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

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• 作者：Eric Van Belle ; MD ; PhD^a ; Christian Hengstenberg ; MD^b ; ^c ; Thierry Lefevre ; MD^d ; Christian Kupatt ; MD^e ; Nicolas Debry ; MD^a ; Oliver Husser ; MD ; PhD^b ; Franç ; ois Pontana ; MD ; PhD^f ; Gré ; gory Kuchcinski ; MD^f ; Efthymios N. Deliargyris ; MD^g ; Roxana Mehran ; MD^h ; Debra Bernstein ; PhD^g ; Prodromos Anthopoulos ; MDⁱ ; George D. Dangas ; MD ; PhD^h ; ^{George.Dangas@mountsinai.org" class="auth_mail" title="E-mail the corresponding author} ; ^{gdangas@crf.org" class="auth_mail" title="E-mail the corresponding author} ; for the BRAVO-3 MRI Study Investigators
• 关键词：stenosis ; stroke ; valvuloplasty
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：9 August 2016
• 年：2016
• 卷：68
• 期：6
• 页码：589-599
• 全文大小：1401 K

文摘

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] mm³ vs. 33 [IQR: 0 to 133] mm³; 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. (Open-Label, Randomized Trial in Patients Undergoing TAVR to Determine Safety and Efficacy of Bivalrudin vs. UFH [BRAVO-2/3]; class="interref" data-locatorType="https" data-locatorKey="//www.clinicaltrials.gov/ct2/show/NCT01651780?term=NCT01651780&rank=1">NCT01651780)