Document Type
Article
Publication Title
JACC Cardiovasc Interv
Abstract
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 cm
CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.
First Page
1032
Last Page
1044
DOI
10.1016/j.jcin.2024.02.015
Publication Date
4-22-2024
Recommended Citation
Stinis, Curtiss T; Abbas, Amr E; Teirstein, Paul; Makkar, Raj R; Chung, Christine J; Iyer, Vijay; Généreux, Philippe; Kipperman, Robert M; Harrison, John K; Hughes, G Chad; Lyons, Jefferson M; Rahman, Ayaz; Kakouros, Nikolaos; Walker, Jennifer; Roberts, David K; Huang, Pei-Hsiu; Kar, Biswajit; Dhoble, Abhijeet; Logsdon, Daniel P; Khanna, Puneet K; Aragon, Joseph; and McCabe, James M, "Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States." (2024). Heart and Vascular Articles. 43.
https://scholarlyworks.ohiohealth.com/heart-vascular-articles/43