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 -