Late Breaking Abstract - A Pilot study of a novel Endoscopic Lung Volume Reduction device

Background: Several technologies and devices had been developed for endoscopic lung volume reduction (ELVR). A new device, LVR-reversers, has been developed by Lifetech Scientific but its effect is unknown. Aim: To investigate the safety and effectiveness of a novel ELVR device in pig model Method: 12 healthy Wuzhishan miniature swines were enrolled. LVR-reversers (Lifetech Scientific) were implanted under bronchoscope unilaterally by randomly deciding the treated side. The procedures were performed with the guide of fluoroscopy under general anesthesia. The LVR-reversers are helical shaped with flexible distal ends. 12 animals were randomly divided into 1, 3, 6 month endpoint groups (4 per group). Chest high resolution CT scanning were performed before procedure, and at 1, 3, 6 month after procedure for the survived animals. Bronchoscopy, gross and pathology tissue examination were performed at different endpoints. Result: In 12 procedures 47 LVR-reversers(median 4, range[2,5]) were placed into the animal bronchus. All devices were placed successfully, animals were well tolerable. The chest CT scanning of 1 month follow-up showed significant lung volume reduction (P=0.048), no pneumothorax, no hemoptysis and no device expectoration was observed. 4 animals were sacrificed at 1 month endpoint. Secretion increasing around LVR-reversers can be observed during bronchoscopy. Gross examination did not indicate any abnormality. Pathology showed alveolar space was collapsed with some fibroplasia. The study was still ongoing. Conclusion: LVR-reverser is safe and effective for ELVR in swine model in a short term observation and further research is needed for the evaluation of its long term effects.