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: ; 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.