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The Early neo2 Registry : Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population

Rück, Andreas ; Kim, Won Keun ; Abdel-Wahab, Mohamed ; Thiele, Holger ; Rudolph, Tanja K. ; Wolf, Alexander ; Wambach, Jan Martin ; Backer, Ole De ; Sondergaard, Lars and Hengstenberg, Christian , et al. (2023) In Journal of the American Heart Association 12(15).
Abstract

BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and... (More)

BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory–adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. CONCLUSIONS: In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
aortic regurgitation, aortic stenosis, TAVI
in
Journal of the American Heart Association
volume
12
issue
15
article number
e029464
pages
8 pages
publisher
Wiley-Blackwell
external identifiers
  • scopus:85166742506
  • pmid:37489732
ISSN
2047-9980
DOI
10.1161/JAHA.122.029464
language
English
LU publication?
yes
additional info
Funding Information: The Early neo2 registry was supported in part by a grant from Boston Scientific Corporation. Publisher Copyright: © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
id
63977c1e-e0ff-4230-9be4-9abcdacf8eee
date added to LUP
2023-08-14 08:56:39
date last changed
2024-02-19 22:25:47
@article{63977c1e-e0ff-4230-9be4-9abcdacf8eee,
  abstract     = {{<p>BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory–adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. CONCLUSIONS: In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.</p>}},
  author       = {{Rück, Andreas and Kim, Won Keun and Abdel-Wahab, Mohamed and Thiele, Holger and Rudolph, Tanja K. and Wolf, Alexander and Wambach, Jan Martin and Backer, Ole De and Sondergaard, Lars and Hengstenberg, Christian and Laine, Mika and Miyashita, Hirokazu and Bjursten, Henrik and Götberg, Matthias and Pellegrini, Costanza and Toggweiler, Stefan and Wykrzykowska, Joanna J. and Soliman, Osama and Saleh, Nawzad and Meduri, Christopher U.}},
  issn         = {{2047-9980}},
  keywords     = {{aortic regurgitation; aortic stenosis; TAVI}},
  language     = {{eng}},
  month        = {{08}},
  number       = {{15}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Journal of the American Heart Association}},
  title        = {{The Early neo2 Registry : Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population}},
  url          = {{http://dx.doi.org/10.1161/JAHA.122.029464}},
  doi          = {{10.1161/JAHA.122.029464}},
  volume       = {{12}},
  year         = {{2023}},
}