- In patients with heterogeneous emphysema distribution and absence of collateral ventilation (CV), Zephyr endobronchial valves (EBVs) improve lung function, dyspnoea, exercise tolerance, and QoL over the current standard of care (SoC) medical therapy.
Why this matters
- Previous single-centre randomised controlled clinical trials reported significant benefits with EBVs over best medical care.
- This is the first multicentre study in patients with heterogeneous emphysema and without CV.
- Responder rates (≥12% improvement in FEV1) were 55.4% in the EBV group and 6.5% in the SoC group (P<.001) at 3 mo post-procedure, and 56.3% vs 3.2% (P<.001) at 6 mo.
- EBV achieved greater improvements in residual volume (−0.7 L; P=.002), 6-min walking distance (78.7 m; P<.001), St. George’s Respiratory Questionnaire total score (−6.5 points; P=.031), and BODE Index score (−1.8 points; P<.001).
- At 6 mo, there were 44 respiratory-related serious adverse events (SAEs) in 31 (47.7%) patients in the EBV group compared with 4 events in 3 (9.4%) patients in the SoC group (P<.001).
- Most SAEs occurred within 30 d of the procedure.
- Over 6 mo, there were 20 pneumathoraces in 19/65 (29.2%) EBV patients, with a median time to onset of 1 d.
- Prospective, multicentre randomised controlled trial involving 97 patients.
- Funding: Pulmonx Corporation.
- Small sample.
- Follow-up only 6 mo.
- No sham bronchoscopy.