Valvular & structural heart disease
30-Day Outcomes of a Single-Stage Transfemoral Mitral Valve Replacement System in Severe Mitral Valve Disease
Authors' conclusion
TF TMVR in patients with complex anatomies achieved a high rate of implantation success, low 30-day mortality, and no significant residual MR.
Study context
- Population
- High-risk patients with symptomatic mitral valve disease (mitral regurgitation (MR) grade ≥III or isolated mitral stenosis) treated with the Cephea transfemoral (TF) transcatheter mitral valve replacement (TMVR) system, August 2021 to June 2024
- Participants
- 31 consecutive high-risk patients
- Comparison
- Early feasibility study (EFS) vs Compassionate use
- EFSn = 24
- Compassionate usen = 7
- Outcome
- Safety: survival; efficacy: MR reduction to mild or less
- Follow-up
- 30 days
Methodological detailssingle-arm, consecutive patients, independent echocardiographic core laboratory (EFS)
- Single-arm
- Consecutive patients
- Independent echocardiographic core laboratory (EFS)
Main finding
As reported in the abstract
Primary safety endpoint: 30-day survival
97%
30 of 31
Primary efficacy endpoint: MR reduction to mild or less (patients with evaluable echocardiograms)
100%
27 of 27
Further findings
Implantation success
- Prosthetic valve implanted in attempted subjects
- 96.8% (30 of 31)
- Mean device time
- 56 ± 32 minutes
- Converted to surgical bioprosthetic mitral valve implantation
- One subject
Procedural deaths or strokes
- No procedural deaths or strokes
Original publication
30-Day Outcomes of a Single-Stage Transfemoral Mitral Valve Replacement System in Severe Mitral Valve Disease. JACC Cardiovasc Interv. Published 11 May 2026. doi:10.
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