1-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States
- PMID: 39665706
- DOI: 10.1016/j.jcin.2024.11.015
1-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States
Abstract
Background: Longer term outcomes of transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA (S3UR) valve over its predecessors have not been reported in a national registry.
Objectives: The aim of this study was to compare the 1-year clinical and echocardiographic outcomes of the S3UR with those of the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry.
Methods: From September 2022 to March 2023, patients who underwent native TAVR with the S3UR or the S3 or S3U valve were propensity matched and compared. Predictors of 1-year outcomes were identified. The median follow-up time was 358 days (Q1-Q3: 47-365 days) for the S3UR and 364 days (Q1-Q3: 80-365 days) for the S3 and S3U.
Results: A total of 4,598 S3UR patients were propensity matched with 4,598 and 32,536 S3 and S3U patients. At discharge, effective orifice areas were larger in the S3UR group (P < 0.0001). The lower discharge mean gradient in the S3UR group was maintained at 30 days and 1 year (P < 0.0001 for all). At 1 year, all-cause mortality (7.6% vs 9.7%; HR: 0.8; 95% CI: 0.67-0.93; P = 0.004), mild or greater paravalvular leak (PVL) (15.6% vs 18.5%; HR: 0.82; 95% CI: 0.69-0.97; P = 0.02), and life-threatening bleeding (2.0% vs 2.7%; HR: 0.7; 95% CI: 0.54-0.94; P = 0.03) were lower in the S3UR group. S3UR and mild or greater PVL were predictive of 1-year mortality in the overall cohort and in low-risk patients. Valve reintervention remained rare at 1 year (0.6% vs 0.4%; HR: 1.46; 95% CI: 0.77-2.78; P = 0.25).
Conclusions: TAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention. Longer follow-up will determine the durability of the RESILIA technology in the SAPIEN valve platform.
Keywords: SAPIEN 3 Ultra RESILIA; hemodynamic status; mortality; paravalvular leak; transcatheter aortic valve replacement.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures The views or opinions presented here do not represent those of the American College of Cardiology, STS, or the TVT Registry. As this analysis was restricted to the Edwards Lifesciences S3, S3U, and S3UR transcatheter heart valves, statistical analyses were performed by Edwards Lifesciences. Dr Tang has received speaker honoraria from and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria from and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical, NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Stinis has received consulting fees from Edwards Lifesciences, Boston Scientific, Shockwave Medical, and Medtronic; and has served on an advisory board for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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