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In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation technique. The detection of cerebral emboli is performed not-invasively by transcranial Doppler detection of high-intensity transient signals representing solid or gaseous microembolism in the middle cerebral arteries. The investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism during aortic valve surgery using extracorporeal circulation.
Background
The gold standard to treat severe aortic valve stenosis is currently the surgical aortic valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR, however, can be performed also on minimized extracorporeal circulation (MECC), which is characterized by reduced priming volume and interfaces between blood and artificial surfaces and blood-air interface, respectively. Further technical developments of the MECC system together with reports on less induction of the coagulation cascade and activation of inflammatory systemic response may account for a reduced incidence of microbubble generation with MECC system.
Objective
The aim of the is to investigate the procedural-related incidence of high-intensity transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.
Methods
Patients undergoing SAVR are included in the study and randomised to either MECC or CECC technique. HITS are continuously bilaterally detected during the entire intraoperative period by transcranial Doppler ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Extracorporeal Circulation Technique | Active Comparator | Conventional Extracorporeal Circulation Technique |
|
| Minimized Extracorporeal Circulation Technique | Experimental | Minimized Extracorporeal Circulation Technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimized Extracorporeal Circulation (MECC) | Procedure | This group of patients receives surgical aortic valve replacement using MECC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total and interval-related cerebral microembolic load as measured by transcranial Doppler | Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral complications, e.g. delirium and stroke as detected clinically | In-hospital period (until hospital discharge, duration approx. 7-10 days) | |
| Redo surgery | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Carrel, MD, PhD | Department of Cardiovascular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bern | Bern | 3010 | Switzerland |
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| Conventional Extracorporeal Circulation (CECC) | Procedure | This group of patients receives surgical aortic valve replacement using CECC. |
|
| ICU length of stay | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
| Extubation time | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
| Thromboembolic complications | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
| In-hospital infections | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
| In-hospital Mortality | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D020766 | Intracranial Embolism |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
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