Moellmann, Helge and Holzhey, David M. and Hilker, Michael and Toggweiler, Stefan and Schaefer, Ulrich and Treede, Hendrik and Joner, Michael and Sondergaard, Lars and Christen, Thomas and Allocco, Dominic J. and Kim, Won-Keun (2021) The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes. CLINICAL RESEARCH IN CARDIOLOGY, 110 (12). pp. 1912-1920. ISSN 1861-0684, 1861-0692
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | REPLACEMENT; RISK; REGURGITATION; MULTICENTER; PROSTHESIS; MISMATCH; IMPACT; Aortic valve stenosis; Transcatheter aortic valve replacement; Transfemoral aortic valve implantation; Paravalvular regurgitation |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 21 Sep 2022 08:10 |
| Last Modified: | 21 Sep 2022 08:10 |
| URI: | https://pred.uni-regensburg.de/id/eprint/47800 |
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