Goode Dylan, Dhaliwal Ruby, Mohammadi Hadi
The Heart Valve Performance Laboratory, School of Engineering, Faculty of Applied Science, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.
Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Cardiovasc Eng Technol. 2020 Jun;11(3):229-253. doi: 10.1007/s13239-020-00460-4. Epub 2020 Mar 4.
The emergence of transcatheter aortic valve replacement (TAVR) has segued the development of transcatheter mitral valve (MV) repair devices. Transcatheter mitral valve repair has become a well-established alternative for patients with severe primary and secondary mitral regurgitation (MR) and with a perceived surgical risk. Transcatheter mitral valve replacement (TMVR) could become a more complete form of reduction of severe MR compared to MV repair devices, albeit with significant engineering challenges and all the risks associated with a bioprosthetic heart valve. The development of TMVR devices has become prominent while companies race to become the first commercially available system. Careful consideration of design challenges should be conducted by the developmental companies to ensure successful devices. Preclinical and clinical trials have shown promising results, showcasing the feasibility of total valve replacement utilizing transcatheter procedure techniques. Further development, testing, and trials need to be conducted before TMVR can become a sensible MR treatment. This review describes design challenges and considerations along with the state of the art, involving designs in both clinical and preclinical stages.
经导管主动脉瓣置换术（TAVR）的出现推动了经导管二尖瓣（MV）修复装置的发展。经导管二尖瓣修复术已成为重度原发性和继发性二尖瓣反流（MR）且被认为存在手术风险的患者的一种成熟替代方案。与二尖瓣修复装置相比，经导管二尖瓣置换术（TMVR）可能成为更彻底减轻重度MR的方式，尽管存在重大工程挑战以及与生物人工心脏瓣膜相关的所有风险。在各公司竞相成为首个上市系统之际，TMVR装置的研发已变得十分突出。研发公司应仔细考虑设计挑战，以确保装置成功。临床前和临床试验已显示出有前景的结果，展示了利用经导管手术技术进行全瓣膜置换的可行性。在TMVR成为合理的MR治疗方法之前，还需要进行进一步的研发、测试和试验。本综述描述了设计挑战与考量以及当前的技术水平，涉及临床和临床前阶段的设计。
