中国介入心脏病学杂志2024,Vol.32Issue(2) :89-95.DOI:10.3969/j.issn.1004-8812.2024.02.005

经导管缘对缘修复二尖瓣的体外流体力学性能评价

An in vitro evaluation of the hydromechanical properties on transcatheter edge-to-edge repair

王颢 朱达 卢志骞 贺照明 刘丽 潘湘斌
中国介入心脏病学杂志2024,Vol.32Issue(2) :89-95.DOI:10.3969/j.issn.1004-8812.2024.02.005

经导管缘对缘修复二尖瓣的体外流体力学性能评价

An in vitro evaluation of the hydromechanical properties on transcatheter edge-to-edge repair

王颢 1朱达 2卢志骞 3贺照明 4刘丽 5潘湘斌6
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作者信息

  • 1. 江苏大学电气信息工程学院,江苏镇江 212013
  • 2. 云南省阜外心血管病医院结构性心脏病中心,云南昆明 650000
  • 3. 江苏大学流体机械工程技术研究中心,江苏镇江 212013
  • 4. 德州理工大学机械工程系,美国拉伯克TX 79409
  • 5. 中国食品药品检定研究所,北京 102629
  • 6. 云南省阜外心血管病医院结构性心脏病中心,云南昆明 650000;国家心血管病中心北京协和医学院中国医学科学院阜外医院结构性心脏病中心,北京 100037
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摘要

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)cm2比(2.2±0.5)cm2,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.

Abstract

Objective To establish a method for testing isolated mitral valve in vitro and quantitatively evaluate the effect of transcatheter edge-to-edge repair technology(TEER)on functional mitral regurgitation(FMR)(non-A2-P2 regurgitation).Methods In this study,an FMR(non-A2-P2 regurgitation)model was developed by dilating the annulus orifice and displacing the papillary muscle in isolated porcine mitral valve.The hydrodynamics characteristics of 6 valves were tested by a pulsatile flow testing system under different physiological and pathological conditions before and after TEER.Results The results show that the valve regurgitation improved from moderate-severe[regurgitant fraction(60.2±17.5)%]to mild-moderate[regurgitant fraction(34.7±12.0)%]by repair(P<0.001).The EOA[(3.8±1.6)cm2 vs.(2.2±0.5)cm2,P<0.001]and the forward cross valve pressure difference[(1.8±1.3)mmHg vs.(3.8± 1.8)mmHg,P<0.001],which characterize the forward flow performance of the valve,were compared before and after repair,and the differences were statistically significant.At the same time,the repair caused valve stenosis(the effective orifice area decreased by 40%and the positive differential pressure increased by 110%),but the valves was still within the normal physiological range,and no iatrogenic stenosis was caused.Conclusions It can be seen that TEER has an effect on FMR.This study provides validation and evaluation methods in vitro for expanding indications and improving TEER,and reference for developing standards of transcatheter valve repair testing in vitro.

关键词

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

Key words

Functional mitral regurgitation/Transcatheter edge-to-edge repair/Test and assessment of heart valve in vitro

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基金项目

国家重点研发计划(十四五)(2022YFC2503400)

云南省科技重大专项(202302AA310045)

出版年

2024
中国介入心脏病学杂志
北京大学

中国介入心脏病学杂志

CSTPCDCSCD
影响因子:1.224
ISSN:1004-8812
参考文献量25
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