Patient-specific in vitro testing for evaluating TAVR clinical performance-A complementary approach to current ISO standard testing.
Patient-specific in vitro testing for evaluating TAVR clinical performance-A complementary approach to current ISO standard testing.
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DOI：
10.1111/aor.13841
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发表时间：
2021-04
影响因子：
2.4
通讯作者：
Bluestein D
中科院分区：
文献类型：
--
作者：
Kovarovic BJ;Rotman OM;Parikh P;Slepian MJ;Bluestein D
在为外科人工心脏瓣膜建立体外试验后，在理想几何形状下对经导管主动脉瓣（TAV）进行类似试验-排除可能妨碍原位TAVR性能的影响。在包含患者特定复制品的脉冲复制器系统中进行体外测试将通过使其更接近临床场景来提高测试的准确性。为此，我们将根据ISO标准在理想几何结构中测试的TAV血流动力学性能（基线性能）与在患者特定复制品中展开后通过测试TAV获得的性能进行了比较。在模拟循环系统（遵循ISO 5840-3指南）中以理想化几何结构对可扩张（n=2）和自扩张（n=3）TAV进行了试验，并与适用于5个患者特定复制品的专用模拟循环系统中的测量值进行了比较。与基线理想化试验相比，患者特异性展开导致性能下降，以及取决于每件器械设计特征的性能变化，这与展开的TAV支架的径向扩张和偏心率（通过展开瓣膜的CT扫描获得）进一步相关。通过排除不规则几何结构中的展开效应，当前理想化的ISO试验仅限于表征基线器械性能。利用患者特定的解剖轮廓提供了在体内可能遇到的更严格条件下的性能指标。它有可能加强测试和开发，补充ISO标准，以提高TAV的安全性和有效性。
Following in vitro tests established for surgical prosthetic heart valves, transcatheter aortic valves (TAV) are similarly tested in idealized geometries- excluding effects that may hamper TAVR performance in situ. Testing in vitro in pulse duplicator systems that incorporated patient specific replicas would enhance the testing veracity by bringing it closer to the clinical scenario. To that end we compare TAV hemodynamic performance tested in idealized geometries according to the ISO standard (baseline performance) to that obtained by testing the TAVs following deployment in patient-specific replicas. Balloon-expandable (n=2) and self-expandable (n=3) TAVs were tested in an idealized geometry in mock-circulation system (following ISO 5840–3 guidelines) and compared to measurements in a dedicated mock-circulation system adapted for the five patient-specific replicas. Patient-specific deployments resulted in a decline in performance as compared to the baseline idealized testing, as well as a variation in performance that depended on the design features of each device that was further correlated with the radial expansion and eccentricity of the deployed TAV stent (obtained with CT-scans of the deployed valves). By excluding deployment effects in irregular geometries, the current idealized ISO testing is limited to characterize baseline device performance. Utilizing patient-specific anatomic contours provides performance indicators under more stringent conditions likely encountered in vivo. It has the potential to enhance testing and development complementary to the ISO standard, for improved TAV safety and effectiveness.
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影响因子：
5.4
作者：
Poulin, Frederic;Yingchoncharoen, Teerapat;Thavendiranathan, Paaladinesh
通讯作者：
Thavendiranathan, Paaladinesh
DOI：
10.1016/s0022-5223(00)70092-4
发表时间：
2000-05-01
影响因子：
6
作者：
Capps, SB;Elkins, RC;Fronk, DM
通讯作者：
Fronk, DM
影响因子：
1.8
作者：
Rotman, Oren M.;Kovarovic, Brandon;Bluestein, Danny
通讯作者：
Bluestein, Danny
影响因子：
5
作者：
Liu, F;Coursey, CA;Austin, JHM
通讯作者：
Austin, JHM
影响因子：
3.5
作者：
Tanaka, Yutaka;Saito, Shigeru;Iwasaki, Kiyotaka
通讯作者：
Iwasaki, Kiyotaka