Cerebral Embolism During Transcatheter Aortic Valve Replacement The BRAVO-3 MRI Study

被引:36
作者
Van Belle, Eric [1 ,2 ]
Hengstenberg, Christian [3 ,4 ]
Lefevre, Thierry [5 ]
Kupatt, Christian [6 ]
Debry, Nicolas [1 ,2 ]
Husser, Oliver [3 ]
Pontana, Francois [7 ]
Kuchcinski, Gregory [7 ]
Deliargyris, Efthymios N. [8 ]
Mehran, Roxana [9 ]
Bernstein, Debra [8 ]
Anthopoulos, Prodromos [10 ]
Dangas, George D. [9 ]
机构
[1] Ctr Hosp Reg Univ CHRU Lille, Dept Cardiol, Lille, France
[2] Unite Mixte Rech UMR1011, Lille, France
[3] Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany
[4] Partner Site Munich Heart Alliance, Deutsch Zentrum Herz Kreislauf Forsch EV DZHK, Munich, Germany
[5] Inst Cardio Vasc Paris Sud, Paris, France
[6] Ludwig Maximilian Univ Munich LMU Munich, Munich, Germany
[7] CHRU Lille, Dept Radiol, Lille, France
[8] Medicines Co, Parsippany, NJ USA
[9] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, One Gustave L Levy Pl,KCC 6th Floor 82,Box 1030, New York, NY 10029 USA
[10] Medicines Co, Zurich, Switzerland
关键词
stenosis; stroke; valvuloplasty; LESION VOLUME; IMPLANTATION; RISK; STROKE; ANTICOAGULATION; BIVALIRUDIN; REGISTRY; SYSTEM; SILENT; TRIALS;
D O I
10.1016/j.jacc.2016.05.006
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND 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. OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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. (C) 2016 by the American College of Cardiology Foundation.
引用
收藏
页码:589 / 599
页数:11
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