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Updated: Jun 27, 2026
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A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
Published on: October 16, 2021
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Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience
Ye Yang1, Jinmiao Chen1, Lili Dong2
1Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Summary
Transcatheter mitral valve replacement (TMVR) using the Mi-thos system is safe and feasible for high-risk patients with severe mitral regurgitation (MR). Short-term outcomes show successful implantation and no major complications, indicating a promising alternative therapy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Severe mitral regurgitation (MR) poses significant risks for high-risk patients.
- Transcatheter mitral valve replacement (TMVR) is emerging as a less invasive alternative.
- Evaluating novel TMVR systems is crucial for expanding treatment options.
Purpose of the Study:
- To assess the safety and feasibility of the Mi-thos TMVR system.
- To evaluate the Mi-thos system in high-risk patients with severe MR.
- To determine the efficacy of the Mi-thos system in a real-world clinical setting.
Main Methods:
- Prospective, two-center, single-arm early feasibility study.
- Enrollment of ten high-risk patients with severe MR.
- Assessment of intraoperative success, 30-day mortality, and major complications.
Main Results:
- Successful implantation of the Mi-thos TMVR system in all ten patients via transapical access.
- No procedural mortality or major complications within 30 days post-procedure.
- Excellent valve function with no or trace regurgitation and low gradients post-implantation.
Conclusions:
- The Mi-thos TMVR system demonstrated favorable short-term safety and feasibility.
- The system shows potential as a therapeutic alternative for high-risk severe MR patients.
- Further investigation and long-term evaluation of the Mi-thos TMVR system are warranted.
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