Objective To evaluate the feasibility,safety and efficacy of the new soft-waisted single riveting patent foramen ovale(PFO)occluder guided by intracardiac echocardiography(ICE).Methods From February 2023 to October 2023,10 healthy adult dogs were selected from the Clinical Research Center of Changhai Hospital,and a PFO model was established under ICE guidance.The endothelialization process after implantation of the occluder was evaluated by the cardiac gross specimens,light microscopy and electron microscopy immediately,1 month,3 months and 6 months after the surgery,and the complications such as residual shunt and thrombosis were observed meanwhile.Results All 10 dogs successfully completed the PFO model modeling and were implanted the soft-waisted single-riveting PFO occluder under the guidance of ICE,with a molding success rate of 100%and a 100%success rate of occluder implantation,but no complications occurred during the operation;all the experimental dogs reached the follow-up endpoint.The gross cardiac specimens of 10 dogs were taken out immediately,1-month group,3-month group and 6-month group after surgery for observation and the results showed that there was no displacement,alloy wire breakage,thrombus attachment and vegetations;and light microscopy and electron microscopy showed that the occluder completed endothelial coverage in the 3-month group and 6-month group.Conclusion The novel flexible waist single riveting PFO occluder is scientifically designed.It is feasible,safe and effective for canine PFO occlureation;and the ICE-guided atrial septal puncture and PFO occluder are intuitive,safe and efficient.
关键词
卵圆孔未闭/心腔内超声/房间隔穿刺/残余分流/内皮化/封堵器/动物实验
Key words
Patent foramen ovale/Intracardiac echocardiography/Atrial septal puncture/Residual right to left shunt/Endothelialisation/Occluder/Animal study
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