D-Shant心房分流器的初步动物实验研究

Early animal experimental study of atrial shunt device D-Shant

目的观察D-Shant心房分流器的动物预实验效果是否能达到预期。方法对4只实验用犬实施D-Shant心房分流器置入术,置入前后测量血流动力学及超声心动图检查相关心脏指标,并于饲养3个月后实施病理解剖学和组织学检查。结果4只实验犬全部成功置入D-Shant心房分流器,即刻置入成功率100%,未见并发症发生。4只实验犬均存活至实验终点。心导管检查手术前后血流动力学显示,左心房压力由(16.75±3.20)mmHg(1 mmHg=0.133 kPa)降低至(9.25±2.63)mmHg(P=0.125),肺循环/体循环分流量由(0.97±0.02)上升至(1.30±0.14)(P=0.125);超声心动图检查手术前后左心房直径由术前(24.22±1.51)mm缩小至(18.68±0.87)mm(P=0.125),左心室直径由术前(36.52±2.27)mm缩小至(30.20±2.11)mm(P=0.125),左心室射血分数由术前(57.00±1.83)%升高至(61.25±2.50)%(P=0.125),二尖瓣反流程度由(3.25±0.50)级降低至(0.67±0.58)级(P=0.125),但因样本量小均未达到统计学差异。3个月后超声心动图观察所有实验犬房间隔分流仍然存在,均为单纯左向右分流。病理解剖学和组织学检查未见异常。结论动物实验初步验证了D-Shant心房分流器的置入具备可行性和较高的安全性,在改善心力衰竭血流动力学方面具备良好前景,是一个有希望的技术。

Objective To observe whether the animal experiment of Atrial shunt Device(D-Shant)can achieve the expected effect.Methods Four dogs were implanted in the heart with the Atrial Shunt Device D-Shant.Hemodynamics and echocardiography evaluation were examined before and after the procedure.Pathological anatomy and histology were performed three months later.Results The devices were implanted successfully in all 4 dogs.Immediate implantation success rate was 100%without any complications.All 4 dogs survived well at the end of the experiment.Immediate hemodynamics from cardiac catheterization examination showed that left atrial pressure decreased from(16.75±3.20)mmHg(1 mmHg=0.133 kPa)to(9.25±2.63)mmHg(P=0.125),and Qp/Qs increased from(0.97±0.02)to(1.30±0.14)(P=0.125)after the operation.Echocardiography showed that the diameter of left atrium decreased from(24.22±1.51)mm to(18.68±0.87)mm(P=0.125),and left ventricle decreased from(36.52±2.27)mm to(30.20±2.11)mm(P=0.125).Left ventricular ejection fraction increased from(57.00±1.83)%to(61.25±2.50)%(P=0.125),and the degree of mitral regurgitation decreased from(3.25±0.50)to(0.67±0.58)(P=0.125)after the device implanted.Three months later,echocardiography showed that atrial septal shun(only left-to-right)preserved well in all dogs.No abnormality found in pathological anatomy and histology.Conclusions Animal experiments preliminarily verifi ed the feasibility and safety of D-Shant atrial shunt device implantation.It is a promising technology and device which has a good prospect in improving the hemodynamics of heart failure.