A New-Designed Lung-Bending Device for Bronchoscopic Lung Volume Reduction of Severe Emphysema: A Feasibility Study in Pigs

Abstract

Background: Bronchoscopic therapies are less invasive alternatives of surgical lung volume reduction for severe emphysema. Bending of lung tissue by implanting metallic coils into bronchi is one of the procedures. A new-designed device with a similar rationale, Reverser, has been developed with some improvements. Objectives: The aim of the study was to evaluate the safety and feasibility of the Reversers. Methods: Twelve healthy pigs were randomly divided into 3 groups (groups A, B, and C). The Reversers were implanted bronchoscopically into the selected airways using a proprietary delivery system. Physical examination, chest fluoroscopy, computed tomography (CT) scans, and bronchoscopic observations were performed before implantation and during the follow-up period. Necropsy was performed respectively at 1 month (group A), 3 months (group B), and 6 months (group C) after implantation. Results: A total of 47 Reversers were implanted successfully. The procedure was feasible and well tolerated by all pigs. No severe complications, such as pneumothorax, abscesses, and airway hemorrhage, were found. No unintended injuries or death occurred. Mild granulation and inflammation were observed in the airway wall. Opacities around Reversers were shown on CT scans in some pigs. In the pigs with opacities, histological evaluation revealed widened alveolar septa due to inflammatory cell infiltration in the vicinity of the Reversers. On the analysis of CT data, there was a trend for volume reduction of the treated lung at 1 and 3 months after treatment compared with baseline. Conclusions: This study showed that Reversers were safe and feasible for bronchoscopic lung volume reduction in pigs.