initials: G
authors.lastname: Snell
mesh_terms: D055011:Ablation Techniques / Q000009:adverse effects; D000368:Aged; D001315:Australia; D001999:Bronchoscopy / Q000009:adverse effects; D005060:Europe; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000503:physiopathology / Q000601:surgery*; D008176:Lung Volume Measurements; D008297:Male; D008875:Middle Aged; D010993:Plethysmography, Whole Body; D011013:Pneumonectomy / Q000009:adverse effects / Q000379:methods*; D011653:Pulmonary Diffusing Capacity; D011656:Pulmonary Emphysema / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D020127:Recovery of Function; D012115:Residual Volume; D012720:Severity of Illness Index; D013147:Spirometry; D011795:Surveys and Questionnaires; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D014109:Total Lung Capacity; D016896:Treatment Outcome; D014481:United States; D016138:Walking