Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis
Why the study?
Does TAVR with the SAPIEN 3 system improve clinical and echocardiographic outcomes in inoperable, high-risk, and intermediate-risk patients with severe aortic stenosis?
Population
1,661 patients with severe, symptomatic aortic stenosis across 57 sites in the USA and Canada.
Design
Cohort
Follow-up
30 days
Authors
Discussion
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Member takes
Implication
Supports TAVR consideration in high-/intermediate-risk aortic stenosis; hypothesis-generating and should not yet change practice.
Structured PICO
Does TAVR with the SAPIEN 3 system improve clinical and echocardiographic outcomes in inoperable, high-risk, and intermediate-risk patients with severe aortic stenosis?
P
Population
1,661 patients with severe, symptomatic aortic stenosis (583 high surgical risk or inoperable and 1,078 intermediate risk) across 57 sites in the USA and Canada.
I
Intervention
Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 system via transfemoral (86.9%) or transapical/transaortic (13.1%) access.
O
Outcome
30-day all-cause mortalityhard clinical
TAVR with the SAPIEN 3 system demonstrates low 30-day mortality and stroke rates, along with low rates of paravalvular regurgitation, in high- and intermediate-risk patients with severe aortic stenosis.
Cite This Study
Kodali et al. (2016) studied this question.