CAROTID ARTERY DISEASE
(Impaired arterial blood flow to the brain)

CRL VASCULAR ASSOCIATES

Lewis V. Owens, M.D., Latham B. Murray, M.D.,
Anthony W. Spinelli, M.D., Pradeep Rajagopalan, M.D.

TABLE OF CONTENTS

Introduction
Smoking
High blood pressure
High cholesterol or triglycerides
Diabetes mellitus
Exercise
Drug therapy for patients with cerebrovascular arteriosclerosis

•Aspirin
•Ticlopidine
•Persantine
•Vitamin E
•Blood thinners - Coumadin
•Hormone replacement in postmenopausal women.

INTRODUCTION
You may have impaired arterial blood flow to the brain because of narrowed, ulcerated, or obstructed carotid arteries (which are the arteries that supply most of the blood flow to the brain). Because this carotid artery disease may cause a stroke that could lead to permanent disability or death, and, because you may need an arteriogram or an operation to reduce this risk of stroke, we have prepared this information at Martha Jefferson Hospital. We have also included other information you may find useful. This web page is not intended to scare you but rather to educate you about both the adverse as well as the good consequences of treatment options. If you have questions, please call our office and, if our office personnel are unable to answer you satisfactorily, we will be happy to call you back if you will leave us your number.

In over 95% of patients the arterial disease you have is caused by arteriosclerosis or hardening of the arteries. This arteriosclerosis has a number of causes. Chief among them are smoking, high blood pressure, high cholesterol and diabetes mellitus.

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SMOKING
Smoking is simply the worst thing you can do as far as arterial disease is concerned. It causes heart attacks, disease in the arteries to your legs and, in you if you are or have been a smoker, disease in the arteries to your brain. In addition, of course, smoking is well known to cause lung disease including cancer of the lung. If you are still smoking, please quit immediately as it will markedly help your lung function. If you are unable to quit ask your personal physician for advice about how to quit.

HIGH BLOOD PRESSURE
High blood pressure or hypertension (they are the same thing) accelerates the development of arteriosclerosis. If you have high blood pressure, it is important that this be controlled with diet and medication. You should have your blood pressure checked regularly by your physician (remember high blood pressure itself produces no symptoms so there is no way for you to know whether you have it except by getting it checked regularly, preferably by your personal physician since the blood pressure machines available in drug stores and the like are not highly reliable).

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HIGH CHOLESTEROL OR TRIGLYCERIDES
You should have your blood levels of cholesterol and triglycerides checked once a year by your personal physician (a blood test done after you have not eaten for 12 hours). Though no data exist to support the concept that a rigid low cholesterol diet helps someone with a normal blood cholesterol level (see # 3 under WHEN YOU GO HOME), strong data do exist that suggest that lowering the part of the cholesterol called the low density lipoprotein (LDL) to under 100 mg/dl can cause regression of arteriosclerosis (that is the arteriosclerotic plaques that are already present can become smaller). Since people with carotid artery disease have associated arteriosclerosis, you should employ every reasonable effort to reduce the progression of arteriosclerosis. This includes careful monitoring of your cholesterol and, if it is elevated, lowering it into the normal range.

If you have an elevated total cholesterol (one that is greater than 200 mg/dl) or an elevated LDL cholesterol (one that is greater than 130 mg/dl), it should be reduced to normal by diet or by diet combined with medication. You should see your physician about how to proceed. We believe strongly in patients with vascular disease making sure their cholesterol is in the normal range. Be sure to follow up on this with your personal physician and, if you have questions or doubts, discuss this with us.

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DIABETES MELLITUS
Diabetes mellitus is known to accelerate the development of arteriosclerosis. Careful monitoring and treatment of diabetes by your personal physician can slow the progression of arteriosclerosis as well as many of the other adverse consequences of diabetes.

EXERCISE
Exercise, primarily in the form of walking, is highly beneficial. If you develop chest, jaw, left shoulder, or left arm pain while exercising, you should immediately stop and consult your personal physician to see if this type of pain is caused by a heart problem.

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DRUG THERAPY FOR PATIENTS WITH CEREBROVASCULAR ARTERIOSCLEROSIS

ASPIRIN
Aspirin has been shown to provide a modest benefit in reducing the incidence of heart attack in men but not women. Aspirin has also shown a very slight beneficial effect in reducing stroke in men. Once again it has shown no benefit in women. The dose of aspirin used in these studies has been between two and four regular aspirin tablets (325mg each) per day. There are experimental data that suggest that lower dose aspirin may be equally effective, though there are no clinical studies to our knowledge that confirm this hypothesis. We recommend that men take one to four buffered aspirin tablets a day. If aspirin bothers them but they can take a baby aspirin (80mg), they probably should take that.

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TICLOPIDINE (TICLID)
Ticlopidine has been shown to be an effective drug in reducing stroke. Its primary effectiveness appears to be in those patients with stroke like symptoms but without tight narrowing of their carotid arteries. Because it has a number of side effects, some potentially dangerous, and because we primarily take care of those with tight narrowing of the carotid arteries (and because it is expensive as well), we rarely prescribe this drug. Nonetheless your primary care doctor or your neurologist may want you to take this and we would support this decision as long as you are carefully monitored for possible side effects.

PERSANTINE
This is a drug that has often been prescribed in the past. It is thought to act similar to the way aspirin does. Unfortunately, no vascular benefit has been demonstrated for this drug and we see little reason to take it.

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VITAMIN E
As those who believe vitamin supplements are beneficial already know, the medical profession is generally poorly informed about the effects and benefits of vitamins. This comes from two beliefs: 1. Americans already receive adequate vitamin intake (there are few cases of overt vitamin deficiency) and 2. Convincing scientific data showing benefit of vitamin supplementation are sparse - primarily because the studies necessary to prove effectiveness require many patients and much money. Nonetheless, there is increased interest in this subject. Much more solid information about vitamin therapy, especially as it relates to cancer and arteriosclerosis (which causes heart and vascular disease) should emerge over the next decade. Antioxidants, such as Vitamin C (water soluble), carotine, and Vitamin E (both fat soluble) have been postulated to inhibit the development of arteriosclerosis. At one point it seemed that Vitamin E was effective in reducing the incidence of arteriosclerosis in the arteries supplying blood flow to the heart (those responsible for heart attacks). Unfortunately, a careful article in the New England Journal of Medicine in late 1999 or early 2000 could find no persuasive evidence that this was so. As a consequence, we no longer recommend Vitamin E. Carotine has been effective in men who smoked but not in non-smokers or women, and Vitamin C was not found to be effective in women or men.

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COUMADIN
Blood thinners or, more precisely, anticoagulants, are sometimes used in patients with poor blood supply to the brain, though this is unusual. There aren't strong data to support the use of anticoagulants for this purpose; nonetheless, we will occasionally recommend the use of moderate anticoagulation in special circumstances. The drug used for this comes in a pill form and is called Coumadin. The blood test used to monitor effectiveness of the anticoagulation produced by Coumadin is the Prothrombin Time or Pro Time or PT (all the same test).

If you are taking Coumadin, you will need to assume the major responsibility for monitoring your prothrombin time (PT) to make sure that you stay in the appropriate range. Prothrombin times are reported in seconds and as an international normalized ratio (INR). The normal time for most people is 10 to 12 seconds. With Coumadin therapy we want to aim for an international normalized ratio (INR) of between 2 and 3. You'll need to get a prothrombin test done once a week for 3 or 4 weeks until we and you are sure that the dose you are taking is a correct dose. Dosages of Coumadin can range anywhere form 2.5 mg to 10 mg a day with a wide variation among people. Once your standard dose is established, you should maintain your dietary habits as well as take all of the medicines that your physician has prescribed for you. If you start other medicines or change your diet in any substantial way, you should again repeat your prothrombin time within a week or so because Coumadin can cross react with so many different substances that it's always safe to make sure you are not creeping up or creeping down. If you have an INR of 2-3 (the rate we aim for), there is about a 2% per year or less major complication rate of bleeding. Despite its relative safety, however, you should be aware that Coumadin itself is a formidable drug with potential serious consequences and one should not be on anticoagulation therapy cavalierly.

After the first 3 or 4 weeks of getting weekly prothrombin time checks you can switch to every 2 weeks for a couple of times and then every 3 - 4 weeks for the remainder of your time taking the Coumadin. We will assist you in arranging this service with your primary physician. You should not assume that, because you have not heard what your Protime results are that they are acceptable. Lots of communication errors can occur and we think it is always safest if you make sure that you have called your doctor's office two to three days after each blood test to confirm that your prothrombin time or INR is in the appropriate range. We will be happy to communicate with your physician regarding our thoughts about the appropriate range if that information is desired.

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HORMONE REPLACEMENT IN POSTMENOPAUSAL WOMEN
Estrogen replacement in postmenopausal women is associated with a lower incidence of osteoporosis, a lower incidence of coronary artery disease, a higher incidence of cancer of the uterus, and a slightly higher incidence of breast cancer (but there doesn't seem to be a higher incidence of breast cancer if the total time of taking hormones is less than five years) (See Footnotes1-4). The higher incidence of cancer of the uterus is negated by adding progestins in women who have not had their uterus removed (hysterectomy). Therefore, the trade-off seems to be to accept a slightly higher incidence of breast cancer in exchange for a lower incidence of osteoporosis (bone wasting) and heart disease if you take hormone replacement. Because (by the fact that you have come to specialists in vascular diseases) you probably have at least a moderate amount of arteriosclerosis, it may be to your advantage to try to gain the significant reduction in both heart disease and the incidence of osteoporosis by taking replacement therapy, even though we now know there is a slightly increased incidence of breast cancer with this approach. This subject, however, is not within our field of expertise and advice will be changing as newer studies of this important topic are published. We recommend, therefore, that you consult your gynecologist and follow his or her advice about replacement therapy.

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SUMMARY OF NON INVASIVE THERAPY FOR ARTERIOSCLEROSIS

WOMEN and MEN

1. No smoking
2. Control of hypertension if present
3. Control of diabetes if present
4. Control of elevated cholesterol if present
5. Daily exercise (primarily walking)
6. Coumadin if appropriate

Probably no need for Trental or Persantine.

• In addition for WOMEN: Hormone replacement therapy for those who are post menopausal (discuss this recommendation with your gynecologist). Aspirin one pill (325mg each) a day.
• In addition for MEN: Aspirin one to four pills (325mg each) a day

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CAROTID ARTERY DISEASE (See also Figure 1, Figure 2 & Figure 3)
In an effort to prevent strokes, approximately 100,000 patients have a clean out of a narrowed artery to the brain (called a carotid endarterectomy) in the U.S. each year. This operation, first done in 1954, is a relatively simple procedure. The two major arteries to the brain are called carotid arteries (from the Greek term karotides meaning "to sleep") and are located in the neck on each side of the windpipe (trachea) (See Figure 1). In most people who have a stroke, the arteriosclerotic lesion responsible for the stroke is located in one of the carotid arteries in the neck. Fortunately, the portion of the carotid artery that is most often diseased (point X or Y, Figure 2) is relatively accessible with an incision in the neck. The obstructive plaque material (depicted in Figure 3) usually is able to be removed from the artery with relative ease. This arteriosclerotic plaque material causes strokes in one of two ways: (1) it narrows the carotid artery to such an extent that much of the brain on the affected side has a markedly diminished blood supply, or (2) blood clots or debris form on the surface of this roughened arteriosclerotic plaque and then dislodge and occlude the small arteries of the brain. Either situation may result in the death of brain tissue (which is what a stroke is) caused by a lack of blood supply to that segment of brain.

If an internal carotid artery is completely blocked (occluded), it is not possible to perform an endarterectomy on that carotid artery, i.e., an operation will not be successful in opening up that artery.

Three groups of patients have been identified as being benefited by this carotid endarterectomy operation:

• Patients who have no symptoms (called "asymptomatic" in medical jargon) but who have a tight narrowing in one or both of their carotid arteries.
• Patients who have had symptoms of stroke (caused by "ischemia" which is loss of oxygen to brain tissue) for a short period but who have complete recovery within twenty-four hours. These patients are said to have experienced "Transient Ischemic Attacks" or "TIAs".
• Patients who have had a previous stroke, from which they have substantially improved, caused by a plaque in their carotid artery.

Patients with one of these three conditions have an increased risk of having a stroke. Ten to twenty percent of the asymptomatic patients (with a narrowing of 70% or more of the diameter of the carotid artery) and twenty to thirty percent of the TIA patients will have a stroke over a five year period; fifty percent of the strokes in TIA patients occur within one year of their first symptom. Of those who have had previous strokes caused by carotid plaques, one-third will develop a second stroke and two-thirds of these will be fatal. Looking at these statistics in simple terms, the rate of stroke (without warning signs) in the asymptomatic patients is two to four percent per year, in the TIA patients it is five to six percent per year, and slightly higher in the stroke patients. In other words, the more symptoms you have had, the worse the prognosis if untreated.

Unfortunately, currently there are no medicines that will dissolve or cause regression of these arteriosclerotic plaques. Drugs that retard the ability of blood to clot, such as aspirin or anticoagulants, have not been demonstrated to be of much benefit in reducing the incidence of subsequent stroke (aspirin in one not very good study showed a slight reduction in stroke incidence in men [not women] with TIA symptoms over a 26 month period). Carotid endarterectomy is effective in reducing the incidence of stroke to about one percent per year in patients in the asymptomatic and TIA groups; the rate is somewhat higher in those who have previously had a stroke.

Several scientific papers, newspaper articles, and TV segments have questioned the effectiveness of this operation in the past and the number of operations was termed excessive. This public debate, though disquieting to most vascular surgeons and many patients, was appropriate and healthy. Now that two randomized prospective studies looking at TIA and mild stroke patients (NASCET) and asymptomatic patients (ACAS) studies have been published (See footnotes 5-7) (see also the NASCET study and the ACAS study), the benefit of carotid endarterectomy (when performed by experienced surgeons with a good track record) is well established. Though we think carotid endarterectomy has been conclusively demonstrated to be of great value in reducing the incidence of stroke for a number of different indications, you should be aware of the arguments, pro and con, before agreeing to an operation.

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Argument against carotid endarterectomy
For those who are skeptical as to the efficacy of the carotid endarterectomy operation, their argument is as follows: 1. Accurate data about how many strokes are caused by arteriosclerotic carotid arteries are hard to obtain. 2. Some strokes are "inappropriate" to the location of the carotid artery lesion - that is the stroke occurs on the side of the brain opposite the diseased carotid. 3. There is great expense for the operation (hospitalization, surgeon's and anesthesiologist's fees total $10,000 or more). 4. There does not seem to be any documented prolongation of life. 5. The carotid endarterectomy procedure is a high risk procedure; thus, when the strokes caused by the procedure are added to the strokes observed each year after carotid endarterectomy, there is no overall reduction in stroke.

Argument in favor of carotid endarterectomy
For those who believe carotid endarterectomy has benefit, the countervailing arguments are offered: 1. There are now enough studies that indicate many strokes are caused by diseased carotid arteries. 2. The location within the brain of subsequent stroke has now been documented to almost always be on the side of the carotid artery narrowing. 3. Though there is indeed considerable expense associated with carotid endarterectomy, there are far greater rehabilitation costs in caring for patients with strokes. 4. Though there is no evident prolongation of life, the improvement of the quality of life of a patient who is prevented from having a stroke versus the quality of life of a patient with permanent disability from a stroke is a highly desirable goal. 5. The risks of carotid endarterectomy, when performed by appropriately trained and experienced surgeons as documented by the NASCET and ACAS studies, are low; these excellent results far outnumber the rare and atypical results giving high death and complication rates. For instance, the survey of surgeons participating in the asymptomatic carotid atherosclerosis study (ACAS) have reported an overall combined 30 day operative stroke rate and mortality of 2.2% in 5641 carotid endarterectomies performed for a variety of indications and 1.7% in 1,511 carotid endarterectomies performed for patients without symptoms (asymptomatic) but with greater than 70% narrowed carotid arteries.

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I. ANALYSIS OF PATIENTS WITHOUT SYMPTOMS (ASYMPTOMATIC)

Patients who have no neurological symptoms (transient blindness in one eye, limb weakness, or speech difficulty) and have simply come to be evaluated because a noise (bruit, pronounced "bruie") was heard in their neck are placed in this category. If, after non-invasive evaluation, they are found to have a narrowing of one of their carotid arteries of less than 60% diameter they simply need to return for non-invasive testing on a yearly basis (and immediately if they develop a focal neurologic defect such as transient blindness in one eye, one sided limb weakness, or speech difficulty).

We are still somewhat skeptical of operating on someone, particularly a woman, who has about a 60% narrowing of their internal carotid artery even though this was the cut-off point for the ACAS study. Each clinical situation is different and solid conclusions cannot necessarily be drawn from a single study, even if that study was carefully performed. We tend to believe that if non-invasive evaluation shows someone to have a narrowing of one of their carotid arteries of 70% diameter or more, they probably should then have another imaging study (digital subtraction arteriogram, MRA, or formal arteriogram) of their carotid arteries. If this other study confirms the non-invasive findings, they should consider having this narrowed area removed. We are comfortable in adhering to the recommendations drawn from the ACAS study and operate on a male with a 60% narrowing, particularly if he is fairly young and has a number of major risk factors (diabetes, history of smoking relatively frequently, high blood pressure, elevated cholesterol).

Risk without carotid endarterectomy
If one of the carotid arteries is narrowed 70% diameter or more and if no operation is performed, the risk of stroke without warning symptoms is 2%-4% each year or 10%-20% over five years. Of patients who developed a stroke during the observation of an asymptomatic lesion, more than 80% had no warning symptoms.

Risk with carotid endarterectomy
If a carotid endarterectomy is performed, the risk of death (usually heart attack) within 30 days is about 0.5% (1 in 200) and the risk of stroke within 30 days is about 0.5% (1 in 200) (30 days is used by convention in all medical reports so that we can be sure we are all talking about similar risks when we compare the risks of one treatment with those of another. Obviously, with this operation, if some adverse event occurs, it will almost always do so within the first 2-3 days after the operation). Starting thirty days after the operation, the yearly risk of stroke is about 1%. Thus the risk of ominous events (operative plus yearly stroke rates) in the next five years is 5-6%.

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Asymptomatic atherosclerosis study (ACAS STUDY)
On September 30, 1994 the National Institutes of Health (NIH) prematurely terminated a study of asymptomatic patients who had at least a 60% narrowing of one their carotid arteries because the results, showing a clear benefit for carotid endarterectomy, reached such significance that continuation of the study could not be justified.

One group of 834 patients was randomly chosen to receive best medical therapy and another 828 patients received best medical therapy plus carotid endarterectomy. The study found only 4.8% of the surgical group had strokes over a five year period; whereas 10.6% of the non-surgical group had a stroke over the same period. For men this was a 69% reduction in stroke incidence.

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SUMMARY OF RISK WITH AND WITHOUT CAROTID ENDARTERECTOMY (in those without symptoms and with a 60% or more narrowing of their carotid artery):

Without Operation: Cumulative five year risk of stroke is 10%-20%.
With Operation: Cumulative five year risk of death and stroke (caused by the operation plus subsequent yearly stroke rate) is 5%-6%.

Thus, if you are without symptoms and have a 60% or more narrowing of your carotid artery, over the next five years you have about a 15%-20% chance of stroke if you do not have a carotid endarterectomy and a 5% chance of stroke (plus a 0.5% [1 in 200] operative death rate) if you do have a carotid endarterectomy.

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II. ANALYSIS OF PATIENTS WITH SYMPTOMS BUT NO STROKE (TIAs)

Patients who have temporary neurological symptoms lasting less than 24 hours (called transient ischemic attacks or TIAs) such as transient blindness in one eye, limb weakness, or speech difficulty are placed in this category. If non-invasive evaluation shows they have a narrowing of one of their carotid arteries of 50% diameter or more, they should then have a digital subtraction arteriogram (DSA) of their carotid arteries. If this study confirms the non-invasive findings, they should consider having a cleanout of their narrowed artery (carotid endarterectomy).

Risk without carotid endarterectomy
If of one of the carotid arteries is narrowed 50% diameter or more and if no operation is performed, the risk of stroke without further warning symptoms is 12-13% the first year after the onset of symptoms and a cumulative risk of about 30%-35% at the end of five years.

Risk with carotid endarterectomy
If a carotid endarterectomy is performed, the risk of death (usually heart attack) within 30 days is about 1%-2% and the risk of stroke within 30 days is also 1%-2%. Thereafter the yearly risk of stroke is about 1%-2%. Thus the risk of ominous events (operative plus yearly stroke rates) over the next five years is 7%-9%.

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NASCET STUDY
In early 1991, the National Institute of Neurological Disorders and Stroke (a branch of the National Institutes of Health [NIH]) announced that the North American Symptomatic Carotid Endarterectomy Trial (NASCET) was being terminated at an interim stage for those symptomatic patients with a tight carotid artery narrowing (70% to 99%) because high statistical significance was found indicating that "carotid endarterectomy was beneficial in the prevention of any stroke of any severity in any territory." Moreover the study also showed that "the risk of any severe stroke or death from any cause was indeed reduced by carotid endarterectomy."

It is of value to look closely at the details of this report (N Engl J Med August 1991; 325:445-53): The design of the study was as follows: Patients with TIAs (or non-disabling strokes) and a 70%-99% carotid artery narrowing on the side appropriate to the symptoms were randomly divided into two groups. One group was given "optimal medical care, including antiplatelet treatment (usually aspirin) and, as indicated, antihypertensive, antilipid, and antidiabetic therapy" (331 patients) and the other group was given similar medical care plus a carotid endarterectomy (328 patients). The results showed that life table estimates of the cumulative risk of a stroke within two years on the side of the tight narrowing was 26% for the patients treated with drugs alone and 9% for the patients operated upon. If only major strokes or death were considered, the two year risk was 13.1% for the non operative group and 2.5% for the operative group. Two other major findings were noted. The first was that there was no evidence that the advantage to the surgical group decreased over 30 months. Indeed, those operated upon continued to have an increasing advantage over those not operated upon (confirming the impression gleaned from retrospective studies previously conducted). The second was the confirmation of the impression that the tighter the lesion, the worse the prognosis if not operated upon. The patients that were not operated upon and had a 90 to 99% narrowing did worse than those with a 80 to 89% narrowing who, in turn, did worse than those with a 70 to 79% narrowing.

In brief, this study conclusively established that patients with TIAs or and a 70%-99% carotid artery narrowing are clearly benefited by carotid endarterectomy. Those patients with TIAs and a less than 70% carotid artery narrowing are still being studied. Our prediction, based on numerous retrospective studies, is that patients with TIAs and 50%-69% narrowing will also be shown to be benefited by carotid endarterectomy.

Note that the NASCET study reports less optimistic results than the risk of stroke percentages we are quoting, both for the patients operated upon as well as for the patients not operated upon. This, in our view, is because the NASCET study included some patients who had previously had a stroke, thus increasing their risk for another stroke whether or not they were operated upon. This doesn't change the strong impression that carotid endarterectomy, when performed for appropriate indications, is an effective operation. If anything, the NASCET results support carotid endarterectomy even more strongly than do the stroke rates we've cited from the retrospective studies.

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SUMMARY OF RISK WITH AND WITHOUT CAROTID ENDARTERECTOMY (in those with transient symptoms (TIAs) and with a 50% or more narrowing of their carotid artery):

Without Operation: Cumulative five year risk of major stroke is 20%-30%.
With Operation: Cumulative five year risk of death and stroke (caused by the operation plus subsequent yearly stroke rate) is 7%-8%.

Thus, if you have had transient symptoms and have a 50% or more narrowing of your carotid artery, over the next five years you have about a 20%-30% chance of a major stroke if you do not have a carotid endarterectomy and a 6%-7% chance of stroke (plus a 1%-2% operative death rate) if you do have a carotid endarterectomy.

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III. ANALYSIS OF PATIENTS WHO HAVE HAD A STROKE (CVA)

Patients who have had a permanent neurological defect (CerebroVascular Accident or CVA) (blindness in one eye, limb weakness, or speech difficulty) are placed in this category. If, after non-invasive evaluation, they are found to have a narrowing of one of their carotid arteries of less than 50% diameter they should probably take aspirin daily and return for non-invasive testing on a yearly basis (and immediately if they develop more focal neurologic defects such as transient blindness in one eye, increased one sided limb weakness, or speech difficulty).

If non-invasive evaluation shows they have a narrowing of one of their carotid arteries of 50% diameter or more, they should then have a digital subtraction arteriogram (DSA) of their carotid arteries. If this study confirms the non-invasive findings, they should consider having a cleanout of their narrowed artery (carotid endarterectomy).

Risk without carotid endarterectomy
If of one of the carotid arteries is narrowed 50% diameter or more and if no operation is performed, the risk of another stroke without warning symptoms is about 5%-9% each year or 25%-45% over five years.

Risk with carotid endarterectomy
If a carotid endarterectomy is performed, the risk of death (usually heart attack) within 30 days is about 3% and the risk of stroke within 30 days is also about 3%. Thereafter the yearly risk of stroke is about 2%-3%. Thus the risk of ominous events (operative plus yearly stroke rates) over the next five years is about 16%.

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NASCET STUDY
This study also applies to patients who have had nondisabling strokes. (See NASCET study)

SUMMARY OF RISK WITH AND WITHOUT CAROTID ENDARTERECTOMY (in patients with a previous stroke and with a 50% or more narrowing of their carotid artery):

Without operation: Cumulative five year risk of stroke is 35%-40%.
With operation: Cumulative five year risk of death and stroke (caused by the operation plus subsequent yearly stroke rate) is about 16%.

Thus, if you have had a stroke and have a 50% or more narrowing of your carotid artery, over the next five years you have about a 35%-40% chance of stroke if you do not have a carotid endarterectomy and a 11% chance of stroke (plus a 4% operative death rate) if you do have a carotid endarterectomy.

Candidly, this is the group of patients that some neurologists tend to want operated upon since they see the consequences of the stroke. We, on the other hand, believe this is the group we help the least. These patients have already had a stroke (the operation will not help the stroke that has already occurred - that stroke is permanent and, though the patient's symptoms may improve, an operation will not help or hasten this improvement). The carotid endarterectomy operation helps prevent strokes but only has modest benefits in patients who have already had a stroke. If the patient who has had a stroke has marked impairment of their neurological function or has other fairly severe medical problems such as heart or lung disease, we would recommend that serious consideration be given to not having a carotid endarterectomy.

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NON-INVASIVE LABORATORY EVALUATION STUDIES

Patients may be found to have noises in the neck caused by blood flow turbulence within the artery. This turbulence is caused by narrowed arteries (called stenoses) and the noise that is detected by the stethoscope is called a bruit (pronounced "bruie"). Some people may also have transient ischemic attacks (TIAs) characterized by a brief focal neurologic deficit such as loss of the use of an arm or loss of vision in one eye. These attacks usually last for less than a half hour and, by definition, last less than 24 hours. Finally, some people have previously had strokes. Patients falling into any of these categories would appropriately qualify for these tests.

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DUPLEX SCAN
This painless test combines the use of color imaging with a Doppler sound wave analysis of the moving blood within the carotid arteries. It non-invasively images the blood vessels of the neck and generally will accurately detect the extent of narrowing, if any, within the carotid arteries of the neck. It is a highly reliable test and of great value in assessing the status of the neck arteries (see next paragraph). It is safe as there are no needles and no radiation is used.

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ARTERIOGRAM or MRA
If an operation is contemplated you may need to have an imaging study aside from the duplex scan. This is because the accuracy of duplex scans are dependant on the quality of the scanner and the skill of the technician. The three registered vascular technicians (RVT's) who performs our studies, are exceptionally skilled and accurate. The decision of which additional study to perform or even whether an additional study is necessary varies with the clinical situation and also with the individual surgeon. This decision will be made at the time of your evaluation.

The choices for this other imaging study are either magnetic resonance angiography (MRA) or arteriography using iodinated contrast (you get an arteriogram, an angiogram or an aortogram - they are all more or less interchangable terms) in order to localize precisely the location and extent of the arteriosclerosis you have.

The advantages of an MRA is that it is cheaper and safer (no risks that we know of - check with the radiologist). The disadvantages are that it is less accurate in that it tends to overestimate the degree of narrowing and it does not give as good a view of the blood vessels above the neck level. We will order a MRA if we are convinced that you have a tight narrowing and an overreading of the amount of narrowing will not alter the decision to operate (for instance if you had two episodes of profound left arm paralysis lasting 30 minutes each and our duplex study indicated you had a greater than 80% narrowing - unless the MRA indicated you had a less than 50% narrowing we would advise operation; indeed, if the MRA showed less than 50% narrowing, we would want a formal arteriogram to try to resolve the discrepancy between the two studies).

The other option is to obtain an arteriogram. This is a study in which the radiologist will inject contrast material (a clear fluid that shows up on an x-ray as white) into your aorta or carotid arteries. X-ray pictures will then be taken of your neck and head at the time of the injection. The catheter (or tube delivering the contrast material) is usually inserted through the groin artery, though occasionally it will be inserted in the arm. There is some mild discomfort but the radiologist will numb the skin by injection with a local anesthetic before inserting the catheter. At the time of the injection of the contrast material you may feel a very warm or even hot burning sensation. It clears completely after 10 to 20 seconds. You should have few other symptoms associated with the injection. The catheter is then removed and pressure is applied to the area where you were stuck so as to get the hole to seal. The entire arteriogram usually takes about an hour.

This is a study that is done as an outpatient procedure in a hospital (you will not need to stay in the hospital overnight). Before the arteriogram you will be asked not to eat any solids for 5-8 hours. You should continue to drink fluids, especially water. You can urinate as often as you like but you should have drunk plenty of fluid. This increases the amount of fluid your kidneys filter and reduces any potential kidney damage that might be caused by the arteriogram. Once the radiologist is satisfied that it is safe for you to leave (4-6 hours after the arteriogram) you may go home. If we have not been able to discuss the findings of the arteriogram that day, please call us the next day and we will tell you what was found (if you are interested, ask the interventional radiologists, Dr. Spinelli or Dr. Rajagopalan to show you the X-rays and tell you what they show).

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RISKS OF THE ARTERIOGRAM
The major risk is an allergic reaction to the contrast agent used (risk of arteriogram, not of MRA). These agents almost all have iodine in them so, if you have had a previous reaction to an injection of contrast (for an IVP for instance) or you know you are allergic to iodine, you should let the radiologist know. Other risks include giving you a stroke or damaging the kidneys with the contrast (this is minimized by drinking large quantities of water prior to the arteriogram) and damage to the artery where the catheter is inserted. If necessary, damage to the artery can usually be fixed by a small groin operation. After the arteriogram you may find that you have swelling or a hard lump in the groin. This is from a small amount of blood that almost invariably leaks out around the catheter during the procedure or out the small hole in the artery immediately after the catheter is removed. This may cause bruising and mild discomfort for a few days but will usually improve without problems. The lump may persist for 1-3 months as it takes time for the blood to be broken down and reabsorbed. This clot, however, is not risky - it is not within a blood vessel so it can't break off and go to your leg or heart. In general, arteriograms are safe and have a major complication rate of 1% or less.

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CAROTID ENDARTERECTOMY
You will be admitted the morning of the operation. You will usually be able to go home on the second postoperative day (counting the day after the operation as the first postoperative day).

ANESTHESIA
You will have an anesthesiologist in charge of your anesthesia. He or she will see you before the operation and review with you the risks and approaches that will be employed when you have your anesthesia. Anesthesia is an important aspect of your care and you should be sure to ask the anesthesiologist any questions you may have.

For a carotid endarterectomy operation, the anesthesiologist may choose a general anesthetic which will consist of putting you to sleep through an IV injection and then keeping you asleep with gasses delivered through a tube in your windpipe (that is put in after you are asleep). Or the anesthesiologist may choose to give you a regional anesthetic whereby you will have the area of the operation numbed but you will remain awake, though sedated.

The anesthesiologists we use at Martha Jefferson Hospital are excellent. The risks of anesthesia are small, but nonetheless should not be dismissed. One of the great advances in anesthesia over the last 20 years has been the development of an oxygen saturation monitor. This is a device that is put on a finger during the operation in order to monitor the oxygenation of your blood. This works by shining a light through your finger and detecting color changes if you are not being adequately oxygenated. Alarms go off if your oxygen saturation drops slightly. This gives the anesthesiologist lots of time to make the necessary adjustments and tends to reduce the anesthetic complications due to anesthetic error down to an extremely small number.

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OPERATION
A carotid endarterectomy is a cleanout of the arteriosclerotic plaque in your carotid artery. Though it is a big operation the results are, in general, excellent. These cleanouts tend to stay open for a long time and prevention of stroke and relief of transient ischemic attacks is usually quite good (see statistics cited above).

After you have been put to sleep a tube (Foley catheter) may be inserted into your bladder through your urethra (the tube you urinate through). This will be left in place for a day or so after the operation to allow us to measure the amount of urine you produce (a good measure of kidney function and adequate fluid balance).

You may also wake up with a tube in your windpipe that allows the ventilator to breathe for you. This will prevent you from speaking and may cause you some anxiety (you can communicate by writing - the nurses will provide you with a writing pad). The best approach is to relax as much as possible and we will remove the tube as soon as breathing and blood tests indicate you can get an adequate amount of oxygen when you are breathing without ventilator assistance. In most instances, however, we will not insert a Foley catheter in your bladder nor will you wake up with the tube still in your windpipe.

The operation consists of an incision in your neck, opening up your carotid artery, and putting in a temporary shunt to maintain blood flow to the brain during the cleanout. The plaque is almost localized to the middle portion of the neck where the carotid artery divides into the portion that goes to your brain and the portion that goes to your face (see Figure 3). The plaque itself is easily removed from the inside of the artery. If there is a rough edge on the side of the artery going to the brain, it is carefully tacked down to try to prevent any postoperative obstruction of the artery. Additionally, we may feel it would be best we will sew in a patch of synthetic material to make your artery slightly bigger in this area. After the plaque is removed we will sew up the artery, removing the shunt just before we finish. We will oftern leave a small drain in your neck area overnight.

After the operation you will go to the recovery room for a couple of hours and then you will be sent to the intensive care unit (ICU) for 12-24 hours to make sure your blood pressure is stable and that you are all right. After that you will be moved to a regular hospital bed for 24-48 hours and then you will be able to go home. This operation is not particularly painful and the incisions will only hurt moderately. This pain steadily lessens over the next day or two so that by the time you leave the hospital you will be able to control it easily with pain pills. At first, though, you may need narcotic injections and we will order these for you - all you will need to do is ask the nurse for a pain shot. If you aren't getting them frequently enough or getting adequate relief, let us know and we will increase the frequency or amount. You will not become addicted; we are not concerned about it nor should you be.

Normally all of us sigh or take an extra large breath several times a minute. This sighing expands our lungs and prevents tiny areas of collapse called "atelectasis". After your operation you should concentrate on taking deep breaths as often as you can think of it. If you do this fairly frequently, it will improve your lung function.

We will encourage you to get out of bed and start walking quite early. You will find that it will hasten your recovery and also lessen the likelihood you will develop clots in the veins of your legs. Also, again to reduce the likelihood of clots in the leg veins, you should move your feet and contract the muscles of your calves starting when you wakeup. When you first start to walk be sure to have the nurses help you - you won't be as strong as you think and you certainly don't want to fall and break a bone.

One effect of the operation will almost always be that you will have some numbness of your neck and ear after the operation. The extent and degree varies from patient to patient depending on the anatomy of their nerve supply to the skin. This numbness will inevitably improve but, again, the degree to which it improves will vary from patient to patient. You will always be left with some difference in your ability to perceive touch on one side as opposed to the other non operated side. Few patients, however, find this numbness a problem.

In summary, the things you need to remember to do starting as soon as you wake up from the operation are:

• Breathe deeply fairly frequently.
• Move your feet and calves frequently. Try to push yourself to be more and more active as this will prevent vein clots.

This recovery period passes relatively quickly and, though you certainly wouldn't want to volunteer for this kind of operation on a frequent basis, it is likely you will find that the anticipation will turn out to have been much worse than the actual event. If you have problems, the nurses and we will help as soon and as effectively as we can.

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COMPLICATIONS OF CAROTID ENDARTERECTOMY
The major risk associated with entering a hospital or having any procedure performed is death; this unassailable fact must always be kept in mind. The major risks of carotid endarterectomy (the operation described in this handout) are death, stroke, heart attack, bleeding, infection, nerve damage so that your tongue deviates to the side or you are permanently hoarse, and clots forming in the legs and possibly going to the lungs.

Death is usually caused by a heart attack in the postoperative period but can be caused by many other factors as well. The risk of death or stroke within 30 days of the operation is summarized above. Bleeding, blood transfusion complications, and infection are unusual after this operation but all can and, on occasion, do occur. Nerves to your tongue or vocal cords can be damaged. Clots can form in the legs and cause leg problems later or can break off, go to your lungs, and interfere with your ability to breathe. You will almost certainly be left with some numbness of your neck and ear. Much of this will improve over 6-12 months, but some may be permanent as there are sensory nerves that cross the line of the incision and often must be divided in order to provide adequate exposure of the diseased carotid artery. This is a short but by no means comprehensive review of some of the complications that can occur. Fortunately complications (other than some neck and ear numbness) occur infrequently and we will do our best to minimize the incidence. If you have any questions or want a more detailed explanation of any of these complications, please make sure you discuss it with us before you enter the hospital. We will certainly try to avoid or minimize the likelihood of operative complications. Nonetheless this operation is not now, and never will be, risk free. You should feel very comfortable with your understanding - not only of the benefits, but also of the risks.

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BLOOD
You may need blood during or after your operation though this is extremely rare. We will try to lose as little as possible; additionally, the risk of transmitting hepatitis or AIDS virus is exceedingly small as our blood supply is carefully checked and monitored.

ALTERNATIVE PROCEDURES
Some physicians have been using stents inserted through the groin to try to open up narrowed areas in the carotid artery. Though the stents being using are approved by the FDA for use in other areas, they have not been approved for use in the carotid artery. Moreover, in the hands of experienced radiologists who do arteriography every day, the stroke rate of simple arteriography of the carotid arteries is about 1% (ACAS study). Passing a wire through a narrowed and often friable diseased carotid artery and then passing a catheter with an attached stent over this wire and through the diseased portion of the artery is highly likely to cause a significant incidence of strokes from the plaque material that is either brushed loose when the catheter is moved into position or broken loose when the artery is dilated as part of expanding the stent. Finally, no one knows the longer term consequences of stent placement. What is the incidence of recurrent disease? If you get a recurrence, will you need a more extensive operation later because the stent will prevent the relatively simple operation we now do? (The answer to the latter question is almost certainly yes).

Placing a stent in the carotid artery may turn out to be as safe as carotid endarterectomy (it needs to have less than a 3% major complication rate) but we believe that, until carefully performed studies are conducted to confirm that, as yet unconfirmed, hypothesis, the apparent risks of stent placement far outweigh the benefit of avoiding what is a proven effective operation that has low risks and only modest discomfort. We urge great caution before you agree to have a stent placed in your carotid artery (we refer numerous patients to radiologists for placement of stents in the arteries of the pelvis so it isn't that we are opposed to this technology, its just that we do not believe, based on data to date, that placement of a stent in a carotid artery is nearly as safe or has as good long term prognosis as does carotid endarterectomy).

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WHEN YOU GO HOME:

1. You should resume all the medications you were taking before the operation unless your personal physician has changed them.
2. You should not drive until you are completely confident of your stamina and your ability to turn your head rapidly or to put the brakes on suddenly should an emergency arise. This usually takes 2-3 weeks.
3. You can resume your normal diet. You might want to use this opportunity to reduce the fats in your diet. More fish, poultry, vegetables and unsaturated fats; less butter, cheese, pork, eggs, cream etc. A prudent diet is best. A rigid low fat diet, though probably somewhat beneficial, is difficult to comply with, probably doesn't make a great deal of difference unless started earlier in life, and isn't worth the inevitable marital discord, "Now, remember Honey, the doctor said you shouldn't have that scrambled egg". "GRRR". [Back]
4. You should not smoke again. Not even a little. Not at all. If you cannot comply with this, ask your doctor for his or her suggestions or we will refer you to someone who will try to help you.
5. You may drink alcohol in moderation.
6. You may take baths or showers and get your incisions wet - you don't need to wear bandages over your incisions.
7. You should walk daily and slowly increase the distance each day.
8. You should see your personal physician within two weeks after you leave the hospital. Bring all your medicines to him or her so they can be checked to make sure you are taking the medicines the way your personal physician wants you to.
9. Return to our office within a week of your operation so that we can take your skin sutures or staples out.
10. You may resume sexual relations when you feel strong enough. Be aware, however, you may find your desires and abilities diminished for some time.
11. You should get a non-invasive evaluation of your carotid vessels in our peripheral vascular lab in about 4-8 weeks in order to have a postoperative baseline study for the future. Because arteriosclerosis is a progressive disease, you should then return to us at least once a year for repeat non-invasive testing to make sure the side the carotid artery repair was done on does not start to close and also to monitor your other carotid artery to make sure this doesn't become tightly narrowed.

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A WARNING
This operation is a big one. Patients are understandably focused on two aspects: "Will I die and will I have a major complication"? After the operation when they realize they are doing well, they are obviously pleased and become reasonably happy when they see substantial improvement each day after the operation. After about three weeks, however, they stop noticing daily improvement and observe that they are still weak, fatigue easily, and require daily naps. Frequently, patients then become depressed and irritable - not so nice to be around. This depression will last 3-6 weeks but improves when the patient realizes that he or she is still improving week to week. Recovery from the operation to the point you can get about is relatively quick but complete recovery to the point where you feel as well or perhaps even better than you did before the operation may take 3-6 months. Be patient and continue to try to walk further each day.

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BEFORE YOU ARE ADMITTED TO THE HOSPITAL
You should call or see your personal physician. We would like him or her to thoroughly evaluate you to make sure you are in optimal condition to have an operation. Ideally, we would like you to have a complete physical examination and blood tests.

In addition, if appropriate, we would like your physician to send you to a cardiologist to make sure your heart is in reasonable shape. The cardiologist will check your blood pressure, perform an EKG, and perhaps do other tests to detect unsuspected heart disease (arteriosclerosis is a systemic disease and, in addition to causing problems in your carotid artery in your neck, it can also cause problems in the arteries supplying your heart). Though you may view this additional testing as inconvenient or unnecessary, in the unlikely event you have a problem postoperatively, it is reassuring to know that both your personal physician and a cardiologist have recently examined you and are quite familiar with your overall condition.

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BILLING
Our charges for the operation include the admission evaluation, the operation, the in hospital postoperative care, and the postoperative visits over the 2-3 months after the operation. You should check with our office personnel for the amount you will be charged and the extent to which your insurance will cover it. You will also receive other related bills - the hospital, radiologists and anesthesiologists all will have separate bills. Be sure to check with our office regarding any questions you have about what your financial obligation is.

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REFERENCES
1. Belchetz, PE. Hormonal treatment of postmenopausal women. N Engl J Med, 1994; 330:1062-71.
2. Golditz, GA et.al. The use of estrogens and progestrins and the risk of breast cancer in postmenopausal women. N Engl J Med, June 15, 1995; 332:1589-93.
3. Martin KA et al. Postmenopausal hormone-replacement therapy. (Editorial) N Engl J Med, April 15, 1993; 328:1115-1117.
4. Davidson NE. Hormone-replacement therapy - breast vs. heart vs. bone. (Editorial). N Engl J Med, June 15, 1995; 332:1638-9. 1. Stroke Vol 22, June 1991
5. Stroke Vol 22, June 1991
6. N Engl J Med Vol 325, August 1991
7. JAMA Vol 273, May 10, 1995

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