Key result
Transfemoral TAVI with the ACURATE neo valve showed comparable composite device success (IPTW-adjusted OR 0.35; 95% CI 0.12-1.18) and early safety to the Sapien 3 valve at up to 6 months.
Why the study?
Differences in clinical outcomes between the balloon-expandable Sapien 3 and self-expanding ACURATE neo valve systems in a real-world transfemoral TAVI population were unclear.
Does the ACURATE neo valve system improve device success and clinical safety compared to the Sapien 3 valve system in patients undergoing transfemoral TAVI?
Cohort (n=345)
Yes
Does the ACURATE neo valve system improve device success and clinical safety compared to the Sapien 3 valve system in patients undergoing transfemoral TAVI?
Odds Ratio: 0.35 (95% CI 0.12–1.18)
p-value: p=NS
The self-expanding ACURATE neo and balloon-expandable Sapien 3 valves demonstrated comparable device success and early safety outcomes in a real-world TAVI population, with NEO showing a lower mean aortic gradient.
Authors
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Does not support changing TAVI valve selection; leaves open need for randomized confirmation of equivalence.
Kooistra et al. (2020) conducted a cohort in Aortic valve disease requiring TAVI (n=345). ACURATE neo valve system vs. Sapien 3 valve system was evaluated on Composite device success (OR 0.35, 95% CI 0.12-1.18, p=NS). Transfemoral TAVI with the ACURATE neo valve showed comparable composite device success (IPTW-adjusted OR 0.35; 95% CI 0.12-1.18) and early safety to the Sapien 3 valve at up to 6 months.
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