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 Søndergaard, Corrado Tamburino, Marco Barbanti

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2398-2407
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume15
Issue number23
DOIs
StatePublished - Dec 12 2022

Keywords

  • balloon expandable
  • comparison
  • outcomes
  • self-expanding
  • Valve Academic Research Consortium-3

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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