title: Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort.
abstract: The Endobronchial Valve for Emphysema Palliation Trial (VENT) was a multi-centre, prospective, randomised, controlled trial conducted to evaluate the safety and effectiveness of unilateral endobronchial valve (EBV) treatment. The purpose of this analysis was to assess outcomes in the previously unreported European VENT study cohort. Patients with advanced emphysema were randomly assigned (2:1) to receive Zephyr® (Pulmonx Inc., Redwood City, CA, USA) EBV treatment (n = 111) or medical management (n = 60). At 6 months, EBV patients demonstrated a significant improvement compared with the controls for mean ± SD change in forced expiratory volume in 1 s (7 ± 20% versus 0.5 ± 19%; p = 0.067), cycle ergometry (2 ± 14 W versus -3 ± 10 W; p = 0.04) and St George's Respiratory Questionnaire (-5 ± 14 points versus 0.3 ± 13 points; p = 0.047). At 12 months, the magnitude of the difference between groups for change from baseline was of similar magnitude to the differences seen at 6 months. Rates for complications did not differ significantly. EBV patients with computed tomography (CT) scans suggestive of complete fissure and lobar occlusion had a mean ± SD lobar volume reduction of -80 ± 30% and >50% met minimal clinical difference thresholds. The degree of emphysema heterogeneity did not preclude excellent outcomes. Unilateral lobar volume reduction using EBV treatment is safe and superior clinical results correlated with CT suggestive of complete fissures and successful lobar occlusion. Emphysema heterogeneity was not critical for determining positive outcomes.
authors.affiliation: Hospital Thoraxklinik, University of Heidelberg, D-69126 Heidelberg, Germany. Felix.Herth@thoraxklinik-heidelberg.de
authors.forename: Felix J F
authors.initials: FJ
authors.lastname: Herth
authors.forename: Marc
authors.initials: M
authors.lastname: Noppen
authors.forename: Arschang
authors.initials: A
authors.lastname: Valipour
authors.forename: Sylvie
authors.initials: S
authors.lastname: Leroy
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Vergnon
authors.forename: Joachim H
authors.initials: JH
authors.lastname: Ficker
authors.forename: Jim J
authors.initials: JJ
authors.lastname: Egan
authors.forename: Stefano
authors.initials: S
authors.lastname: Gasparini
authors.forename: Carlos
authors.initials: C
authors.lastname: Agusti
authors.forename: Debby
authors.initials: D
authors.lastname: Holmes-Higgin
authors.forename: Armin
authors.initials: A
authors.lastname: Ernst
mesh_terms: D000368:Aged; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000097:blood; D011013:Pneumonectomy / Q000379:methods*; D011656:Pulmonary Emphysema / Q000000981:diagnostic imaging / Q000601:surgery*; D011788:Quality of Life; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D010100:Oxygen