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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
This group of patients receives surgical aortic valve replacement using MECC.
This group of patients receives surgical aortic valve replacement using CECC.
University Hospital Bern
Bern, Switzerland
Total and interval-related cerebral microembolic load as measured by transcranial Doppler
Time frame: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
Cerebral complications, e.g. delirium and stroke as detected clinically
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Redo surgery
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
ICU length of stay
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Extubation time
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Thromboembolic complications
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital infections
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital Mortality
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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