Aortic Valve Stenosis, Extracorporeal Circulation
Conditions
Keywords
Intracranial Embolism, Ultrasonography, Doppler, Transcranial
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMinimized Extracorporeal Circulation (MECC)
This group of patients receives surgical aortic valve replacement using MECC.
This group of patients receives surgical aortic valve replacement using CECC.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Isolated Severe Aortic Valve Stenosis * No other cardiac disease * No other coronary heart disease * Written informed consent
Exclusion criteria
* Double valve surgery * Concomitant coronary artery bypass surgery * Vascular surgery * Age \< 18 yrs. * Age \> 80 yrs.
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital Mortality | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
| 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) |
| In-hospital infections | 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) |
| ICU length of stay | In-hospital period (until hospital discharge, duration approx. 7-10 days) |
Countries
Switzerland
Outcome results
None listed