A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE) 

Criner GJ et al. 

Am J Respir Crit Care Med. Volume 198, Issue 9, November 2018, Pages 1151-1164

Abstract

What is the key question?

  • In patients with severe heterogeneous emphysema and little-to-no collateral ventilation, does bronchoscopic lung volume reduction (BLVR) using the Zephyr Endobronchial Valve (EBV) improve the post-bronchodilator (post-BD) FEV1 (increase by ≥15%) at 1 year compared to standard of care (SoC)?

What is the bottom line?

  • Patients with advanced emphysema are characterized by hyperinflation that precipitates breathlessness and predisposes individuals to exacerbations.
  • Lung volume reduction surgery (LVRS) is underused because of concerns about the invasiveness of the procedure, increased associated perioperative morbidity and mortality, and narrow patient eligibility criteria.
  • Lobar deflation from the EBV leads to partial or full lobar atelectasis, thus reducing hyperinflation and mimicking the mechanisms of LVRS. In a post hoc analysis of the VENT trial, only patients with complete fissures in the treated lung and in whom lobar occlusion was achieved had clinically meaningful outcomes.
  • This randomized controlled multicenter international trial (LIBERATE) enrolled 190 subjects with severe heterogeneous emphysema and little-to-no collateral ventilation. Subjects were randomized 2:1 to Zephyr EBV stents versus SoC.
  • Results showed that Zephyr EBV treatment in carefully selected patients with little or no collateral ventilation in the target lobe provides clinically meaningful and statistically significant benefits in lung function, exercise tolerance, dyspnea, and quality of life over current SoC medical therapy out to at least 12 months. The benefits are comparable with those seen with LVRS but with a reduction in post-procedure morbidity.

Why read on?

  • BLVR with the Zephyr EBV provides a viable treatment option for patients with severe emphysema and hyperinflation.