One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry

Stefano Cannata, Caterina Gandolfo, Flavio L. Ribichini, Nicolas van Mieghem, Sergio Buccheri, Marco Barbanti, Sergio Berti, Rui Campante Teles, Antonio L. Bartorelli, Giuseppe Musumeci, Tommaso Piva, Luis Nombela-Franco, Ketty La Spina, Tullio Palmerini, Rik Adrichem, Augusto Esposito, Pedro Lopes, Paolo Olivares, Gianmarco Annibali, Elisa NicoliniLuis Marroquin, Corrado Tamburino, Giuseppe Tarantini, Francesco Saia

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4 Citations (Scopus)


BACKGROUND: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce. AIMS: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3). METHODS: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year. RESULTS: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups. CONCLUSIONS: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Original languageEnglish
Pages (from-to)1418-1427
Number of pages10
JournalEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Issue number17
Publication statusPublished - 24 Apr 2023

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