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介入用新型高分子材料人工主动脉瓣膜

Development of a novel polymeric transcatheter aortic valve: a preliminary study in sheep

摘要目的 评价自主研制的介入用新型高分子材料人工主动脉瓣膜动物体内原位置换后的即时效果.方法 选用超微孔聚四氟乙烯薄膜制作成三叶球囊扩张型介入瓣膜.采用雄性绵羊6只,体质量(22.1±1.4) ks.全麻下左侧开胸,经心尖入路行经导管主动脉瓣原位置换术.术后即时通过心血管造影和经胸超声心动图对介入瓣膜功能进行早期评价,并随机选取1只羊进行解剖观察介入瓣膜置入情况.结果 1只羊因位置过低导致瓣周漏死亡,1只羊因位置过高影响冠状动脉供血导致心室颤动死亡.4只羊手术成功,术后即时心血管造影和经胸超声心动图提示人工瓣膜位置满意,开闭良好,冠状动脉供血良好,无瓣周漏,2只羊无或仅有微量反流,2只羊少量反流,峰值跨瓣压差(15.0±9.4) mmHg(1 mmHg =0.133 kPa).尸检见介入瓣膜置入位置准确,形态正常,支架扩张充分,冠状动脉或二尖瓣未受影响.结论 超微孔聚四氟乙烯材料介入主动脉瓣绵羊体内原位置换可行,即时效果良好.

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abstractsObjective To evaluate valvular functionality after transcatheter aortic valve implantation in sheep using a novel polymeric prosthetic valve.Methods In this study,we designed a novel polymeric trileaflet transcatheter aortic valve with a balloon-expandable stent,and the valve leaflet was made of 0.1-mm expanded polytetrafluoroethylene (ePTFE).Polymeric aortic valves were implanted in situ by left ventricular apical approach in 6 healthy sheep,weighing(22.1 ± 1.4) kg.Angiography and color doppler echocardiography were performed after implantation to assess immediate valvular function.One sheep was chosed to be sacrificed 2h after valve implantation for macroscopic examination.Results One sheep died of severe aortic valve regurgitation because the stented valve was implanted below the normal position.One sheep died of ventricular fibrillation because the stented valve was higher than the normal position and influenced the blood-supply of coronary artery.Implantation was successful in the other 4 sheep.Angiography showed all the prosthetic valves demonstrated orthotopic position and exhibited normal open and close functionality and no influence of blood-supply of coronary artery.Echocardiography showed good functionality for all prosthetic valves,none or trace valve regurgitation in two sheep,and mild valve regurgitation in the other two sheep.The peak-peak transvalvular pressure gradient of the prosthetic valves was(15.0 ± 9.4) mmHg(1 mmHg =0.133 kPa).Autopsy showed the prosthetic valve fully replaced the native valve and did not influence coronary artery and mitral valve.Conclusion Placement of the novel ePTFE transcatheter aortic valve in sheep is feasible and effective.

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