Valvular & structural heart diseaseCohort study
1-Year Outcomes of Transfemoral Transcatheter Mitral Valve Replacement With the Eos System
- Prospective single-arm study
- multicentre
Enrollment ceased due to safety concerns related to LV pseudoaneurysm
Authors' conclusion
1-year MISCEND results demonstrate the feasibility of TMVR with the Eos system.
Study context
- Population
- Patients with clinically significant, symptomatic mitral regurgitation (MR) at high surgical risk
- Participants
- 60 patients
- Outcome
- Device success, procedural success, MR ≤1+ and composite major adverse event rate
- Follow-up
- 30 days
Main finding
As reported in the abstract
Device success, procedural success, MR ≤1+ at 30 days, 30-day composite major adverse event rate
Device success
100.0%
Procedural success
100.0%
MR ≤1+ at 30 days
98.1%
30-day composite major adverse event rate
43.3%
Observational data: associations, not effects.
Further findings
| Outcome | Estimate | P value |
|---|---|---|
| Change in 6-minute walk distance · 1 year | improvement 40.5 m (95% CI 13.8–97.2) | P = 0.003 |
| Change in KCCQ overall score · 1 year | improvement 17.7 points (95% CI 11.2–27.3) | P < 0.01 |
MR ≤1+ and none/trace MR · 1 year
- MR ≤1+ at 1 year
- 100.0%
- None/trace MR at 30 days
- 63.0%
- None/trace MR at 1 year
- 78.4%
NYHA class I/II · 1 year
- Patients in NYHA class I/II
- 86.8%
Mortality and LV pseudoaneurysm · 1 year
- Mortality
- 20.3%
- LV pseudoaneurysm
- 10.0%
- LV pseudoaneurysm safety concerns led to cessation of enrollment
Safety
Components of 30-day composite major adverse events
- All-cause mortality
- 5.0%
- All-cause hospitalization
- 21.7%
- Nonelective mitral valve reintervention
- 1.7%
- Severe bleeding
- 28.3%
- Renal complication requiring unplanned dialysis or renal replacement therapy
- 5.0%
- Major cardiac structural complication
- 8.3%
Original publication
1-Year Outcomes of Transfemoral Transcatheter Mitral Valve Replacement With the Eos System. JACC Cardiovasc Interv. Published 22 September 2025. doi:10.1016/j.jcin.2025.08.009
Summarised from the published abstract; every number is checked against it