SARASOTA (Jan. 25, 2017) – Sarasota Memorial Hospital is among the first in Florida to offer high-risk patients a less invasive treatment for carotid stenosis – the buildup of plaque inside the carotid arteries that can lead to potentially disabling strokes and death.
Recently cleared by the FDA for the treatment of high-risk patients who have suffered symptoms of a warning stroke (TIA), TransCarotid Artery Revascularization (TCAR) is a new endovascular procedure that potentially avoids some of the complications that may occur with current treatment options.
Sarasota Vascular Surgeon Russell Samson, MD, is currently one of only two surgeons performing TCAR in Florida (the other is in Naples) for patients deemed too high risk for carotid endarterectomy, the open surgery commonly used to treat severe carotid stenosis. While it minimizes the chance of stroke, carotid endarterectomy carries a small risk of heart attack and injury to nerves that are present near the surgical incision. In order to avoid a neck incision, possible nerve damage and to decrease the risk of heart attack, some surgeons will treat carotid blockage with a stent threaded up through a catheter placed via a groin artery. However, manipulation of the stent with this approach carries a higher risk of stroke than carotid endarterectomy because pieces of blockage can break loose and travel to the brain.
TCAR is performed through a small incision at the base of the neck and safely reverses blood flow away from the brain to protect it from dangerous bits of plaque and blood clots that can break away during standard treatments.
“Repair of the carotid artery carries some risks that vary depending on the type of treatment; these include nerve damage, heart attack and stroke from carotid endarterectomy and stroke and heart attack from current stent techniques,” said Dr. Samson. “TCAR is designed to reduce the incidence of these complications.”
A minimally invasive outpatient procedure, TCAR involves placing a stent through a catheter inserted directly into the common carotid artery at the base of the neck, bypassing vessels near the heart. Although this does require a small incision, the direct approach, coupled with technology that reverses blood flow, diverts dangerous debris away from the brain, helps prevent the risk of a procedural stroke and reduces the chance of nerve damage with standard carotid endarterectomy surgery.
Every year, more than 300,000 people in the United States are diagnosed with blockages, or plaques, in their carotid artery. Left untreated, these blockages can fragment, flow into the brain and lead to a stroke, a leading cause of death and life-altering disability in the United States.
Medicare will cover TCAR procedures for patients deemed high risk for adverse events from traditional carotid endarterectomy procedures. Use of the device also requires that clinical data and outcomes be entered into the national TCAR Surveillance Project a database provided by the Society for Vascular Surgery and Sarasota Memorial. Others on Sarasota Memorial’s vascular surgery team are completing the credentialing process and will join Dr. Samson in offering the procedure in the coming months.
In December, Bradenton retiree Elizabeth Johnson was the first patient to undergo the procedure at Sarasota Memorial. Challenged by carotid and peripheral artery disease, she underwent carotid surgery 15 years ago to remove the plaque from clogged arteries on both sides of her neck.
When she found out that scar tissue was blocking her carotid arteries again, the TCAR procedure was a welcome alternative.
“It seemed so easy compared to the others I’ve had, and the recovery was much faster,” said Johnson, 67, who was considered too high risk for standard procedures. “I was out of the hospital the day after the procedure with a much smaller scar than I expected. I feel great and am looking forward to getting the other side done very soon.”
At this time, Silk Road Medical’s ENROUTE Transcarotid Neuroprotection and Stent System is the only device currently approved for TCAR procedures by the FDA.
About Sarasota Memorial Health Care System
Sarasota Memorial Health Care System is a regional referral center offering Southwest Florida’s greatest breadth and depth of care, with more than 900,000 patient visits a year. In 2016, Sarasota Memorial’s flagship 819-bed acute care hospital was named among the 50 Top Heart Hospitals and was recognized among the nation’s 100 top hospitals for overall care by Truven Health Analytics. It is the only hospital in the region that has been recognized repeatedly as one of the nation’s best and safest, with superior patient outcomes and a complete continuum of outpatient services– from urgent care clinics and physician groups, laboratory and diagnostic imaging centers, to home health and skilled nursing & rehabilitation. For more information, call the hospital’s HealthLine at (941) 917-7777.
About Silk Road Medical’s ENROUTE Transcarotid Neuroprotection and Stent System
The ENROUTE Transcarotid Neuroprotection System and Stent is a first-in-class device 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., 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. For more information, visit: silkroadmed.com.