Why the study?
Long-term outcomes with balloon-expandable transcatheter aortic valve replacement across device generations remain incompletely characterized.
Do newer-generation balloon-expandable TAVR devices improve survival and procedural outcomes compared to older generations in patients with severe aortic stenosis?
Cohort (n=4,137)
No
Do newer-generation balloon-expandable TAVR devices improve survival and procedural outcomes compared to older generations in patients with severe aortic stenosis?
The transition to newer-generation balloon-expandable TAVR devices like SAPIEN 3 is associated with lower procedural complications, improved survival, and excellent long-term valve hemodynamics.
Background Transcatheter aortic valve replacement (TAVR) has transformed the management of severe aortic stenosis, with expanding indications and progressive device refinements. Long-term outcomes with balloon-expandable valves across device generations remain incompletely characterized. Methods We analyzed 4,137 patients who underwent balloon-expandable TAVR at a high-volume tertiary center from 2006 to 2022. Patients were stratified by device generation (SAPIEN 9000TFX, SAPIEN XT, and SAPIEN 3). Procedural outcomes, survival, echocardiographic follow-up, and reintervention rates were assessed. Cox regression and competing-risk analyses were performed to evaluate associations with mortality, stroke, and myocardial infarction. Results The mean age of the cohort was 79 ± 9.6 years, and 60.5% were male. Transfemoral access increased significantly with newer devices (90% with S3 vs. 74% with SXT and 41% with S9000TFX). Periprocedural complications declined across generations, with the S3 valve demonstrating the lowest rates of in-hospital mortality (0.3%), tamponade (0.1%), stroke (0.5%), and acute kidney injury (0.2%). During follow-up, all-cause mortality was significantly higher with S9000TFX compared with S3 (HR 1.43, 95% CI 1.25–1.64; p < 0.001). Long-term echocardiography demonstrated stable aortic valve gradients (<20 mmHg) and minimal PVL, especially in the S3 group. Only 10 patients required TAV-in-TAV intervention, with a median interval of ∼6 years, most of whom underwent repeat implantation of a similar-sized S3 valve. Conclusions In this large single-center experience with balloon-expandable TAVR, the contemporary era of newer-generation devices was associated with lower procedural complication rates, improved survival, and stable valve hemodynamics during follow-up among patients with available imaging. These findings underscore the rapid maturation of TAVR as a therapeutic option complementing surgical treatment in expanding treatment options for a wider spectrum of patients. Improved long-term survival has enabled a more robust assessment of valve durability, and TAV-in-TAV remains a viable treatment strategy for structural valve degeneration.
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Layoun et al. (2026) conducted a cohort in Severe aortic stenosis (n=4,137). Older generation balloon-expandable TAVR (SAPIEN 9000TFX) vs. Newer generation balloon-expandable TAVR (SAPIEN 3) was evaluated on All-cause mortality (HR 1.43, 95% CI 1.25-1.64, p=< 0.001).
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