Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound (AKE-MECC)

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 4

Conditions: Aortic Valve Stenosis; Extracorporeal Circulation

Treatments: Procedure: Minimized Extracorporeal Circulation (MECC); Procedure: Conventional Extracorporeal Circulation (CECC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02308566

034/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

Conventional Extracorporeal Circulation Technique

Active Comparator group

Description:

Conventional Extracorporeal Circulation Technique

Treatment:

Procedure: Conventional Extracorporeal Circulation (CECC)

Minimized Extracorporeal Circulation Technique

Experimental group

Description:

Minimized Extracorporeal Circulation Technique

Treatment:

Procedure: Minimized Extracorporeal Circulation (MECC)