Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry

Andrea Scotti; Matteo Sturla; Giuliano Costa; Francesco Saia; Thomas Pilgrim; Mohamed Abdel-Wahab; Philippe Garot; Caterina Gandolfo; Luca Branca; Ignacio Amat Santos; Darren Mylotte; Francesco Bedogni; Ole De Backer; Luis Nombela Franco; John Webb; Flavio Luciano Ribichini; Andrea Mainardi; Stefano Andreaggi; Alessandro Mazzapicchi; Daijiro Tomii; Pietro Laforgia; Stefano Cannata; Claudia Fiorina; Simone Fezzi; Enrico Criscione; Mattia Lunardi; Enrico Poletti; Mattia Mazzucca; Angelo Quagliana; Nicholas Montarello; Breda Hennessey; Matias Mon-Noboa; Myriam Akodad; David Meier; Federico De Marco; Marianna Adamo; Carmelo Sgroi; Claudia Maria Reddavid; Roberto Valvo; Orazio Strazzieri; Silvia Crescenzia Motta; Valentina Frittitta; Elena Dipietro; Alessandro Comis; Chiara Melfa; Mariachiara Calì; Sofia Sammartino; Giulia Laterra; Holger Thiele; Lars Sondergaard; Corrado Tamburino; Marco Barbanti; Azeem Latib

doi:10.1016/j.jcin.2024.01.006

Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry

Andrea Scotti, Matteo Sturla, Giuliano Costa, Francesco Saia, Thomas Pilgrim, Mohamed Abdel-Wahab, Philippe Garot, Caterina Gandolfo, Luca Branca, Ignacio Amat Santos, Darren Mylotte, Francesco Bedogni, Ole De Backer, Luis Nombela Franco, John Webb, Flavio Luciano Ribichini, Andrea Mainardi, Stefano Andreaggi, Alessandro Mazzapicchi, Daijiro TomiiPietro Laforgia, Stefano Cannata, Claudia Fiorina, Simone Fezzi, Enrico Criscione, Mattia Lunardi, Enrico Poletti, Mattia Mazzucca, Angelo Quagliana, Nicholas Montarello, Breda Hennessey, Matias Mon-Noboa, Myriam Akodad, David Meier, Federico De Marco, Marianna Adamo, Carmelo Sgroi, Claudia Maria Reddavid, Roberto Valvo, Orazio Strazzieri, Silvia Crescenzia Motta, Valentina Frittitta, Elena Dipietro, Alessandro Comis, Chiara Melfa, Mariachiara Calì, Sofia Sammartino, Giulia Laterra, Holger Thiele, Lars Sondergaard, Corrado Tamburino, Marco Barbanti, Azeem Latib

Medicine

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

Background: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. Objectives: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. Methods: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. Results: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm² were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). Conclusions: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

Original language	English (US)
Pages (from-to)	681-692
Number of pages	12
Journal	JACC: Cardiovascular Interventions
Volume	17
Issue number	5
DOIs	https://doi.org/10.1016/j.jcin.2024.01.006
State	Published - Mar 11 2024

Keywords

aortic stenosis
balloon expandable
self-expanding
small annuli
transcatheter aortic valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2024.01.006

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Scotti, A., Sturla, M., Costa, G., Saia, F., Pilgrim, T., Abdel-Wahab, M., Garot, P., Gandolfo, C., Branca, L., Santos, I. A., Mylotte, D., Bedogni, F., De Backer, O., Nombela Franco, L., Webb, J., Ribichini, F. L., Mainardi, A., Andreaggi, S., Mazzapicchi, A., ... Latib, A. (2024). Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry. JACC: Cardiovascular Interventions, 17(5), 681-692. https://doi.org/10.1016/j.jcin.2024.01.006

Scotti, A, Sturla, M, Costa, G, Saia, F, Pilgrim, T, Abdel-Wahab, M, Garot, P, Gandolfo, C, Branca, L, Santos, IA, Mylotte, D, Bedogni, F, De Backer, O, Nombela Franco, L, Webb, J, Ribichini, FL, Mainardi, A, Andreaggi, S, Mazzapicchi, A, Tomii, D, Laforgia, P, Cannata, S, Fiorina, C, Fezzi, S, Criscione, E, Lunardi, M, Poletti, E, Mazzucca, M, Quagliana, A, Montarello, N, Hennessey, B, Mon-Noboa, M, Akodad, M, Meier, D, De Marco, F, Adamo, M, Sgroi, C, Reddavid, CM, Valvo, R, Strazzieri, O, Motta, SC, Frittitta, V, Dipietro, E, Comis, A, Melfa, C, Calì, M, Sammartino, S, Laterra, G, Thiele, H, Sondergaard, L, Tamburino, C, Barbanti, M & Latib, A 2024, 'Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry', JACC: Cardiovascular Interventions, vol. 17, no. 5, pp. 681-692. https://doi.org/10.1016/j.jcin.2024.01.006

@article{01857c3c986548d79df7f6b401511d52,

title = "Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry",

abstract = "Background: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. Objectives: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. Methods: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. Results: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). Conclusions: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.",

keywords = "aortic stenosis, balloon expandable, self-expanding, small annuli, transcatheter aortic valve replacement",

author = "Andrea Scotti and Matteo Sturla and Giuliano Costa and Francesco Saia and Thomas Pilgrim and Mohamed Abdel-Wahab and Philippe Garot and Caterina Gandolfo and Luca Branca and Santos, {Ignacio Amat} and Darren Mylotte and Francesco Bedogni and {De Backer}, Ole and {Nombela Franco}, Luis and John Webb and Ribichini, {Flavio Luciano} and Andrea Mainardi and Stefano Andreaggi and Alessandro Mazzapicchi and Daijiro Tomii and Pietro Laforgia and Stefano Cannata and Claudia Fiorina and Simone Fezzi and Enrico Criscione and Mattia Lunardi and Enrico Poletti and Mattia Mazzucca and Angelo Quagliana and Nicholas Montarello and Breda Hennessey and Matias Mon-Noboa and Myriam Akodad and David Meier and {De Marco}, Federico and Marianna Adamo and Carmelo Sgroi and Reddavid, {Claudia Maria} and Roberto Valvo and Orazio Strazzieri and Motta, {Silvia Crescenzia} and Valentina Frittitta and Elena Dipietro and Alessandro Comis and Chiara Melfa and Mariachiara Cal{\`i} and Sofia Sammartino and Giulia Laterra and Holger Thiele and Lars Sondergaard and Corrado Tamburino and Marco Barbanti and Azeem Latib",

note = "Publisher Copyright: {\textcopyright} 2024 American College of Cardiology Foundation",

year = "2024",

month = mar,

day = "11",

doi = "10.1016/j.jcin.2024.01.006",

language = "English (US)",

volume = "17",

pages = "681--692",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "5",

}

TY - JOUR

T1 - Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli

T2 - The OPERA-TAVI Registry

AU - Scotti, Andrea

AU - Sturla, Matteo

AU - Costa, Giuliano

AU - Saia, Francesco

AU - Pilgrim, Thomas

AU - Abdel-Wahab, Mohamed

AU - Garot, Philippe

AU - Gandolfo, Caterina

AU - Branca, Luca

AU - Santos, Ignacio Amat

AU - Mylotte, Darren

AU - Bedogni, Francesco

AU - De Backer, Ole

AU - Nombela Franco, Luis

AU - Webb, John

AU - Ribichini, Flavio Luciano

AU - Mainardi, Andrea

AU - Andreaggi, Stefano

AU - Mazzapicchi, Alessandro

AU - Tomii, Daijiro

AU - Laforgia, Pietro

AU - Cannata, Stefano

AU - Fiorina, Claudia

AU - Fezzi, Simone

AU - Criscione, Enrico

AU - Lunardi, Mattia

AU - Poletti, Enrico

AU - Mazzucca, Mattia

AU - Quagliana, Angelo

AU - Montarello, Nicholas

AU - Hennessey, Breda

AU - Mon-Noboa, Matias

AU - Akodad, Myriam

AU - Meier, David

AU - De Marco, Federico

AU - Adamo, Marianna

AU - Sgroi, Carmelo

AU - Reddavid, Claudia Maria

AU - Valvo, Roberto

AU - Strazzieri, Orazio

AU - Motta, Silvia Crescenzia

AU - Frittitta, Valentina

AU - Dipietro, Elena

AU - Comis, Alessandro

AU - Melfa, Chiara

AU - Calì, Mariachiara

AU - Sammartino, Sofia

AU - Laterra, Giulia

AU - Thiele, Holger

AU - Sondergaard, Lars

AU - Tamburino, Corrado

AU - Barbanti, Marco

AU - Latib, Azeem

PY - 2024/3/11

Y1 - 2024/3/11

N2 - Background: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. Objectives: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. Methods: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. Results: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). Conclusions: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

AB - Background: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. Objectives: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. Methods: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. Results: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). Conclusions: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

KW - aortic stenosis

KW - balloon expandable

KW - self-expanding

KW - small annuli

KW - transcatheter aortic valve replacement

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U2 - 10.1016/j.jcin.2024.01.006

DO - 10.1016/j.jcin.2024.01.006

M3 - Article

C2 - 38479968

AN - SCOPUS:85186619756

SN - 1936-8798

VL - 17

SP - 681

EP - 692

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 5

ER -

Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry

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