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Wednesday, March 23, 2016
TCAR clinically proven to reduce the risk of procedural and post-procedural stroke
Physicians in the Fireman Vascular Center at Massachusetts General Hospital (MGH) are now offering a new and less invasive method of treatment for carotid artery disease known as transcarotid artery revascularization, or TCAR. The U.S. Food and Drug Administration (FDA) recently approved TCAR, which involves accessing the common carotid artery through a small incision above the collarbone. A stent is delivered directly into the artery, reducing the risk of periprocedural stroke and other complications associated with more conventional stenting or surgical approaches. MGH is the first hospital in the Boston area to offer the TCAR procedure.
Started three years ago, the first clinical study of TCAR, known as the ROADSTER trial, was conducted at 18 sites worldwide. Two MGH surgeons, Richard Cambria, MD, and Christopher Kwolek, MD, led the study in the United States. One of their colleagues, Michael R. Jaff, DO, runs VasCore, the vascular ultrasound core laboratory supporting the ROADSTER trial. A paper published in the November 2015 Journal of Vascular Surgery reported the study achieved best-ever results in carotid artery stenting, demonstrating a 1.4 percent 30-day stroke rate, similar to results seen with the more standard approach of surgically removing dangerous plaque, called a carotid endarterectomy (CEA). The study also showed a lower incidence of heart attacks and nerve injuries and resulted in shorter hospital stays for patients. The resulting data supported FDA clearance of the ENROUTE® Transcarotid Neuroprotection and Stent System – the tools used during TCAR.
“The TCAR procedure is especially helpful in treating some of our highest-risk patients, for whom traditional methods may pose a greater chance for complications during and after intervention,” says Cambria, chief of the Division of Vascular and Endovascular Surgery at MGH. Our participation in the initial study yielded positive results for many of these patients, easing the path to recovery. We are quite pleased to now be opening up this procedure to more patients who could benefit from it.”
During TCAR, blood flow is temporarily reversed in the carotid artery to divert dangerous debris away from the brain, preventing procedural strokes. A stent is implanted through the collarbone incision, aimed at maintaining carotid blood flow and protecting patients from future strokes.
MGH patient Edward Sullivan, Jr., had a CEA more than 10 years before he experienced another complication of carotid artery disease in 2013. “At that time I felt TCAR was the safer option available to me, and the end result was a much shorter recovery,” says Sullivan.
Patients who now receive TCAR at MGH and other centers will be entered into a national clinical registry, with the goal of verifying results through larger patient numbers. Learn more about Vascular and Endovascular Surgery at MGH
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $800 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine. In July 2015, MGH returned into the number one spot on the 2015-16 U.S. News & World Report list of "America's Best Hospitals."
ENROUTE® is a registered trademark of Silk Road Medical, Inc.
Julie Cunningham, email@example.com, 617-724-6433
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