Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry
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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; 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.
I: JACC: Cardiovascular Interventions, Bind 15, Nr. 23, 2022, s. 2398-2407.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 - Søndergaard, Lars
AU - Tamburino, Corrado
AU - Barbanti, Marco
N1 - Publisher Copyright: © 2022 American College of Cardiology Foundation
PY - 2022
Y1 - 2022
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 - balloon expandable
KW - comparison
KW - outcomes
KW - self-expanding
KW - Valve Academic Research Consortium 3
U2 - 10.1016/j.jcin.2022.08.057
DO - 10.1016/j.jcin.2022.08.057
M3 - Journal article
C2 - 36121242
AN - SCOPUS:85140743561
VL - 15
SP - 2398
EP - 2407
JO - J A C C: Cardiovascular Interventions
JF - J A C C: Cardiovascular Interventions
SN - 1936-8798
IS - 23
ER -
ID: 327287967