Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery

Study Overview
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Brief Summary
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Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of complications is commonly caused by embolization in the brain due to manipulation of atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan, to reduce the risk of embolization and thus subsequent neurologic complications. Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound scanning has become the gold standard, but is seldom used as it interferes often with surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE) is a widely used imaging method permitting evaluation of the aorta preoperatively, but assessment of distal AA is hampered by interposition of air-filled trachea between esophagus and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the A-View® have successfully been shown in previous studies. The hypothesis of this study is that the use of A-View will reduce cerebral embolization secondary to a change of surgical technique.

Official Title
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Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery

Conditions
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Coronary Artery Atherosclerosis

Intervention / Treatment
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* Other: A-View


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated CABG Elective surgery Stroke Risk Index <75(Newman, '96) Exclusion Criteria: Other than isolated CABG Contra-indication for TEE Contra-indication for A-View Contra-indication for MRI

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-View<br> | Other: A-View<br>* Pre-operative imaging of the thoracic aorta with A-View technique<br>* Other names: FDA: 070515;|
| No Intervention: No A-View<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New diffusion-weighted lesions on cerebral MRI |  | 3 - 4 Days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number, size, and location of new ischemic lesions on the postoperative DW-MRI |  | 3 - 4 Days after intervention | 
| Any neurologic event during the first six postoperative weeks, which is manifested as either stroke, or transient ischemic attack (TIA), epileptic insults, or delirium, or cognitive deficit |  | 6 weeks postoperative | 
| Stroke or TIA during the first three postoperative months |  | 3 months postoperative | 
| Delirium during hospital stay |  | Until hospital discharge | 
| Quality of life |  | 6 weeks and 1 year after the intervention | 
| Number of HITS detected by Transcranial Doppler |  | peroperive | 
| Incidence of Near Infrared Spectrography desaturations (NIRO 2000) |  | Peroperative | 
| Short psychometric test |  | 6 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis aorta, A-View, Distal ascending aorta, Transoesophageal echocardiography, CABG, Cerebral embolisation