Frequently Asked Questions (FAQs)

Yes. 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.[1]

REFERENCES

1. Magalhaes PG, Kooistra NHM, Leenders GEH, et al. First pilot study with the TriGUARD 3™ Cerebral Embolic Protection Device [published online ahead of print, 2020 Feb 25]. EuroIntervention. 2020;EIJ-D-19-00741. doi:10.4244/EIJ-D-19-00741

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.

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

The methods now being used to assess brain injury include an advanced sequence of magnetic resonance imaging (MRI) called diffusion weighted (DW)-MRI,[1] to routine computerized tomography (CT) scans and neurological evaluations.

REFERENCES

1. Gress D, J Am Coll Cardiol. 2012 Oct 23;60(17):1614-6

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.[1]

REFERENCES

1. Messe SR, et al. Circulation.2014, Linke et al TCT 2014, Lansky et al EHJ 2015

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.[1] 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.[2] 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.[3]

REFERENCES

1. http://dx.doi.org/10.1016/j. amjcard.2016.08.013
2. http://dx.doi.org/10.1016/j.amjcard.2016.08.013
3. Xiumei Sun, MD, et al. JACC 2012;60:9, Silent Brain Injury After Cardiac Surgery: A Review. Cognitive Dysfunction and Magnetic Resonance Imaging Diffusion-Weighted Imaging Findings

Twenty percent of the blood pumping through your heart travels to the brain.[1] When you have a heart procedure, what happens in the heart can impact the brain.[2] There is a direct connection between your heart and your brain through the body’s vascular system.[3] 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.[4] 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.[5]

REFERENCES

1. https://www.drugabuse.gov/publications/teaching-packets/power-science/section-i/2-brain-most-complex-organ-in-body
2. http://dx.doi.org/10.1016/j.amjcard.2016.08.013
3. http://dx.doi.org/10.1016/j.amjcard.2016.08.013
4. https://www.ncbi.nlm.nih.gov/pubmed/21087747
5. https://www.ncbi.nlm.nih.gov/pubmed/21087747