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Use of ACIST™ contrast injection device in carotid artery stenting in high-surgical-risk patients
Punnaiah C Marella1, Siva Talluri, Renata Schwartz
1Department of Internal Medicine, Banner Estrella Medical Center, Phoenix, AZ, USA; Midwestern School of Medicine, Glendale, AZ, USA.
Insights
The ACIST™ device is feasible for carotid stenting in high-risk patients, showing comparable safety to historic controls. This method reduces contrast volume and fluoroscopy time during the procedure.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Vascular Surgery
Background:
- Carotid stenting offers an alternative to endarterectomy for high-surgical-risk patients.
- Traditional angiography in carotid stenting uses excess contrast and increases fluoroscopy time.
- The ACIST™ device aims to regulate and reduce contrast volume and fluoroscopy time.
Purpose of the Study:
- To evaluate the feasibility of using the ACIST™ device during carotid stenting.
- To determine if ACIST™ device use increases primary endpoints compared to historic controls.
- To assess the impact of ACIST™ device on contrast volume and fluoroscopy time.
Main Methods:
- A consecutive, non-randomized, open-label study involving 133 high-risk, asymptomatic patients with ≥80% carotid stenosis.
- Primary endpoints included 30-day death, myocardial infarction, transient ischemic attack, or stroke.
- Secondary endpoints focused on contrast volume and fluoroscopy time.
Main Results:
- The study included 133 patients, predominantly male, with a mean age of 73.64 years.
- The incidence of stroke was 3%, TIA 0.8%, myocardial infarction 0.8%, and death 2.3%.
- Mean contrast volume was 121.24 mL and mean fluoroscopy time was 18.34 minutes.
Conclusions:
- The ACIST™ device is feasible for carotid stenting in high-risk populations.
- Its use did not result in an increase in primary endpoints compared to historic controls.
- The device potentially aids in reducing contrast volume and fluoroscopy time in carotid stenting procedures.
Objective:
The 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.
Background:
Carotid 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.
Methods:
This 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.
Results:
Four 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.
Conclusions:
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 historic controls.
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