Valvular & structural heart diseaseResearch article
30-Day Outcomes of a Single-Stage Transfemoral Mitral Valve Replacement System in Severe Mitral Valve Disease
- Early feasibility study with compassionate use experience
- single-arm
- consecutive patients
- independent echocardiographic core laboratory (early feasibility study (EFS))
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
- Thirty-one consecutive high-risk patients
- Comparison
- EFS vs Compassionate use
- EFSn = 24
- Compassionate usen = 7
- Outcome
- Safety: survival; efficacy: MR reduction to mild or less
- Follow-up
- 30 days
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:10.1016/j.jcin.2026.02.029
Summarised from the published abstract; every number is checked against it