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

Giuliano Costa, Francesco Saia, Thomas Pilgrim, Mohamed Abdel-Wahab, Philippe Garot, Sofia Sammartino, Caterina Gandolfo, Luca Branca, Azeem Latib, Ignacio Amat-Santos, Darren Mylotte, Federico De Marco, Ole De Backer, Luis Nombela Franco, Mariama Akodad, Flavio Luciano Ribichini, Francesco Bedogni, Alessandro Mazzapicchi, Daijiro Tomii, Pietro LaforgiaStefano Cannata, Claudia Fiorina, Andrea Scotti, Simone Fezzi, Enrico Criscione, Enrico Poletti, Mattia Mazzucca, Mattia Lunardi, Andrea Mainardi, Stefano Andreaggi, Angelo Quagliana, Nicholas Montarello, Breda Hennessey, Matias Mon-Noboa, David Meier, Marianna Adamo, Carmelo Sgroi, Claudia Maria Reddavid, Orazio Strazzieri, Silvia Crescenzia Motta, Valentina Frittitta, Elena Dipietro, Alessandro Comis, Chiara Melfa, Mariachiara Calì, Giulia Laterra, Holger Thiele, John G Webb, Lars Sondergaard, Corrado Tamburino, Marco Barbanti*

*Corresponding author af dette arbejde


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.

TidsskriftEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Udgave nummer1
Sider (fra-til)95-103
Antal sider9
StatusUdgivet - 1 jan. 2024


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