Key result
Transfemoral aortic valve replacement with the Edwards Sapien 3 valve resulted in none/trace aortic regurgitation at 30 days in 89.7% of patients compared to 34.3% with the Edwards Sapien XT valve.
Why the study?
Does the Edwards Sapien 3 valve improve none/trace aortic regurgitation at 30 days compared to the Edwards Sapien XT valve in intermediate-high-risk surgical patients with symptomatic aortic stenosis?
Cohort (n=209)
Does the Edwards Sapien 3 valve improve none/trace aortic regurgitation at 30 days compared to the Edwards Sapien XT valve in intermediate-high-risk surgical patients with symptomatic aortic stenosis?
Absolute Event Rate: 89.7% vs 34.3%
The Edwards Sapien 3 valve significantly reduces residual paravalvular leakage at 30 days compared to the older Edwards Sapien XT valve in patients undergoing transfemoral TAVR.
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Associated with less AR; extends observational valve comparisons but leaves open randomized outcome confirmation.
Bocksch et al. (2016) conducted a cohort in symptomatic aortic stenosis (n=209). Edwards Sapien 3 (ES3) valve vs. Edwards Sapien XT (ESXT) valve was evaluated on none/trace aortic regurgitation derived by TTE 30-days after TAVR. Transfemoral aortic valve replacement with the Edwards Sapien 3 valve resulted in none/trace aortic regurgitation at 30 days in 89.7% of patients compared to 34.3% with the Edwards Sapien XT valve.
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