New Mexico Heart Institute Vascular Surgeons the First in the Southwest Region to Offer TCAR, an Innovative Procedure for Stroke Prevention
The TCAR procedure, a less invasive alternative to open surgery, involves placing a carotid stent in high-risk patients, to reduce the risk of stroke
Albuquerque, NM – The vascular surgeons at New Mexico Heart Institute have adopted a new procedure called Transcarotid Artery Revascularization, or TCAR, to prevent strokes in high-risk patients with blocked carotid arteries, the blood vessels that supply the brain.
Typically, when cardiologists attempt to treat carotid disease, there is some risk of causing a stroke due to plaque and blood clots breaking off and flowing to the brain during the procedure. The TCAR procedure involves placement of a stent in the blocked artery and creating a protective, temporary reversal of blood flow and plaque away from the brain, and has been clinically proven to reduce the risk of stroke and reduce the risks of complications from traditional surgery.
Vascular surgeons at New Mexico Heart Institute are within a select group of experts in clinical research that were asked to participate in this study that is transforming the treatment for carotid disease. New Mexico Heart Institute started conducting the new procedure in October 2016 and now have performed nearly 20 cases with overall outcomes that are as good as traditional open stroke-prevention surgery. In addition to less risk of stroke, benefits to the patient also include a lower risk of heart attack, less time under anesthesia, an easier recovery and a shorter hospital stay.
“This is truly a game-changing technology,” said Dr. Steve Henao, MD, FACS, FACC, Chief of Vascular Surgery at New Mexico Heart Institute since 2006. “This procedure will revolutionize the way we take care of patients at risk for stroke. This helps patients avoid major open vascular surgery, delivering the same excellent outcomes but with less risk of complications. I believe this is going to be the future standard of care for stroke and carotid disease, and I’m thrilled to be able to offer this to our patients.”
New Mexico Heart Institute is one of less than 50 sites in the United States currently enrolling patients into the ROADSTER 2 post-approval study. The ROADSTER 2 Study is a follow up to the ROADSTER Study, is currently enrolling a minimum of 600 patients to be treated with the TCAR Procedure using the ENROUTE Transcarotid Neuroprotection and Stent System.
The recently published ROADSTER Clinical Study demonstrated a low, overall stroke rate of 1.4% – “the lowest reported to date for any prospective multi-center trial for carotid stenting.” (J Vasc Surg 2015;62:1227-35). The 1.4% 30-day stroke rate is similar to results seen with CEA, but with a lower incidence of heart attacks, nerve injuries and a shorter length of stay.
Stroke is a leading cause of death and life-altering disability. Every year, there are over 800,000 ischemic strokes in the US alone, and an estimated 20-30% of these are caused by disease in the carotid arteries which carry blood to the brain. If left untreated, these blockages can fragment, flow to the brain and lead to a potentially disabling stroke, also known as a “brain attack.”
A common treatment option for carotid artery disease involves an open surgery known as carotid endarterectomy (CEA). CEA has proven effective in preventing stroke, but carries the risks of surgical complications like myocardial infarction (heart attack) and injury to nerves that are present near the surgical incision. The FDA cleared TCAR procedure adopted many of the surgical principles of CEA, but uses less invasive tools such as carotid stents and wires in order to avoid those surgical complications, making it a better choice for older and high-risk patients.
Due to the positive results of TCAR, the Society for Vascular Surgery and the Center for Medicare & Medicaid Services are supporting TCAR by setting up an outcomes database known as the TCAR Surveillance Project. The TCAR Surveillance Project allows participating physicians and hospitals to receive reimbursement for eligible symptomatic and asymptomatic patients that undergo the TCAR procedure.
New Mexico Heart Institute is one of the leading cardiology teams in the Southwest with more than 28 staff surgeons and cardiologists, all of which are board certified. NMHI practices state-of-the-art medicine by employing the latest cardiovascular imaging and fully integrated interventional, cardiothoracic, and vascular surgical approaches. The Institute’s services, a number of which are conducted in conjunction with the Heart Hospital of New Mexico, located next door, address a full-range of preventive, diagnostic, treatment, surgical, and rehabilitation needs. In addition, NMHI’s Clinical Research Department is represented by a team of full-time research coordinators who are dedicated to carrying out the research component of our mission through heightened patient knowledge, the development of new therapies, and the innovation of new technologies.
About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
The ENROUTE system is currently the only FDA-cleared device indicated for use in a TCAR procedure. The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and is intended to be used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS). The ENROUTE Transcarotid NPS is used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE Transcarotid Stent.
ENROUTE is a registered trademark of Silk Road Medical, Inc.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please refer to package insert for indications, contraindications, warnings, precautions, and instructions for use.
About Silk Road Medical
Silk Road Medical, Inc. is a private company located in Sunnyvale, CA, that develops and manufactures less-invasive medical devices intended to improve the treatment of carotid artery disease through proprietary transcarotid therapies. Detailed information can be found at www.silkroadmed.com.
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