Bronchoscopic lung volume reduction for patients with emphysema

Conditions

COPD - heterogeneous emphysema Respiratory Emphysema

Zoumot Z, Davey C, Jordan S, McNulty WH, Carr DH, Hind MD, Polkey MI, Shah PL, Hopkinson NS.

2016-12-2014 citations

10.1136/thoraxjnl-2016-208865

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

Zaid Zoumot, Claire Davey, Simon Jordan, William McNulty, Denis H. Carr et al. (12 authors)

Efficacy and Mechanism Evaluation2015-09-0110 citations

10.3310/eme02050

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

Davey C, Zoumot Z, Jordan S, McNulty WH, Carr DH, Hind MD, Hansell DM, Rubens MB, Banya W, Polkey MI, Shah PL, Hopkinson NS.

2015-06-23244 citations

10.1016/s0140-6736(15)60001-0

Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (The BeLieVeR-HIFi trial): study design and rationale

Claire Davey, Zaid Zoumot, S. Jordan, Denis H. Carr, Michael I. Polkey et al. (7 authors)

Thorax2014-03-2453 citations

10.1136/thoraxjnl-2014-205127

Interventions

Patients in the active treatment arm would have Zephyr (Pulmonx, California) valves placed bronchoscopically to occlude all segmental bronchi of the target lobe. The one way valves are placed via a de

the x-ray will be reviewed by the treating physician.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients with stable severe COPD (GOLD stage III or IV with FEV1100%predicted, residual volume (RV)>150% predicted 4. Six minute walk distance of 2 (according to the NETT study scoring system), that it is at least 1 point higher than ipsilateral lobes and that it has intact fissures visible on at least one projection

Exclusion criteria

Exclusion criteria: 1. Significant co morbidity which limits their exercise capacity or prognosis 2. Significant daily sputum production 3. Hypoxia (i.e. PO2<6.5Pa)

Design outcomes

Primary

Measure	Time frame
The percentage change in post-bronchodilator FEV1 measured 90 days post procedure.	—

Secondary

Measure	Time frame
Exercise Secondary endpoints will be change in endurance time on cycle ergometry at 70% baseline peak workload with a metabolic measurement cart to allow measurement of dynamic hyperinflation. The endurance exercise tests will be performed immediately after the lung function testing. Patients will perform inspiratory capacity (IC) manoeuvres each minute through the test. The IC value is subtracted from TLC to calculate end expiratory lung volume (EELV). Changes in EELV at isotime will be compared. Isotime refers to the last 30 second period completed in the shorter of the two exercise tests. Patients will perform an initial incremental test with 5-10 watt increments to establish the workload for the endurance test. This will be performed on a separate day from the first endurance cycle or with at least a two hour gap to ensure recovery. A 6 minute walk test will also be performed at last one hour after the cycle test to allow time to recover according to ATS guidelines. Patients will have practised this on a previous occasion to reduce learning effects. The 6MWT has been chosen as this walking test is in the process of becoming accredited as an outcome measure by the FDA. CT scanning: Changes in CT lung volume (total and lobar) will also be assessed as explanatory variables for improvement in exercise capacity and lung function. Health status: The COPD assessment (CAT) score will be used to evaluate quality of life - this symptom score has been shown to be responsive both to exacerbations and to pulmonary rehabilitation. The SGRQ will be used alongside this as well as the EQ-5D to allow QALYs to be estimated.	—

Measure

Time frame

Exercise Secondary endpoints will be change in endurance time on cycle ergometry at 70% baseline peak workload with a metabolic measurement cart to allow measurement of dynamic hyperinflation. The endurance exercise tests will be performed immediately after the lung function testing. Patients will perform inspiratory capacity (IC) manoeuvres each minute through the test. The IC value is subtracted from TLC to calculate end expiratory lung volume (EELV). Changes in EELV at isotime will be compared. Isotime refers to the last 30 second period completed in the shorter of the two exercise tests. Patients will perform an initial incremental test with 5-10 watt increments to establish the workload for the endurance test. This will be performed on a separate day from the first endurance cycle or with at least a two hour gap to ensure recovery. A 6 minute walk test will also be performed at last one hour after the cycle test to allow time to recover according to ATS guidelines. Patients will have practised this on a previous occasion to reduce learning effects. The 6MWT has been chosen as this walking test is in the process of becoming accredited as an outcome measure by the FDA. CT scanning: Changes in CT lung volume (total and lobar) will also be assessed as explanatory variables for improvement in exercise capacity and lung function. Health status: The COPD assessment (CAT) score will be used to evaluate quality of life - this symptom score has been shown to be responsive both to exacerbations and to pulmonary rehabilitation. The SGRQ will be used alongside this as well as the EQ-5D to allow QALYs to be estimated.

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Countries

United Kingdom

Outcome results

None listed