Use of ACIST™ contrast injection device in carotid artery stenting in high-surgical-risk patients

ObjectiveThe objective is to see if use of the ACIST™ device during carotid stenting would be feasible without an increase in primary end points when compared to historic controls.BackgroundCarotid stenting has been studied as an effective alternative to endarterectomy in high-surgical-risk patients. Traditional angiography involves manual contrast injection. It leads to excess contrast volume and greater fluoroscopy times. The Acist contrast injection device helps with the regulation and lowering of contrast volume.MethodsThis is a consecutive, non-randomized, open-label, multiple-operator-based study. Inclusion criteria were as follows: (a) subject is considered at high risk for carotid endarterectomy, (b) subject requires percutaneous carotid angioplasty and stenting for carotid disease, and (c) subject must be asymptomatic with ≥ 80% stenosis of the internal and/or common carotid artery. 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.ResultsFour operators in one institution performed interventions from June 2007 to May 2012 on 133 consecutive patients. They were predominantly men (59.4%). The 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%). The mean (SD) contrast volume was 121.24 (67.79) mL. The mean (SD) fluoroscopy time was 18.34 (11.31) minutes.ConclusionsThe use of the ACIST™ device was feasible in carotid stenting in a high-risk population without an increase in end points when compared to historic controls.