The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes
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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.]
Originalsprog | Engelsk |
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Tidsskrift | Clinical Research in Cardiology |
Vol/bind | 110 |
Udgave nummer | 12 |
Sider (fra-til) | 1912-1920 |
Antal sider | 9 |
ISSN | 1861-0684 |
DOI | |
Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:
The authors thank Songtao Jiang, MS (Boston Scientific Corporation) for statistical analysis; and MaryEllen Carlile Klusacek, PhD (Boston Scientific Corporation) for assistance in manuscript preparation.
Funding Information:
H.M. reports receipt of honoraria or consultation fees from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, St. Jude Medical. D.H. is a proctor for Boston Scientific. M.H. reports receipt of honoraria or consultation fees from Boston Scientific and New Valve Technology. S.T. is a consultant and proctor for Boston Scientific, Abbott Vascular and New Valve Technology /Biosensors, has received speaker honoraria from Medtronic, institutional research grants from Boston Scientific and Fumedica, and is a board member of and holds equity in Hi-D Imaging. U.S. reports receipt of honoraria or consultation fees from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences and Medtronic. H.T. reports receipt of honoraria or consultation fees from Medtronic, Biotronik, Boston Scientific, TriCares, JenaValve. M.J. did not report any conflicts of interest. L.S. has received consultant fees and institutional research grants from Boston Scientific. T.C. and D.A. are employees of and shareholders in Boston Scientific. W.K. reports receipt of honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic.
Funding Information:
The ACURATE neo AS study was sponsored and funded by Symetis S.A., a subsidiary of Boston Scientific Corporation.
Publisher Copyright:
© 2021, The Author(s).
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