Keystone Heart is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, atrial fibrillation ablation and other structural heart procedures.

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Clinical Evidence

Why is Cerebral Embolic Protection Necessary?

Cerebral Embolic Events

Cerebral emboli are commonly associated with left-sided cardiac procedures. During cardiovascular procedures, 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. There is potential that this embolic debris may travel in your blood stream up to your brain and cause damage, which is referred to as a brain lesion. Cerebral damage may not be clinically evident after cardiovascular procedures and it can take months or years for symptoms to manifest. However, embolic brain lesions can be objectively and consistently detected by diffusion-weighted magnetic resonance imaging (DW MRI).


Clinical Manifestations

Acute Manifestations in Context

During cardiovascular procedures, debris from the aortic valve, ascending aorta and other sources may embolize and cause cerebral infarction. Embolic brain lesions may lead to potentially devastating outcomes — stroke, dementia and cognitive decline.

Moderate to mild brain injuries, which are caused by new lesions in the brain, can affect the patient’s processing speed, executive function, and fundamental skills such as memory, language, and balance. 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. 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.


Brain Injury Reporting

While many studies evaluating the safety of TAVR and other cardiovascular procedures only recorded the most devastating strokes, a new consensus paper published in Journal of American College of Cardiology and European Heart Journal highlights the need for improved testing to better ensure the safety of cardiac procedures.  The paper was developed by The Neurologic Academic Research Consortium (NeuroARC) in response to a growing body of evidence of the existence of “covert” brain injury to patients undergoing transcatheter aortic valve replacement (TAVR) and other cardiac procedures.

The paper offers a simple classification of the levels of potential damage to the brain in an effort to allow for better consistency and comprehensive reporting of results

  • Type 1: Overt damage to the central nervous system represent neurologic damage with symptoms of stroke, such as weakness or paralysis
  • Type 2: Covert injury to the central nervous system, represent neurologic damage without apparent symptoms of stroke, but recognized by brain imaging
  • Type 3: Neurologic dysfunction without detectable injury, include transient neurological symptoms such as temporary weakness, numbness, slurred speech or delirium without any evidence of damage on brain imaging

Innovation for Specialists

Keystone Heart is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other structural heart procedures. Novel devices developed by Keystone Heart are designed to help interventional cardiologists and electrophysiologists protect the brain while performing these procedures. The TriGUARD 3™ Cerebral Embolic Protection Device is designed to cover all three major cerebral branches to minimize the risk of brain damage during cardiovascular procedures.

ACC and EuroPCR Benefits of TriGuard™ Cerebral Embolic Protection Device

Data presented at ACC (March 2015) and EuroPCR (May 2015) demonstrate benefits of Keystone Heart’s TriGuard™ Cerebral Embolic Protection Device during TAVR. Based upon results from the DEFLECTIII trial, the CE marked TriGuard™ Cerebral Embolic Protection Device has improved in-hospital safety outcomes and cognitive scores at discharge during Transcatheter Aortic Valve Replacement (TAVR). Using the new detailed NIH Stroke Scale (NIHSS), patients protected with TriGuard™ had 10% absolute reduction in stroke (4.9% vs. 14.3%).  Minor stokes, which could impact a patient’s daily life, were undetected without the use of the new detailed NIHSS.