Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.

The purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. The significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.

Inclusion Criteria:

• Undergoing a total arch replacement
• Less than 75 years old

Exclusion Criteria:

• EF less than 35%
• Pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection
• Pt unable to complete preop neuro assessment
• Pt is unwilling or able to complete followup requirements
• Pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint
• Pt is a female who is pregnant or lactating
• Pt has history of stroke