Valvular & structural heart diseaseCohort study
Transcatheter Mitral Valve Replacement for Severe Mitral Annular Calcification
- Prospective single-group trial (severe mitral annular calcification (MAC) cohort of the SUMMIT study)
- echocardiography core laboratory
- independent clinical events committee
- performance goal
Authors' conclusion
In this first report of the primary outcomes of the SUMMIT-MAC clinical trial, transcatheter mitral valve replacement with Tendyne led to successful treatment of mitral valve disease due to MAC and significant improvements in heart failure symptoms and quality of life.
Study context
- Population
- Symptomatic patients with mitral disease due to severe MAC at high surgical risk
- Participants
- 103 patients
- Outcome
- Freedom from all-cause mortality and HF hospitalization
- Follow-up
- 12 months postindex procedure
Main finding
As reported in the abstract
12 months
Freedom from all-cause mortality and HF hospitalization (primary endpoint met)
60.4%
Performance goal
43%
P vs performance goal
P = 0.0002
Observational data: associations, not effects.
Further findings
Technical success
- Technical success
- 94.2%
30-day mortality
- 30-day mortality
- 6.8%
NYHA class I/II (paired baseline vs 12 months)
- NYHA class I/II at baseline
- 30.6%
- NYHA class I/II at 12 months
- 87.5%
- P
- P < 0.0001
- paired baseline vs 12 months
KCCQ Overall Summary (mean paired increase)
- Mean paired increase in KCCQ Overall Summary
- 18.7 ± 24.4 points
- P
- P < 0.0001
Original publication
Transcatheter Mitral Valve Replacement for Severe Mitral Annular Calcification. J Am Coll Cardiol. Published 27 October 2025. doi:10.1016/j.jacc.2025.10.025
Summarised from the published abstract; every number is checked against it