Division of Cardiology, The Children's Hospital of Philadelphia, Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-5156, USA.
Ann Thorac Surg. 2013 Aug;96(2):670-4. doi: 10.1016/j.athoracsur.2013.02.065.
Transcatheter mitral valve replacement would represent a major advance in heart valve therapy. Such a device requires a specialized anchoring and sealing technology. This study was designed to test the feasibility of a novel mitral valve replacement device (the sutureless mitral valve [SMV]) designed to anchor and seal in the mitral position without need for sutures.
The SMV is a self-expanding device consisting of a custom-designed nitinol framework and a pericardial leaflet valve mechanism.
Ten sheep underwent successful surgical SMV device implantation. All animals underwent cardiac catheterization 6 hours postoperatively. Hemodynamic, angiographic, echocardiographic and necroscopic data were recorded. The mean aortic cross-clamp time was 9.5 ± 3.1 minutes. Echocardiography and angiography revealed excellent left ventricular systolic function, no significant perivalvular leak, no mitral valve stenosis, no left ventricular outflow tract obstruction, and no aortic valve insufficiency. Necropsy demonstrated that the SMV devices were anchored securely.
This study demonstrates the feasibility and short-term success of sutureless mitral valve replacement using a novel SMV device.
经导管二尖瓣置换术将代表心脏瓣膜治疗的重大进展。此类设备需要专门的锚固和密封技术。本研究旨在测试一种新型二尖瓣置换装置(无缝线二尖瓣[SMV])的可行性,该装置旨在无需缝线的情况下在二尖瓣位置锚固和密封。
SMV 是一种自扩张装置,由定制设计的镍钛诺框架和心包瓣叶阀机构组成。
十只绵羊成功接受了 SMV 装置的手术植入。所有动物均在术后 6 小时接受了心导管检查。记录了血流动力学、血管造影、超声心动图和组织学数据。平均主动脉阻断时间为 9.5 ± 3.1 分钟。超声心动图和血管造影显示左心室收缩功能良好,无明显瓣周漏,无二尖瓣狭窄,无左心室流出道梗阻,无主动脉瓣关闭不全。尸检显示 SMV 装置固定牢固。
本研究证明了使用新型 SMV 装置进行无缝线二尖瓣置换的可行性和短期成功。