OBJECTIVETo evaluate the efficacy and safety of domestic left-disk-coated atrial septal occluder on treating patent foramen ovale in a miniswine model.

METHODSForamen ovale was punctured in 12 Guangxi BA-MA miniswine and occluded by domestic left-disk-coated atrial septal occluder (Spider(TM) PFO closure system) under the guidance of fluoroscopy. After occlusion, miniswine were executed after transthoracic echocardiography examination with color Doppler at month 1, 2, 3 and 6 respectively for gross inspection and microscopic examinations.

RESULTSThere were no vegetation, thrombosis, broken stent, or erosion on the surface of all devices. The PFOs were completed occluded as evidenced by transthoracic echocardiography at 1 to 6 months after operation. The surface of the device was fully covered by collagen tissue and endothelial tissue at 1 month after operation and the thickened gradually thereafter.

CONCLUSIONSThe domestic left-disk-coated atrial septal occluder can efficiently occlude patent foramen ovale. Satisfactory biocompatibility, rapid and complete endothelium covering and low incidence of complication are also evidenced for this closure system in our experiment.