Valvular & structural heart disease

2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System

JACC Cardiovasc IntervPublished Pooled analysis of a pilot study and a trial cohort

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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