Valvular & structural heart disease

Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets

Circ Cardiovasc IntervPublished Pooled patient-level analysis of 3 prospective studies

Authors' conclusion

Furthermore, bioprosthetic valve failure rates were low with no incidence of severe hemodynamic structural valve deterioration at 5 years, irrespective of annular size.

Study context

Population
Severe symptomatic AS at high or extreme surgical risk
Participants
1,464 participants3 studies
Outcome
Clinical outcomes and valve durability
Follow-up
5 years
Methodological detailsrandom-effects meta-analysis model, independent core laboratory echocardiographic analysis, independent clinical events committee adjudication
  • Random-effects meta-analysis model
  • Independent core laboratory echocardiographic analysis
  • Independent clinical events committee adjudication

Main finding

As reported in the abstract

All-cause mortality
49.4%
Stroke
12.3%
Transvalvular gradient
6.2 mm Hg
Effective orifice area
1.83 cm²
Paravalvular leak ≥moderate
1.9%
Bioprosthetic valve failure
2.7%
Valve-related death
0.7%
Valve reintervention
2.0%
Severe hemodynamic structural valve deterioration
0
Moderate hemodynamic structural valve deterioration
0.9%

Observational data: associations, not effects.

Further findings

Hemodynamics and durability by annular size

Remained stable irrespective of annular size

Original publication

Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets. Circ Cardiovasc Interv. Published 24 October 2025. doi:10.1161/circinterventions.125.015430

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