Abstract
Objective(s): This open labeled multicenter study was performed to evaluate the safety and efficacy of single-session bilateral 4-site lung volume reduction therapy with the AeriSeal® Emphysematous Lung Sealant System (ELS) in patients with advanced upper lobe heterogeneous (ULP) and homogeneous (Ho) emphysema.
Methods: 20 patients with advanced Ho (n=4) and ULP (n=16) emphysema received 4-site bilateral upper lobe volume reduction with ELS under conscious sedation. Outcome measures include pulmonary function tests (at 6, 12 and 24 wks), exercise capacity, symptoms, and health related quality of life (HRQL, at 12 and 24 wks).
Results: 4-site therapy was well tolerated. Procedure duration was 14±4 minutes. Average hospital length of stay was 0.9±1.5 days. There were 5 SAEs during the first 85±32 days of follow-up (3 treatment related, 1 COPD exacerbation). Interim 6-week results (n=14; ΔFEV1 = +16.1±27.5%; ΔFVC =+10.7±17.4%) demonstrated clinically significant improvements in spirometry (Δ > +12%) in 8 of 14 patients. 12 week data for the first 4 patients demonstrated additional physiological improvement (ΔFEV1 = +37.6%; ΔFVC = +14.1%) from their corresponding 6-week responses (ΔFEV1 = +17.1%; ΔFVC = 8.2%).
Conclusions: Bilateral single session endoscopic lung volume reduction therapy can be achieved safely using ELS in patients with advanced Ho and ULP emphysema under conscious sedation. Initial results indicate that efficacy responses are similar to those reported with surgical volume reduction, and treatment is associated with short hospital length of stay and minimal morbidity.
- © 2011 ERS