Transcatheter aortic valve replacement with the navitor system: real-world united kingdom experience

Background The Navitor (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. Aims To assess early safety and efficacy outcomes of the Navitor Transcatheter Heart Valve (THV) using registry data from six high-volume UK TAVR centers. Methods Demographic, procedural and in-hospital outcome data were retrieved from six UK centers. The primary safety end-point was 30-day mortality. Primary efficacy end-points were procedural success, mean aortic gradient, and ≥moderate paravalvular leak (PVL). Secondary endpoints included rates of new pacemaker implantation (PPM), stroke and vascular injury. Results 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±4.8mmHg (95% CI [7.2, 8.3], p<0.001) and 5.1% of patients had ≥moderate PVL (p̂=0.051, 95% CI [0.035, 0.073, p<0.001). New PPM to discharge was required in 11% (p̂ =0.119, 95% CI [0.088, 0.158], p<0.001), stroke occurred in 1.2% of patients (p̂= 0.017, 95% CI [0.006, 0.036], p<0.001) and significant vascular injury in 1.6% (p̂= 0.014, 95% CI [0.005, 0.032], p<0.001). Conclusion Early procedural outcomes with Navitor TAVR compare favorably to new generation THVs. Procedural success was high with a low incidence of complications.