Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system

Objectives: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with Acurate neo™ (Boston Scientific, Boston, MA).

Background: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves.

Methods: All consecutive patients (n = 104) who underwent Acurate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions.

Results: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5-4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm² at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm² at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months.

Conclusions: Acurate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.