Transcatheter Mitral Valve Replacement: Functional Requirements for Device Design, Bench-Top, and Pre-Clinical Evaluation
Transcatheter Mitral Valve Replacement: Functional Requirements for Device Design, Bench-Top, and Pre-Clinical Evaluation
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DOI：
10.1007/s13239-018-0364-z
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发表时间：
2018-09-01
影响因子：
1.8
通讯作者：
Morris, John
中科院分区：
文献类型：
--
作者：
Iyer, Ramji;Chalekian, Aaron;Morris, John
经导管二尖瓣置换术（TMVR）作为二尖瓣反流（MR）的可行治疗方案目前正在临床研究中。因此，概述TMVR假体的关键功能要求是很重要的，以便提供一种综合体外和临床前方法评估二尖瓣置换术装置的总体方法。本文综述了二尖瓣疾病，以及根据国际工业标准开发TMVR装置的一般考虑和指导。关于二尖瓣装置的具体细节，二尖瓣疾病的形态，特定患者群体的评估以及评估和开发TMVR设备治疗特定患者群体的危害分析已经包括在内。本报告中包含的细节并不包括或解释每一项正在开发的技术，而是被认为是关于如何根据国际工业标准开发TMVR技术的一般指南。从经导管主动脉瓣置换术（TAVR）经验中获得的关键经验在概述TMVR的一般指南时也被考虑和考虑。TAVR开发经验的关键学习要点包括：在治疗原生主动脉瓣时，量化可接受的瓣旁泄漏水平，使用各种锚定方法的瓣膜迁移潜力以及整体植入物框架失效模式。值得注意的是，与TMVR相比，TAVR在开发和临床经验方面领先了十年以上。所有经导管开发项目都应考虑到这些从TAVR早期经验中获得的关键经验。
Transcatheter Mitral Valve Replacement (TMVR) is currently under clinical investigation as a viable treatment option for mitral regurgitation (MR). Therefore, it is important to outline the key functional requirements of a TMVR prosthesis in order to provide an overall approach to assessing mitral valve replacement devices utilizing a combination of in vitro and preclinical methods. This article provides a review of the mitral valve disease as well as general considerations and guidance for developing a TMVR device based on International Industry Standards. Specific details pertaining to the mitral valve apparatus, morphology of mitral valve disease, assessment of specific patient population as well as hazard analysis to evaluate and develop a TMVR device to treat a specific patient population have been included. The details contained within this report are not all inclusive or explicate for every technology being developed but rather thought of as a general guide on how a TMVR technology could be developed in alignment with International Industry Standards. Key learnings from the Transcatheter Aortic Valve Replacement (TAVR) experience has also been considered and taken into account when outlining this general guidance for TMVR. Key learning points from the TAVR development experience included the following: quantification of acceptable levels of paravalvular leak, valve migration potential using various anchoring methods and overall implant frame failure modes when treating the native aortic valve. It should be noted that TAVR is over a decade further along in development and clinical experience compared to TMVR. These key learnings from the early experience with TAVR should be considered with all transcatheter development projects.