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

EuroIntervention 2024;20:. DOI: 10.4244/EIJ-D-23-00720

Giuliano Costa
Giuliano Costa1, MD; Francesco Saia2, MD; Thomas Pilgrim3, MD; Mohamed Abdel-Wahab4, MD; Philippe Garot5, MD; Sofia Sammartino1, MD; Caterina Gandolfo6, MD; Luca Branca7, MD; Azeem Latib8, MD; Ignacio Amat-Santos9, MD; Darren Mylotte10, MD; Federico De Marco11, MD; Ole De Backer12, MD; Luis Nombela Franco13, MD; Mariama Akodad5,14, MD, PhD; Flavio Luciano Ribichini15, MD; Francesco Bedogni16, MD; Alessandro Mazzapicchi2, MD; Daijiro Tomii3, MD; Pietro Laforgia5, MD; Stefano Cannata6, MD; Claudia Fiorina7, MD; Andrea Scotti8, MD; Simone Fezzi10, MD; Enrico Criscione16, MD; Enrico Poletti16, MD; Mattia Mazzucca16, MD; Mattia Lunardi15, MD; Andrea Mainardi15, MD; Stefano Andreaggi15, MD; Angelo Quagliana12, MD; Nicholas Montarello12, MD; Breda Hennessey13, MD; Matias Mon-Noboa13, MD; David Meier14, MD; Marianna Adamo7, MD; Carmelo Sgroi1, MD; Claudia Maria Reddavid1, MD; Orazio Strazzieri1, MD; Silvia Crescenzia Motta1, MD; Valentina Frittitta1, MD; Elena Dipietro1, MD; Alessandro Comis1, MD; Chiara Melfa1, MD; Mariachiara Calì1, MD; Giulia Laterra17, MD; Holger Thiele4, MD; John G. Webb14, MD; Lars Sondergaard12,18, MD; Corrado Tamburino1, MD; Marco Barbanti19, MD
1. Division of Cardiology, A.O.U. Policlinico “G. Rodolico-San Marco”, Catania, Italy; 2. Cardiovascular Department, Policlinico S. Orsola, University of Bologna, Bologna, Italy; 3. Bern University Hospital, Inselspital, Bern, Switzerland; 4. Heart Center Leipzig, University of Leipzig, Leipzig, Germany; 5. Institut Cardiovasculaire Paris Sud (ICPS), Hôpital Jacques Cartier, Ramsay-Santé, Massy, France; 6. Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), Palermo, Italy; 7. Spedali Civili, Brescia, Italy; 8. Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA; 9. Division of Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; 10. Department of Cardiology, University Hospital, University of Galway, Ireland; 11. Interventional Cardiology Department, IRCSS Centro Cardiologico Monzino, Milan, Italy; 12. The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 13. Cardiovascular Institute, Hospital Clinico San Carlos, IdISSC, Madrid, Spain; 14. Centre for Heart Valve Innovation, St. Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada; 15. Division of Cardiology, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy; 16. Division of Cardiology, IRCSS Policlinico San Donato, San Donato Milanese, Milan, Italy; 17. Ospedale Umberto I, ASP 4 di Enna, Enna, Italy; 18. Abbott Vascular, Santa Clara, CA, USA; 19. Università degli Studi di Enna “Kore”, Enna, Italy

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 pinteraction>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.

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