Key result
The Sapien 3 transcatheter heart valve was superior to the Sapien XT, demonstrating a significantly lower incidence of ≥mild aortic regurgitation (15.9% vs 46.2%, P=0.003).
Why the study?
Does the Sapien 3 THV reduce aortic regurgitation and vascular complications compared to the Sapien XT THV in patients undergoing TAVI for severe aortic stenosis?
Cohort (n=167)
No
Does the Sapien 3 THV reduce aortic regurgitation and vascular complications compared to the Sapien XT THV in patients undergoing TAVI for severe aortic stenosis?
Absolute Event Rate: 15.9% vs 46.2%
p-value: p=0.003
The Sapien 3 THV significantly reduces the incidence of mild or greater aortic regurgitation compared to the Sapien XT THV in patients undergoing TAVI.
May favor Sapien 3 to reduce AR in TAVI; leaves open randomized confirmation and outcome impact.
BACKGROUND: The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis. METHODS AND RESULTS: Eligible patients were retrospectively identified in our institutional database and periprocedural clinical and imaging data were collected. Non-parsimonious one-to-many propensity score matching was performed to account for differences in baseline characteristics. Between November 2011 and December 2014, 167 patients underwent balloon-expandable transcatheter aortic valve implantation with either the S3-THV (n=49) or SXT-THV (n=118). Forty-four (89.8%) S3-THV patients were matched to 66 (55.9%) SXT-THV patients (mean age 80.3±8.4 and 80.5±7.8 years, median EuroSCORE 15.8 and 16.5%, respectively). In the S3-THV and SXT-THV groups, transfemoral approach (77.3% versus 78.8%) and postdilatation rates (15.9% versus 12.1%) were similar. Predischarge echocardiography demonstrated a lower incidence of ≥mild AR (15.9% versus 46.2%, P=0.003) for the S3-THV, despite reduced annulus area to prosthesis oversizing (8.2±5.1 versus 18.2±10.7%, P=0.001). Transfemoral access site-related life-threatening or major bleedings and vascular complications were absent in the S3-THV group (0% versus 7.7%, P=0.15). No differences were observed in pacemaker implantation rate (9.8% versus 8.8%, P=0.94) and 30-day mortality (both 5%). CONCLUSIONS: In this retrospective, propensity score-matched analysis, the S3-THV performed superiorly to the SXT-THV, as demonstrated by improved valve patency and increased transfemoral access safety.
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Nijhoff et al. (2015) conducted a cohort in symptomatic severe native aortic stenosis (n=167). Sapien 3 transcatheter heart valve (S3-THV) vs. Sapien XT THV (SXT-THV) was evaluated on incidence of ≥mild aortic regurgitation on predischarge echocardiography (p=0.003). The Sapien 3 transcatheter heart valve was superior to the Sapien XT, demonstrating a significantly lower incidence of ≥mild aortic regurgitation (15.9% vs 46.2%, P=0.003).
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