Key result
Self-expanding valves show better hemodynamics but no 5-year clinical benefit over balloon-expandable valves.
Why the study?
SEVs demonstrate superior hemodynamics and comparable 1-year outcomes to BEVs in small aortic annulus, but long-term data are limited.
Does transcatheter aortic valve replacement with self-expanding valves improve the composite of all-cause mortality, stroke, or heart failure hospitalization compared to balloon-expandable valves in patients with a small aortic annulus?
Does transcatheter aortic valve replacement with self-expanding valves improve the composite of all-cause mortality, stroke, or heart failure hospitalization compared to balloon-expandable valves in patients with a small aortic annulus?
In patients with a small aortic annulus undergoing TAVR, self-expanding valves provide superior early hemodynamics but do not improve 5-year clinical outcomes compared to balloon-expandable valves, while carrying a higher risk of permanent pacemaker implantation.
No outcome difference despite better hemodynamics in this cohort cautions valve choice by hemodynamics alone; leaves open need for randomized trials in small annuli.
Background Self‐expanding valves (SEVs) have demonstrated superior hemodynamic performance and comparable clinical outcomes to balloon‐expandable valves (BEVs) at 1 year in patients with a small aortic annulus. However, long‐term data are limited. This study aimed to evaluate 5‐year echocardiographic and clinical outcomes of SEVs versus BEVs in patients with small aortic annulus underwent transcatheter aortic valve replacement. Methods We analyzed RESOLVE registry patients who underwent transcatheter aortic valve replacement at Cedars‐Sinai between 2015 and 2020. Patients with a small aortic annulus (<430 mm 2 by computed tomography) were included and followed for up to 5 years. The primary outcome was a composite of all‐cause mortality, stroke, or heart failure hospitalization. Secondary outcomes included myocardial infarction, pacemaker implantation, aortic valve reintervention, and structural bioprosthetic valve dysfunction. Results Among 1392 transcatheter aortic valve replacement recipients, 423 (78 SEVs, 345 BEVs) met the small annulus criteria. SEVs were associated with lower transvalvular gradients and larger indexed effective orifice area at discharge and 1 year ( P <0.001). Moderate‐to‐severe paravalvular leak was more frequent with SEVs at 30 days (7.7% versus 1.5%, P <0.001), as was permanent pacemaker implantation (17.9% versus 6.1%, P <0.001). At 5 years, the primary outcome did not differ significantly (hazard ratio, 1.21; 95% CI, 0.81–1.82; P <0.33). All‐cause mortality, stroke, heart failure hospitalization, structural bioprosthetic valve dysfunction, and reintervention rates were similar between groups. Conclusion Although SEVs provide better hemodynamic performance in patients with severe aortic stenosis and small annuli, this advantage did not translate into improved survival or reduced cardiovascular events at 5 years.
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Pawar et al. (2025) studied this question. Self‐expanding valves showed better hemodynamic performance but no significant difference in 5-year composite clinical outcomes compared to balloon‐expandable valves (HR 1.21, P < 0.33).
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