Trans Carotid Artery Revascularization (TCAR)

TCAR – Procedure Details

A small incision is made just above the collar bone to expose the common carotid artery. A soft, flexible sheath is placed directly into the carotid artery and connected to a system that will reverse the flow of blood away from the brain to protect against fragments of plaque that may come loose during the procedure. The blood is filtered and returned through a second sheath placed in the femoral vein in the patient’s thigh. The Neuroprotection system allows balloon angioplasty and stenting to be performed while blood flow is reversed. After the stent is placed successfully to stabilize the plaque in the carotid artery, flow reversal is turned off and blood flow to the brain resumes in its normal direction.

Microembolism Matters

The TCAR Procedure is designed to protect the brain from most sizes and types of embolic debris when introducing interventional devices into the carotid artery. Small emboli, not large enough to cause a major stroke, can still cause a minor brain infarction and impact cognitive function.1-3 A sensitive imaging technology called Diffusion Weighted -Magnetic Resonance Imaging (DW-MRI) can be used to detect these small brain infarctions.

TCAR is a surgically inspired procedure and is designed to mimic the arterial access and safeguards of surgery. In carotid artery surgery, the arteries are clamped above and below the blockage to block blood flow and prevent plaque from traveling to the brain during treatment. Similarly, the ENROUTE® Transcarotid Neuroprotection System isolates the blockage from forward blood flow during stent placement by actually reversing blood flow away from the brain. Because the flow reversal method does not rely on a distally placed filter to capture emboli before they reach the brain, it collects both small and large debris.

Research studies on other neuroprotection devices have shown that filters placed in the artery beyond the disease (distal filters) may not adequately protect the brain from these micro emboli.4 Distal filters, designed to capture plaque but allow blood to pass through them during the procedure, cannot stop the smallest debris from passing through.

Additionally, the process of placing the filter itself can create microemboli. In some research studies, 75-85% of patients undergoing CAS showed evidence of small brain infarctions post-procedure.5

1 Palombo G et al. AJNR Am J Neuroradiol 2008;29:1340-3
2 Wolf O et al. Eur J Vasc Endovasc Surg 2004;27:167-71.
3 Zhou W et al. J Vasc Surg 2009;50:1224-31
4 PROFI: Bijuklic et al. J Am Coll Cardiol 2012; 59:000–000
5 ICSS: Bonati LH et al.  Lancet 2010; DOI:10.1016/S1474-4422(10)70057-0.

Silk Road Medical introduced TransCarotid Artery Revascularization using the ENROUTE® Transcarotid Neuroprotection and Stent System. The TCAR procedure combines direct carotid artery access with robust blood flow reversal during ENROUTE Transcarotid Stent placement to remove micro and macro emboli throughout the intervention for CEA-like neuroprotection in a less invasive, more patient-friendly approach.

Vascular Surgery

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PRESS RELEASE

Dr. Eddy Luh of Las Vegas Surgical Associates was the FIRST in the state of Nevada to treat carotid artery disease and prevent future strokes using a new procedure called TransCarotid Artery Revascularization (TCAR). TCAR (tee-kahr) is a clinically proven, minimally invasive and safe approach for high surgical risk patients who need carotid artery treatment.

Carotid artery disease is a form of atherosclerosis, or a buildup of plaque, in the two main arteries in the neck that supply oxygen-rich blood to the brain. If left untreated, carotid artery disease can often lead to stroke; it is estimated to be the source of stroke in up to a third of cases, with 427,000 new diagnoses of the disease made every year in the U.S. alone.

“TCAR is an important new option in the fight against stroke, and is particularly suited for the large portion of patients we see who are at higher risk of complications from carotid surgery due to age, anatomy, or other medical conditions,” said Dr. Luh. “Because of its low stroke risk and faster patient recovery, I believe TCAR represents the future of carotid repair.”

TCAR is unique in that blood flow is temporarily reversed during the procedure so that any small bits of plaque that may break off are diverted away from the brain, preventing a stroke from happening. A stent is then placed inside the artery to stabilize the plaque, minimizing the risk of a future stroke.

Prior to TCAR, the main treatment option for severe carotid artery disease was an open surgical procedure called carotid endarterectomy (CEA). CEA removes plaque from inside the carotid artery to restore normal blood flow to the brain, but the large incision leaves a visible scar the length of the neck and carries risks of surgical complications, including bleeding, infection, heart attack and cranial nerve injuries that can cause issues with swallowing, speaking and sensation in the face.

The TCAR procedure was developed by Sunnyvale, California-based Silk Road Medical, Inc. and includes the ENROUTE® Transcarotid Neuroprotection (NPS) and Stent System – the first devices designed and FDA-approved specifically for TCAR. Over 10,000 TCAR procedures have been performed worldwide through clinical trial and commercial use. TCAR has been studied extensively, and the clinical data have been excellent. Additional information about TCAR is available at Silk Road Medical.