Key result
At 30 days, balloon-expandable valves reduced all-cause mortality compared to self-expanding valves, though there was no significant difference in mortality at 1 or 3 years.
Why the study?
Distinct clinical differences exist between balloon-expandable valves and self-expanding valves used in TAVR for aortic stenosis, but randomised data on comparative outcomes are limited.
Do balloon-expandable valves improve short- and long-term clinical outcomes compared to self-expanding valves in patients undergoing transcatheter aortic valve replacement?
Meta-Analysis (n=45,947)
Do balloon-expandable valves improve short- and long-term clinical outcomes compared to self-expanding valves in patients undergoing transcatheter aortic valve replacement?
In TAVR, balloon-expandable valves are associated with lower 30-day mortality, less paravalvular leak, and fewer pacemaker implantations compared to self-expanding valves, though self-expanding valves offer better hemodynamics and long-term mortality is similar.
Answers are grounded in this paper and cite their sources.
Favors balloon-expandable valves to lower 30-day TAVR mortality; confirms short-term advantage with long-term equivalence to self-expanding valves.
Background: Distinct clinical differences exist between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) used in transcatheter aortic valve replacement (TAVR) for aortic stenosis. However, randomised data on comparative outcomes are limited. The aim of this meta-analysis was to analyse the differences in short- and longer-term clinical outcomes between the two valve designs. Methods: A comprehensive literature search for all studies up to and including April 2020 on the clinical outcomes of BEVs versus SEVs was performed. Study outcomes were divided into short term (in-hospital or 30 days), intermediate term (1 year) and long term (3 years). The primary outcome was all-cause mortality. Secondary endpoints were stroke or transient ischaemic attack (TIA), life-threatening or major bleeding, at least moderate paravalvular leak (PVL), permanent pacemaker (PPM) implantation, aortic valve area (AVA) and aortic valve mean pressure gradient (AV MPG). Results: A total of 41 studies (BEV, n=23,892; SEV, n=22,055) were included. At in-hospital/30 days, all-cause mortality favoured BEV (OR 0.85; 95% CI [0.75–0.96]). BEV had lower rates of PVL (OR 0.42; 95% CI [0.35–0.51]) and PPM (OR 0.56; 95% CI [0.44–0.72]), but smaller AVA (mean −0.09 cm2; 95% CI [−0.17, 0.00]) and higher AV MPG (mean 2.54 mmHg; 95% CI [1.84–3.23]). There were no significant differences in the incidence of stroke/TIA or bleeding between the two valve designs. At 1 year a lower PPM implantation rate (OR 0.44; 95% CI [0.37–0.52]), fewer PVLs (OR 0.26; 95% CI [0.09–0.77]), smaller AVA (mean −0.23 cm2; 95% CI [−0.35, −0.10]) and higher AV MPG (mean 6.05 mmHg; 95% CI [1.74–10.36]) were observed with BEV. No significant differences were observed in mortality, stroke/TIA or bleeding. There was no significant difference in mortality at 3 years between the two valve designs. Conclusion: In the short–intermediate term, SEVs had better valve haemodynamics but had higher PVL and PPM implantation rates than BEVs. However, there were no differences in intermediate–long-term mortality, stroke or TIA, or bleeding complications. A better understanding of these differences will enable TAVR operators to tailor their valve choice based on individual patient profile.
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Wong et al. (2023) conducted a meta-analysis in Aortic stenosis (n=45,947). Balloon-expandable valves (BEVs) vs. Self-expanding valves (SEVs) was evaluated on All-cause mortality at 30 days (OR 0.85, 95% CI 0.75-0.96). At 30 days, balloon-expandable valves reduced all-cause mortality compared to self-expanding valves, though there was no significant difference in mortality at 1 or 3 years.
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