Inoue Masahiro, McCarthy Patrick M, Popović Zoran B, Doi Kazuyoshi, Schenk Soren, Nemeh Hassan, Ootaki Yoshio, Kopcak Michael W, Dessoffy Raymond, Thomas James D, Fukamachi Kiyotaka
Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, Ohio, USA.
Heart Surg Forum. 2004 Apr 1;7(2):E117-21. doi: 10.1532/HSF98.200344395.
Myocor developed a unique system, the Coapsys annuloplasty system, to treat functional mitral regurgitation (MR) without cardiopulmonary bypass (CPB). This study was conducted to test the feasibility of the Coapsys implantation procedure in a canine functional MR model.
Functional MR with heart failure was induced in 9 dogs by rapid ventricular pacing (230 beats/min for 30 +/- 4 days). The Coapsys device, which consists of anterior and posterior epicardial pads connected by a subvalvular chord, was then surgically implanted. Under epicardial echocardiographic guidance, we placed the Coapsys device across the left ventricular chamber using the delivery instrument and needle assembly. We sized the Coapsys device by drawing the posterior leaflet and annulus toward the anterior leaflet with the sizing instrument. Final device size was selected when MR was minimized or eliminated as assessed by 2-dimensional color Doppler echocardiography.
In all cases, we successfully implanted the Coapsys device without CPB or atriotomy. MR was reduced an average of 2 grades. No adverse events, such as hemodynamic compromise or structural valve damage, were noted.
Coapsys device implantation was feasible and safe on a beating canine heart. All accessory tools used for device implantation were found useful.
Myocor公司研发了一种独特的系统——Coapsys瓣环成形系统,用于在不进行体外循环(CPB)的情况下治疗功能性二尖瓣反流(MR)。本研究旨在测试在犬功能性MR模型中植入Coapsys系统的可行性。
通过快速心室起搏(230次/分钟,持续30±4天)在9只犬中诱发伴有心力衰竭的功能性MR。然后通过手术植入Coapsys装置,该装置由通过瓣下腱索连接的前、后心外膜垫组成。在心外膜超声心动图引导下,我们使用输送器械和穿刺针组件将Coapsys装置穿过左心室腔。我们使用尺寸测量器械将后叶和瓣环拉向前叶来确定Coapsys装置的尺寸。当通过二维彩色多普勒超声心动图评估MR最小化或消除时,选择最终的装置尺寸。
在所有病例中,我们均成功在未进行CPB或心房切开术的情况下植入了Coapsys装置。MR平均降低了2级。未观察到血流动力学不稳定或瓣膜结构损伤等不良事件。
在跳动的犬心脏上植入Coapsys装置是可行且安全的。发现所有用于装置植入的辅助工具均有用。