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T-CAR And Stroke Risk

For patients with carotid artery disease, the risk of stroke is a serious threat. Until recently, those who needed surgery to reduce that risk had two options: an open procedure called carotid endarterectomy or minimally invasive transfemoral carotid angioplasty and stenting (cas) through an incision in the groin. Neither is ideal.

Endarterectomy can lead to a painful recovery and temporary swallowing problems. And people who undergo transfemoral CAS have a higher risk of suffering a stroke during the procedure than those  who have endarterectomy.

But people with carotid artery disease now have a third option, called TCAR, or transcarotid artery revascularization. And ongoing clinical research has shown it to yield promising results.

“TCAR is a hybrid of older procedures that takes the best of both worlds and results in better outcomes for the patient,” says Jeffrey Jim, MD, a Washington University vascular surgeon at Barnes-Jewish Hospital.

TCAR involves a tiny incision — just 2 or 3 centimeters —  at the base of the neck. The surgeon inserts a catheter and clamps the artery to temporarily reverse blood flow away from the brain. This keeps any potential arterial plaque that’s knocked loose during the procedure from reaching the brain and causing a stroke. 

The catheter is connected to a circuit outside the body that directs the blood back into the body through 
a second tiny incision in the leg. Next, the surgeon inserts a stent to open the blocked artery. Any plaque that comes loose is caught and filtered out of the blood. Finally, the surgeon removes the catheter and closes  the incisions.

“Patients have to spend the night in the hospital because insurance requires it, but recovery is pretty minimal,” Jim says. “They shouldn’t do anything too strenuous for the first week, but most patients are  back to normal by then and feel really good at their follow-up visit.”

Because the incision is small and just above the collarbone, it doesn’t hurt much. The larger incision made during a carotid endarterectomy, on the other hand, can cause much more pain because it’s toward the top of the neck, an area that moves every time the head is turned.

Jim and fellow researchers are part of a multicenter clinical trial to evaluate the safety and effectiveness 
of TCAR. The pivotal phase of the trial, called ROADSTER, enrolled 141 people with carotid artery disease. Just 1.4 percent of them suffered strokes during TCAR procedures. A previous trial published  in 2010 found that the rate of procedural stroke was  2.3 percent in people undergoing endarterectomy and 4.1 percent in transfemoral CAS.

The TCAR system received approval from the Food and Drug Administration after the results of the ROADSTER trial were published in 2015. Jim and colleagues are currently participating in the ROADSTER II trial, which will enroll about 600 people and collect more data on TCAR’s safety and effectiveness.

Another milestone occurred in late 2016, when the Centers for Medicare and Medicaid Services (CMS) began covering TCAR for people deemed to be at high risk for adverse events, including stroke and death, from carotid endarterectomy. Previously, CMS covered the procedure only in people who were high-risk and exhibiting symptoms such as stroke and transient ischemic attack — a temporary blockage of blood flow to the brain. As Jim explains, this was problematic because “about 80 percent of patients with carotid artery disease treated in the United States don’t have symptoms but are still at high risk for stroke.”

Jim now performs TCAR for almost all of his patients with carotid artery disease. He still performs some open procedures — necessary if the blockage is at the base of the neck, for example — but infrequently performs transfemoral CAS, reserving it for rare cases, including for people who have laryngeal stomas and can’t have neck incisions.

As with any new procedure, there is a learning curve for vascular surgeons training to perform TCAR. But Jim, who’s been involved in training other surgeons, says it’s a relatively small one.

“Most vascular surgeons are pretty comfortable doing a dissection at the base of the neck, and TCAR simplifies the stent delivery,” he says. “I’m eager to teach more surgeons how to perform it.”

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