Valvular & structural heart diseaseCohort study
Initial Multicenter Experience With a Novel Self-Expanding TAVR System in Patients With Aortic Valve Stenosis
- Multicentre observational study
- consecutive patients
- 5 German sites
- VARC-3 criteria
Authors' conclusion
Treatment of AS patients with this novel transfemoral THV system is safe and effective.
Study context
- Population
- Patients with severe aortic stenosis (AS) treated by transfemoral TAVRconsecutive
- Participants
- 43 patients
- Outcome
- Technical success
Main finding
As reported in the abstract
Technical success
98% (n = 42 of 43)
Converted to open surgery
1
Observational data: associations, not effects.
Further findings
Median aortic gradient
- Median aortic gradient (Q1-Q3: 4.0-7.0 mm Hg)
- 5.0 mm Hg
Paravalvular regurgitation
- Moderate or greater paravalvular regurgitation
- 0
- None or trace paravalvular regurgitation
- 88% [n = 37 of 42]
Safety
30-day clinical outcomes
- Major vascular complications
- 1 (2.3%)
- Stroke
- 1 (2.3%)
- Death
- 2 (4.7%)
- Permanent pacemaker implantation
- 4.9% (n = 2 of 41)
- Early safety achieved
- 82% (n = 27 of 33)
Original publication
Initial Multicenter Experience With a Novel Self-Expanding TAVR System in Patients With Aortic Valve Stenosis. JACC Cardiovasc Interv. Published 13 January 2025. doi:10.1016/j.jcin.2024.10.056
Summarised from the published abstract; every number is checked against it