BACKGROUND: Predictors of bleeding and mortality after trans femoral transcatheter aortic valve replacement (TF-TAVR) has not been thoroughly investigated. OBJECTIVE: 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. METHODS: 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. RESULTS: 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; p < 0.001) and mortality (HR, 2.04, 95% CI, 1.56-2.69, P < 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%, P < 0.001) and mortality (16.2% vs. 4.0%, P < 0.001). CONCLUSIONS: 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.
BACKGROUND: Predictors of bleeding and mortality after trans femoral transcatheter aortic valve replacement (TF-TAVR) has not been thoroughly investigated. OBJECTIVE: 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. METHODS: 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. RESULTS: 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; p < 0.001) and mortality (HR, 2.04, 95% CI, 1.56-2.69, P < 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%, P < 0.001) and mortality (16.2% vs. 4.0%, P < 0.001). CONCLUSIONS: 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.