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JACC Cardiovasc Interv ; 17(8): 1032-1044, 2024 Apr 22.
Article de Anglais | MEDLINE | ID: mdl-38456883

RÉSUMÉ

BACKGROUND: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. OBJECTIVES: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. RESULTS: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.


Sujet(s)
Sténose aortique , Valve aortique , Valvuloplastie par ballonnet , Prothèse valvulaire cardiaque , Conception de prothèse , Récupération fonctionnelle , Enregistrements , Remplacement valvulaire aortique par cathéter , Sujet âgé , Sujet âgé de 80 ans ou plus , Femelle , Humains , Mâle , Valve aortique/chirurgie , Valve aortique/imagerie diagnostique , Valve aortique/physiopathologie , Sténose aortique/imagerie diagnostique , Sténose aortique/chirurgie , Sténose aortique/physiopathologie , Valvuloplastie par ballonnet/effets indésirables , Hémodynamique , Complications postopératoires/étiologie , Études rétrospectives , Appréciation des risques , Facteurs de risque , Facteurs temps , Remplacement valvulaire aortique par cathéter/instrumentation , Remplacement valvulaire aortique par cathéter/effets indésirables , Remplacement valvulaire aortique par cathéter/mortalité , Résultat thérapeutique , États-Unis
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