Valvular & structural heart diseaseCohort study
1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve
- Prospective single-arm trial
- multicenter
- 8 sites in India
- Patients maintained on VKA (target INR 2.5)
Authors' conclusion
The polymer surgical MV demonstrated an acceptable safety profile and maintained stable hemodynamic performance through 1 year in patients undergoing MV replacement.
Study context
- Population
- Adults requiring mitral valve (MV) replacement for MV disease, primarily rheumatic, in India, 2023
- Participants
- 67 adults
- Outcome
- 1-year outcomes
- Follow-up
- 1 year
Main finding
As reported in the abstract
1-year rates: all-cause mortality, thromboembolic events, stroke, structural valve deterioration, valve reintervention
- All-cause mortality
- 9.1%
- Thromboembolic events
- 7.5%
- Stroke
- 4.9%
- Structural valve deterioration
- 0%
- Valve reintervention
- 0%
Observational data: associations, not effects.
Further findings
Effective orifice area · 1 year
- Effective orifice area (cm²), mean ± SD
- 1.4 ± 0.4
Mean inflow gradient · 1 year
- Mean inflow gradient (mm Hg), mean ± SD
- 4.6 ± 1.7
Safety
Thrombotic events and ischemic strokes
- Thrombotic events
- 2
- Ischemic strokes
- 3
- all in patients with subtherapeutic INR
Original publication
1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve. J Am Coll Cardiol. Published 27 June 2025. doi:10.1016/j.jacc.2025.06.017
Summarised from the published abstract; every number is checked against it