Outcomes in early trials of bronchoscopic lung volume reduction using endobronchial valves for the treatment of patients with advanced emphysema were inconsistent. However improvements in patient selection with focus on excluding those with interlobar collateral ventilation and homogeneous emphysema resulted in significant benefits in the BeLieVeR-HIFi study compared with sham treated controls. In this manuscript we present data from the control patients in the BeLieVeR-HIFi study who went on to have open label endobronchial valve treatment after completion of the clinical trial (n=12), combined with data from those in the treatment arm who did not have collateral ventilation (n=19). Three months after treatment FEV1 increased by 27.3 (36.4)%, residual volume reduced by 0.49 (0.76) L, the 6 min walk distance increased by 32.6 (68.7) m and the St George Respiratory Questionnaire for COPD score improved by 8.2 (20.2) points. These data extend the evidence for endobronchial valve placement in appropriately selected patients with COPD.
Trial registration number: ISRCTN04761234; Results.
- Lung Volume Reduction Surgery
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Contributors NSH, MIP, SJ, PLS developed the study. NSH, MIP, SJ, DHC were involved in patient selection. PLS, ZZ and WHM performed procedures. CD performed assessments. ZZ performed statistical analyses. ZZ and NSH prepared the first draft of this paper which all authors subsequently contributed to and approved. NSH is the guarantor.
Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme (Grant number: EME 10/90/10) and is funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership. The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland. It is managed by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton. The study was supported by the NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London who part funded MIP's salary and wholly funded ZZ's salary. The endobronchial valves were provided free of charge by the manufacturers PulmonX Ltd. PulmonX had no input into the trial design, data analysis or presentation. The views expressed in this publication are those of the authors and not necessarily those of the MRC, NHS, NIHR or the UK Department of Health.
Competing interests PLS, SJ, MIP, ZZ, WHM and NSH have been investigators in trials of endobronchial valves, coils, thermal ablation and the airway bypass procedure, and the authors' institution reimbursed for trial expenses by the device manufacturers.
Ethics approval London—Bentham Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Requests for anonymised individual patient data can be made to the corresponding author.
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