Key result
Self-expanding THVs linked to ~44% higher 5-year mortality vs balloon-expandable THVs in reduced LVEF.
Why the study?
The impact of transcatheter heart valve design on long-term outcomes in patients with severe aortic stenosis and reduced left ventricular ejection fraction was unknown.
Does TAVI with self-expanding valves reduce 5-year mortality compared to balloon-expandable valves in patients with severe aortic stenosis and LVEF <50%?
Cohort (n=759)
Does TAVI with self-expanding valves reduce 5-year mortality compared to balloon-expandable valves in patients with severe aortic stenosis and LVEF <50%?
Answers are grounded in this paper and cite their sources.
In patients with severe aortic stenosis and LV systolic dysfunction, self-expanding TAVI valves were associated with higher 5-year mortality and more paravalvular regurgitation compared to balloon-expandable valves.
The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown. We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable vs. self-expanding THVs. In a retrospective analysis from the Bern TAVI registry, patients with LVEF <50% who underwent TAVI with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups. A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; P < .001) and a higher incidence of ≥mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; P < .001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, HR adjusted : 1.44; 95% CI: 1.02-2.03; P = .037). There were no significant differences in other clinical outcomes up to 5 years between groups. In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV. https://www.clinicaltrials.gov . NCT01368250.
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Nakase et al. (2024) conducted a cohort in Severe aortic stenosis with reduced left ventricular ejection fraction (n=759). Self-expanding THV vs. Balloon-expandable THV was evaluated on All-cause mortality at 5 years (HR 1.44, 95% CI 1.02-2.03, p=0.037). Self-expanding THVs were associated with higher 5-year all-cause mortality than balloon-expandable THVs in patients with reduced LVEF (67.8% vs 55.8%; HR 1.44; 95% CI 1.02-2.03; P=0.037).
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