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ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty : direct ACURATE neo2

Elkoumy, Ahmed ; Rück, Andreas ; Abdel-Wahab, Mohamed ; Thiele, Holger ; Rudolph, Tanja K. ; Wolf, Alexander ; Wambach, Jan Martin ; De Backer, Ole ; Sondergaard, Lars and Hengstenberg, Christian , et al. (2024) In International Journal of Cardiology 400.
Abstract

Background: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. Aim: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. Methodology: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab.... (More)

Background: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. Aim: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. Methodology: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. Results: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. Conclusion: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
ACURATE neo2, Aortic valve calcification, Balloon aortic valvuloplasty, Self expandable valves, TAVI, Transcatheter aortic valve
in
International Journal of Cardiology
volume
400
article number
131792
pages
10 pages
publisher
Elsevier
external identifiers
  • scopus:85185175505
  • pmid:38244892
ISSN
0167-5273
DOI
10.1016/j.ijcard.2024.131792
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2024 The Authors
id
452a9376-9821-43b6-b7ce-4486ecfd7c18
date added to LUP
2024-02-29 12:28:05
date last changed
2024-04-14 08:17:52
@article{452a9376-9821-43b6-b7ce-4486ecfd7c18,
  abstract     = {{<p>Background: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. Aim: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. Methodology: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. Results: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p &lt; 0.001) and lower calcium volume (163 vs 581 mm<sup>3</sup>; p &lt; 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. Conclusion: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.</p>}},
  author       = {{Elkoumy, Ahmed and Rück, Andreas and Abdel-Wahab, Mohamed and Thiele, Holger and Rudolph, Tanja K. and Wolf, Alexander and Wambach, Jan Martin and De Backer, Ole and Sondergaard, Lars and Hengstenberg, Christian and Abdelshafy, Mahmoud and Arsang-Jang, Shahram and Elzomor, Hesham and Laine, Mika and Bjursten, Henrik and Götberg, Matthias and Wykrzykowska, Joanna J. and Mohamed, Sameh K. and Pellegrini, Costanza and Rheude, Tobias and Toggweiler, Stefan and Saleh, Nawzad and Meduri, Christopher U. and Kim, Won Keun and Soliman, Osama}},
  issn         = {{0167-5273}},
  keywords     = {{ACURATE neo2; Aortic valve calcification; Balloon aortic valvuloplasty; Self expandable valves; TAVI; Transcatheter aortic valve}},
  language     = {{eng}},
  month        = {{04}},
  publisher    = {{Elsevier}},
  series       = {{International Journal of Cardiology}},
  title        = {{ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty : direct ACURATE neo2}},
  url          = {{http://dx.doi.org/10.1016/j.ijcard.2024.131792}},
  doi          = {{10.1016/j.ijcard.2024.131792}},
  volume       = {{400}},
  year         = {{2024}},
}