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Carotid stenting has been extensively studied recently as an effective alternative to endarterectomy in high surgical risk patients. Traditional angiography involves manual contrast injection and leads to excess contrast volume, greater fluoroscopy times with an increase in radiation exposure. The Acist contrast injection device helps with adequate regulation and lowering of contrast volume. The objective of our study is to see if use of this device during carotid stenting would be feasible without an increase in primary end points when compared to historic controls.
This is a consecutive, non-randomized, open label, multiple operator based, safety/efficacy study. Abbott Vascular, Inc. funded the Choice registry and all patients were part of this. High surgical risk patients with multiple co-morbid conditions were included. Inclusion criteria were: a) Subject is considered at high risk for carotid endarterectomy b) Subject requires percutaneous carotid angioplasty and stenting for carotid artery disease c) Must be asymptomatic with ≥ 80% stenosis of the internal and/or common carotid artery by ultrasound or angiogram. NIH stroke scale scoring system was performed on all patients prior to, after and at 30 days from the procedure. The primary end points measured were, death from any cause, myocardial infarction, transient ischemic attack or stroke within 30 days of intervention. Secondary end points were contrast volume and fluoroscopy time. Acist device was used for contrast injection in all patients and carotid stenting successfully performed.
Four operators in one institution did interventions from June 2007 to May 2012 on 133 consecutive patients. They were predominantly men (59.4%). Mean age (SD) was 73.64 (7.952) years. Stroke occurred in 3% (N=4), transient ischemic attack in 0.8% (N=1) and myocardial infarction in 0.8% (N=1). Three study subjects died (2.3%). Mean (SD) contrast volume was 121.24 (67.79) ml. Mean (SD) fluoroscopy time was 18.34 (11.31) minutes.
The use of the Acist device was feasible in carotid stenting in a high-risk population without an increase in end points when compared to other high-risk studies.
- 2013 American College of Cardiology Foundation