CONSENT INFORMATION PATIENT COPY CAROTID STENTING PLEASE READ THIS SHEET BEFORE YOU CONSENT FOR YOUR

R SURGERY
This information sheet provides general information to a person having a Carotid Stenting. It does not provide advice to the individual. It is important that the content is discussed between the patient and the concerned doctors who understand the level of fitness and medical condition. What are the carotid arteries? Cholesterol, calcium, and fibrous tissue make up the plaque. As more plaque builds up, your arteries can narrow and stiffen. Eventually, enough plaque may build up to reduce blood flow through your arteries, or cause blood clots or pieces of the plaque to break away and block the arteries in the brain beyond the plaque. When plaque builds up and causes significant narrowing of the vessel, you have carotid artery disease. There are two carotid arteries (one on each side of the neck) that supply blood to the brain. You can feel your carotid arteries by feeling the pulse on your lower neck, on either side of your windpipe. The carotid arteries supply the large, front part of the brain, where thinking, speech, personality and sensory and motor functions reside. What is carotid artery disease? Hardening of the arteries, also known as What is the role of carotid artery in stroke? Stroke is third most common cause of death and disability. According to WHO Survey in 1990, out of 9.4 million deaths in India 6, 19,000 were due to stroke. Most of the strokes (approximately 75%) are ischemic (due to reduced blood supply) in nature and large vessel disease accounts for approximately 40% of ischemic strokes. It has
MSSH/Physician/Consent Carotid Stenting/Ver.1/Oct.2007

This is a serious issue because clots can form on the plaque and block the blood flow to your brain. If a clot or plaque blocks the blood flow to your brain, it can cause a stroke, which can cause brain damage or death.

atherosclerosis, can cause the build up of plaque. In hardening of the arteries, plaque builds up in the walls of your arteries as you age.
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been estimated that approximately 20-30% of strokes may be caused by stenosis of carotid artery. What are the various means to diagnose carotid artery stenosis? Carotid Doppler Doppler is a noninvasive investigations which is quite accurate in assessment of carotid stenosis. Advantages of Doppler include availability, low cost and repeatability. However

injection of contrast and one should be careful about renal function in this group of patients which commonly have diabetes and hypertension. MRA can be performed with or without contrast injection. New techniques with contrast enhancement have enabled acquisition of good quality images of whole of the cerebral arterial tree including the arch in a short while. What are the treatment options in carotid artery stenosis? Medical treatment- All patients with significant carotid stenosis should be treated medically for any of the risk factors for atherosclerosis such as hypertension, diabetes mellitus, and dyslipidemia. They should also be told to stop smoking. Antiplatelet drugs are useful to prevent embolic events. Usually dispirin (150mg-325mg) is prescribed to these patients. Patient with recurrent symptoms can be given additional anti-platelet agent such as clopidogrel (75mg once a day). Patients surgical with marked stenosis or require

Doppler is operator dependent and in certain situations such as high carotid bifurcation, may not be accurate. Catheter angiography/ Digital subtraction angiography (DSA) is the Gold standard for diagnosis of carotid stenosis. DSA is most accurate in determining degree of stenosis. DSA also helps in assessing complete arterial tree as well in assessment of cerebral blood flow and intracranial thermodynamics. However, it is an invasive investigation and it is usually reserved to evaluate stenosis detected in non-invasive investigations as well when the non-invasive investigations are no-conclusive. MR angiography (MRA)/ CT angiography (CTA) - recent advances in technology has now enabled excellent quality imaging of carotid artery by this relatively non-invasive method. CTA is always performed with
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revascularization which can be achieved by (endarterectomy) endovascular (angioplasty & stenting) means. Carotid endarterectomy- is the surgical removal of the plaque. This surgery is usually performed general anesthesia. Through an incision in the

MSSH/Physician/Consent Carotid Stenting/Ver.1/Oct.2007

neck the plaque causing the stenosis is removed surgically. Carotid angioplasty & stenting- this procedure is performed percutaneously under local anesthesia. Usually it is performed through the femoral artery. Under radiological guidance, a carotid stent is placed across the stenosis. Balloon angioplasty is also performed before and/or after stent placement if needed. What are the indications for carotid

When should we treat carotid artery stenosis? For patients with severe stenosis and a recent transient ischemic attack or non-disabling stroke, stenting should be performed without delay, preferably within 2 weeks of the patient's last symptomatic event. If a large size infarct has occurred, then it is ideal to wait for 4-6 weeks before the revascularization. How do I prepare for the procedure? Your physician may give you specific instructions to follow before the procedure, such as fasting. You should always inform your physician about any medications that you are taking. In most cases, your physician will instruct you take

revascularization (stenting/ endarterectomy)? Symptomatic carotid stenosis Carotid stenosis more than 70%- should be revascularized Carotid stenosis is (50%69%)for Revascularization recommended

aspirin

and

prescription

medication

that

prevents clots for 3 to 5 days before the procedure. Your physician may also order a duplex ultrasound, a computed tomography (CT) scan, an angiogram, or magnetic resonance imaging (MRI) to evaluate the degree of blockage in your carotid artery. What happens during the procedure? Before the procedure begins, your physician will connect you to a monitor that shows your heart rate and blood pressure. While some physicians may perform the procedure under general anesthesia, in most instances, the procedure is performed while you are awake and alert.

patients who have had recent transient ischemic attack or stroke depending upon patient-specific initial symptoms Carotid stenosis less than 50%- No benefit of surgery is demonstrated in these patients Asymptomatic carotid stenosis- Treatment of asymptomatic carotid stenosis is more controversial. The guidelines indicate that patients benefit from treatment if the operator has a low complication rate
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factors

such

as

age,

gender, co morbidities, and severity of

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Your physician will give you medications such as heparin to prevent clots, atropine to reduce the chances of your heart slowing down, and a local anesthetic to numb the catheter insertion area. Your physician then locates the narrow areas in your arteries by injecting a dye into your arteries and taking live X rays. The dye does not allow x rays to pass through, so physicians can see your arteries and use the live x rays to guide them to the blockage. Before inserting the stent, your physician will usually perform angioplasty. In angioplasty, your physician inserts a long, thin tube called a catheter with an attached balloon into a small incision or puncture over an artery in your arm or groin. Your physician guides the catheter to the blockage site in your carotid artery using live X ray imaging. You will not feel the catheters as they move through your arteries because there are no nerve endings inside your arteries. At this point in the procedure, your physician may insert a small balloon, basket, or filter called an embolic protection device. This device helps to prevent strokes by catching the clots or debris that may break away from the plaque during the procedure. At the blockage site, your physician inflates and deflates the angioplasty balloon to flatten the plaque and widen the space where the blood flows through. After the artery is open, your physician
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then removes the catheter with the balloon attached. Using a different catheter, your physician guides a compressed stent to the same area in your carotid artery. Once the stent is in place, your physician releases it. The stent then expands to fit the artery. Your physician then removes the stentcarrying catheter and any embolic protection devices. Stents remain permanently in your carotid artery. Because stents are made of stainless steel or metal alloys, they resist rust. How long does the operation take? Carotid stenting usually takes about 30 min. to 1hour but may take longer in some circumstances. What can I expect after the procedure? Immediately after the procedure, your physician applies pressure to the catheter insertion site in the groin or arm for 15 to 30 minutes to allow it to close and prevent bleeding. Sometimes to close the incision, your physician may use, instead, a cork-like closure device or stitches that dissolve. If your physician inserts the catheters and other instruments through your femoral artery, your physician may instruct you to stay in bed for the next several hours so that he or she can watch for any complications, such as bleeding from the puncture site.

MSSH/Physician/Consent Carotid Stenting/Ver.1/Oct.2007

Your physician may instruct you not to lift anything more than about 5 to 10 pounds, after you return home, to avoid any pressure on the incision. Your physician may also instruct you not to take a bath for a few days (but showers are fine), and to drink plenty of water to help flush the dye out of your system. You will be advised to take blood thinning medications and also be scheduled for periodic follow-up examinations, usually including carotid ultrasound examinations, to monitor the function of your stent over time. What is a protection device and what is its role in carotid stenting? Filter protection devices are umbrellashaped devices that are placed temporarily in the internal carotid artery beyond the site of stenosis during the procedure. These devices have small pores designed to exclude particulate debris embolization to cranial circulation during the procedure. Use of distal protection has become routine despite lack of randomized controlled data supporting its benefit. Case series of stenting with and without distal protection demonstrate slightly lower rates of neurologic complications period when in the distal postprocedural

Expectations: For most people, the carotid angioplasty and stenting procedure increases blood flow to the brain and decreases the risk of a stroke. Although the carotid stenting procedure opens up a blocked carotid artery, it does not cure carotid artery disease. You will still need to focus on reducing your risk factors and making certain lifestyle changes to prevent future disease development or progression. What can I do to stay healthy? To prevent changes: o o o o o Eat more foods low in saturated fat, cholesterol, and calories. Exercise regularly, especially aerobic exercises such as walking Maintain your ideal body weight Quit smoking Follow your physicians recommendations for medications to control cholesterol and to thin the blood General Risks of having an Operation: These have been mentioned in the Anesthesia Consent Form. Please discuss this with your hardening of the arteries from

occurring again, you should consider the following

protective devices are used. However, in some cases usage of these devices can results in complications.

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Anesthetist before signing the Anesthesia Consent Form. What are the risks of the procedure? While majority of patients have an uneventful surgery and recovery, few cases may be associated with complications. These are seen infrequently and not all the ones listed below are applicable to one individual. However it is important that you are aware of the complications/risks that may arise out of this procedure which are as below:

The most serious potential risks involved with carotid stenting are the risk of a disrupted plaque particle that breaks free from the site, called an embolism, and blocks an artery in the brain, causing a stroke.

Hyper perfusion, or the sudden increased blood flow through a previously blocked carotid artery and into the arteries of the brain, may occur after stenting, and can cause a hemorrhagic stroke.

How does carotid stenting compare to surgical There are some risks/ complications, which include: Allergic reaction to the medication or contrast procedure Bleeding at the catheter insertion site Slight risk of stroke because of a loose piece of plaque or a blood clot blocking an artery during or immediately following surgery Abrupt closure of the artery after surgery Restenosis (the reoccurrence of plaque buildup) that occurs after a stent has been placed in the carotid artery Short periods of reduced blood pressure and heart rate that may occur, which is treated with medications. Stroke or death
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endarterectomy? Patients who have coexisting medical conditions, such as recent , Unstable angina, Congestive heart failure, inevitable cardiac surgery, chronic obstructive lung disease, advanced age (>80) generally were not included in the surgical trials. These conditions increase the risk of surgery and endovascular techniques may be better suited for stroke prevention in this high-risk population. Patients having certain anatomical features such as prior ipsilateral CEA, prior neck irradiation, contralateral ICA occlusion, high cervical stenosis, tandem lesions, cervical immobility, tracheostomy and contralateral laryngeal palsy are better

material

used

during

the

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suited

for

stenting

as

compared

to

10. Consent Acknowledgement: The doctor has explained my medical condition and the proposed surgical procedure. I understand the risks of the procedure, including the risks that are specific to me, and the likely outcomes. The doctor has explained other relevant treatment options and their associated risks, the prognosis and the risks of not having the procedure. I have been given an Anesthesia Informed Consent Form. I have been given a Patient Information

endarterectomy. . Patients who have femoral or iliac access problems, patients who have marked toruosity of the carotid arteries, or those who have contraindications to anti-platelet therapy commonly prescribed to prevent post procedure thrombotic complications may not be suitable candidates for endovascular therapy Can stenosis of other cranial arteries such as vertebral and intracranial arteries be treated? Among atherosclerotic ischemic strokes, many studies have shown that there are significant racial ethnic differences in the distribution of the atherosclerotic lesions. Chinese, Japanese, I was able to ask questions and raise concerns with the doctor about my condition, the procedure and its risks, and my treatment options. My questions and concerns have been Hispanics and blacks have greater preponderance of intracranial atherosclerosis while Caucasians have more cases of extra cranial carotid disease. Both vascular involvement patterns are seen in India and this has been referred to many as the Indian pattern. On the other hand both types are seen in Indian patients. Many cases of stroke occur due to stenosis in vertebral & intracranial atherosclerotic disease. Recent studies have shown that these patients with intracranial stenosis have high risk of stroke in spite of medical treatment. Recent advances in technology has made angioplasty and stenting possible in these patients
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Sheet about the Condition, the Procedure, and associated risks.

discussed and answered to my satisfaction. I understand that the procedure may include a blood / blood product transfusion. I understand that if organs or tissues are removed during the surgery, that these may be retained for tests for a period of time and then disposed of sensitively by the hospital.

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 The doctor has explained to me that if immediate appropriate. It has been explained to me, that during the course of or subsequent to the Operation/Procedure, unforeseen conditions may be revealed or encountered which may necessitate urgent surgical or other procedures in addition to or different from those contemplated. In such exigency, I further request and authorize the above named Physician / Surgeon or his designee to perform such additional surgical or other procedures as he or they consider necessary or desirable. On the basis of the above statements, life-threatening events happen during the procedure, they will be treated as

I REQUEST TO HAVE THE PROCEDURE. Name of Patient/Substitute Decision

Maker. Relationship . Signature Date Name of the Witness Relationship/Designation Signature.. Date

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MSSH/Physician/Consent Carotid Stenting/Ver.1/Oct.2007

INFORMED CONSENT: CAROTID STENTING

Patient Identification Label to be affixed here

A. INTERPRETER An interpreter service is required.Yes______________No_______________ If Yes, is a qualified interpreter present.Yes_____________No___________ B. CONDITION AND PROCEDURE The doctor has explained that I have the following condition: (Doctor to document in patients own words) _______________________________________________and I have been advised to undergo the following treatment/procedure______________________________________________________________________ ______________________________________________________________________________________ See patient information sheet- "Carotid Stenting for more C.ANAESTHETIC Please see your Anesthesia Consent Form. This gives you information of the General Risks of Surgery. If you have any concern, talk these over with your anesthetist. OPERATION: Your physician may insert a small balloon, basket, or filter called an embolic protection device. At the blockage site, your physician inflates and deflates the angioplasty balloon to flatten the plaque
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and widen the space where the blood flows through. After the artery is open, your physician then removes the catheter with the balloon attached. Using a different catheter, your physician guides a compressed stent to the same area in your carotid artery. Once the stent is in place, your physician releases it. The stent then expands to fit the artery. Your physician then removes the stent-carrying catheter and any embolic protection devices. D.RISKS OF THIS PROCEDURE While majority of patients have an uneventful surgery and recovery, few cases may be associated with complications. These are seen infrequently and not all the ones listed below are applicable to one individual. However it is important that you are aware of the complications/risks that may arise out of this procedure which are as below: There are some risks/ complications, which include: Allergic reaction to the medication or contrast material used during the procedure Bleeding at the catheter insertion site Slight risk of stroke because of a loose piece of plaque or a blood clot blocking an artery during or immediately following surgery Abrupt closure of the artery after surgery Restenosis (the reoccurrence of plaque buildup) that occurs after a stent has been placed in the carotid artery Short periods of reduced blood pressure and heart rate that may occur, which is treated with medications. Stroke or death The most serious potential risks involved with carotid stenting are the risk of a disrupted plaque particle that breaks free from the site, called an embolism, and blocks an artery in the brain, causing a stroke. Hyper perfusion, or the sudden increased blood flow through a previously blocked carotid artery and into the arteries of the brain, may occur after stenting, and can cause a hemorrhagic stroke. SIGNIFICANT RISKS AND RELEVANT TREATMENT OPTIONS:F. SIGNIFICANT RISKS AND

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The doctor has explained any significant risks and problems specific to me, and the likely outcomes if complications occur. The doctor has also explained relevant treatment options as well as the risks of not having the procedure. Alternative modalities are CT and MR Angiography but they are of low resolution and complete morphological evaluation of pathology may not be possible.

Risk

of

not

having

the

procedure

include

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Doctor to document in Medical Record if necessary. Cross out if not applicable. )

PATIENT CONSENT: CONSENT I acknowledge that: The doctor has explained my medical condition and the proposed procedure. I understand the risks of the procedure, including the risks that are specific to me, and the likely outcomes. The doctor has explained other relevant treatment options and their associated risks. The doctor has explained my prognosis and the risks of not having the procedure. I have been given a Patient Information Sheet on Anesthesia. I have been given the patient information sheet regarding the condition, procedure, risks and other associated information. I was able to ask questions and raise concerns with the doctor about my condition, the procedure and its risks, and my treatment options. My questions and concerns have been discussed and answered to my satisfaction. I understand that the procedure may include a blood transfusion.

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 I understand that if organs or tissues are removed during the surgery, that these may be retained for tests for a period of time and then disposed of sensitively by the hospital. The doctor has explained to me that if immediate life-threatening events happen during the procedure, they will be treated accordingly. I understand that photographs or video footage maybe taken during my operation. These may then be used for teaching health professionals. (You will not be identified in any photo or video). I understand that no guarantee has been made that the procedure will improve the condition, and that the procedure may make my condition worse. On the basis of the above statements, I hereby authorize Drand those he may designate as associates or assistants to perform upon me the following medical treatment, surgical operation and / or diagnostic / therapeutic procedure.. I REQUEST TO HAVE THE PROCEDURE Name of Patient/Substitute Decision Maker. Relationship . SignatureDate. Name of the Witness Relationship/Designation SignatureDate FERENCES INTERPRETERS STATEMENT: I have given a translation in Name of interpreter. SignatureDate DOCTORS STATEMENTS I have explained The patient s condition
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 Need for treatment The procedure and the risks Relevant treatment options and their risks Likely consequences if those risks occur The significant risks and problems specific to this patient I have given the Patient/ Guardian an opportunity to: Ask questions about any of the above matters Raise any other concerns, which I have answered as fully as possible. I am of the opinion that the Patient/ Substitute Decision Maker understood the above information. Name of doctor.. Designation SignatureDate

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