Comparison Between the Acurate Neo and the Acurate Neo 2 Transcatheter Heart Valve System: Impact of Midframe Under‐Expansion
- 1Department of Internal Medicine and Cardiology Heart Center Dresden, Technische Universität Dresden Dresden Germany
- 2Department of Cardiac Surgery Heart Center Dresden, Technische Universität Dresden Dresden Germany
Abstract
Background: Transcatheter aortic valve implantation (TAVI) with the Acurate Neo has been linked to a significant incidence of paravalvular leakage (PVL), addressed by the Acurate Neo 2 incorporating an active sealing skirt. Recent findings suggest that midframe under‐expansion is associated with worse outcomes.
Aims: We investigated the hemodynamic and clinical outcomes after TAVI with Acurate Neo 2 compared to Acurate Neo and assessed the impact of midframe under‐expansion.
Methods: Patients who received Acurate Neo (n = 124) or Acurate Neo 2 (n = 133) between February 2018 and December 2021 (switch to Acurate Neo 2 in November 2020) were included. The primary outcomes were VARC‐3 defined device success and early safety.
Results: Device success was higher with Acurate Neo 2 compared with Acurate Neo (94.7% vs. 86.3%, p = 0.020), as was early safety (87.2% vs. 74.2%, p = 0.008). The rate of mild/moderate PVL was significantly lower in Acurate Neo 2. Kaplan−Meier estimated 1‐year survival (Acurate Neo 2: 87.8% vs. Acurate Neo: 89.0, p = 0.930) and freedom from the combined clinical endpoint death, stroke, myocardial infarction, and heart failure rehospitalization at 1 year (Acurate Neo 2: 81.2% vs. Acurate Neo: 79.3%, p = 0.528) were comparable between groups. A long‐term analysis of these endpoints revealed no difference between groups. Midframe under‐expansion occurred in 13.3% and was associated with lower freedom from the combined clinical endpoint at 1 year, irrespective of prosthesis generation.
Conclusion: Acurate Neo 2 demonstrated significant improvements in device success and early safety compared to Acurate Neo. Midframe under‐expansion occurred with both generations and was associated with worse clinical outcomes within the first year.
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BibTeX
@article{crusius2026comparison,
title = {{Comparison Between the Acurate Neo and the Acurate Neo 2 Transcatheter Heart Valve System: Impact of Midframe Under‐Expansion}},
author = {Lisa Crusius and Thaddäus Ast and Stephan Haussig and Jean‐Honoré Steul and Felix J. Woitek and Peter Sick and Tomas Madej and Utz Kappert and Axel Linke and Norman Mangner},
journal = {Catheterization and Cardiovascular Interventions},
year = {2026},
month = sep,
doi = {10.1002/ccd.70839},
url = {https://doi.org/10.1002/ccd.70839},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Comparison Between the Acurate Neo and the Acurate Neo 2 Transcatheter Heart Valve System: Impact of Midframe Under‐Expansion
AU - Lisa Crusius
AU - Thaddäus Ast
AU - Stephan Haussig
AU - Jean‐Honoré Steul
AU - Felix J. Woitek
AU - Peter Sick
AU - Tomas Madej
AU - Utz Kappert
AU - Axel Linke
AU - Norman Mangner
PY - 2026
DA - 2026/09/01
JO - Catheterization and Cardiovascular Interventions
DO - 10.1002/ccd.70839
UR - https://doi.org/10.1002/ccd.70839
AB - Background: Transcatheter aortic valve implantation (TAVI) with the Acurate Neo has been linked to a significant incidence of paravalvular leakage (PVL), addressed by the Acurate Neo 2 incorporating an active sealing skirt. Recent findings suggest that midframe under‐expansion is associated with worse outcomes. Aims: We investigated the hemodynamic and clinical outcomes after TAVI with Acurate Neo 2 compared to Acurate Neo and assessed the impact of midframe under‐expansion. Methods: Patients who received Acurate Neo (n = 124) or Acurate Neo 2 (n = 133) between February 2018 and December 2021 (switch to Acurate Neo 2 in November 2020) were included. The primary outcomes were VARC‐3 defined device success and early safety. Results: Device success was higher with Acurate Neo 2 compared with Acurate Neo (94.7% vs. 86.3%, p = 0.020), as was early safety (87.2% vs. 74.2%, p = 0.008). The rate of mild/moderate PVL was significantly lower in Acurate Neo 2. Kaplan−Meier estimated 1‐year survival (Acurate Neo 2: 87.8% vs. Acurate Neo: 89.0, p = 0.930) and freedom from the combined clinical endpoint death, stroke, myocardial infarction, and heart failure rehospitalization at 1 year (Acurate Neo 2: 81.2% vs. Acurate Neo: 79.3%, p = 0.528) were comparable between groups. A long‐term analysis of these endpoints revealed no difference between groups. Midframe under‐expansion occurred in 13.3% and was associated with lower freedom from the combined clinical endpoint at 1 year, irrespective of prosthesis generation. Conclusion: Acurate Neo 2 demonstrated significant improvements in device success and early safety compared to Acurate Neo. Midframe under‐expansion occurred with both generations and was associated with worse clinical outcomes within the first year.
SN - 1522-1946
SN - 1522-726X
ER -