In selected patients with emphysema endobronchial valve placement results in improvements in lung function similar to that seen with lung volume reduction surgery, an independent randomised trial finds.
The single-centre, double-blind sham-controlled BeLieVeR-HIFi study involved 50 stable outpatients with both heterogeneous emphysema and a target lobe with intact interlobar fissures on CT of the thorax.
Participants were randomised (1:1) to receive either valves placed to achieve unilateral lobar occlusion (bronchoscopic lung volume reduction/BLVR) or a bronchoscopy with sham valve placement (control).
Patients and researchers were masked to treatment allocation and the study was powered to detect a 15% improvement in the primary endpoint, the FEV1 three months after the procedure.
Results showed that in the BLVR group, FEV increased by a median 8·77% (IQR 2·27–35·85) versus 2·88% (0–8·51) in the control group (p=0·0326).
The BLVR group also had a significant improvement in 6 min walking distance and TLIM on cycle ergometry.
This result was accompanied by significant improvements in lung volumes and gas transfer, reported the researchers led by Nicholas Hopkinson from The Royal Brompton Hospital in London.
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.
“Our data suggest that in appropriately selected patients, endobronchial valve placement results in improvements in lung function which are of a similar order of magnitude to those seen with LVRS,” the researchers wrote in the Lancet.
The improvement in gas transfer was important because it was the lung function variable most strongly associated with survival in people with COPD, they said.
However they noted that a key issue was the safety of this treatment approach as spontaenous pneumothorax could occur when valve placement leads to a change in the conformation of the lung.
In the study pneumothorax occurred in two treated patients (8%) and in one control patient (4%).
It was important that patients were selected who were considered likely to be able to withstand the associated acute lung function impairment a pneumothorax will cause, they said.
Further work was needed to establish how the technique should best be deployed relative to LVRS and other developing techniques, such as lung volume reduction coils and bronchoscopic thermal vapour ablation, they added.
The study was funded by the UK National Institute for Health Research and therefore independent of industry, the study authors noted.