Philippe Généreux1, David J Cohen2, Michael Mack3, Josep Rodes-Cabau4, Mayank Yadav5, Ke Xu5, Rupa Parvataneni5, Rebecca Hahn6, Susheel K Kodali6, John G Webb7, Martin B Leon8. 1. 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. 2. Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri. 3. Baylor Healthcare System, Plano, Texas. 4. Quebec Heart and Lung Institute, Laval University Quebec, Quebec City, Quebec, Canada. 5. The Cardiovascular Research Foundation, New York, New York. 6. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York. 7. St. Paul's Hospital, Vancouver, British Columbia, Canada. 8. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York. Electronic address: ml2398@columbia.edu.
Abstract
BACKGROUND: The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown. OBJECTIVES: The aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR. METHODS: Clinical 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. RESULTS: Among 2,401 patients who underwentTAVR 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). CONCLUSIONS:MLBCs 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).
RCT Entities:
BACKGROUND: The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown. OBJECTIVES: The aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR. METHODS: Clinical 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. RESULTS: Among 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). CONCLUSIONS: MLBCs 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).
Authors: Alexander C Fanaroff; Pratik Manandhar; David R Holmes; David J Cohen; J Kevin Harrison; G Chad Hughes; Vinod H Thourani; Michael J Mack; Matthew W Sherwood; W Schuyler Jones; Sreekanth Vemulapalli Journal: Circ Cardiovasc Interv Date: 2017-10 Impact factor: 6.546
Authors: Nicolas A Geis; Christina Kiriakou; Emmanuel Chorianopoulos; Lorenz Uhlmann; Hugo A Katus; Raffi Bekeredjian Journal: Clin Res Cardiol Date: 2018-04-11 Impact factor: 5.460