Direct Cervical Carotid Angioplasty with Flow Reversal: A Single-Center Report from the Roadster Trial.

ABSTRACT

BACKGROUND: Carotid stent and/or angioplasty (CAS) via the transfemoral route with distal protection carries twice the risk of stroke and/or death when compared with carotid endarterectomy (CEA) in multiple randomized trials. Potential causes for this include disadvantaged aortic arch anatomy and the need to traverse the lesion to place a distal protection device. This report describes the technique and our experience with direct CAS using flow reversal for embolic protection. METHODS: University of California at Los Angeles (UCLA) division of Vascular and Endovascular surgery was a participant in the multi-institutional Roadster Trial of high-risk patients. We are reporting on our experience with 8 patients who met high-risk criteria. Using a small supraclavicular cutdown, the Michi sheath from Silk Road Medical was inserted into the common carotid artery. This provides a working channel for internal CAS as well as a side port to reverse and divert blood flow to the femoral vein, for embolic protection. All patients qualified as medically high risk because of a combination of factors including advanced age, smoking history, hypertension, diabetes, coronary artery disease, or hostile neck anatomy. RESULTS: All 8 patients had 3 or more risk factors including age >75 years (6 of 8), smoking (6 of 8), hypertension (7 of 8), overt coronary artery disease (4 of 8), diabetes (2 of 8), and chronic obstructive pulmonary disease (1 of 8). All stenoses were in the 80-99% category, and all were asymptomatic. All patients tolerated temporary clamping with flow reversal with no electroencephalogram changes. There were no deaths, strokes, transient ischemic attacks, or myocardial infarctions. All patients were discharged on the first postoperative day. Follow-up ranged from 7 to 21 months. One patient developed in-stent restenosis (asymptomatic). CONCLUSIONS: Direct CAS with flow reversal appears to be a safe, less invasive alternative to CEA.