Valvular & structural heart diseaseCohort study
1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement
- Prospective nonrandomized feasibility study
- multicentre
- 13 sites
- independent echocardiographic core laboratory
Authors' conclusion
The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention.
Study context
- Population
- Patients with moderate to severe or severe symptomatic mitral regurgitation (MR) at high surgical risk
- Participants
- 30 patients
- Outcome
- Safety and performance of the HighLife TSMVR system
- Follow-up
- 1-year follow-up
Main finding
As reported in the abstract
Technical success
HighLife Trans-Septal Mitral Valve Replacement (TSMVR)
90%
27 of 30
Observational data: associations, not effects.
Further findings
Device success · 30 days
- Device success
- 83%
Residual MR in implanted patients · 1 year
- No or trace MR
- 78%
- Mild MR
- 22%
HighLife valve mean gradient · 1 year
- Mean gradient
- 5.1 mm Hg
LV outflow tract obstruction · 1 year
- No signs of LV outflow tract obstruction; mean gradient
- 2.0 mm Hg
Death · 1 year
- Patients who died
- 5 (17%)
Safety
Mitral valve reintervention in implanted patients · 1 year
- Patients requiring mitral valve reintervention
- 0
Original publication
1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement. JACC Cardiovasc Interv. Published 22 November 2023. doi:10.1016/j.jcin.2023.09.003
Summarised from the published abstract; every number is checked against it