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J. Am. Coll. Cardiol. · Dec 2014
Randomized Controlled Trial Multicenter StudyIncidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement.
- Philippe Généreux, David J Cohen, Michael Mack, Josep Rodes-Cabau, Mayank Yadav, Ke Xu, Rupa Parvataneni, Rebecca Hahn, Susheel K Kodali, John G Webb, and Martin B Leon.
- Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada.
- J. Am. Coll. Cardiol. 2014 Dec 23;64(24):2605-15.
BackgroundThe incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown.ObjectivesThe aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR.MethodsClinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER (Placement of Aortic Transcatheter Valves) trial were analyzed after stratifying by the occurrence of MLBCs. Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed.ResultsAmong 2,401 patients who underwent TAVR and survived to 30 days, MLBCs occurred in 142 (5.9%) at a median time of 132 days (interquartile range: 71 to 230 days) after the index procedure. Gastrointestinal complications (n = 58 [40.8%]), neurological complications (n = 22 [15.5%]), and traumatic falls (n = 11 [7.8%]) were identified as the most frequent types of MLBCs. Independent predictors of MLBCs were the presence of low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, the presence of moderate or severe paravalvular leak at 30 days, and greater left ventricular mass at 30 days. MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year (adjusted hazard ratio: 3.91; 95% confidence interval: 2.67 to 5.71; p < 0.001).ConclusionsMLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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