Valvular & structural heart disease
Early U.S. Real-World Experience With a Novel Intra-Annular Self-Expanding Valve for Transcatheter Aortic Valve Replacement
Authors' conclusion
Early U.S. experience with the Navitor valve demonstrates favorable early clinical and hemodynamic outcomes, with improved PPI rate associated with procedural experience.
Study context
- Population
- Patients with native AS at high or extreme risk treated with TAVR, US, January 2023–December 2024
- Participants
- 2,958 patients
- Outcome
- All-cause mortality or stroke
- Follow-up
- 30 days
Methodological detailsprospectively collected, retrospectively analyzed, STS/ACC TVT Registry
- Prospectively collected, retrospectively analyzed
- STS/ACC TVT Registry
Main finding
As reported in the abstract
30-day all-cause mortality or stroke
5.2%
30-day mortality
2.8%
30-day stroke
2.7%
Observational data: associations, not effects.
Further findings
Technical success
- Technical success rate
- 97.9%
In-hospital mortality
- In-hospital mortality rate
- 1.3%
Hemodynamics · 30 days
- Mean transvalvular gradient
- 7.3 ± 3.8 mm Hg
- Aortic valve area
- 1.98 ± 0.64 cm²
New permanent pacemaker implantation (PPI) by site experience (>20 cases vs fewer)
- Navitor Classic: reduced PPI rate with site experience beyond 20 cases
- 19.4% vs 13.5%; P = 0.0039
- Vision: reduced PPI rate with site experience beyond 20 cases
- 19.1% vs 10.6%; P = 0.047
KCCQ Overall Summary score · 30 days
- Improvement from baseline
- 23.8 points
- Baseline
- 52.1 ± 24.8
- 30 days
- 75.9 ± 22.6
- P
- P < 0.0001
Safety
Major vascular complications
- Major vascular complications
- 1.8%
New PPI
- New permanent pacemaker implantation
- 17.8%
Moderate or greater PVL · 30 days
- Moderate or greater PVL
- 1.8%
Original publication
Early U.S. Real-World Experience With a Novel Intra-Annular Self-Expanding Valve for Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. Published 9 January 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →