Valvular & structural heart disease
2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System
Authors' conclusion
Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years.
Study context
- Population
- Patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical riskPilot Study n = 95
- Participants
- 252 patients
- Outcome
- Safety and performance of the Intrepid TA-TMVR system
- Follow-up
- 2 years
Methodological detailssingle-arm, multicentre, 58 international sites, independent clinical events committee, independent echocardiography core laboratory
- Single-arm
- Multicentre
- 58 international sites
- Independent clinical events committee
- Independent echocardiography core laboratory
Pooled result
As reported in the abstract
All-cause mortality · 30 days, 1 year, 2 years
All-cause mortality, 30-day
13.1%
All-cause mortality, 1-year
27.3%
All-cause mortality, 2-year
36.2%
Safety
- 30-day ≥major bleeding event rate
- 22.3%
Original publication
2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System. JACC Cardiovasc Interv. Published 17 April 2024. doi:10. 1016/ j. jcin. 2024. 02. 033
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