The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes

Helge Möllmann, David M Holzhey, Michael Hilker, Stefan Toggweiler, Ulrich Schäfer, Hendrik Treede, Michael Joner, Lars Søndergaard, Thomas Christen, Dominic J Allocco, Won-Keun Kim

Abstract

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve.

METHODS: The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months.

RESULTS: The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL.

CONCLUSIONS: One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve.

OriginalsprogEngelsk
TidsskriftClinical research in cardiology : official journal of the German Cardiac Society
Vol/bind110
Udgave nummer12
Sider (fra-til)1912-1920
Antal sider9
ISSN1861-0684
DOI
StatusUdgivet - dec. 2021

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