ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2022
Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study.
Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 19 citations in OpenAlex.
- Innovation and Challenges in Materials for Transcatheter Aortic Valves.Journal of cardiovascular translational research · 2026Review
- Lessons Learned From the ACURATE IDE Trial for Transcatheter Aortic Valve Replacement.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Review
- Case Report: A case of transcatheter aortic valve replacement in a patient with a small aortic annulus using the Acurate Neo2.Frontiers in cardiovascular medicine · 2025Article
- Conditional 1-year outcomes after emergent conversion to open heart surgery during transcatheter aortic valve implantation: a propensity-matched landmark analysis.Frontiers in cardiovascular medicine · 2025Article
- Impact of Accidental High or Low Implantation Depth on Peri-Procedural Outcomes after Implantation with the Self-Expanding ACURATE neo2.Journal of clinical medicine · 2024Article
- Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study.Structural heart : the journal of the Heart Team · 2024Article
- Short-Term Outcomes of ACURATE neo2.Structural heart : the journal of the Heart Team · 2024Review
- Conduction Abnormalities after Transcatheter Aortic Valve Implantation: Incidence, Impact and Management Using CT Data Interpretation.Interventional cardiology (London, England) · 2024Review
- ACURATE neo2: jack of all trades or master of none?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023Article
Corrections and comments
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Authors and funding
22 authors at 16 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
aimsTo 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).
methodsACURATE 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.
resultsThe 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%.
conclusionsThe study results support the safety and efficacy of TAVI with ACURATE neo2 in patients in routine clinical practice.
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