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Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial

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Title: Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial
Authors: Davey, C
Zoumot, Z
Jordan, S
McNulty, WH
Carr, DH
Hind, MD
Hansell, DM
Rubens, MB
Banya, W
Polkey, MI
Shah, PL
Hopkinson, NS
Item Type: Journal Article
Abstract: Background Lung volume reduction surgery improves survival in selected patients with emphysema, and has generated interest in bronchoscopic approaches that might achieve the same effect with less morbidity and mortality. Previous trials with endobronchial valves have yielded modest group benefits because when collateral ventilation is present it prevents lobar atelectasis. Methods We did a single-centre, double-blind sham-controlled trial in patients with both heterogeneous emphysema and a target lobe with intact interlobar fissures on CT of the thorax. We enrolled stable outpatients with chronic obstructive pulmonary disease who had a forced expiratory volume in 1 s (FEV1) of less than 50% predicted, significant hyperinflation (total lung capacity >100% and residual volume >150%), a restricted exercise capacity (6 min walking distance <450 m), and substantial breathlessness (MRC dyspnoea score ≥3). Participants were randomised (1:1) by computer-generated sequence to receive either valves placed to achieve unilateral lobar occlusion (bronchoscopic lung volume reduction) or a bronchoscopy with sham valve placement (control). Patients and researchers were masked to treatment allocation. The study was powered to detect a 15% improvement in the primary endpoint, the FEV1 3 months after the procedure. Analysis was on an intention-to-treat basis. The trial is registered at controlled-trials.com, ISRCTN04761234. Findings 50 patients (62% male, FEV1 [% predicted] mean 31·7% [SD 10·2]) were enrolled to receive valves (n=25) or sham valve placement (control, n=25) between March 1, 2012, and Sept 30, 2013. In the bronchoscopic lung volume reduction group, FEV1 increased by a median 8·77% (IQR 2·27–35·85) versus 2·88% (0–8·51) in the control group (Mann-Whitney p=0·0326). There were two deaths in the bronchoscopic lung volume reduction group and one control patient was unable to attend for follow-up assessment because of a prolonged pneumothorax. Interpretation Unilateral lobar occlusion with endobronchial valves in patients with heterogeneous emphysema and intact interlobar fissures produces significant improvements in lung function. There is a risk of significant complications and further trials are needed that compare valve placement with lung volume reduction surgery.
Issue Date: 23-Jun-2015
Date of Acceptance: 23-Jun-2015
URI: http://hdl.handle.net/10044/1/33862
DOI: 10.1016/S0140-6736(15)60001-0
ISSN: 1474-547X
Publisher: Elsevier
Start Page: 1066
End Page: 1073
Journal / Book Title: Lancet
Volume: 386
Issue: 9998
Copyright Statement: © Davey et al. Open Access article distributed under the terms of CC BY.
Sponsor/Funder: National Institute for Health Research
Funder's Grant Number: UD99999959
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
MINIMAL IMPORTANT DIFFERENCE
COPD ASSESSMENT TEST
MULTICENTER
HYPERINFLATION
VALIDATION
EXERCISE
Aged
Bronchoscopy
Double-Blind Method
Exercise Tolerance
Female
Forced Expiratory Volume
Humans
Lung Volume Measurements
Male
Middle Aged
Prostheses and Implants
Prosthesis Implantation
Pulmonary Emphysema
Tomography, X-Ray Computed
Treatment Outcome
Humans
Pulmonary Emphysema
Tomography, X-Ray Computed
Bronchoscopy
Lung Volume Measurements
Forced Expiratory Volume
Treatment Outcome
Prosthesis Implantation
Double-Blind Method
Prostheses and Implants
Exercise Tolerance
Aged
Middle Aged
Female
Male
General & Internal Medicine
11 Medical and Health Sciences
Publication Status: Published
Open Access location: http://www.sciencedirect.com/science/article/pii/S0140673615600010
Online Publication Date: 2015-06-23
Appears in Collections:National Heart and Lung Institute
Faculty of Medicine