title: Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study.
abstract: Cerebral embolization is a frequent complication after transcatheter aortic valve replacement (TAVR). We hypothesized that cerebral embolization may be reduced by anticoagulation with bivalirudin during TAVR.
  
  
  
  This study sought to determine the proportion of patients with new cerebral embolus after TAVR and to investigate whether parenteral procedural anticoagulation strategies affect cerebral embolization.
  
  
  
  The BRAVO (Effect of Bivalirudin on Aortic Valve Intervention Outcomes)-3 randomized trial compared bivalirudin with unfractionated heparin in patients undergoing transfemoral TAVR. A prospective cerebral magnetic resonance imaging (MRI) substudy was conducted in 4 sites; 60 patients were imaged with brain MRI after TAVR. Primary endpoint was proportion of patients with new cerebral emboli on MRI. Secondary endpoints included quantitative MRI analyses of cerebral lesions and neurological outcomes at 48 h and 30 days.
  
  
  
  Patients were randomized to bivalirudin (n = 29) versus heparin (n = 31). The proportion of patients with new cerebral emboli on MRI did not differ between bivalirudin and heparin groups (65.5% vs. 58.1%; p = 0.55). Groups were similar for median number of emboli per patient (1 [interquartile range (IQR): 0 to 3] vs. 1 [IQR: 0 to 1]; p = 0.08), total volume of emboli (45 [IQR: 0 to 175] mm(3) vs. 33 [IQR: 0 to 133] mm(3); p = 0.86), or proportion of patients with a clinical neurological deficit at 48 h or 30 days. All patients who presented clinically with stroke had evidence of new emboli on MRI.
  
  
  
  This study documented cerebral embolization in nearly two-thirds of patients during contemporary TAVR. There were no significant differences in cerebral embolization for bivalirudin versus heparin anticoagulation during TAVR. (Open-Label, Randomized Trial in Patients Undergoing TAVR to Determine Safety and Efficacy of Bivalrudin vs. UFH [BRAVO-2/3]; NCT01651780).
authors.affiliation: Department of Cardiology, Centre Hospitalier Régional Universitaire (CHRU) Lille and Unité Mixte de Recherche (UMR1011), Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Van Belle
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz-Kreislauf-Forschung E.V. (DZHK), partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Hengstenberg
authors.affiliation: Institut Cardio Vasculaire Paris Sud, Paris, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefevre
authors.affiliation: Ludwig Maximilian University of Munich (LMU) Munich, Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Kupatt
authors.affiliation: Department of Cardiology, Centre Hospitalier Régional Universitaire (CHRU) Lille and Unité Mixte de Recherche (UMR1011), Lille, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Debry
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Husser
authors.affiliation: Department of Radiology, CHRU Lille, Lille, France.
authors.forename: François
authors.initials: F
authors.lastname: Pontana
authors.affiliation: Department of Radiology, CHRU Lille, Lille, France.
authors.forename: Grégory
authors.initials: G
authors.lastname: Kuchcinski
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Debra
authors.initials: D
authors.lastname: Bernstein
authors.affiliation: The Medicines Company, Zurich, Switzerland.
authors.forename: Prodromos
authors.initials: P
authors.lastname: Anthopoulos
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: George.Dangas@mountsinai.org.
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
mesh_terms: D000369:Aged, 80 and over; D000991:Antithrombins / Q000008:administration & dosage; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001921:Brain / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage*; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D020766:Intracranial Embolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D007431:Intraoperative Complications; D008279:Magnetic Resonance Imaging; D008297:Male; D010446:Peptide Fragments / Q000008:administration & dosage*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*
chemical_list: D000991:Antithrombins; D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: stenosis; stroke; valvuloplasty