What is the key question?

• What is the effectiveness and safety of bronchoscopic lung volume reduction (BLVR) with the Spiration Valve System (SVS) in patients with severe heterogeneous emphysema compared to optimal medical management?

What is the bottom line?

• There is a need for minimally invasive, non-surgical, treatment options for patients with severe emphysema.
• This multicenter study randomized subjects in a 2:1 unblinded fashion to SVS with medical management (treatment) versus medical management alone (control).
• Eligible subjects had mMRC ≥ 2, post-bronchodilator FEV1 ≤ 45% predicted, TLC ≥ 100% predicted and RV ≥ 150% predicted.
• Investigators used High-Resolution Computed Tomography (HRCT) analysis to identify their BLVR candidates. They chose subjects with >40% emphysema destruction in the target lobe and a >10% disease emphysema severity difference with the ipsilateral lobe. The target and ipsilateral lobes were required to be separated by an intact fissure, estimated visually to be >90% complete with no segmental vessels crossing between adjacent lobes.
• Unlike the LIBERATE trial with the Zephyr valves, they did not assess for collateral ventilation using an endobronchial balloon-tipped catheter (Chartis System) to measure flow and pressure distally in the targeted lobe and relied entirely on the fissure integrity analysis provided by the HRCT.
• Enrolled subjects had to complete a pulmonary rehabilitation (PR) program in the 2 years prior but were not required to maintain a supervised PR throughout the study follow-up. The intent was to reflect real-life poor adherence of COPD patients to PR.
• This study found that BLVR using SVS to treat severe heterogeneous emphysema subjects with maintained fissure integrity achieved significant improvements in FEV1, hyperinflation, target lobe volume (TLV), dyspnea, and quality of life measures compared with optimal medical management alone.
• Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax.

Why read on?

• BLVR with SVS can improve FEV1, dyspnea and quality of life in selected patients with severe emphysema. Although there are risks with the therapy, they are mostly manageable.
• The results of this study, like other valve trials, have led to the inclusion of endobronchial valve therapy as a treatment option for the underserved patient population with severe emphysema.