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1. Sex-Related Outcomes of Transcatheter Aortic Valve Implantation With Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry

Author

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

Published
2024
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3. Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry

Author

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, and Latib, Azeem

Published
2024
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6. Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation

Author

Witberg, Guy, primary, Levi, Amos, additional, Talmor-Barkan, Yeela, additional, Barbanti, Marco, additional, Valvo, Roberto, additional, Costa, Giuliano, additional, Frittitta, Valentina, additional, de Backer, Ole, additional, Willemen, Yannick, additional, van Der Dorpel, Mark, additional, Mon, Matias, additional, Sugiura, Atsushi, additional, Sudo, Mitsumasa, additional, Masiero, Giulia, additional, Pancaldi, Edoardo, additional, Arzamendi, Dabit, additional, Santos-Martinez, Sandra, additional, Baz, Jose A., additional, Steblovnik, Klemen, additional, Mauri, Victor, additional, Adam, Matti, additional, Wienemann, Hendrik, additional, Zahler, David, additional, Hein, Manuel, additional, Ruile, Philipp, additional, Aodha, Brídóg Nic, additional, Grasso, Carmelo, additional, Branca, Luca, additional, Estévez-Loureiro, Rodrigo, additional, Amat-Santos, Ignacio J., additional, Mylotte, Darren, additional, Bunc, Matjaz, additional, Tarantini, Giuseppe, additional, Nombela-Franco, Luis, additional, Sondergaard, Lars, additional, Van Mieghem, Nicolas M., additional, Finkelstein, Ariel, additional, and Kornowski, Ran, additional

Published
2024
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7. Management of Myocardial Revascularization in Patients With Stable Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation

Author

Costa, Giuliano, Pilgrim, Thomas, Amat Santos, Ignacio J., De Backer, Ole, Kim, Won-Keun, Barbosa Ribeiro, Henrique, Saia, Francesco, Bunc, Matjaz, Tchetche, Didier, Garot, Philippe, Ribichini, Flavio Luciano, Mylotte, Dzxcfewarren, Burzotta, Francesco, Watanabe, Yusuke, De Marco, Federico, Tesorio, Tullio, Rheude, Tobias, Tocci, Marco, Franzone, Anna, Valvo, Roberto, Savontaus, Mikko, Wienemann, Hendrik, Porto, Italo, Gandolfo, Caterina, Iadanza, Alessandro, Bortone, Alessandro Santo, Mach, Markus, Latib, Azeem, Biasco, Luigi, Taramasso, Maurizio, Zimarino, Marco, Tomii, Daijiro, Nuyens, Philippe, Sondergaard, Lars, Camara, Sergio F., Palmerini, Tullio, Orzalkiewicz, Mateusz, Steblovnik, Klemen, Degrelle, Bastien, Gautier, Alexandre, Del Sole, Paolo Alberto, Mainardi, Andrea, Pighi, Michele, Lunardi, Mattia, Kawashima, Hideyuki, Criscione, Enrico, Cesario, Vincenzo, Biancari, Fausto, Zanin, Federico, Joner, Michael, Esposito, Giovanni, Adam, Matti, Grube, Eberhard, Baldus, Stephan, De Marzo, Vincenzo, Piredda, Elisa, Cannata, Stefano, Iacovelli, Fortunato, Andreas, Martin, Frittitta, Valentina, Dipietro, Elena, Reddavid, Claudia, Strazzieri, Orazio, Motta, Silvia, Angellotti, Domenico, Sgroi, Carmelo, Kargoli, Faraj, Tamburino, Corrado, and Barbanti, Marco

Published
2022
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8. Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation

Author

Rheude, Tobias, primary, Costa, Giuliano, additional, Ribichini, Flavio Luciano, additional, Pilgrim, Thomas, additional, Amat Santos, Ignacio J., additional, De Backer, Ole, additional, Kim, Won‐Keun, additional, Ribeiro, Henrique Barbosa, additional, Saia, Francesco, additional, Bunc, Matjaz, additional, Tchétché, Didier, additional, Garot, Philippe, additional, Mylotte, Darren, additional, Burzotta, Francesco, additional, Watanabe, Yusuke, additional, Bedogni, Francesco, additional, Tesorio, Tullio, additional, Tocci, Marco, additional, Franzone, Anna, additional, Valvo, Roberto, additional, Savontaus, Mikko, additional, Wienemann, Hendrik, additional, Porto, Italo, additional, Gandolfo, Caterina, additional, Iadanza, Alessandro, additional, Bortone, Alessandro S., additional, Mach, Markus, additional, Latib, Azeem, additional, Biasco, Luigi, additional, Taramasso, Maurizio, additional, Zimarino, Marco, additional, Tomii, Daijiro, additional, Nuyens, Philippe, additional, Sondergaard, Lars, additional, Camara, Sergio F., additional, Palmerini, Tullio, additional, Orzalkiewicz, Mateusz, additional, Steblovnik, Klemen, additional, Degrelle, Bastien, additional, Gautier, Alexandre, additional, Del Sole, Paolo Alberto, additional, Mainardi, Andrea, additional, Pighi, Michele, additional, Lunardi, Mattia, additional, Kawashima, Hideyuki, additional, Criscione, Enrico, additional, Cesario, Vincenzo, additional, Biancari, Fausto, additional, Zanin, Federico, additional, Esposito, Giovanni, additional, Adam, Matti, additional, Grube, Eberhard, additional, Baldus, Stephan, additional, De Marzo, Vincenzo, additional, Piredda, Elisa, additional, Cannata, Stefano, additional, Iacovelli, Fortunato, additional, Andreas, Martin, additional, Frittitta, Valentina, additional, Dipietro, Elena, additional, Reddavid, Claudia, additional, Strazzieri, Orazio, additional, Motta, Silvia, additional, Angellotti, Domenico, additional, Sgroi, Carmelo, additional, Xhepa, Erion, additional, Kargoli, Faraj, additional, Tamburino, Corrado, additional, Joner, Michael, additional, and Barbanti, Marco, additional

Published
2023
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9. Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation

Author

Rheude, Tobia, Costa, Giuliano, Ribichini, Flavio Luciano, Pilgrim, Thoma, Amat Santos, Ignacio J, De Backer, Ole, Kim, Won-Keun, Ribeiro, Henrique Barbosa, Saia, Francesco, Bunc, Matjaz, Tchetche, Didier, Garot, Philippe, Mylotte, Darren, Burzotta, Francesco, Watanabe, Yusuke, Bedogni, Francesco, Tesorio, Tullio, Tocci, Marco, Franzone, Anna, Valvo, Roberto, Savontaus, Mikko, Wienemann, Hendrik, Porto, Italo, Gandolfo, Caterina, Iadanza, Alessandro, Bortone, Alessandro S, Mach, Marku, Latib, Azeem, Biasco, Luigi, Taramasso, Maurizio, Zimarino, Marco, Tomii, Daijiro, Nuyens, Philippe, Sondergaard, Lar, Camara, Sergio F, Palmerini, Tullio, Orzalkiewicz, Mateusz, Steblovnik, Klemen, Degrelle, Bastien, Gautier, Alexandre, Del Sole, Paolo Alberto, Mainardi, Andrea, Pighi, Michele, Lunardi, Mattia, Kawashima, Hideyuki, Criscione, Enrico, Cesario, Vincenzo, Biancari, Fausto, Zanin, Federico, Esposito, Giovanni, Adam, Matti, Grube, Eberhard, Baldus, Stephan, De Marzo, Vincenzo, Piredda, Elisa, Cannata, Stefano, Iacovelli, Fortunato, Andreas, Martin, Frittitta, Valentina, Dipietro, Elena, Reddavid, Claudia, Strazzieri, Orazio, Motta, Silvia, Angellotti, Domenico, Sgroi, Carmelo, Xhepa, Erion, Kargoli, Faraj, Tamburino, Corrado, Joner, Michael, Barbanti, Marco, Burzotta, Francesco (ORCID:0000-0002-6569-9401), Porto, Italo (ORCID:0000-0002-9854-5046), Rheude, Tobia, Costa, Giuliano, Ribichini, Flavio Luciano, Pilgrim, Thoma, Amat Santos, Ignacio J, De Backer, Ole, Kim, Won-Keun, Ribeiro, Henrique Barbosa, Saia, Francesco, Bunc, Matjaz, Tchetche, Didier, Garot, Philippe, Mylotte, Darren, Burzotta, Francesco, Watanabe, Yusuke, Bedogni, Francesco, Tesorio, Tullio, Tocci, Marco, Franzone, Anna, Valvo, Roberto, Savontaus, Mikko, Wienemann, Hendrik, Porto, Italo, Gandolfo, Caterina, Iadanza, Alessandro, Bortone, Alessandro S, Mach, Marku, Latib, Azeem, Biasco, Luigi, Taramasso, Maurizio, Zimarino, Marco, Tomii, Daijiro, Nuyens, Philippe, Sondergaard, Lar, Camara, Sergio F, Palmerini, Tullio, Orzalkiewicz, Mateusz, Steblovnik, Klemen, Degrelle, Bastien, Gautier, Alexandre, Del Sole, Paolo Alberto, Mainardi, Andrea, Pighi, Michele, Lunardi, Mattia, Kawashima, Hideyuki, Criscione, Enrico, Cesario, Vincenzo, Biancari, Fausto, Zanin, Federico, Esposito, Giovanni, Adam, Matti, Grube, Eberhard, Baldus, Stephan, De Marzo, Vincenzo, Piredda, Elisa, Cannata, Stefano, Iacovelli, Fortunato, Andreas, Martin, Frittitta, Valentina, Dipietro, Elena, Reddavid, Claudia, Strazzieri, Orazio, Motta, Silvia, Angellotti, Domenico, Sgroi, Carmelo, Xhepa, Erion, Kargoli, Faraj, Tamburino, Corrado, Joner, Michael, Barbanti, Marco, Burzotta, Francesco (ORCID:0000-0002-6569-9401), and Porto, Italo (ORCID:0000-0002-9854-5046)

Abstract

Background: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. Aims: We sought to compare different PCI timing strategies in TAVI patients. Methods: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. Results: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. Conclusions: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Published
2023

10. Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation

Author

Rheude, Tobias, Costa, Giuliano, Ribichini, Flavio Luciano, Pilgrim, Thomas, Amat-Santos, Ignacio J., De Backer, Ole, Kim, Won Keun, Ribeiro, Henrique Barbosa, Saia, Francesco, Bunc, Matjaz, Tchétché, Didier, Garot, Philippe, Mylotte, Darren, Burzotta, Francesco, Watanabe, Yusuke, Bedogni, Francesco, Tesorio, Tullio, Tocci, Marco, Franzone, Anna, Valvo, Roberto, Savontaus, Mikko, Wienemann, Hendrik, Porto, Italo, Gandolfo, Caterina, Iadanza, Alessandro, Bortone, Alessandro S., Mach, Markus, Latib, Azeem, Biasco, Luigi, Taramasso, Maurizio, Zimarino, Marco, Tomii, Daijiro, Nuyens, Philippe, Sondergaard, Lars, Camara, Sergio F., Palmerini, Tullio, Orzalkiewicz, Mateusz, Steblovnik, Klemen, Degrelle, Bastien, Gautier, Alexandre, Del Sole, Paolo Alberto, Mainardi, Andrea, Pighi, Michele, Lunardi, Mattia, Kawashima, Hideyuki, Criscione, Enrico, Cesario, Vincenzo, Biancari, Fausto, Zanin, Federico, Esposito, Giovanni, Adam, Matti, Grube, Eberhard, Baldus, Stephan, De Marzo, Vincenzo, Piredda, Elisa, Cannata, Stefano, Iacovelli, Fortunato, Andreas, Martin, Frittitta, Valentina, Dipietro, Elena, Reddavid, Claudia, Strazzieri, Orazio, Motta, Silvia, Angellotti, Domenico, Sgroi, Carmelo, Xhepa, Erion, Kargoli, Faraj, Tamburino, Corrado, Joner, Michael, Barbanti, Marco, Rheude, Tobias, Costa, Giuliano, Ribichini, Flavio Luciano, Pilgrim, Thomas, Amat-Santos, Ignacio J., De Backer, Ole, Kim, Won Keun, Ribeiro, Henrique Barbosa, Saia, Francesco, Bunc, Matjaz, Tchétché, Didier, Garot, Philippe, Mylotte, Darren, Burzotta, Francesco, Watanabe, Yusuke, Bedogni, Francesco, Tesorio, Tullio, Tocci, Marco, Franzone, Anna, Valvo, Roberto, Savontaus, Mikko, Wienemann, Hendrik, Porto, Italo, Gandolfo, Caterina, Iadanza, Alessandro, Bortone, Alessandro S., Mach, Markus, Latib, Azeem, Biasco, Luigi, Taramasso, Maurizio, Zimarino, Marco, Tomii, Daijiro, Nuyens, Philippe, Sondergaard, Lars, Camara, Sergio F., Palmerini, Tullio, Orzalkiewicz, Mateusz, Steblovnik, Klemen, Degrelle, Bastien, Gautier, Alexandre, Del Sole, Paolo Alberto, Mainardi, Andrea, Pighi, Michele, Lunardi, Mattia, Kawashima, Hideyuki, Criscione, Enrico, Cesario, Vincenzo, Biancari, Fausto, Zanin, Federico, Esposito, Giovanni, Adam, Matti, Grube, Eberhard, Baldus, Stephan, De Marzo, Vincenzo, Piredda, Elisa, Cannata, Stefano, Iacovelli, Fortunato, Andreas, Martin, Frittitta, Valentina, Dipietro, Elena, Reddavid, Claudia, Strazzieri, Orazio, Motta, Silvia, Angellotti, Domenico, Sgroi, Carmelo, Xhepa, Erion, Kargoli, Faraj, Tamburino, Corrado, Joner, Michael, and Barbanti, Marco

Abstract

Background: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. Aims: We sought to compare different PCI timing strategies in TAVI patients. Methods: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. Results: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI., Background: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. Aims: We sought to compare different PCI timing strategies in TAVI patients. Methods: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. Results: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. Conclusions: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Published
2023

11. Balloon-Expandable Valve for Treatment of Self-Expanding Supra-Annular Valve Failure

Author

Strazzieri, Orazio, primary, Motta, Silvia Crescenzia, additional, Costa, Giuliano, additional, Valvo, Roberto, additional, Reddavid, Claudia, additional, Frittitta, Valentina, additional, Dipietro, Elena, additional, Melfa, Chiara, additional, Comis, Alessandro, additional, Sgroi, Carmelo, additional, Tamburino, Corrado, additional, and Barbanti, Marco, additional

Published
2023
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12. Plug-Based Endovascular Closure of Large Bore Aortofemoral Graft Arteriotomy for Transcatheter Aortic Valve Replacement

Author

Dipietro, Elena, primary, Costa, Giuliano, additional, Valvo, Roberto, additional, Reddavid, Claudia, additional, Strazzieri, Orazio, additional, Motta, Silvia, additional, Frittitta, Valentina, additional, Comis, Alessandro, additional, Melfa, Chiara, additional, Giaquinta, Alessia, additional, Veroux, Pierfrancesco, additional, Sgroi, Carmelo, additional, Barbanti, Marco, additional, and Tamburino, Corrado, additional

Published
2023
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15. Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves

Author

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

Published
2022
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17. Long-term outcomes of concomitant transcatheter aortic valve implantation and percutaneous coronary intervention

Author

VALVO, Roberto, primary, COSTA, Giuliano, additional, CRISCIONE, Enrico, additional, REDDAVID, Claudia, additional, STRAZZIERI, Orazio, additional, MOTTA, Silvia, additional, DIPIETRO, Elena, additional, FRITTITTA, Valentina, additional, CARCIOTTO, Gabriele, additional, MIGNOSA, Carmelo, additional, INSERRA, Cristina, additional, SGROI, Carmelo, additional, TAMBURINO, Corrado, additional, and BARBANTI, Marco, additional

Published
2022
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18. TCT-498 Outcomes of Transcatheter Aortic Valve implantation With Evolut PRO/PRO+ or SAPIEN 3 Ultra devices: The International, Multicenter OPERA-TAVI Registry

Author

Costa, Giuliano, primary, Saia, Francesco, additional, Pilgrim, Thomas, additional, Abdel-Wahab, Mohamed, additional, Garot, Philippe, additional, Gandolfo, Caterina, additional, Branca, Luca, additional, Latib, Azeem, additional, Amat-Santos, Ignacio, additional, Mylotte, Darren, additional, De Marco, Federico, additional, De Backer, Ole, additional, Franco, Luis Nombela, additional, Webb, John, additional, Valvo, Roberto, additional, Mazzapicchi, Alessandro, additional, Tomii, Daijiro, additional, Laforgia, Pietro, additional, Cannata, Stefano, additional, Fiorina, Claudia, additional, Scotti, Andrea, additional, Lunardi, Mattia, additional, Poletti, Enrico, additional, Quagliana, Angelo, additional, Sondergaard, Lars, additional, Hennessey, Breda, additional, Meier, David, additional, Reddavid, Claudia, additional, Strazzieri, Orazio, additional, Motta, Silvia Crescenzia, additional, Frittitta, Valentina, additional, Dipietro, Elena, additional, Barbanti, Marco, additional, and Tamburino, Corrado, additional

Published
2022
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21. Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves:The Multicenter OPERA-TAVI Registry

Author

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

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 devi

Published
2022

24. Characterization and Management of Stable Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation.

Author

Sammartino S, Laterra G, Pilgrim T, Amat Santos IJ, De Backer O, Kim WK, Ribeiro HB, Saia F, Bunc M, Tchetche D, Garot P, Ribichini FL, Mylotte D, Burzotta F, Watanabe Y, Bedogni F, Tesorio T, Rheude T, Sardella G, Tocci M, Franzone A, Valvo R, Savontaus M, Wienemann H, Porto I, Gandolfo C, Iadanza A, Bortone AS, Mach M, Latib A, Biasco L, Taramasso M, De Marco F, Frittitta V, Dipietro E, Reddavid C, Strazzieri O, Motta S, Comis A, Melfa C, Calì M, Sgroi C, Abdel-Wahab M, Stefanini G, Tamburino C, Barbanti M, and Costa G

Abstract

Background/Objectives : To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods : REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results : A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, p log-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, p log-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions : Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively., Competing Interests: Thomas Pilgrim received research grants to the institution from Biotronik, Boston Scientific, and Edwards Lifesciences; and speaker/consultancy fees from Medtronic, Boston Scientific, Biotronik, and HighLifeSAS. Ole De Backer received institutional research grants and/or consulting fees from Abbott and Boston Scientific. Lars Sondergaard received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Maurizio Taramasso is a consultant for Abbott, Edwards Lifesciences, Boston Scientific, Shenqi Medical, CoreMedic, MEDIRA, 4tech, Simulands, Occlufit, and MTEX. Corrado Tamburino is a consultant for Medtronic. All other authors have nothing to disclose.

Published
2024
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25. One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

Author

Costa G, Saia F, Pilgrim T, Abdel-Wahab M, Garot P, Sammartino S, Gandolfo C, Branca L, Latib A, Amat-Santos I, Mylotte D, De Marco F, De Backer O, Nombela Franco L, Akodad M, Ribichini FL, Bedogni F, Mazzapicchi A, Tomii D, Laforgia P, Cannata S, Fiorina C, Scotti A, Fezzi S, Criscione E, Poletti E, Mazzucca M, Lunardi M, Mainardi A, Andreaggi S, Quagliana A, Montarello NJ, Hennessey B, Mon-Noboa M, Meier D, Adamo M, Sgroi C, Reddavid CM, Strazzieri O, Crescenzia Motta S, Frittitta V, Dipietro E, Comis A, Melfa C, Calì M, Laterra G, Thiele H, Webb JG, Sondergaard L, Tamburino C, and Barbanti M

Subjects
Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Treatment Outcome, Registries, Prosthesis Design, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis surgery, Heart Valve Prosthesis adverse effects, Stroke etiology
Abstract

Background: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking., Aims: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice., Methods: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology., Results: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all p interaction >0.10)., Conclusions: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

Published
2024
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26. [Evolution of transcatheter aortic valve implantation from a high-volume Italian center: report of 2058 procedures over 15-year experience].

Author

Tamburino C, Costa G, Frittitta V, Valvo R, Reddavid C, Criscione E, Strazzieri O, Motta S, Di Pietro E, Deste W, Veroux P, Garretto V, Sgroi C, Mignosa C, Giuffrida A, and Barbanti M

Subjects
Aged, Aged, 80 and over, Aortic Valve surgery, Fluoroscopy, Humans, Retrospective Studies, Treatment Outcome, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement methods
Abstract

Background: To assess the longitudinal changes in transcatheter aortic valve implantation (TAVI) practice and patients' outcomes in a high-volume Italian center., Methods: We analyzed all patients undergoing TAVI at our Institution from June 2007 to August 2021. We stratified the overall population considering four time periods according to procedural advancements and changes in clinical practice: period 1 (2007-2009, n=107) vs period 2 (2010-2014, n=449) vs period 3 (2015-2019, n=864) vs period 4 (2019-2021, n=638). Baseline and procedural characteristics, and in-hospital outcomes among the four groups were compared., Results: A total of 2058 patients underwent TAVI receiving all the available devices. Patients had a median age of 82 years (78-85) with no differences among time periods. A stepwise reduction of median Society of Thoracic Surgeons mortality risk score (3.7 [2.8-5.3] vs 3.6 [2.6-5.4] vs 3.6 [2.5-5.5] vs 3.3 [2.2-4.9]; p=0.01) was observed. In-hospital all-cause-death (7.5% vs 5.1% vs 2.9% vs 3.0%; p<0.05), major stroke (4.7% vs 0.7% vs 1.0% vs 0.8%; p<0.05), major vascular complications (17.8% vs 8.7% vs 10.5% vs 5.8%; p<0.05) and permanent pacemaker implantation (23.4% vs 12.0% vs 8.7% vs 8.8%; p<0.05) rates significantly lowered over time. Device success markedly improved (80.4% vs 87.1% vs 95.0% vs 96.3%; p<0.05) with significant improvement of paravalvular regurgitation after TAVI (moderate-to-severe 16.8% vs 8.1% vs 0.7% vs 0.2%; mild 61.4% vs 38.2% vs 38.5% vs 25.6%; p<0.05)., Conclusions: All-cause death and in-hospital outcomes of patients undergoing TAVI significantly improved accordingly to technical advancements and changes in clinical practice over 15-year experience.

Published
2022
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