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

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• A novel intra-annular, self-expanding transcatheter heart valve (Navitor) was introduced in the U.S. for high- or extreme-risk patients with native aortic stenosis.
• This study evaluates the early real-world performance of the Navitor valve.

Purpose of the Study:

• To report early real-world clinical and hemodynamic outcomes of the Navitor transcatheter heart valve.
• To assess safety and effectiveness using data from the STS/ACC TVT Registry.

Main Methods:

• Prospective data collection and retrospective analysis of 2,958 patients treated between January 2023 and December 2024.
• Primary outcome: composite of all-cause mortality or stroke at 30 days.
• Evaluation of procedural success, mortality, complications, pacemaker implantation, and patient-reported outcomes.

Main Results:

• High technical success rate (97.9%) with low in-hospital mortality (1.3%).
• 30-day mortality or stroke rate was 5.2%; major vascular complications occurred in 1.8%.
• Significant improvement in Kansas City Cardiomyopathy Questionnaire scores and reduced permanent pacemaker implantation rates with increased procedural experience.

Conclusions:

• The Navitor valve demonstrates favorable early clinical and hemodynamic outcomes in U.S. real-world practice.
• Procedural experience is associated with a reduced rate of permanent pacemaker implantation.
• The valve offers a viable option for high-risk aortic stenosis patients.