新型左心耳封堵器封堵犬左心耳的实验研究

A novel occluder for occluding the left atrial appendage:an experimental study with canines

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 adopt a novel domestic double-disc nitinol occluder to occlude the left atrial appendage of canines and evaluate its feasibility,safety and biocompatibility in experimental canine model. Methods Totally 12 healthy dogs were used in this study; their atrial septal was punctured to occlude the left atial appendage via the femoral vein. The position and effect of the implanted occluders were evaluated by electrocardiogram （ECG） monitoring, atrial septal puncture angiography, transesophageal echocardiography （TEE）, and pathological examination immediately, 1, 3, and 6 months after the operation. Results Among the 12 dogs, 11 were successfully implanted with the occluders immediately after operation, with the occluder in 1 case dropped after the operation. Two cases were firstly implanted with occluders of inappropriate size, which were withdrawn and successfully replaced by appropriate ones. The shape and location of the occluders were good as shown by TEE and left atrial angiography examination, with 3 cases having a little shunt and other cases completely occluded immediately after the operation as shown by TEE and left atrial angiography examination. There was no occluder shift, residual shunt or influence on coronary blood flow at 1, 3, and 6 months after the operation. It was shown that the left atrial appendage was completely blocked at 6 months after operation, and there was no thrombus formation on the surface of occluders or in the left atrium; there was no embolization or infarction in the liver,kidney or spleen, with the surface of the occluders completely covered with endothelial cells. Conclusion The novel self-made nitinol occluder has good biological compatibility, making it feasible to occlude the left atrial appendage via transcatheter approach, with satisfactory middle-term effects.