Abstract

The aim of this study was to compare the feasibility, safety, and clinical outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis. At present, limited observational data exist supporting TAVR in the context of bicuspid anatomy. Primary endpoints were 1-year survival and device success. Secondary endpoints included moderate to severe paravalvular leak (PVL) and a composite endpoint of periprocedural complications; incidence rates of individual procedural endpoints were also explored individually. In the main analysis, 17 studies and 181,433 patients undergoing TAVR were included, of whom 6,669 (0.27%) had BAV. A secondary analysis of 7,071 matched subjects with similar baseline characteristics was also performed. Device success and 1-year survival rates were similar between subjects with BAV and those with TAV (97% vs 94% [P=0.55] and 91.3% vs 90.8% [P=0.22], respectively). In patients with BAV, a trend toward a higher risk for periprocedural complications was observed in our main analysis (risk ratio [RR]: 1.12; 95% CI: 0.99-1.27; P=0.07) but not in the matched population secondary analysis (RR: 1.00; 95%CI: 0.81-1.24; P=0.99). The risk for moderate to severe PVL was higher in subjects with BAV (RR: 1.42; 95%CI: 1.29-1.58; P< 0.0001) as well as the incidence of cerebral ischemic events (2.4% vs 1.6%; P=0.015) and of annular rupture (0.3% vs 0.02%; P=0.014) in matched subjects. TAVR is a feasible option among selected patients with BAV anatomy, but the higher rates of moderate to severe PVL, annular rupture, and cerebral ischemic events observed in the BAV group warrant caution and further evidence.

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