1. One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloonexpandable valve : the S3U registry
- Author
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Cannata, Stefano, Gandolfo, Caterina, Ribichini, Flavio, Van Mieghem, Nicolas, Buccheri, Sergio, Barbanti, Marco, Berti, Sergio, Teles, Rui Campante, Bartorelli, Antonio L., Musumeci, Giuseppe, Piva, Tommaso, Nombela-Franco, Luis, La Spina, Ketty, Palmerini, Tullio, Adrichem, Rik, Esposito, Augusto, Lopes, Pedro, Olivares, Paolo, Annibali, Gianmarco, Nicolini, Elisa, Marroquin, Luis, Tamburino, Corrado, Tarantini, Giuseppe, Saia, Francesco, Cannata, Stefano, Gandolfo, Caterina, Ribichini, Flavio, Van Mieghem, Nicolas, Buccheri, Sergio, Barbanti, Marco, Berti, Sergio, Teles, Rui Campante, Bartorelli, Antonio L., Musumeci, Giuseppe, Piva, Tommaso, Nombela-Franco, Luis, La Spina, Ketty, Palmerini, Tullio, Adrichem, Rik, Esposito, Augusto, Lopes, Pedro, Olivares, Paolo, Annibali, Gianmarco, Nicolini, Elisa, Marroquin, Luis, Tamburino, Corrado, Tarantini, Giuseppe, and Saia, Francesco
- Abstract
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.
- Published
- 2023
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