国产左心耳封堵器 LAMax^TM 动物实验研究

目的：探讨国产左心耳封堵器（LAMax^TM） 封堵犬左心耳的早期有效性及安全性。方法：30 只健康杂交犬，体重为（27.8±3.7）kg，于左心耳封堵术前行经食管超声心动图（TEE）检查及左心耳造影术，分别测量左心耳开口最大径、深度及 LAMax^TM 工作轴线，观察左心耳分叶，根据测量结果选择封堵伞大小及型号，进行左心耳封堵术，术后即刻再次行 TEE 及左心耳造影术评价封堵效果。结果：30 只犬均完成左心耳造影，根据封堵器选择及释放原则，均成功封堵，其中 27 只应用 LAMax^TM，3 只应 用 LAMaxTMplus，即刻封堵成功率 100％。术后即刻 TEE 检查显示，30 只封堵器形态良好；5 只有残余分流，3 只有少量心包积液，4 只封堵伞盘对二尖瓣环造成压迫，锚定盘压缩比为 10%~50%。结论：置入 LAMaxTM 早期有效、安全，TEE 和左心耳造影相结合对 LAMax^TM 置入术具有重要指导意义。 Objectives: To evaluate the early effectiveness and feasibility of a left atrial appendage (LAA) occluder (LAMax^TM) in a canine model under the guidance of transesophageal echocardiography (TEE) and angiography. Methods: A total of 30 healthy dogs (body weight: 27.8±3.7 kg) were used in this study. TEE and LAA angiography were performed, maximal LAA orifice diameter, depth and LAMax^TM working axis were determined, LAA morphology was observed. Type and size of LAMax^TM occluder was chosen based on above examination results. Percutaneous LAA occlusion was then performed through trans-septal approach under the guidance of TEE and angiography. After releasing the device from the delivery cable, the effectiveness of occlusion was evaluated by angiography and TEE. Results: LAMaxTM devices (27 LAMax^TM，3 LAMax^TMplus) were successfully implanted in all 30 dogs. The success rate of instant occlusion was 100%. Small amount of residual shunt was evidenced in 5 dogs, small amounts of pericardial effusion was seen in 3 dogs. The occlusion disc of the device compressed the mitral annulus in 4 dogs. The compression ratio of anchoring disc was 10%-50%. Conclusions: Our results demonstrate that the LAMax^TM LAA occluder is safe, and effective on instant occlusion of LAA under the guidance of angiography and TEE.