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

Ahmed Elkoumy; Andreas Rück; Mohamed Abdel-Wahab; Holger Thiele; Tanja K. Rudolph; Alexander Wolf; Jan Martin Wambach; Ole De Backer; Lars Sondergaard; Christian Hengstenberg; Mahmoud Abdelshafy; Shahram Arsang-Jang; Hesham Elzomor; Mika Laine; Henrik Bjursten; Matthias Götberg; Joanna J. Wykrzykowska; Sameh K. Mohamed; Costanza Pellegrini; Tobias Rheude; Stefan Toggweiler; Nawzad Saleh; Christopher U. Meduri; Won Keun Kim; Osama Soliman

doi:10.1016/j.ijcard.2024.131792

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

Ahmed Elkoumy, Andreas Rück, Mohamed Abdel-Wahab, Holger Thiele, Tanja K. Rudolph, Alexander Wolf, Jan Martin Wambach, Ole De Backer, Lars Sondergaard, Christian Hengstenberg, Mahmoud Abdelshafy, Shahram Arsang-Jang, Hesham Elzomor, Mika Laine, Henrik Bjursten, Matthias Götberg, Joanna J. Wykrzykowska, Sameh K. Mohamed, Costanza Pellegrini, Tobias RheudeStefan Toggweiler, Nawzad Saleh, Christopher U. Meduri, Won Keun Kim, Osama Soliman^*

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

2 Citations (Scopus)

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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. 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.

Original language	English
Article number	131792
Journal	International Journal of Cardiology
Volume	400
Number of pages	10
ISSN	0167-5273
DOIs	https://doi.org/10.1016/j.ijcard.2024.131792
Publication status	Published - 2024
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2024 The Authors

Keywords

ACURATE neo2
Aortic valve calcification
Balloon aortic valvuloplasty
Self expandable valves
TAVI
Transcatheter aortic valve

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Elkoumy, A., Rück, A., Abdel-Wahab, M., Thiele, H., Rudolph, T. K., Wolf, A., Wambach, J. M., De Backer, O., Sondergaard, L., Hengstenberg, C., Abdelshafy, M., Arsang-Jang, S., Elzomor, H., Laine, M., Bjursten, H., Götberg, M., Wykrzykowska, J. J., Mohamed, S. K., Pellegrini, C., ... Soliman, O. (2024). ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2. International Journal of Cardiology, 400, [131792]. https://doi.org/10.1016/j.ijcard.2024.131792

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; Hengstenberg, Christian; Abdelshafy, Mahmoud; Arsang-Jang, Shahram; Elzomor, Hesham; Laine, Mika; Bjursten, Henrik; Götberg, Matthias; Wykrzykowska, Joanna J.; Mohamed, Sameh K.; Pellegrini, Costanza; Rheude, Tobias; Toggweiler, Stefan; Saleh, Nawzad; Meduri, Christopher U.; Kim, Won Keun; Soliman, Osama.

In: International Journal of Cardiology, Vol. 400, 131792, 2024.

Research output: Contribution to journal › Journal article › Research › peer-review

Elkoumy, A, Rück, A, Abdel-Wahab, M, Thiele, H, Rudolph, TK, Wolf, A, Wambach, JM, De Backer, O , Sondergaard, L, Hengstenberg, C, Abdelshafy, M, Arsang-Jang, S, Elzomor, H, Laine, M, Bjursten, H, Götberg, M, Wykrzykowska, JJ, Mohamed, SK, Pellegrini, C, Rheude, T, Toggweiler, S, Saleh, N, Meduri, CU, Kim, WK & Soliman, O 2024, 'ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2', International Journal of Cardiology, vol. 400, 131792. https://doi.org/10.1016/j.ijcard.2024.131792

Elkoumy, Ahmed ; Rück, Andreas ; Abdel-Wahab, Mohamed ; Thiele, Holger ; Rudolph, Tanja K. ; Wolf, Alexander ; Wambach, Jan Martin ; De Backer, Ole ; Sondergaard, Lars ; Hengstenberg, Christian ; Abdelshafy, Mahmoud ; Arsang-Jang, Shahram ; Elzomor, Hesham ; Laine, Mika ; Bjursten, Henrik ; Götberg, Matthias ; Wykrzykowska, Joanna J. ; Mohamed, Sameh K. ; Pellegrini, Costanza ; Rheude, Tobias ; Toggweiler, Stefan ; Saleh, Nawzad ; Meduri, Christopher U. ; Kim, Won Keun ; Soliman, Osama. / ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2. In: International Journal of Cardiology. 2024 ; Vol. 400.

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title = "ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2",

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. 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.",

keywords = "ACURATE neo2, Aortic valve calcification, Balloon aortic valvuloplasty, Self expandable valves, TAVI, Transcatheter aortic valve",

author = "Ahmed Elkoumy and Andreas R{\"u}ck and Mohamed Abdel-Wahab and Holger Thiele and Rudolph, {Tanja K.} and Alexander Wolf and Wambach, {Jan Martin} and {De Backer}, Ole and Lars Sondergaard and Christian Hengstenberg and Mahmoud Abdelshafy and Shahram Arsang-Jang and Hesham Elzomor and Mika Laine and Henrik Bjursten and Matthias G{\"o}tberg and Wykrzykowska, {Joanna J.} and Mohamed, {Sameh K.} and Costanza Pellegrini and Tobias Rheude and Stefan Toggweiler and Nawzad Saleh and Meduri, {Christopher U.} and Kim, {Won Keun} and Osama Soliman",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors",

year = "2024",

doi = "10.1016/j.ijcard.2024.131792",

language = "English",

volume = "400",

journal = "International Journal of Cardiology",

issn = "0167-5273",

publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2

AU - Elkoumy, Ahmed

AU - Rück, Andreas

AU - Abdel-Wahab, Mohamed

AU - Thiele, Holger

AU - Rudolph, Tanja K.

AU - Wolf, Alexander

AU - Wambach, Jan Martin

AU - De Backer, Ole

AU - Sondergaard, Lars

AU - Hengstenberg, Christian

AU - Abdelshafy, Mahmoud

AU - Arsang-Jang, Shahram

AU - Elzomor, Hesham

AU - Laine, Mika

AU - Bjursten, Henrik

AU - Götberg, Matthias

AU - Wykrzykowska, Joanna J.

AU - Mohamed, Sameh K.

AU - Pellegrini, Costanza

AU - Rheude, Tobias

AU - Toggweiler, Stefan

AU - Saleh, Nawzad

AU - Meduri, Christopher U.

AU - Kim, Won Keun

AU - Soliman, Osama

PY - 2024

Y1 - 2024

N2 - 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.

AB - 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.

KW - ACURATE neo2

KW - Aortic valve calcification

KW - Balloon aortic valvuloplasty

KW - Self expandable valves

KW - TAVI

KW - Transcatheter aortic valve

U2 - 10.1016/j.ijcard.2024.131792

DO - 10.1016/j.ijcard.2024.131792

M3 - Journal article

C2 - 38244892

AN - SCOPUS:85185175505

VL - 400

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

M1 - 131792

ER -