王颢,朱达,卢志骞,贺照明,刘丽,潘湘斌

• 1:江苏大学电气信息工程学院
• 2:云南省阜外心血管病医院结构性心脏病中心
• 3:江苏大学流体机械工程技术研究中心
• 4:德州理工大学机械工程系

摘要(Abstract)：

目的 建立一套适用于离体二尖瓣体外测试的方法，定量评价国产经导管缘对缘修复术（TEER）对功能性二尖瓣反流（FMR；非A2-P2反流）的修复效果。方法 本研究通过对离体猪二尖瓣瓣环扩张和乳头肌非对称移位建立模拟真实解剖结构的FMR病理模型（非A2-P2反流）。使用离体二尖瓣脉动流测试系统，测试6个FMR病理瓣膜经国产TEER器械修复前、后，不同生理和病理条件下的流体力学特征。结果 病理瓣膜由修复前的中-重度及重度反流下降到修复后的轻度及轻-中度反流[反流分数（60.2±17.5）%比（34.7±12.0)%,P<0.001]，差异有统计学意义。表征瓣膜正向流性能的EOA[(3.8±1.6)cm~2比（2.2±0.5)cm~2,P<0.001]和正向跨瓣压差[（1.8±1.3)mmHg比（3.8±1.8)mmHg,P<0.001]修复前、后比较，差异均有统计学意义。修复带来一定程度上的瓣膜狭窄，有效孔口面积降低约40%，正向跨瓣压差升高约110%，但瓣膜正向流性能仍处于正常生理范围内，未造成医源性狭窄。结论 证实国产TEER器械对于治疗FMR（非A2-P2反流）具有良好的修复效果。本研究为TEER器械的设计、优化及可靠性和有效性的验证、评价提供了全面的数据和有效的测试方法，同时也为该类产品测试相关标准的制订提供了可参考的资料。

关键词(KeyWords)： 功能性二尖瓣反流;经导管缘对缘修复术;瓣膜体外测试与评价

Abstract:

Keywords:

基金项目(Foundation): “十四五”重点研发计划项目（2022YFC2503400）;; 云南省重大科技专项计划项目（202302AA310045）

作者(Author): 王颢,朱达,卢志骞,贺照明,刘丽,潘湘斌

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