title: Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement.
abstract: BACKGROUND
  The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown.
  
  
  OBJECTIVE
  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.affiliation: 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.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Baylor Healthcare System, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Quebec Heart and Lung Institute, Laval University Quebec, Quebec City, Quebec, Canada.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodes-Cabau
authors.affiliation: The Cardiovascular Research Foundation, New York, New York.
authors.forename: Mayank
authors.initials: M
authors.lastname: Yadav
authors.affiliation: The Cardiovascular Research Foundation, New York, New York.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: The Cardiovascular Research Foundation, New York, New York.
authors.forename: Rupa
authors.initials: R
authors.lastname: Parvataneni
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Hahn
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York.
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: 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.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000601:surgery*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D000077144:Clopidogrel; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000145:classification / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D017063:Outcome Assessment, Health Care; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000379:methods
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: TAVR; aortic stenosis; bleeding; paravalvular leak