Abstract
Introduction: Bilateral ELS therapy has previously been shown to improve physiology and functional outcomes at 1 year in patients with advanced homogenous (Ho) and upper lobe predominant (ULP) emphysema.1
Objective: Assess safety and efficacy out to 2 years post treatment.
Methods: All 18 patients (63±7 yrs, 9 ULP, 9 Ho) completing the 1 year study (NCT 01320566) enrolled in a follow-on registry (NCT 01520064). Outcomes are available for these 18 patients at 2 year follow-up.
Results: Improvements from baseline after 2 years were observed in FEV1 (mean = +14.5%; +161 mL; range -25.2% to 88.7%), FVC (+5.8%; 106 mL; range -25.1% to +62.2%), and DLco (7.7%; range -16.4% to +45.2%). Eight of 16 experienced improvements in FEV1 > 12% and 100 mL out to 2 years. Mean responses were larger, and individual responses more consistent in ULP vs. Ho patients. Between year 1 and 2, there were 3 all-cause hospitalizations: 1 episode of acute coronary syndrome requiring percutaneous stenting, 1 lung cancer, and 1 hospitalization for lung transplantation. There were no COPD exacerbations, pneumonias, or episodes of respiratory failure or hemoptysis. Change in FEV1 vs. time followed an exponential decay with a time constant of 23.4 months, predicting a >5% increase in FEV1 from baseline out to 4.1 years.
Conclusions: ELS therapy is associated with physiological benefit out to 2 years in patients with advanced emphysema with a favorable safety profile. Modeling results predict improvements in lung function beyond 4 years.
1. Kramer M.R. et al., Chest 2012; 142(5): 1111-1117.
- © 2013 ERS