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

  • Academic Journal
  • Costa G; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Saia F; Cardiovascular Department, Policlinico S. Orsola, University of Bologna, Bologna, Italy.
    Pilgrim T; Bern University Hospital, Inselspital, Bern, Switzerland.
    Abdel-Wahab M; Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
    Garot P; Institut Cardiovasculaire Paris Sud (ICPS), Hôpital Jacques Cartier, Ramsay-Santé, Massy, France.
    Valvo R; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Gandolfo C; Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), Palermo, Italy.
    Branca L; Spedali Civili, Brescia, Italy.
    Latib A; Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
    Santos IA; Division of Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
    Mylotte D; Department of Cardiology, University Hospital, National University of Ireland Galway, Ireland.
    De Marco F; Interventional Cardiology Department, IRCSS Centro Cardiologico Monzino, Milan, Italy.
    De Backer O; The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
    Franco LN; Hospital Clinico San Carlo, Madrid, Spain.
    Akodad M; Centre for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
    Mazzapicchi A; Cardiovascular Department, Policlinico S. Orsola, University of Bologna, Bologna, Italy.
    Tomii D; Bern University Hospital, Inselspital, Bern, Switzerland.
    Laforgia P; Institut Cardiovasculaire Paris Sud (ICPS), Hôpital Jacques Cartier, Ramsay-Santé, Massy, France.
    Cannata S; Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), Palermo, Italy.
    Fiorina C; Spedali Civili, Brescia, Italy.
    Scotti A; Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
    Lunardi M; Department of Cardiology, University Hospital, National University of Ireland Galway, Ireland.
    Poletti E; Division of Cardiology, IRCSS Policlinico San Donato, San Donato Milanese (MI), Italy.
    Mazzucca M; Division of Cardiology, IRCSS Policlinico San Donato, San Donato Milanese (MI), Italy.
    Quagliana A; The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
    Hennessey B; Hospital Clinico San Carlo, Madrid, Spain.
    Meier D; Centre for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
    Adamo M; Spedali Civili, Brescia, Italy.
    Sgroi C; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Reddavid CM; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Strazzieri O; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Motta SC; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Frittitta V; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Dipietro E; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Comis A; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Melfa C; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Thiele H; Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
    Webb JG; Centre for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
    Sondergaard L; The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
    Tamburino C; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy.
    Barbanti M; Division of Cardiology, A.O.U. Policlinico 'G. Rodolico-San Marco', Catania, Italy. Electronic address: mbarbanti83@gmail.com.
  • JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2022 Sep 08. Date of Electronic Publication: 2022 Sep 08.
  • English
  • 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+ or balloon-expandable (BE) Sapien 3 ULTRA devices.
    Methods: The OPERA-TAVI 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 to both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were VARC-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 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 (PPI) (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 VARC-3 device success rates, but the BE device had a higher rate of early safety. The higher PPI and disabling stroke rates in SE device recipients drove this composite endpoint.
    (Copyright © 2022. Published by Elsevier Inc.)
Additional Information
Ahead of Print
Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE
Original Publication: New York : Elsevier
Keywords: Balloon-expandable; Self-expanding; TAVR; VARC-3; comparison; outcomes
Date Created: 20220919 Latest Revision: 20220919
20220920
10.1016/j.jcin.2022.08.057
36121242
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