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

Bharucha, AH.; Kanyal, R.; Mullen, M.; Patel, K.; Smith, D.; Shome, J.; Blackman, DJ.; Aktaa, S.; Williams, PD.; Khogali, S.; Dworakowski, R.; Eskandari, M.; Byrne, J.; MacCarthy, P.

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

All Authors

Bharucha, AH.

Kanyal, R.

Mullen, M.

Patel, K.

Smith, D.

Shome, J.

Blackman, DJ.

Aktaa, S.

Williams, PD.

Khogali, S.

Show 4 more

LTHT Author

Blackman, Daniel
Aktaa, Suleman

LTHT Department

Cardiology
Cardio-Respiratory

Publication Date

2024

Item Type

Journal Article
Multicenter Study

Abstract

The Navitor transcatheter heart valve (THV) is the latest iteration of the Portico self-expanding valve system. Early prospective studies have shown promising outcomes, however, there is a lack of complementary 'real-world' data. This study aimed to assess early safety and efficacy outcomes of the Navitor THV using registry data from 6 high-volume United Kingdom transcatheter aortic valve replacement (TAVR) centers. Demographic, procedural, and in-hospital outcome data were retrieved from 6 United Kingdom centers. The primary safety end point was 30-day mortality. Primary efficacy end points were procedural success, mean aortic gradient, and >=moderate paravalvular leak. Secondary end points included rates of new permanent pacemaker implantation, stroke, and vascular injury. A total of 574 patients (mean age 83.4 years; 54.5% female) underwent Navitor TAVR between January 2020 and May 2023. The 30-day mortality in this patient cohort was 1.6%. Procedural success was 98.1%, mean echo-derived gradient post-TAVR was 7.7 +/- 4.8 mm Hg (95% confidence interval [CI] 7.2 to 8.3, p <0.001) and 5.1% of patients had >=moderate paravalvular leak (sample proportion estimate [p^] = 0.051, 95% CI [0.035, 0.073], p <0.001). New permanent pacemaker implantation to discharge was required in 11% (p^ = 0.119, 95% CI 0.088 to 0.158, p <0.001), stroke occurred in 1.2% of patients (p^ = 0.017, 95% CI 0.006 to 0.036, p <0.001) and significant vascular injury in 1.6% (p^ = 0.014, 95% CI 0.005 to 0.032, p <0.001). In conclusion, early procedural outcomes with Navitor TAVR compare favorably to new-generation THVs. Procedural success was high with a low incidence of complications.