Transcatheter Aortic Valve Replacement With the Navitor System: Real-World United Kingdom Experience

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• The Navitor transcatheter heart valve (THV) is an advanced self-expanding valve system.
• Limited 'real-world' data exists for the Navitor THV, despite promising early prospective studies.

Purpose of the Study:

• To evaluate the early safety and efficacy of the Navitor THV in a real-world setting.
• To analyze outcomes from a registry of transcatheter aortic valve replacement (TAVR) procedures across multiple high-volume centers.

Main Methods:

• Retrospective analysis of demographic, procedural, and in-hospital data from 574 patients undergoing Navitor TAVR.
• Data collected from 6 high-volume UK TAVR centers between January 2020 and May 2023.
• Primary safety endpoint: 30-day mortality. Primary efficacy endpoints: procedural success, mean aortic gradient, and paravalvular leak.

Main Results:

• The 30-day mortality rate was 1.6%.
• Procedural success was high at 98.1%, with a mean post-TAVR gradient of 7.7 mmHg.
• Incidence of ≥moderate paravalvular leak was 5.1%, new permanent pacemaker implantation was 11%, stroke was 1.2%, and vascular injury was 1.6%.

Conclusions:

• Early procedural outcomes of Navitor TAVR are favorable compared to other new-generation THVs.
• The Navitor THV demonstrates high procedural success and a low incidence of complications in real-world practice.
• These findings support the Navitor THV as a safe and effective option for patients with aortic stenosis.