Background: A clinical study was performed to assess the safety and efficacy of bilateral AeriSeal Emphysematous Lung Sealant System (ELS) treatment in patients with advanced emphysema out to 1 year.
Methods: Twenty patients received treatment at four subsegments, two in each upper lobe. Tenhad upper lobe disease, and 10 had homogeneous disease. Treatments were administered under moderate sedation. Efficacy was assessed at 3, 6, and 12 months.
Results: Procedure times were short (15.2 ± 9.6 min), and hospital length of stay averaged 1.1 days. The study was successful in reaching its primary end point of a reduction at 3 months in upper lobe lung volume assessed by quantitative CT scan analysis ( - 895 ± 484 mL, P < .001). Treatment was associated with improvements in spirometry ( Δ FEV 1 at 6 months = 31.2% ± 36.6%, 12 months = 25.0% ± 33.4%), gas trapping ( Δ residual volume/total lung capacity at 6 months = 2 7.2% 12.7%, 12 months = - 10.9% 14.0%), diffusing capacity of lung for carbonmonoxide (6 months = 12.7% ± 16.4%, 12 months = 12.3% ± 21.1%), symptom scores ( Δ Medical Research Council dyspnea score at 6 months = median 0, range - 2 to 1, 12 months = median - 1, range - 3 to 0), and health-related quality of life ( Δ St. George Respiratory Questionnaire at 6 months = 8.0 ± 17.2 U, 12 months = 7.0 ± 15.8 U). There was one serious procedural complication and seven all-cause significant respiratory adverse events over 17 patient-years of follow-up.
Conclusions: Bilateral ELS treatment administered under conscious sedation in patients with advanced emphysema is associated with short procedure time and length of hospital stay and produces physiologic and functional improvement out to 1 year.