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

Research output: Contribution to journalArticlepeer-review

39 Scopus citations

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. Graphic Abstract: [Figure not available: see fulltext.]

Original languageEnglish
Pages (from-to)1912-1920
Number of pages9
JournalClinical research in cardiology : official journal of the German Cardiac Society
Volume110
Issue number12
DOIs
StatePublished - Dec 2021

Keywords

  • Aortic valve stenosis
  • Paravalvular regurgitation
  • Transcatheter aortic valve replacement
  • Transfemoral aortic valve implantation

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