The Manufacture Of A New Left Atrial Appendage Occlusion Device And Experimental Study In Animal Model

Objective: To evaluate the feasibility, safety and biocompatibility of a new LAA occlusion device by transcatheter in an experimental canine model(in vivo). Methods: A new self- manufactured LAA occluder was implanted into the LAA through a transseptal catheter in 20 dogs. Follow-up was performed 2 weeks to 6 months after implantation. After imaging assessment, LAA was examined for device intima growth, migration and any thrombosis, both grossly and histologically. Results: 14 of 20 dogs were implanted successfully with new device. The LAA was occluded completely and no mobile thrombi were seen on the device surface. Endothelialization on the atrial-facing surface was seen at 1 month and was complete by 3 months, which was confirmed by gross, histological, and SEM examination. The structure of endothelial cell was normal by TEM examination. Light microscopic examination of kidney, lung, spleen and liver showed no evidence of emboli and infarct. Conclusions: The new LAA occlusion device was implanted successfully into the LAA. The device has good structural stability and excellent biocompatibility. The study shows that the new-type device was safe, feasible and efficient to occlude the LAA.