[Efficacy of a domestic left-disk-coated atrial septal occluder on treating patent foramen Ovale in a miniswine model].
OBJECTIVE
To evaluate the efficacy and safety of domestic left-disk-coated atrial septal occluder on treating patent foramen ovale in a miniswine model.


METHODS
Foramen 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.


RESULTS
There 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.


CONCLUSIONS
The 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.
Department of Cardiology, Guangdong General Hospital, Guangdong Cardiovascular Institute, Guangzhou 510100, China.
Yi-gao
YG
Huang
Cao-jin
CJ
Zhang
Tao
T
Huang
Wen-hui
WH
Huang
Xin-sheng
XS
Huang
D000818:Animals; D006328:Cardiac Catheterization / Q000295:instrumentation*; D054092:Foramen Ovale, Patent / Q000628:therapy*; D013552:Swine; D013556:Swine, Miniature