Valvular & structural heart diseaseMeta-analysis
2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System
- Pooled analysis of a pilot study and a trial cohort (single-arm)
- multicentre
- 58 international sites
- independent clinical events committee
- independent echocardiography core laboratory
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
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
≥Major bleeding · 30 days
- 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
Summarised from the published abstract; every number is checked against it