MITRAL VALVE REPLACEMENT WITH AND WITHOUT CHORDAL EXCISION

带或不带索状切除的二尖瓣置换术

• 批准号: 3966638
• 负责人: R E CLARK
• 金额: --
• 依托单位: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3966638
• 关键词: cardiac output; cardiovascular stress test; child (0-11); heart /lung bypass; heart circulation; heart dimension /size; heart disorder diagnosis; heart enlargement; heart surgery; heart valve transplantation; hemodynamics; human subject; mitral valve; mitral valve insufficiency; postoperative complications; ultrasound blood flow measurement

The purpose of this clinical trial is to test the hypothesis that the mitral valve apparatus (leaflet, chordae tendineae and papillary muscles), if left intact at the time of valve replacement, will prevent the nearly uniform postreperfusion left ventricular dilation and low cardiac output associated with surgical treatment of mitral insufficiency of long duration. The specific aims are: (1) measure LV hemodynamics and dimensions with ultrasound prior to and after cardiopulmonary bypass in the OR; (2) replace the mitral valve in patients with pure mitral regurgitation with and without resection of the entire mitral valve apparatus; (3) determine immediate postoperative hemodynamic characteristics of each group; (4) analyze 6 month and 3 year results in terms of exercise capacity, LV dimensions, and hemodynamic criteria. The rationale of this investigation is that if the immediate postbypass course of patients receiving mitral valve replacement for long-standing mitral insufficiency can be altered by the mechanism of preventing left ventricular dilation by maintaining the innate physical structures of the left heart, operative mortality and support measures may be reduced and long-term benefits may accrue. The results in five patients have been excellent. Two patients have required postoperative support. There have been no perio-operative deaths associated with the procedure.

这项临床试验的目的是检验以下假设： 二尖瓣装置（瓣叶、腱索和乳头肌）， 如果在瓣膜置换术时保持完整， 再灌注后左室均匀扩张和低心排血量 与长期二尖瓣关闭不全的手术治疗相关。 具体目的是：（1）测量左室血流动力学和尺寸， 在手术室心肺转流术前后进行超声检查;（2）更换 单纯二尖瓣返流患者的二尖瓣， 不切除整个二尖瓣装置;（3）确定 各组术后即刻血流动力学特征;（4） 分析6个月和3年的运动能力、LV 尺寸和血液动力学标准。 本研究的基本原理是，如果旁路术后即刻 长期接受二尖瓣置换术的患者 二尖瓣关闭不全可以通过防止左心室关闭不全的机制来改变。 心室扩张通过维持心脏的先天物理结构 左心，手术死亡率和支持措施可能会减少， 长期的好处可能会增加。 5名患者的结果非常好。 两名患者 需要术后支持。 无围手术期死亡 与手术有关。