Early U.S. Real-World Experience With a Novel Intra-Annular Self-Expanding Valve for Transcatheter Aortic Valve Replacement.

BACKGROUND: A novel intra-annular, self-expanding transcatheter heart valve was introduced in the U.S. market in 2023 for treating native aortic stenosis in high- or extreme-risk patients.

OBJECTIVES: The authors sought to report early real-world experience with the Navitor valve (Abbott Structural Heart) from the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry).

METHODS: Baseline, procedural, and follow-up data were prospectively collected and retrospectively analyzed. The primary outcome was a composite of all-cause mortality or stroke at 30 days. Additional safety and effectiveness outcomes were reported per registry definitions.

RESULTS: A total of 2,958 aortic stenosis patients were treated between January 2023 and December 2024. Mean age was 81.4 ± 7.6 years; 62.4% were female. Mean STS score was 6.6% ± 5.4%. Technical success rate was 97.9%, with in-hospital mortality rate at 1.3%. Thirty-day all-cause mortality or stroke rate was 5.2% (2.8% mortality, 2.7% stroke). Major vascular complications and new permanent pacemaker implantation (PPI) occurred in 1.8% and 17.8%, respectively. At 30 days, mean transvalvular gradient was 7.3 ± 3.8 mm Hg; aortic valve area was 1.98 ± 0.64 cm2; moderate or greater PVL occurred in 1.8%. Analysis of case volume showed reduced PPI rate with site experience beyond 20 cases for Navitor Classic (19.4% vs 13.5%; P = 0.0039) and Vision (19.1% vs 10.6%; P = 0.047). Kansas City Cardiomyopathy Questionnaire Overall Summary score improved by 23.8 points from 52.1 ± 24.8 at baseline to 75.9 ± 22.6 at 30 days (P < 0.0001).

CONCLUSIONS: Early U.S. experience with the Navitor valve demonstrates favorable early clinical and hemodynamic outcomes, with improved PPI rate associated with procedural experience.