Cath Lab Digest

Introduction
Carotid angioplasty and stenting (CAS) is a less invasive alternative to conventional carotid endarterectomy (CEA). CEA remains the mainstay for treatment of obstructive carotid artery disease (CAD) based on randomized trials conducted with low risk surgical patients compared with medical therapy.¹ Results of the Study of Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial have concluded that CAS with an embolic protection device is not inferior to carotid endarterectomy in high risk patients and has been shown to have fewer complications in the short term.² We report data on fifty consecutive cases utilizing a standardized carotid protocol at our institution performed by a single operator. The majority (96%) of procedures include embolic protection devices. We sought to demonstrate that carotid angioplasty and stenting can be accomplished safely and successfully in a community hospital with results comparable to those attained in clinical trials at academic centers.

Methods
Patient Population
Fifty consecutive cases were enrolled between October 20, 2001 and June 28, 2005 at Mount Clemens Regional Medical Center, Mount Clemens, Michigan. Consent was obtained at the time of enrollment. Patients were considered for CAS if one high-risk variable was present. These conditions included cervical immobility, contralateral carotid occlusion, high lesions, low or ostial lesions, prior neck radiation, prior radical neck surgery, short or obese neck, severe CAD/ angina, cardiomyopathy, severe aortic stenosis and severe chronic obstructive pulmonary disease. Symptomatic patients had a transient ischemic attack or stroke within the previous 120 days involving the ipsilateral carotid artery distribution. A symptomatic lesion had to be greater than 60% and an asymptomatic lesion had to be greater than 80% to be considered for CAS. All participants were greater than eighteen years old. Exclusion criteria included pregnancy, stroke within four weeks of the index procedure, persisting ischemic stroke (defined as either a score >/- 15 on the NIH stroke scale, a Rankin score >/- 3 or a Barthel score

The average age of the patients was 71 (54–86). Thirty-one men (65%) and 17 women (35%) were enrolled in the study. Staged bilateral carotid interventions were completed in two patients. Therefore, there were 50 vessels which underwent CAS. Risk factors for carotid atherosclerosis and co-morbid conditions of the study group are listed in Table 1. Sixteen patients (32%) were symptomatic. Indications for CAS included prior CEA 14 patients (28%), 3 patients (6%) with contralateral carotid occlusion, 4 (8%) cases, which were considered to be low or ostial lesions, and one patient (2%) had a prior radical neck surgery. CAS was undertaken in the following high risk co-morbidities — severe CAD/angina defined as > 70% stenosis of 2 or more epicardial coronary arteries or significant (> 50%) left main disease (10 cases, 20%), cardiomyopathy with New York Heart Association Class III-IV symptoms (10 cases, 20%), severe aortic stenosis (1 case, 2%) and severe chronic obstructive pulmonary disease (3 cases, 6%). Two patients did not have high-risk features but refused traditional CEA and were allowed to enroll in the study.

Baseline color duplex ultrasound imaging was obtained in a laboratory accredited by the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL). Carotid angiograms were obtained in all patients prior to (< 120 days) CAS. A neurological assessment was obtained by an independent, board certified neurologist prior to CAS. Baseline NIH, Barthel and Rankin stroke scales were completed. All patients were given aspirin 325 mg (unless an allergy was documented) prior to the procedure. Clopidogrel 75 mg was started 48 hours prior to the intervention and continued for four weeks post procedure or longer if indicated for cardiovascular indications. Ticlopidine (250 mg b.i.d.) was used in one patient with an allergy to clopidogrel.

Carotid Angioplasty and Stenting Protocol
All carotid interventions were performed in the cardiac catheterization laboratory. All procedures were performed by a single interventional cardiologist. Frequent neurological examinations were performed during the procedures. Intravenous sedation was minimized. Antihypertensives were held the day of the procedure.
Anticoagulation was given during the procedure. Intravenous heparin was used in 37 cases (74%). The initial bolus dose of heparin was approximately 3,000 to 5,000 units (with necessary weight adjustments). Additional bolus doses of heparin were given to maintain an ACT near 300 seconds during the procedure. Bivalirudin was given in thirteen (26%) cases. Bivalirudin was administered utilizing standard doses for coronary interventional procedures.