Beschreibung:
<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Predictors of bleeding and mortality after trans femoral transcatheter aortic valve replacement (TF‐TAVR) has not been thoroughly investigated.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>The aim of this study was to assess whether Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly (HAS‐BLED) score has predictive value for bleeding and mortality in patients after TAVR.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Between October 2013 and April 2016, 969 patients underwent TF‐TAVI were prospectively included in the OCEAN‐TAVI registry from Japan. The primary outcomes were severe bleeding (including life‐threatening and major bleeding defined in The Valve Academic Research Consortium‐2 criteria) and mortality within 1 year after TAVR.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Elderly (84 ± 5 years) and high surgical risk patients (The Society of Thoracic Surgery Risk Score 6.7 [4.6–9.3]) were enrolled. Severe bleeding and mortality had occurred in 177 patients (18.2%) and 66 patients (6.8%), respectively. On multivariate analysis, HAS‐BLED score was associated with severe bleeding (hazard ratio [HR], 1.82; 95% confidence interval [CI], 1.41–2.00; <jats:italic>p</jats:italic> < 0.001) and mortality (HR, 2.04, 95% CI, 1.56–2.69, <jats:italic>P</jats:italic> < 0.001). A HAS‐BLED score threshold of 4 points (area under the curve 0.71 for severe bleeding, 0.72 for mortality) predicted a higher rate of severe bleeding (25.3% vs. 14.4%, <jats:italic>P</jats:italic> < 0.001) and mortality (16.2% vs. 4.0%, <jats:italic>P</jats:italic> < 0.001).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>HAS‐BLED score could predict the risk of severe bleeding and mortality in patients who underwent TF‐TAVR independent of the presence of atrial fibrillation.</jats:p></jats:sec>