Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry

Giuliano Costa; Francesco Saia; Thomas Pilgrim; Mohamed Abdel-Wahab; Philippe Garot; Roberto Valvo; Caterina Gandolfo; Luca Branca; Azeem Latib; Ignacio Amat Santos; Darren Mylotte; Federico De Marco; Ole De Backer; Luis Nombela Franco; Mariama Akodad; Alessandro Mazzapicchi; Daijiro Tomii; Pietro Laforgia; Stefano Cannata; Claudia Fiorina; Andrea Scotti; Mattia Lunardi; Enrico Poletti; Mattia Mazzucca; Angelo Quagliana; Breda Hennessey; David Meier; Marianna Adamo; Carmelo Sgroi; Claudia Maria Reddavid; Orazio Strazzieri; Silvia Crescenzia Motta; Valentina Frittitta; Elena Dipietro; Alessandro Comis; Chiara Melfa; Holger Thiele; John G Webb; Lars Sondergaard; Corrado Tamburino; Marco Barbanti

doi:10.1016/j.jcin.2022.08.057

Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry

Giuliano Costa, Francesco Saia, Thomas Pilgrim, Mohamed Abdel-Wahab, Philippe Garot, Roberto Valvo, Caterina Gandolfo, Luca Branca, Azeem Latib, Ignacio Amat Santos, Darren Mylotte, Federico De Marco, Ole De Backer, Luis Nombela Franco, Mariama Akodad, Alessandro Mazzapicchi, Daijiro Tomii, Pietro Laforgia, Stefano Cannata, Claudia FiorinaAndrea Scotti, Mattia Lunardi, Enrico Poletti, Mattia Mazzucca, Angelo Quagliana, Breda Hennessey, David Meier, Marianna Adamo, Carmelo Sgroi, Claudia Maria Reddavid, Orazio Strazzieri, Silvia Crescenzia Motta, Valentina Frittitta, Elena Dipietro, Alessandro Comis, Chiara Melfa, Holger Thiele, John G Webb, Lars Sondergaard, Corrado Tamburino, Marco Barbanti^*

^*Corresponding author af dette arbejde

Afdeling for Hjertesygdomme

44 Citationer (Scopus)

Abstract

BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes.

OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices.

METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium 3 device success and early safety, respectively.

RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01).

CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium 3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

Originalsprog	Engelsk
Tidsskrift	JACC. Cardiovascular interventions
Vol/bind	15
Udgave nummer	23
Sider (fra-til)	2398-2407
Antal sider	10
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2022.08.057
Status	Udgivet - 12 dec. 2022

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Costa, G., Saia, F., Pilgrim, T., Abdel-Wahab, M., Garot, P., Valvo, R., Gandolfo, C., Branca, L., Latib, A., Santos, I. A., Mylotte, D., De Marco, F., De Backer, O., Franco, L. N., Akodad, M., Mazzapicchi, A., Tomii, D., Laforgia, P., Cannata, S., ... Barbanti, M. (2022). Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry. JACC. Cardiovascular interventions, 15(23), 2398-2407. https://doi.org/10.1016/j.jcin.2022.08.057

Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry. / Costa, Giuliano; Saia, Francesco; Pilgrim, Thomas et al.
I: JACC. Cardiovascular interventions, Bind 15, Nr. 23, 12.12.2022, s. 2398-2407.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Costa, G, Saia, F, Pilgrim, T, Abdel-Wahab, M, Garot, P, Valvo, R, Gandolfo, C, Branca, L, Latib, A, Santos, IA, Mylotte, D, De Marco, F, De Backer, O, Franco, LN, Akodad, M, Mazzapicchi, A, Tomii, D, Laforgia, P, Cannata, S, Fiorina, C, Scotti, A, Lunardi, M, Poletti, E, Mazzucca, M, Quagliana, A, Hennessey, B, Meier, D, Adamo, M, Sgroi, C, Reddavid, CM, Strazzieri, O, Motta, SC, Frittitta, V, Dipietro, E, Comis, A, Melfa, C, Thiele, H, Webb, JG, Sondergaard, L, Tamburino, C & Barbanti, M 2022, 'Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry', JACC. Cardiovascular interventions, bind 15, nr. 23, s. 2398-2407. https://doi.org/10.1016/j.jcin.2022.08.057

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title = "Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry",

abstract = "BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes.OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices.METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium 3 device success and early safety, respectively.RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01).CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium 3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.",

keywords = "Heart Valve Prosthesis, Humans, Stroke/etiology, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome, self-expanding, balloon expandable, comparison, outcomes, Valve Academic Research Consortium-3",

author = "Giuliano Costa and Francesco Saia and Thomas Pilgrim and Mohamed Abdel-Wahab and Philippe Garot and Roberto Valvo and Caterina Gandolfo and Luca Branca and Azeem Latib and Santos, {Ignacio Amat} and Darren Mylotte and {De Marco}, Federico and {De Backer}, Ole and Franco, {Luis Nombela} and Mariama Akodad and Alessandro Mazzapicchi and Daijiro Tomii and Pietro Laforgia and Stefano Cannata and Claudia Fiorina and Andrea Scotti and Mattia Lunardi and Enrico Poletti and Mattia Mazzucca and Angelo Quagliana and Breda Hennessey and David Meier and Marianna Adamo and Carmelo Sgroi and Reddavid, {Claudia Maria} and Orazio Strazzieri and Motta, {Silvia Crescenzia} and Valentina Frittitta and Elena Dipietro and Alessandro Comis and Chiara Melfa and Holger Thiele and Webb, {John G} and Lars Sondergaard and Corrado Tamburino and Marco Barbanti",

note = "Copyright {\textcopyright} 2022. Published by Elsevier Inc.",

year = "2022",

month = dec,

day = "12",

doi = "10.1016/j.jcin.2022.08.057",

language = "English",

volume = "15",

pages = "2398--2407",

journal = "JACC. Cardiovascular interventions",

issn = "1936-8798",

publisher = "Elsevier Inc",

number = "23",

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TY - JOUR

T1 - Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves

T2 - The Multicenter OPERA-TAVI Registry

AU - Costa, Giuliano

AU - Saia, Francesco

AU - Pilgrim, Thomas

AU - Abdel-Wahab, Mohamed

AU - Garot, Philippe

AU - Valvo, Roberto

AU - Gandolfo, Caterina

AU - Branca, Luca

AU - Latib, Azeem

AU - Santos, Ignacio Amat

AU - Mylotte, Darren

AU - De Marco, Federico

AU - De Backer, Ole

AU - Franco, Luis Nombela

AU - Akodad, Mariama

AU - Mazzapicchi, Alessandro

AU - Tomii, Daijiro

AU - Laforgia, Pietro

AU - Cannata, Stefano

AU - Fiorina, Claudia

AU - Scotti, Andrea

AU - Lunardi, Mattia

AU - Poletti, Enrico

AU - Mazzucca, Mattia

AU - Quagliana, Angelo

AU - Hennessey, Breda

AU - Meier, David

AU - Adamo, Marianna

AU - Sgroi, Carmelo

AU - Reddavid, Claudia Maria

AU - Strazzieri, Orazio

AU - Motta, Silvia Crescenzia

AU - Frittitta, Valentina

AU - Dipietro, Elena

AU - Comis, Alessandro

AU - Melfa, Chiara

AU - Thiele, Holger

AU - Webb, John G

AU - Sondergaard, Lars

AU - Tamburino, Corrado

AU - Barbanti, Marco

PY - 2022/12/12

Y1 - 2022/12/12

N2 - BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes.OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices.METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium 3 device success and early safety, respectively.RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01).CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium 3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

AB - BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes.OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices.METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium 3 device success and early safety, respectively.RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01).CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium 3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

KW - Heart Valve Prosthesis

KW - Humans

KW - Stroke/etiology

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

KW - self-expanding

KW - balloon expandable

KW - comparison

KW - outcomes

KW - Valve Academic Research Consortium-3

UR - http://www.scopus.com/inward/record.url?scp=85140743561&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2022.08.057

DO - 10.1016/j.jcin.2022.08.057

M3 - Journal article

C2 - 36121242

SN - 1936-8798

VL - 15

SP - 2398

EP - 2407

JO - JACC. Cardiovascular interventions

JF - JACC. Cardiovascular interventions

IS - 23

ER -

Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry

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