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Clinical outcomes of the ACURATE neo2 transcatheter heart valve:a prospective, multicenter, observational, post-market surveillance study
- Source :
- Kim, W-K, Tamburino, C, Möllmann, H, Montorfano, M, Ellert-Gregersen, J, Rudolph, T K, Van Mieghem, N M, Hilker, M, Amat-Santos, I J, Terkelsen, C J, Petronio, A S, Stella, P R, Götberg, M, Rück, A, Kasel, A M, Trillo, R, Appleby, C, Barbanti, M, Blanke, P, Modolo, R, Allocco, D J & Sondergaard, L 2023, ' Clinical outcomes of the ACURATE neo2 transcatheter heart valve : a prospective, multicenter, observational, post-market surveillance study ', EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, vol. 19, no. 1, pp. 83-92 . https://doi.org/10.4244/EIJ-D-22-00914
- Publication Year :
- 2023
-
Abstract
- BACKGROUND: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device.AIMS: To collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS).METHODS: ACURATE neo2 PMCF is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30-days. The primary imaging endpoint was hypo-attenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included VARC safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography.RESULTS: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean STS score: 2.9±2.0%); 246 (98.4%) were successfully treated with ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%.CONCLUSIONS: The study results support the safety and efficacy of TAVI with ACURATE neo2 in patients in routine clinical practice.
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Kim, W-K, Tamburino, C, Möllmann, H, Montorfano, M, Ellert-Gregersen, J, Rudolph, T K, Van Mieghem, N M, Hilker, M, Amat-Santos, I J, Terkelsen, C J, Petronio, A S, Stella, P R, Götberg, M, Rück, A, Kasel, A M, Trillo, R, Appleby, C, Barbanti, M, Blanke, P, Modolo, R, Allocco, D J & Sondergaard, L 2023, ' Clinical outcomes of the ACURATE neo2 transcatheter heart valve : a prospective, multicenter, observational, post-market surveillance study ', EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, vol. 19, no. 1, pp. 83-92 . https://doi.org/10.4244/EIJ-D-22-00914
- Accession number :
- edsair.doi.dedup.....2f945ee8edcc779be8773eb720047f66