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PREPARING FOR A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE

If you have been diagnosed with severe aortic stenosis, your heart team may recommend a transcatheter aortic valve implantation (TAVI) procedure to treat the condition.

Although procedures such as TAVI are known to save lives and increase quality of life ⁽ⁱ⁾, these life-saving medical interventions, include the possibility of risks such as the the potential for brain injury.

Injury to the brain may present as mild neurocognitive dysfunction, such as memory loss and speech challenges that can impact day-to-day life, or may present as a full stroke that could lead to limitation in body movement or sensation.⁽ⁱⁱ⁾ These risks may be reduced with new technologies. ⁽ⁱⁱⁱ⁾

You should discuss both the benefits and risks of interventional heart procedures with your physician.

This content has been developed to help you understand about the TAVI procedure, and how the TriGUARD 3™ cerebral embolic protection device may be incorporated into your procedure to minimize the risk of damage to your brain.

WHAT DOES YOUR BRAIN HAVE TO DO WITH YOUR HEART?

It may seem strange to discuss a neurological event like stroke with your cardiologist, but the heart and the brain are physically connected.

Did you know?

Twenty percent of the blood pumping through your heart travels to the brain.^(iv) When you have a heart procedure, what happens in the heart can impact the brain.^(v)
There is a direct connection between your heart and your brain through the body’s vascular system.^(vi)
During a heart procedure, pieces of calcium, blood clots, parts of vessel walls or other intraluminal matter may break off from your heart chambers, valve, and/or blood vessels.^(vii)
There is potential that this debris may travel in your blood stream up to your brain and cause damage, which is referred to as a brain lesion.^(viii)
The clinical consequences of brain lesions depend on the size, location and through which of the three cerebral branches the debris travels to the brain.^(ix)

The TriGUARD 3™ device is designed to deflect the debris from traveling to your brain by protecting all three major vessels that supply blood to your brain during trans-catheter procedures. In doing so, it can potentially reduce the risk of brain injury during TAVI and other trans-catheter cardic procedures

BRAIN INJURY FOLLOWING CARDIOVASCULAR PROCEDURES

Today’s testing and screening tools have allowed doctors and researchers to discover that brain injury occurs more frequently than originally thought during heart procedures.^(x) Although it has been recognized that cardiovascular interventions have a relatively low risk of severe, disabling strokes, the medical community has become aware that other damage to the brain may occur during interventions.^(xii)

Moderate to mild brain injuries, which are caused by new lesions in the brain, can affect a patient’s processing speed, executive function, and fundamental skills such as memory, language, and balance.^(xii) These lesions may be related to changes in the way your brain functions or processes information, and lesions in the brain stem can impact basic body functions such as breathing, swallowing, heart rate, blood pressure, consciousness, and whether one is awake or fatigued.^(xiii) The location of these lesions determines the damage and clinical symptoms, and where a lesion may occur is unpredictable. In general, the larger the lesion, the higher the risk that the patient will suffer from disabling stroke.^(xiv)

The methods now being used to assess brain injury include an advanced sequence of magnetic resonance imaging (MRI) called diffusion weighted (DW)-MRI,^(xvi) to routine computerized tomography (CT) scans and neurological evaluations.

Data has shown that about

94% of patients have new brain lesions after TAVI

about 1 out of 4 have some neurologic impairment after TAVI, and 4 out of 10 have some neurocognitive worsening when this was measured one month after TAVI.^(xv)

HOW CAN WE KEEP EMBOLIC DEBRIS FROM TRAVELING TO THE BRAIN

There is a growing body of evidence that shows if we can reduce embolic debris going to the brain, we can decrease the risk of brain injury during life-saving procedures such as TAVI. If your physician recommends that you consider TAVI, you may be a candidate to receive a new cerebral embolic protection device called TriGUARD 3^TM, which is a device to provide protection for the brain during a heart procedure.

HOW DOES THE TRIGUARD 3 CEREBRAL EMBOLIC PROTECTION DEVICE WORK

During a life-saving TAVI procedure, a new heart valve is placed inside the pre-existing heart valve.^(xvii) During this procedure, embolic debris may come loose and can travel in the aorta, which carries these particles to different areas of the body, including the brain.^(xvii)

A pilot study was conducted using the TriGUARD 3™ device for cerebral protection during TAVI. It was shown to be feasible and safe. During the study, the device was successfully delivered, deployed, and retrieved without interference with the TAVI procedure in 100% of cases, and achieved complete 3-vessel cerebral embolic protection throughout the procedure in 90% of cases without any clinical evidence of neurological impairment.^(xix)

The TriGUARD 3™ cerebral protection device is a small, flexible, wire mesh filter that is designed to deflect and reduce the passage of embolic debris to the brain during a heart procedure.

It is designed to provide protection for the brain by covering all three of the major arteries that supply blood to the brain. By covering all of these vessels, the device may decrease embolic debris from going to the brain during your TAVI procedure. Once the procedure is completed, the device is removed.

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