Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry
The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. 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) SA...
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| creator | Scotti, Andrea Sturla, Matteo Costa, Giuliano Saia, Francesco Pilgrim, Thomas Abdel-Wahab, Mohamed Garot, Philippe Gandolfo, Caterina Branca, Luca Santos, Ignacio Amat Mylotte, Darren Bedogni, Francesco De Backer, Ole Nombela Franco, Luis Webb, John Ribichini, Flavio Luciano Mainardi, Andrea Andreaggi, Stefano Mazzapicchi, Alessandro Tomii, Daijiro Laforgia, Pietro Cannata, Stefano Fiorina, Claudia Fezzi, Simone Criscione, Enrico Lunardi, Mattia Poletti, Enrico Mazzucca, Mattia Quagliana, Angelo Montarello, Nicholas Hennessey, Breda Mon-Noboa, Matias Akodad, Myriam Meier, David De Marco, Federico Adamo, Marianna Sgroi, Carmelo Reddavid, Claudia Maria Valvo, Roberto Strazzieri, Orazio Motta, Silvia Crescenzia Frittitta, Valentina Dipietro, Elena Comis, Alessandro Melfa, Chiara Calì, Mariachiara Sammartino, Sofia Laterra, Giulia Thiele, Holger Sondergaard, Lars Tamburino, Corrado Barbanti, Marco Latib, Azeem |
| description | The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored.
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.
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.
Among 3,516 patients, 251 matched pairs with aortic annular area 20 mm Hg (SE 1.0% vs BE 13.5%; P |
| doi_str_mv | 10.1016/j.jcin.2024.01.006 |
| format | Article |
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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.
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.
Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm
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).
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.</description><identifier>EISSN: 1876-7605</identifier><identifier>DOI: 10.1016/j.jcin.2024.01.006</identifier><identifier>PMID: 38479968</identifier><language>eng</language><publisher>United States</publisher><ispartof>JACC. Cardiovascular interventions, 2024-03, Vol.17 (5), p.681-692</ispartof><rights>Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38479968$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Scotti, Andrea</creatorcontrib><creatorcontrib>Sturla, Matteo</creatorcontrib><creatorcontrib>Costa, Giuliano</creatorcontrib><creatorcontrib>Saia, Francesco</creatorcontrib><creatorcontrib>Pilgrim, Thomas</creatorcontrib><creatorcontrib>Abdel-Wahab, Mohamed</creatorcontrib><creatorcontrib>Garot, Philippe</creatorcontrib><creatorcontrib>Gandolfo, Caterina</creatorcontrib><creatorcontrib>Branca, Luca</creatorcontrib><creatorcontrib>Santos, Ignacio Amat</creatorcontrib><creatorcontrib>Mylotte, Darren</creatorcontrib><creatorcontrib>Bedogni, Francesco</creatorcontrib><creatorcontrib>De Backer, Ole</creatorcontrib><creatorcontrib>Nombela Franco, Luis</creatorcontrib><creatorcontrib>Webb, John</creatorcontrib><creatorcontrib>Ribichini, Flavio Luciano</creatorcontrib><creatorcontrib>Mainardi, Andrea</creatorcontrib><creatorcontrib>Andreaggi, Stefano</creatorcontrib><creatorcontrib>Mazzapicchi, Alessandro</creatorcontrib><creatorcontrib>Tomii, Daijiro</creatorcontrib><creatorcontrib>Laforgia, Pietro</creatorcontrib><creatorcontrib>Cannata, Stefano</creatorcontrib><creatorcontrib>Fiorina, Claudia</creatorcontrib><creatorcontrib>Fezzi, Simone</creatorcontrib><creatorcontrib>Criscione, Enrico</creatorcontrib><creatorcontrib>Lunardi, Mattia</creatorcontrib><creatorcontrib>Poletti, Enrico</creatorcontrib><creatorcontrib>Mazzucca, Mattia</creatorcontrib><creatorcontrib>Quagliana, Angelo</creatorcontrib><creatorcontrib>Montarello, Nicholas</creatorcontrib><creatorcontrib>Hennessey, Breda</creatorcontrib><creatorcontrib>Mon-Noboa, Matias</creatorcontrib><creatorcontrib>Akodad, Myriam</creatorcontrib><creatorcontrib>Meier, David</creatorcontrib><creatorcontrib>De Marco, Federico</creatorcontrib><creatorcontrib>Adamo, Marianna</creatorcontrib><creatorcontrib>Sgroi, Carmelo</creatorcontrib><creatorcontrib>Reddavid, Claudia Maria</creatorcontrib><creatorcontrib>Valvo, Roberto</creatorcontrib><creatorcontrib>Strazzieri, Orazio</creatorcontrib><creatorcontrib>Motta, Silvia Crescenzia</creatorcontrib><creatorcontrib>Frittitta, Valentina</creatorcontrib><creatorcontrib>Dipietro, Elena</creatorcontrib><creatorcontrib>Comis, Alessandro</creatorcontrib><creatorcontrib>Melfa, Chiara</creatorcontrib><creatorcontrib>Calì, Mariachiara</creatorcontrib><creatorcontrib>Sammartino, Sofia</creatorcontrib><creatorcontrib>Laterra, Giulia</creatorcontrib><creatorcontrib>Thiele, Holger</creatorcontrib><creatorcontrib>Sondergaard, Lars</creatorcontrib><creatorcontrib>Tamburino, Corrado</creatorcontrib><creatorcontrib>Barbanti, Marco</creatorcontrib><creatorcontrib>Latib, Azeem</creatorcontrib><title>Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry</title><title>JACC. Cardiovascular interventions</title><addtitle>JACC Cardiovasc Interv</addtitle><description>The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored.
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.
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.
Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm
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).
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.</description><issn>1876-7605</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNo1kE9LwzAAxYMgbk6_gAfJ0Utr_nRJ6i2MqoPhSlf1WLI01Y40nUkr7NtbUE-P9_jxeDwAbjCKMcLs_hAfdOtigkgSIxwjxM7AHAvOIs7QcgYuQzhMIUo5uQAzKhKepkzMwXv23dtxgHmxhcrVcCfzdfYCXzdlIWFufNP7TjltYOvgrlPWQtn7odVQOjfa9gGWnwZu86yQUSnf1rAwH20Y_OkKnDfKBnP9pwtQPmbl6jnabJ_WK7mJjgTjIUo03jeYKCMauhRKccWM0iTVSE1GENJMS2tqdI0QpbViiiEteJJQnmLU0AW4-609-v5rNGGoujZoY61yph9DRdIlx0wQTib09g8d952pq6NvO-VP1f8X9AfzVF1t</recordid><startdate>20240311</startdate><enddate>20240311</enddate><creator>Scotti, Andrea</creator><creator>Sturla, Matteo</creator><creator>Costa, Giuliano</creator><creator>Saia, Francesco</creator><creator>Pilgrim, Thomas</creator><creator>Abdel-Wahab, Mohamed</creator><creator>Garot, Philippe</creator><creator>Gandolfo, Caterina</creator><creator>Branca, Luca</creator><creator>Santos, Ignacio Amat</creator><creator>Mylotte, Darren</creator><creator>Bedogni, Francesco</creator><creator>De Backer, Ole</creator><creator>Nombela Franco, Luis</creator><creator>Webb, John</creator><creator>Ribichini, Flavio Luciano</creator><creator>Mainardi, Andrea</creator><creator>Andreaggi, Stefano</creator><creator>Mazzapicchi, Alessandro</creator><creator>Tomii, Daijiro</creator><creator>Laforgia, Pietro</creator><creator>Cannata, Stefano</creator><creator>Fiorina, Claudia</creator><creator>Fezzi, Simone</creator><creator>Criscione, Enrico</creator><creator>Lunardi, Mattia</creator><creator>Poletti, Enrico</creator><creator>Mazzucca, Mattia</creator><creator>Quagliana, Angelo</creator><creator>Montarello, Nicholas</creator><creator>Hennessey, Breda</creator><creator>Mon-Noboa, Matias</creator><creator>Akodad, Myriam</creator><creator>Meier, David</creator><creator>De Marco, Federico</creator><creator>Adamo, Marianna</creator><creator>Sgroi, Carmelo</creator><creator>Reddavid, Claudia Maria</creator><creator>Valvo, Roberto</creator><creator>Strazzieri, Orazio</creator><creator>Motta, Silvia Crescenzia</creator><creator>Frittitta, Valentina</creator><creator>Dipietro, Elena</creator><creator>Comis, Alessandro</creator><creator>Melfa, Chiara</creator><creator>Calì, Mariachiara</creator><creator>Sammartino, Sofia</creator><creator>Laterra, Giulia</creator><creator>Thiele, Holger</creator><creator>Sondergaard, Lars</creator><creator>Tamburino, Corrado</creator><creator>Barbanti, Marco</creator><creator>Latib, Azeem</creator><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20240311</creationdate><title>Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry</title><author>Scotti, Andrea ; 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Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Scotti, Andrea</au><au>Sturla, Matteo</au><au>Costa, Giuliano</au><au>Saia, Francesco</au><au>Pilgrim, Thomas</au><au>Abdel-Wahab, Mohamed</au><au>Garot, Philippe</au><au>Gandolfo, Caterina</au><au>Branca, Luca</au><au>Santos, Ignacio Amat</au><au>Mylotte, Darren</au><au>Bedogni, Francesco</au><au>De Backer, Ole</au><au>Nombela Franco, Luis</au><au>Webb, John</au><au>Ribichini, Flavio Luciano</au><au>Mainardi, Andrea</au><au>Andreaggi, Stefano</au><au>Mazzapicchi, Alessandro</au><au>Tomii, Daijiro</au><au>Laforgia, Pietro</au><au>Cannata, Stefano</au><au>Fiorina, Claudia</au><au>Fezzi, Simone</au><au>Criscione, Enrico</au><au>Lunardi, Mattia</au><au>Poletti, Enrico</au><au>Mazzucca, Mattia</au><au>Quagliana, Angelo</au><au>Montarello, Nicholas</au><au>Hennessey, Breda</au><au>Mon-Noboa, Matias</au><au>Akodad, Myriam</au><au>Meier, David</au><au>De Marco, Federico</au><au>Adamo, Marianna</au><au>Sgroi, Carmelo</au><au>Reddavid, Claudia Maria</au><au>Valvo, Roberto</au><au>Strazzieri, Orazio</au><au>Motta, Silvia Crescenzia</au><au>Frittitta, Valentina</au><au>Dipietro, Elena</au><au>Comis, Alessandro</au><au>Melfa, Chiara</au><au>Calì, Mariachiara</au><au>Sammartino, Sofia</au><au>Laterra, Giulia</au><au>Thiele, Holger</au><au>Sondergaard, Lars</au><au>Tamburino, Corrado</au><au>Barbanti, Marco</au><au>Latib, Azeem</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry</atitle><jtitle>JACC. Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2024-03-11</date><risdate>2024</risdate><volume>17</volume><issue>5</issue><spage>681</spage><epage>692</epage><pages>681-692</pages><eissn>1876-7605</eissn><abstract>The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored.
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.
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.
Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm
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).
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.</abstract><cop>United States</cop><pmid>38479968</pmid><doi>10.1016/j.jcin.2024.01.006</doi><tpages>12</tpages></addata></record> |
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| ispartof | JACC. Cardiovascular interventions, 2024-03, Vol.17 (5), p.681-692 |
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| recordid | cdi_proquest_miscellaneous_2957168272 |
| source | Elsevier ScienceDirect Journals Complete |
| title | Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry |
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