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.