Illustration of healthy carotid artery representing TCAR benefits

TCAR: A Safer Route for High-Risk Carotid Revascularization?

Lena Kashyap in Health & Wellness November 2025 • 4 min read.

"Exploring the benefits of Transcarotid Artery Revascularization with the ENROUTE Neuroprotection System for patients unsuitable for traditional surgery."

Carotid artery disease, a condition where plaque builds up inside the carotid arteries, significantly elevates the risk of stroke. For decades, carotid endarterectomy (CEA), a surgical procedure to remove this plaque, has been the gold standard for treatment. However, CEA isn't suitable for everyone, especially those with specific anatomical challenges or underlying health conditions that increase surgical risks.

Transfemoral carotid artery stenting (TF-CAS) emerged as another option, but it comes with its own set of concerns, particularly the risk of cerebral embolization—the release of plaque debris into the brain during the procedure, potentially leading to stroke. This risk is primarily associated with navigating the aortic arch and manipulating plaque before deploying a protective device.

Enter Transcarotid Artery Revascularization (TCAR), a cutting-edge approach that utilizes the ENROUTE Neuroprotection System (ENPS). TCAR distinguishes itself by employing a dynamic flow reversal technique, which temporarily redirects blood flow away from the brain during the procedure, minimizing the risk of debris entering the cerebral circulation. This makes it a potentially safer option for high-risk patients.

Why TCAR Could Be a Game-Changer for High-Risk Patients

Illustration of healthy carotid artery representing TCAR benefits

A recent study published in the Journal of Vascular Surgery sheds light on the real-world outcomes of TCAR using the ENROUTE system in patients deemed high-risk for traditional CEA. The study meticulously tracked patients treated outside the controlled environment of the ROADSTER-2 clinical trial, providing valuable insights into the procedure's effectiveness in everyday practice.

The study, conducted at a single institution between December 2015 and January 2018, involved 75 carotid arteries treated with TCAR. All patients had significant carotid artery stenosis (narrowing), with either symptomatic (≥50% stenosis) or asymptomatic (≥80% stenosis) conditions. Crucially, these patients were considered to be at high risk for complications following traditional CEA.

High Technical Success: The procedure achieved a 97.3% technical success rate, indicating the proficiency and reliability of the technique.
Low Stroke Rate: The perioperative (30-day) ipsilateral stroke rate was a promising 2.7%, suggesting a reduced risk of stroke compared to historical data for high-risk CEA patients.
No Myocardial Infarctions: The study reported a 0% incidence of myocardial infarction (heart attack), highlighting the procedure's safety regarding cardiac events.
Low Mortality Rate: The mortality rate was 2.7%, comparable to outcomes observed in standard-risk CEA trials.
No Cranial Nerve Injuries: The absence of cranial nerve injuries further underscores the procedure's safety profile.

After an average follow-up of 8 months, the study found no instances of carotid stents requiring reintervention. While there was one case of minor in-stent stenosis and one asymptomatic stent thrombosis, these findings suggest good long-term durability of the TCAR procedure. One additional ipsilateral stroke was observed during follow-up, believed to be from a cardiac source rather than related to the carotid stent.

The Future of Stroke Prevention: Is TCAR the Answer?

The study's findings suggest that TCAR with the ENROUTE system is a safe, feasible, and effective alternative to traditional CEA in high-risk patients. By minimizing the risk of stroke and other complications, TCAR offers a promising approach to carotid revascularization, potentially improving outcomes and quality of life for individuals who are not suitable candidates for conventional surgery. As research continues and TCAR becomes more widely adopted, it may well become the preferred method for carotid revascularization in a broader range of patients.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1016/j.jvs.2018.06.222, Alternate LINK

Title: Outcomes Associated With A Transcarotid Artery Revascularization-Centered Protocol In High-Risk Carotid Revascularizations Using The Enroute Neuroprotection System

Subject: Cardiology and Cardiovascular Medicine

Journal: Journal of Vascular Surgery

Publisher: Elsevier BV

Authors: S. Keisin Wang, Andres Fajardo, Alan P. Sawchuk, Gary W. Lemmon, Michael C. Dalsing, Alok K. Gupta, Michael P. Murphy, Raghu L. Motaganahalli

Published: 2019-03-01

Everything You Need To Know

What are the established methods of addressing carotid artery disease, and what are the limitations or risks associated with each?

Carotid artery disease involves plaque buildup in the carotid arteries, increasing stroke risk. Carotid endarterectomy (CEA) has been a standard treatment, surgically removing this plaque. However, CEA isn't always suitable, especially for high-risk patients. Transfemoral carotid artery stenting (TF-CAS) emerged as another option, but poses a risk of cerebral embolization, where plaque debris enters the brain, potentially causing stroke.

How does Transcarotid Artery Revascularization (TCAR) with the ENROUTE Neuroprotection System (ENPS) differ from other carotid revascularization methods in protecting the brain during the procedure?

Transcarotid Artery Revascularization (TCAR) employs the ENROUTE Neuroprotection System (ENPS). It uses a dynamic flow reversal technique, temporarily redirecting blood flow away from the brain during the procedure. This minimizes the risk of debris entering the cerebral circulation. The 'dynamic flow reversal' is a critical element that distinguishes TCAR from other carotid revascularization techniques, contributing to its potentially safer profile.

What specific results were observed in the study assessing the real-world outcomes of TCAR with the ENROUTE system for high-risk patients?

A study in the *Journal of Vascular Surgery* evaluated TCAR using the ENROUTE system in high-risk patients. It showed a 97.3% technical success rate, a 2.7% perioperative stroke rate, no myocardial infarctions, a 2.7% mortality rate, and no cranial nerve injuries. These results suggest TCAR is a safe and effective alternative to traditional CEA for those at high risk.

What were the long-term findings in the study regarding the durability and potential complications associated with the TCAR procedure using the ENROUTE system?

The study followed patients for an average of 8 months, finding no carotid stents needing reintervention. There was one minor case of in-stent stenosis and one asymptomatic stent thrombosis. The long-term durability of TCAR seems promising, though further studies with longer follow-up periods are needed to confirm these initial findings. Monitoring for late stent-related complications remains crucial.

What are the overall implications of TCAR's success for the future of stroke prevention and the treatment of carotid artery disease?

TCAR, utilizing the ENROUTE system, shows promise as a safer alternative to traditional CEA in high-risk patients, potentially improving outcomes and quality of life. While current research is encouraging, continued studies and wider adoption are needed to confirm its role as the preferred method for carotid revascularization in a broader range of patients. Factors such as cost-effectiveness and the learning curve associated with TCAR adoption will also influence its future role.