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Transcatheter Mitral Valve Replacement for Severe Mitral Annular Calcification: Primary Outcomes From the SUMMIT-MAC
Paul Sorajja1, Vinod H Thourani2, Jason H Rogers3
1Banner University Medical Center, Phoenix, Arizona, USA; Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
Journal of the American College of Cardiology
|November 6, 2025
Summary
The Tendyne Transcatheter Mitral Valve System safely and effectively treats severe mitral annular calcification (MAC), significantly improving heart failure symptoms and quality of life in high-risk patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Severe mitral annular calcification (MAC) presents significant risks.
- There is a need for safe and effective transcatheter treatment options for patients with severe MAC.
Purpose of the Study:
- To evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System.
- To assess the Tendyne system in symptomatic patients with mitral disease caused by severe MAC.
Main Methods:
- The SUMMIT-MAC study, a prospective clinical trial, assessed the Tendyne system for severe MAC.
- 103 high-risk patients with severe MAC and mitral valve dysfunction were included.
- The primary endpoint was freedom from all-cause mortality and heart failure hospitalization at 12 months.
Main Results:
- Technical success was achieved in 94.2% of patients.
- Freedom from all-cause mortality and heart failure hospitalization was 60.4% at 12 months, exceeding the performance goal.
- Significant improvements were observed in heart failure symptoms and quality of life.
Conclusions:
- Transcatheter mitral valve replacement with Tendyne successfully treated mitral valve disease due to severe MAC.
- The Tendyne system demonstrated significant improvements in heart failure symptoms and quality of life.
- The SUMMIT-MAC trial provides primary outcomes for transcatheter mitral valve replacement in severe MAC.
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