Valvular & structural heart disease
Mid-Term Outcomes of a Novel Transcatheter Aortic Valve Replacement (TAVR) Device for Pure Aortic Regurgitation: A Prospective, Multicenter Trial
Authors' conclusion
This study demonstrates that the Pioneer Valve provides a safe and effective alternative for high-risk or inoperable patients with severe pure AR, achieving favorable mid-term outcomes with stable hemodynamic performance.
Study context
- Population
- Patients with severe pure native aortic regurgitation (AR), high surgical risk or inoperable
- Participants
- 110 patients
- Outcome
- Mid-term efficacy and safety (VARC-3), up to 1 year
- Follow-up
- Up to 1 year
Methodological detailsmulticentre, 15 centres, consecutive patients
- Multicentre
- 15 centres
- Consecutive patients
Main finding
As reported in the abstract
up to 1 year
Technical success
109 of 110
99.1%
Valve migration
1 case
Mean aortic valve gradient at 30 days
7.88 ± 2.7 mm Hg
Mean effective orifice area at 30 days
2.2 ± 0.64 cm²
Observational data: associations, not effects.
Further findings
All-cause mortality · up to 1 year
- All-cause mortality
- 3 of 110 (2.7%; 95% CI: 0.9%-8.3%)
Safety
- New permanent pacemaker implantation
- 23 of 105 cases (21.9%; 95% CI: 14.3%-29.8%)
Original publication
Mid-Term Outcomes of a Novel TAVR Device for Pure Aortic Regurgitation: A Prospective, Multicenter Trial. JACC Cardiovasc Interv. Published 22 December 2025. doi:10.
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