Feasibility evaluation of the transapical saddle-shaped valved stent for transcatheter mitral valve implantation.

Feasibility evaluation of the transapical saddle-shaped valved stent for transcatheter mitral valve implantation.
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DOI:
10.1111/jocs.16426
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发表时间:
2022-06
影响因子:
1.6
通讯作者:
Zhou, Yongxin
Zhou, Yongxin
中科院分区:
医学4区
文献类型:
--
作者:
Wu, Kaiqin;Gu, Shaorui;Lu, Tiancheng;Dong, Shengting;Dong, Chenglai;Huang, Haitao;Liu, Zhenchuan;Zhang, Xin;Zhou, Yongxin

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经导管二尖瓣植入术(TMVI)是治疗高危二尖瓣返流的一种有前景的微创治疗方法。我们旨在研究一种新型自膨式瓣膜支架经心尖入路治疗TMVI的可行性。我们设计了一种新型自扩张二尖瓣支架系统,由心房凸缘和鞍形心室体组成,由两个相对的锚定件和两个相对的延伸件连接。在瓣膜展开过程中,每个锚均由循环线控制。通过心尖入路使用人工瓣膜对10头猪进行TMVI,以验证技术可行性。超声心动图和心室造影用于评估血流动力学数据和瓣膜功能。4周后处死存活猪以确认支架展开。10只动物使用新型二尖瓣支架进行TMVI。在9只动物中获得了最佳瓣膜展开和准确的解剖结构调整。1例植入失败,1天后动物因支架不匹配死亡。支架植入后,其余动物血流动力学参数稳定,瓣膜功能正常。二尖瓣和左室流出道的平均压力分别为2.98 ± 0.91 mmHg和3.42 ± 0.66 mmHg。肉眼评价证实了支架的稳定和牢固定位。瓣膜植入后4周未观察到明显的瓣膜移位、栓塞或瓣周漏。本研究表明,新型二尖瓣在动物中技术上是可行的。然而,必须改进和验证这种瓣膜支架的长期可行性和耐久性。
Transcatheter mitral valve implantation (TMVI) is a promising and minimally invasive treatment for high‐risk mitral regurgitation. We aimed to investigate the feasibility of a novel self‐expanding valved stent for TMVI via apical access. We designed a novel self‐expanding mitral valve stent system consisting of an atrial flange and saddle‐shaped ventricular body connected by two opposing anchors and two opposing extensions. During valve deployment, each anchor was controlled by a recurrent string. TMVI was performed in 10 pigs using the valve prosthesis through apical access to verify technical feasibility. Echocardiography and ventricular angiography were used to assess hemodynamic data and valve function. Surviving pigs were killed 4 weeks later to confirm stent deployment. Ten animals underwent TMVI using the novel mitral valve stent. Optimal valve deployment and accurate anatomical adjustments were obtained in nine animals. Implantation failed in one case, and the animal died 1 day later due to stent mismatch. After stent implantation, the hemodynamic parameters of the other animals were stable, and valve function was normal. The mean pressure across the mitral valve and left ventricular outflow tract were 2.98 ± 0.91 mmHg and 3.42 ± 0.66 mmHg, respectively. Macroscopic evaluation confirmed the stable and secure positioning of the stents. No obvious valve displacement, embolism, or paravalvular leakage was observed 4 weeks postvalve implantation. This study demonstrated that the novel mitral valve is technically feasible in animals. However, the long‐term feasibility and durability of this valved stent must be improved and verified.
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