ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field?

Author:

Okuno Taishi,Lanz Jonas,Pilgrim ThomasORCID

Abstract

Abstract Purpose of Review Critical appraisal of the available evidence on the self-expanding ACURATE neo transcatheter heart valve (THV) for the treatment of aortic valve disease. Recent Findings In an investigator-initiated, multicenter, randomized non-inferiority trial with broad inclusion criteria, ACURATE neo failed to meet non-inferiority compared with SAPIEN 3 with regard to a primary composite safety and efficacy endpoint at 30 days. The difference was driven by higher rates of moderate or severe paravalvular regurgitation and higher rates of acute kidney injury. In turn, registry data suggest that the safety and efficacy profile of the ACURATE neo is comparable to that of other commercially available devices. Randomized evidence indicated favorable hemodynamic results with large effective orifice areas and low residual gradients. Summary The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV. The supra-annular design with low residual gradients may be advantageous in patients with small anatomy and mild degree of calcification.

Funder

University of Bern

Publisher

Springer Science and Business Media LLC

Subject

Cardiology and Cardiovascular Medicine

Reference41 articles.

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5. •• Lanz J, Kim WK, Walther T, Burgdorf C, Mollmann H, Linke A, et al. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. Lancet (London, England). 2019;394(10209):1619–28 This is the first randomized clinical trial comparing the self-expanding ACURATE neo to the balloon-expandable SAPIEN 3 transcatheter heart valve. ACURATE neo failed to meet non-inferiority compared with SAPIEN 3 with regards to a primary composite safety and efficacy endpoint at 30 days.

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