2017 Buyer’s Guide

This buyer’s guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States.

Boston Scientific's Symetis Acurate Neo TAVR Device Studied in Patients With Small Aortic Annulus

 

October 9, 2017—Victor Mauri, MD, et al published findings from a multicenter propensity score–matched study that compared hemodynamics and early clinical outcomes in 246 patients with an aortic annulus area < 400 mm2 who were undergoing transcatheter aortic valve replacement (TAVR) with either the Symetis Acurate Neo self-expanding transcatheter heart valve (n = 129) or Edwards Lifesciences' Sapien 3 balloon-expandable transcatheter heart valve (n = 117). The study is available online ahead of print in Circulation: Cardiovascular Interventions.

Symetis was acquired by Boston Scientific Corporation in May 2017.

As summarized in Circulation: Cardiovascular Interventions, the 1:1 propensity score matching resulted in 92 matched pairs. Results were similar for Acurate Neo-treated patients versus Sapien 3-treated patients in terms of 30-day mortality (0% vs 1%), 1-year mortality (8.3% vs 13.3%), incidence of stroke (3.3% vs 2.2%), life-threatening bleeding (1.1% vs 1.1%), and major vascular complications (2.2% vs 6.5%), as well as pacemaker implantation rate (12% vs 15.2%). Moderate-or-greater paravalvular regurgitation was rare in both groups (4.5% vs 3.6%).

In addition, the Acurate Neo presented lower mean transvalvular gradients (9.3 vs 14.5 mm Hg; P < .001), larger indexed effective orifice areas (0.96 vs 0.80 cm2/m2; P = .003), and lower rates of severe prosthesis–patient mismatch (3% vs 22%; P = .004). Hemodynamics were sustained at 1-year follow-up.

The investigators concluded that although the two devices showed a similar safety profile with low clinical event rates, TAVR with the Acurate Neo valve resulted in lower transvalvular gradients and consequently less prosthesis-patient mismatch compared with the Sapien 3 in patients with the small annulus. These results emphasize the need of careful prosthesis selection in each individual patient, noted the investigators in Circulation: Cardiovascular Interventions.

 

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About Cardiac Interventions Today

Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.