Cited by 10Chronic Obstructive Pulmonary Disease (COPD) ResearchRespiratory Support and MechanismsInhalation and Respiratory Drug Delivery

A randomised controlled study of Bronchoscopic Lung Volume Reduction with endobronchial valves for patients with Heterogeneous emphysema and Intact interlobar Fissures: the BeLieVeR-HIFi study

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Zoumot, Zaid, Davey, Claire, Jordan, Simon, McNulty, William H, Carr, Denis H, Hind, Matthew D, Hansell, David M, Rubens, Michael B +4 more·2015·Efficacy and Mechanism Evaluation

Abstract

Background Despite optimal therapy many patients with emphysema remain significantly breathless and limited. Bronchoscopic lung volume reduction (BLVR), using valves placed to allow air to leave but not enter the worst-affected areas of the lung, has been proposed as a way to improve lung function in these patients, but response is variable because interlobar collateral ventilation prevents the devices from working. Based on retrospective analysis of clinical trials, patients with heterogeneous emphysema and intact interlobar fissures are most likely to benefit. Objectives To establish whether or not it is possible to identify patients prospectively who will reliably benefit from endobronchial valve placement. Design Prospective, randomised, parallel-group, double-blind, sham-controlled trial. Setting The study was performed at a single specialist centre. Participants Adult patients with heterogeneous emphysema and a target lobe with intact interlobar fissures were eligible if they had significant gas trapping (total lung capacity > 100% predicted, residual volume > 150% predicted), breathlessness [Medical Research Council (MRC) dyspnoea score of ≥ 3] and exercise limitation (6-minute walk distance of < 450 m). Participants were on optimised pharmacotherapy and were non-smokers. Interventions Study participants were randomised to either unilateral lobar endobronchial valve placement aiming to achieve lobar atelectasis or bronchoscopy and ‘sham’ valve placement. Main outcome measures The primary end point was improvement in forced expiratory volume in 1 second (FEV1) in the treatment arm compared with the control arm measured 90 days post procedure. Secondary end points were change in lung volumes, gas transfer, exercise capacity (both walking and endurance cycle ergometry) and health-related quality of life. Results In total, 50 patients were recruited, 25 to each arm; 62% were male and mean (standard deviation) FEV1% predicted was 31.7% (10.2%). The primary end point of the study was met as FEV1increased by 24.8% [95% confidence interval (CI) 8.0% to 41.5%] in the treatment arm and by 3.9% (95% CI 0.7% to 7.1%) in the control arm [between-group difference 20.9% (95% CI 4.3% to 37.5%);p = 0.033]. There were both statistically and clinically significant improvements in lung volumes and carbon monoxide gas transfer as well as endurance time and dynamic hyperinflation during cycle ergometry. Two deaths occurred in the treatment arm and one control patient was unable to attend for follow-up assessment because of a prolonged pneumothorax. Two pneumothoraces occurred in the treatment arm. Conclusions With appropriate selection of patients through a multidisciplinary team it is possible to produce a significant improvement in lung function through lobar occlusion with endobronchial valves in heterogeneous emphysema. Prospective trials are needed to compare the effect of BLVR with surgical approaches in terms of magnitude and duration of benefit. Trial registration Current Controlled Trials ISRCTN04761234. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.

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  • Breathlessness severity is not reliably predicted by the severity of airflow limitation/lung pathology in COPD.

    “Its intensity is not reliably predicted by the severity of lung pathology”

    From The Breathing, Thinking, Functioning clinical model: a proposal to facilitate evidence-based breathlessness management in chronic respiratory disease (2017) · cites this paper as [9]

    The Results section reports that improved FEV1 was associated with reduced breathlessness during exercise, but does not assess whether the severity of lung pathology reliably predicts breathlessness intensity. Searches for that relationship, including dyspnoea severity and airflow obstruction, found no passage addressing the claim. (LLM, conf=0.72)

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  1. Davey C, Zoumot Z, Jordan S, McNulty WH, Carr DH, Hind MD, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (The BeLieVeR-HIFi study) -a randomised controlled trial. Lancet 2015; in press.

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Authors
Zoumot, Z., Davey, C., Jordan, S., McNulty, W. H., Carr, D. H., Hind, M. D., Hansell, D. M., Rubens, M. B., Banya, W., Polkey, M. I., Shah, P. L., & Hopkinson, N. S.
Affiliations
Royal Brompton & Harefield NHS Foundation Trust (GB)
Venue
Efficacy and Mechanism Evaluation
Published
2015-09
Volume
2
Issue
5
Pages
1-34
ISSN
  • 2050-4365 (ISSN-L)
  • 2050-4373
OpenAlex
W2413332282
Cited by
10
References
57
Citations by year
2025: 1 · 2022: 1 · 2021: 2 · 2020: 1 · 2018: 1 · 2017: 1 · 2016: 2 · 2014: 1
FWCI
1.06
Type
journal article
Language
en
Open access
Locations
  • Efficacy and Mechanism Evaluation (publishedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • Efficacy and Mechanism Evaluation programme (10/90/10)
  • Medical Research Council
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Inhalation and Respiratory Drug Delivery
Keywords
heterogeneous emphysema, endobronchial valves, bronchoscopic lung volume reduction, interlobar fissure, lobar atelectasis, air trapping, FEV1, dyspnea, exercise capacity, lung function, patient selection, health-related quality of life, lung volume, gas transfer, cycle ergometry, 6-minute walk distance, chronic obstructive pulmonary disease

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