Percutaneous Left Atrial Appendage Closure With LACBES (R) Occluder - A Preclinical Feasibility Study

Background: Left atrial appendage closure (LAAC) has been developed as an alternative treatment used for the prevention of strokes in high-risk patients with atrial fibrillation. Here, a novel LAAC prosthesis (LACBES (R) device) is developed, and its translational potential is investigated by performing a pre-clinical study to evaluate its safety and effectiveness. Methods and Results: LACBES (R) occluders were implanted in 7 healthy canines percutaneously. Closure effect was evaluated by left atrial angiography. The canines were sacrificed post-procedure on days 45, 80 and 110; gross anatomy was examined subsequently. Endothelialization of device surface was evaluated by HE staining, immunofluorescence staining against CD31 and scanning electron microscope. LACBES (R) occluders were implanted in all canines successfully; a small residual shunt was observed in 1 canine immediately post procedure. One canine died of groin hematoma within 36 h, which was related to the procedure, but there was no device-related death. A layer of white transparent tissue that failed to cover the nut was formed on the surface of the sealing disc on day 80, but the newborn tissue completely covered the sealing disc on day 110. Immunofluorescence staining against CD31 and scanning electron microscope confirmed complete intima formation and neovascularization within 4 months. Conclusions: The current research suggested the LACBES (R) device is feasible for LAAC, with a high success rate, few device-related complications and complete neointima formation in canines.