Abstract
Background Lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves (EBVs) can improve outcomes in appropriately selected patients with emphysema. However, no direct comparison data exist to inform clinical decision-making in people who appear suitable for both procedures. Our aim was to investigate whether LVRS produces superior health outcomes when compared to BLVR at 12 months.
Methods this multi-centre, single-blind parallel-group trial randomised patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR, and compared outcomes at 1 year using the i-BODE score. This composite disease severity measure includes body mass index, airflow obstruction, dyspnoea and exercise capacity (incremental shuttle walk test). The researchers responsible for collecting outcomes were masked to treatment allocation. All outcomes were assessed in the intention-to-treat population.
Findings 88 participants (48% female, mean (sd) age 64.6 (7.7), FEV1%predicted 31.0 (7.9) were recruited at five specialist centres across the UK and randomised to either LVRS (n=41) or BLVR (n=47). At 12 months follow up, the complete i-BODE was available in 49 participants (21 LVRS/28 BLVR). Neither improvement in the i-BODE score (LVRS: −1.10 (1.44), BLVR: −0.82 (1.61) p=0.54) nor in its individual components differed between groups. Both treatments produced similar improvements in gas trapping; RV% predicted (LVRS −36.1 (−54.1, −10), BLVR: −30.1 (−53.7, −9) p=0.81). There was one death in each treatment arm.
Interpretation Our findings do not support the hypothesis that LVRS is a substantially superior treatment to BLVR in individuals who are suitable for both treatments.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: David Waller reports lecture honoraria from Pulmonx ltd, outside the submitted work.
Conflict of interest: Neil Greening reports grants from GKS, consulting fees from Genentech, lecture honoraria from AZ and Chiesi, travel support from Chiesi, outside the submitted work.
Conflict of interest: Pallav L Shah reports lecture honoraria from Pulmonx ltd, outside the submitted work.
Conflict of interest: Rocco Bilancia reports lecture honoraria and travel support from Intuitive, outside the submitted work.
Conflict of interest: Rod Lawson is a Member of British Thoracic Society COPD Specialist Advisory group, a Member of South Yorkshire Clinical Senate, and a Member of South Yorkshire and Bassetlaw Respiratory Clinical Network, outside the submitted work.
Conflict of interest: All other authors have nothing to disclose.
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- Received October 26, 2022.
- Accepted January 13, 2023.
- Copyright ©The authors 2023.
This version is distributed under the terms of the Creative Commons Attribution Licence 4.0.