Neurological Outcome With Carotid Artery Stenting

We hypothesize that the incidence of subtle neuropsychometric injury will be significantly
greater than the incidence of stroke comparable to what we found in patients having carotid
endarterectomy. Patients will be evaluated prospectively to determine the incidence of
neurological morbidity based on both the neurologic/neuropsychometric examinations

The results of this study will serve to (a) determine incidence of
neurologic/neuropsychometric morbidity for patients undergoing carotid artery angioplasty
and/or stenting at ColumbiaPresbyterian Medical Center, (b) ascertain the time course of
these changes, (c) identify intraprocedural markers for these changes, and (d) design
protocols to evaluate the efficacy of therapeutic interventions.

Cerebral injury will be determined three ways.

First, all patients will be evaluated using a battery of neuropsychometric tests before and
after the procedure. Persons presenting to the hospital on the day of the procedure,
referred to hereafter as "Same Day", will be evaluated on the day of the procedure, one day
after and at the 1 month follow up.

Preoperative neurological and neuropsychological evaluation will be performed. The
neuropsychometric tests are designed to demonstrate general neuropsychological pathology.
These tests can be divided into four types: (1) an evaluation of language, (2) an evaluation
of speed of mental processing, (3) an evaluation of ability to learn using a list of words,
and (4) an evaluation of visual perception requiring a patient to copy a complex figure.
Before the battery is administered we will assess each patient's level of pain while sitting
and standing using a 10 point Visual Analog Scale and then gauge their mood with a series
called the Wong/Baker Faces Rating scale.

We will also evaluate each patient's quality of life using two well-known examinations
(Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and
Prevention HealthRelated Quality-of-Life 14Item Measure (CDC HRQOL14)) and a series of
questions investigating how well patients are able to perform activities of daily living
(ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two
time points, once before the surgery and then one month after surgery. We will look for
changes in quality of life that may correlate with neuropsychometric test performance.

Serum levels of neuron specific enolase (NSE) and protein S100B, a neuronal enzyme and glial
cell component respectively, markers of cell injury will demonstrate cerebral injury. Serum
levels of TNFá (Tumor Necrosis Factor Alpha) and IL8 (Interleukin 8) will be used to
evaluate the presence and degree of systemic inflammatory response.

DNA genotyping will be performed either by isolating leukocytes from blood and/or by
obtaining a buccal swab sample. Normally blood is sampled via the femoral arterial catheter
for assessment of hematocrit, and blood gas analysis.

Patients will undergo an intraprocedural transcranial Doppler ultrasonograph (TCD). TCD
monitoring probes will be placed on the patient's head with a standard head frame after
sedation, one probe on each side to measure the cerebral blood flow (CBF) velocity and
determine the presence of emboli in the middle cerebral artery (MCA) on either side of the
brain (Spencer Technologies, Seattle, WA). We hypothesize that there may be a relationship
between emboli and subtle cognitive decline as ascertained by the battery of
neuropsychometric exams. An electroencephalogram (EEG) will be applied to monitor for
significant hemispheric cerebral ischemia which may occur when the balloon is inflated and
occludes the artery. We routinely use EEG monitoring during carotid endarterectomy and its
use exposes the patient to no risk.

Inclusion Criteria:

- ability to speak English

Exclusion Criteria:

- history of permanent neurological impairment

- Axis I psychiatric diagnosis or drug abuse