ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field?
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NEW THERAPIES FOR CARDIOVASCULAR DISEASE (AA BAVRY, SECTION EDITOR)
ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field? Taishi Okuno 1 & Jonas Lanz 1 & Thomas Pilgrim 1
# The Author(s) 2020
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. Keywords Transcatheter aortic valve replacement, ACURATE neo . Self-expanding . Balloon-expandable . Transcatheter heart valve . SCOPE
Introduction Since the introduction of transcatheter aortic valve replacement (TAVR) as an alternative for inoperable patients with severe aortic stenosis [1], advances in treatment strategies and refinement of valve systems have expedited the expansion of TAVR to surgical low-risk patients [2, 3]. Nowadays, TAVR is considered a valuable treatment strategy across the entire spectrum of surgical risk based on robust evidence derived from iterative randomized clinical trials and large-scale realThis article is part of the Topical Collection on New Therapies for Cardiovascular Disease * Thomas Pilgrim [email protected] Taishi Okuno [email protected]; [email protected]
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world registries [4]. Strategy trials comparing TAVR to surgical aortic valve replacement (SAVR) have been performed with different generations of transcatheter heart valve (THV) systems of the balloon-expandable SAPIEN series (Edwards Lifesciences, Irvine, CA, USA) and the self-expanding CoreValve/Evolut series (Medtronic, Minneapolis, MN, USA). A number of novel THVs have been introduced with the aim to overcome limitations of these two dominant market players [5••, 6–9]. Among them, the ACURATE neo THV (Boston Scientific, Marlborough, MA, USA) is one of the leading devices, which has a unique valve design and deployment mechanism [5••]. In this review, we summarize the available evidence on this device and elucidate its strengths and weaknesses as compared to other commercially available THV devices.
Jonas Lanz [email protected]
The ACURATE neo:
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