Valvular & structural heart disease
Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study
Authors' conclusion
The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life.
Study context
- Population
- Patients with symptomatic mitral regurgitation (MR) (ineligible for conventional surgery) treated Nov 2014–Jun 2020
- Participants
- 191 patients
- Outcome
- Outcomes (all-cause mortality) and predictors of short-term mortality
- Follow-up
- Up to 2 years
Main finding
As reported in the abstract
All-cause mortality · 30 days, 1 and 2 years
All-cause mortality at 30 days
7.9%
All-cause mortality at 1 year
30.8%
All-cause mortality at 2 years
40.5%
Observational data: associations, not effects.
Further findings
Technical success
- Technical success
- 96.9% (185/191)
- Intraprocedural deaths
- 0
Complete MR elimination (MR <1+) · 30 days, 1 and 2 years
- Complete MR elimination at 30 days
- 99.3%
- Complete MR elimination at 1 year
- 99.1%
- Complete MR elimination at 2 years
- 96.3%
NYHA class and quality of life · up to 2 years
- Consistent improvement in NYHA class and quality of life
- P < 0.001
Independent predictors of early mortality
- Age, OR 1.11
- P = 0.003
- Pulmonary hypertension, OR 3.83
- P = 0.007
- Institutional experience, OR 0.40
- P = 0.047
Original publication
Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study. EuroIntervention. Published 15 July 2024. doi:10. 4244/ eij-d-23-00904
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