Silent Brain Infarction After Endovascular Arch Procedures

Study Overview
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Brief Summary
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This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.

Detailed Description
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Introduction. Poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. The objective of this work was to quantify these lesions using the STEP registry. Methods. This multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed to identify the location and number of new silent brain infarctions (SBI), microbleeds ans general outcome of the patients.

Official Title
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Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry

Conditions
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Aortic Arch Aneurysm

Intervention / Treatment
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* Device: Endovascular Arch Procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3 Exclusion Criteria: Missing preoperative computed tomography angiography (CTA) scan of the chest and any circumstances that precluded the DW-MRI to be performed in the appropriate time window, such as a medical condition or an MRI contraindication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Silent Brain Infarction<br>treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure with silent brain infarction | Device: Endovascular Arch Procedures<br>* Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)<br>|
| Patients without Silent Brain Infarction<br>treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure without silent brain infarction | Device: Endovascular Arch Procedures<br>* Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of silent cerebral infarcts on DW-MRI | Primary outcomes were the frequency of silent cerebral infarcts on DW-MRI after endovascular arch procedures, and to identify the number, the distribution, and predictors of these lesions. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative ischemic stroke | Secondary outcomes were perioperative ischemic stroke defined as a brain infarction of ischemic etiology which occurs during surgery or within 30 days after surgery, TIA, hemorrhagic stroke, 30-day mortality, spinal cord ischemia, length of stay and discharge disposition. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic endovascular aortic repair, Silent cerebral infarction, Stroke, Magnetic resonance imaging, DW-MRI, Aortic arch disease