Perfusion Techniques for Brain Function in Aortic Valve Replacement

(ACP vs RCP Trial)

Overseen By Bonita Hilliard, RPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Psychiatric drugs, Chemotherapy

Disqualifiers: Stroke, Alcoholism, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Up to 7 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two blood flow techniques during heart surgery affect brain function. Antegrade perfusion sends blood to the brain through an artery, while retrograde perfusion uses a vein. The trial targets individuals scheduled for elective aortic valve or root surgery, including aortic arch replacement. Participants should understand their surgery plan and be able to complete cognitive tests. As an unphased trial, it provides participants the chance to contribute to important research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a psychiatric illness requiring medication, you may not be eligible to participate.

What prior data suggests that these perfusion techniques are safe for brain function during aortic valve replacement?

Research has shown that both antegrade and retrograde perfusion techniques generally protect the brain safely during heart surgery. Studies on antegrade perfusion indicate safety when blood flow to the brain remains under 30 to 40 minutes; exceeding this duration may increase complication risks.

For retrograde perfusion, studies suggest it safely protects the brain, particularly when combined with cooling techniques to lower body temperature. This method can reduce the risk of damage during surgery and is considered effective without increasing harm for most patients.

Overall, both methods have been used safely in surgeries. However, the duration and technique of the procedure are crucial for ensuring safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on perfusion techniques for brain function during aortic valve replacement because it explores two distinct methods for protecting the brain during surgery. Antegrade perfusion directly supplies blood to the brain via arteries branching from the aorta, potentially offering a more natural blood flow pattern. In contrast, retrograde perfusion uses the superior vena cava to deliver blood, which might offer better control and distribution of blood flow to the brain. These approaches could lead to improved outcomes compared to traditional methods, potentially reducing the risk of neurological complications during and after surgery.

What evidence suggests that these perfusion techniques are effective for brain function in aortic valve replacement?

This trial will compare two techniques for brain protection during aortic valve replacement: antegrade perfusion and retrograde perfusion. Research has shown that antegrade perfusion, which directs blood flow to the brain through arteries connected to the aorta, reduces brain problems after heart surgery. One study found that this method significantly lowered the chances of these issues, indicating it provides good brain protection.

Retrograde perfusion, delivering blood through the superior vena cava, has also shown promise. Studies have demonstrated that it helps the brain cope with reduced blood flow during surgery, protecting it for about 40 to 60 minutes. Both techniques have been successfully used to protect brain function during complex heart surgeries. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph Mathew, M.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals undergoing aortic arch surgery who require surgical circulatory arrest. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the procedures involved.

Inclusion Criteria

I am over 18 years old.

I am scheduled for surgery on the upper part of my aorta and nearby areas.

Exclusion Criteria

I am currently taking medication for a psychiatric condition.

Unable to read and thus unable to complete the cognitive testing

Patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical circulatory arrest with either antegrade or retrograde perfusion

Up to 7 days

In-hospital stay

Follow-up

Participants are monitored for cognitive function and brain health post-surgery

4 weeks

MRI at baseline, prior to discharge, and at 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Antegrade Perfusion
• Retrograde Perfusion

Trial Overview The study aims to compare brain function outcomes after aortic arch surgery using two different blood flow techniques: antegrade perfusion (forward flow) and retrograde perfusion (backward flow).

How Is the Trial Designed?

Group I: Arm 1: Antegrade Perfusion Active Control 1 Intervention

In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain.

Group II: Arm 2: Retrograde Perfusion Active Control 1 Intervention

In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11642406/

What Is the Efficacy of Bilateral Antegrade Cerebral Perfusion ... The effectiveness of cerebral perfusion was evaluated using NIRS in both patient groups, and retrograde cerebral perfusion was not required.

2. sciencedirect.com sciencedirect.com/science/article/pii/S144395062500294X?dgcid=rss_sd_all

Unilateral Versus Bilateral Antegrade Cerebral Perfusion in ... Regarding our primary outcomes, the pooled analysis revealed that uACP was associated with a significantly reduced incidence of PND (OR 0.7; 95% ...

3. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(19)31433-X/pdf

Impact of Cerebral Perfusion on Outcomes of Aortic Surgery A retrospective cohort analysis was conducted on out- comes of 18,180 adult patients 18 years of age or older who underwent aortic arch replacement or hemiarch ...

4. jtcvs.org jtcvs.org/article/S0022-5223(14)01266-5/fulltext

A study of brain protection during total arch replacement ... HCA/RCP is a nonphysiologic type of perfusion that provides only a limited protective effect for the brain, and prolonged HCA may cause some neurologic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5056682/

Selective Heart, Brain and Body Perfusion in Open Aortic Arch ... Our perfusion strategy for aortic arch replacement ensures a selective perfusion of heart, brain, and lower body during this complex procedure.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8888319/

Safety Time and Optimal Temperature of Unilateral Antegrade ... Most studies with good uACP results have reported needing less than 40 minutes of circulatory arrest and cerebral perfusion time. Whether more extended uACP can ...

7. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(22)00807-4/fulltext

Prolonged Periods of Antegrade Cerebral Perfusion Are ... Cerebral circulatory arrest times >40 minutes during aortic surgery have previously been shown to be associated with increased morbidity and mortality.

8. jtcvs.org jtcvs.org/article/S0022-5223(14)00989-1/fulltext

Safety and efficacy of retrograde cerebral perfusion as an ... RCP is a safe and effective adjunct for cerebral protection during arch surgery. Patients requiring more extensive arch reconstruction are not at greater risk ...

9. optechtcs.com optechtcs.com/article/S1522-2942(05)00006-1/fulltext

Aortic Arch Replacement/Selective Antegrade Perfusion From extensive clinical and laboratory experience with hypothermic cerebral protection, the safe limit of circulatory arrest is about 30 minutes at 15°C. Longer ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0022522314012665

A study of brain protection during total arch replacement ... The present study compared the results of 2 different methods of brain protection used during total arch replacement.