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目的采用国产新型镍钛合金双盘状镍钛合金封堵器封堵犬左心耳,评估该封堵器的可行性、安全性及生物相容性。方法选取12只健康杂种犬,经股静脉途径穿刺房间隔封堵实验犬左心耳,于术后即刻和术后1、3、6个月通过心电图监测、房间隔穿刺造影、经食管超声、病理检查等方法检测封堵器的位置和植入效果。结果术中即刻12只实验犬中11例成功植入封堵器,1例术后发生封堵器脱落。2例因术中封堵器大小不合适,回收后更换合适封堵器成功植入。术后即刻经食管超声和左房造影检查可见封堵器形态、位置良好,3例实验犬左心耳封堵后出现少量分流,余实验犬左心耳被完全封堵。术后1、3、6个月时造影结果可见封堵器无移位,无残余分流,且对冠脉血流无影响。术后6个月经食管超声复查和病理检查可见左心耳被完全封堵,封堵器表面与左心房内均无血栓形成,肝、肾、脾无栓塞或梗死灶,且封堵器表面完全被内皮细胞覆盖。结论国产新型镍钛合金封堵器具有良好的生物相容性,使用该封堵器行经导管左心耳封堵术切实可行,中期效果理想。
OBJECTIVE To evaluate the feasibility, safety and biocompatibility of this occluder by using a new nickel-titanium alloy dual-disc Ni-Ti occluder made in China. Methods Twelve healthy mongrel dogs were selected and the left atrial appendage was occluded through the femoral vein at the puncture atrial septum. The electrocardiogram (ECG), atrial septal biopsy, transesophageal echocardiography, pathology Check and other methods to detect occluder position and implant effect. Results In the 12 dogs immediately after operation, 11 cases were successfully implanted occluders and 1 case occluded after operation. 2 cases due to intraoperative occluder size is not suitable, the replacement of a suitable occluder after successful implantation. Immediate postoperative transesophageal echocardiography and left atrial angiography showed occluder morphology and location were good. A small amount of shunt occurred in the left atrial appendage of 3 dogs, and the left atrial appendage was completely blocked. At 1, 3, and 6 months after operation, the occluder showed no displacement, no residual shunt and no effect on coronary blood flow. 6 months after trans-esophageal ultrasound and pathological examination showed that the left atrial appendage was completely blocked, occluder surface and left atrium without thrombosis, liver, kidney, spleen without embolization or infarction, and the occluder surface was completely Endothelial cells cover. Conclusion The new Ni-Ti alloy occluder made in China has good biocompatibility. It is practicable to use this occluder to occlude the left atrial appendage via catheter, and the medium-term effect is satisfactory.