ION™ - Angioplasty and Stent Education Guide

ION™ - Angioplasty and Stent Education Guide
Angioplasty and Stent Education Guide
Table of Contents
Treating coronary artery disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
What is coronary artery disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Coronary artery disease treatment options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
What are coronary artery stents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
What are the different types of coronary stents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
How does the drug coating and polymer work on a drug-eluting stent . . . . . . . . . . 8
Risks of treatment options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Before your coronary artery stenting procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
During a typical coronary artery stenting procedure . . . . . . . . . . . . . . . . . . . . . . . . . 12
After a typical coronary artery stenting procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Frequently asked questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1
Treating
coronary artery disease
Your doctor may want you to have a stent placed in your coronary
artery. This is to help treat your coronary artery disease. This guide
explains the procedure and what you can expect from start to finish. A glossary at the end of this guide defines common medical terms
about this procedure. You will also learn steps you can take to live a healthier life with
coronary artery disease.
4
What is coronary artery disease
Coronary Artery Disease (CAD) is the narrowing of the arteries
in the heart. This narrowing can also be called stenosis. It is
usually caused by a build up of fat or calcium deposits called
plaque. Over time, this plaque can build to a total blockage of
the artery. This process is called atherosclerosis. When the heart doesn’t receive enough blood flow due to
blockage in the artery, it may cause mild to severe chest pain
or pressure. This pain or pressure can also spread to the arms
or jaw. If the arteries are completely blocked, it can result in a heart attack. Anyone who experiences symptoms should
promptly call 911. More than 13 million Americans suffer from
CAD each year. However, the treatment of CAD has changed in recent years, and many CAD patients are able to return to a normal lifestyle shortly after treatment.
Aorta
Right
Coronary
Artery
Left
Coronary
Artery
Circumflex
Artery
Posterior
Descending
Artery
Left
Anterior
Descending
Artery
Who is at risk?
If you have a history of high cholesterol, diabetes, smoking, high blood pressure, being overweight
or a family history of CAD, you have an increased chance of developing blockage in your coronary
arteries. As you get older, you have a greater chance of developing CAD. In addition, women who
have reached menopause have a greater chance of having CAD.
How do I know if I have Coronary Artery Disease?
There are a number of tests that your doctor can perform to help determine if you have CAD. A test
that measures the electrical activity in your heart is called an electrocardiogram (ECG or EKG). A
stress test can be done to measure the electrical activity in your heart while you are exercising. These tests may show your doctor if part of your heart has been damaged or is not receiving
enough blood. To directly determine if your arteries may be blocked or narrowing, your doctor may
schedule a procedure with a cardiologist. This procedure is called a coronary angiogram and is
performed in a Cardiac Catheterization Lab by inserting a dye into your coronary arteries. By doing
this procedure, the cardiologist can see your coronary arteries on an X-ray screen and can make a
decision of how best to treat you.
3
Coronary artery disease treatment options
There are many different treatment options for treating coronary artery disease. The options focus on increasing blood flow to the heart, along with changes to
your every day lifestyle, including diet, physical activity and medications. The type
of treatment your doctor recommends for you depends on your symptoms and
how much damage has been done to your heart.
Treatment Options for Coronary Artery Disease may include:
1. Medications
2. Balloon angioplasty
3. Coronary artery stenting
4. Coronary artery bypass graft surgery (CABG)
1. Medications
Nitroglycerin may be given to relieve chest discomfort due to coronary blockages. It does not treat the blockage itself. Your cardiologist may prescribe a number of
medications (aspirin, beta-blockers, cholesterol medications, etc.) to thin your
blood and to help prevent blockage of the arteries.
4
Coronary artery disease treatment options continued
2. Angioplasty
A procedure known as angioplasty can also treat
artery narrowing. A thin tube known as a guide
catheter is inserted into the artery at the groin
or wrist. A small balloon located on the top of a second catheter is moved through the guide
catheter to the site of the narrowing. The balloon
is then inflated to reduce the blockage. The
balloon is deflated and removed after the
angioplasty is done. The patient remains awake
while the cardiologist performs the procedure. The procedure may end here or you could have a
bare-metal or drug-eluting stent implanted to help
keep the artery open.
Side View of Coronary Artery
Plaque Before
Treatment
Balloon Angioplasty
Procedure
Result After
Angioplasty
3. Coronary artery stenting
During this procedure a small mesh tube is
implanted into the artery to widen the artery and
restore adequate blood flow to the heart. This
mesh tube is called a stent. Once the stent is
placed into the coronary artery, it is expanded
with the inflation of a balloon catheter. The stent
is left in the artery to keep it open and help
prevent further narrowing of the coronary artery.
Plaque Before
Treatment
Stent
Procedure
Result After Stent
Procedure
4. Coronary artery bypass graft surgery (CABG)
This surgery is also called a heart bypass or open heart surgery. Your surgeon will need to take
a short length of artery from your inner chest wall and/or a vein from your leg and surgically
attach it above and below the blocked area of the heart artery.
5
What are coronary artery stents
Coronary artery stents are small mesh tubes that can help to reduce blockage of a
coronary artery. The stent is implanted into an artery and expanded to fit the size,
shape and bend of the coronary artery. The stent is propped open to help prevent
any more blockages. Once the stent is in place, the stent will remain in your
artery. Over time, the artery wall will heal around the stent as it continues to
support the artery.
Why are stents used?
Many patients who undergo balloon angioplasty treatment will experience
a re-narrowing of the artery. This re-narrowing is called restenosis. This
re-narrowing of the coronary artery can happen more often following a balloon
angioplasty procedure than for patients who receive a stent. The re-narrowing can
be caused by a combination of factors including the blockage reforming or new
tissue growth within the treated area.
Coronary artery with angioplasty
6
What are coronary artery stents continued
Coronary artery with stenting
7
What are the different types of coronary stents?
There are two kinds of stents, bare-metal and drug-coated. Bare-metal stents provide support
to help keep the artery open after angioplasty. A drug-coated stent is a bare-metal stent with
a special drug coating added to help reduce the chance of the artery becoming blocked again. The drug is released from the stent over the period of time during which re-blockage is most
likely to occur. The stents were designed to be very flexible, allowing them to fit the shape of
your artery.
Boston Scientific offers bare-metal and drug-eluting stents. Depending upon your specific
needs, your doctor may choose to place a bare metal, drug-eluting or some combination of these stents. There are differences between the two stent types (such as the need for
longer-term dual antiplatelet therapy with drug-eluting stents) that you should discuss
with your doctor. Please reference the ION Patient Information Guide for more details about the stent.
How does the drug coating and polymer work on a drug-eluting stent?
Polymer Coating
The stent is coated with a proprietary polymer, which was developed specifically for drugeluting stents. The polymer carries and protects the drug before and during the procedure. Once the stent is implanted, it helps control drug release into the coronary arterial wall. This contributes to even and consistent distribution of the drug from the stent.
Drug Release
The drug-eluting stent is coated with a drug and polymer and has been designed to allow for a
consistent and controlled release of the drug from the stent surface into the artery walls. Both
the amount of drug and release rate have been determined so that healing can occur while
allowing the processes leading to restenosis to be minimized, thus reducing the need for
additional treatment in the stented area. 8
Risks of treatment options
You should not have a drug eluting stent placed in your coronary artery if you
have any of the following conditions:
• You are allergic to the drug or related drugs
• You are allergic to the polymer
• You are allergic to stainless steel or platinum chromium
• You are unable to take medicines that make your blood take longer to clot (also called anticoagulants)
• You are unable to take medicines that make your blood cells slippery and make it more difficult for your blood to clot (also called antiplatelets)
• You have a blockage that will not allow proper placement of the stent
• You are allergic to the dye used during the procedure (also called contrast agent)
• Your doctor decides that you are not able to have the required medication prior to stent placement
Your doctor and the medical staff will monitor you during and after the procedure for
complications. If a complication does occur, your doctor will decide what type of treatment you may need.
9
Risks of treatment options continued
The placement of stents in arteries is done to treat
blockages and to try to prevent re-narrowing.
As with any stent procedure, there is a chance
that complications may occur, including, but not
limited to, the following:
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10
Air bubbles, tissue or clots which can block the artery (emboli)
Allergic reaction to the drug
Allergic reaction to the polymer
Allergic reaction to the metal used to make the stent (stainless steel or platinum chromium)
Allergic reaction to the contrast dye (which could cause kidney failure)
Aneurysm
Bleeding (which may require a blood transfusion)
Bruising at the access site
Bruising which occurs on a blood vessel (pseudo-aneurysm)
Chest pain or discomfort
Collection of blood in the lining of the heart
Coronary spasm
Death
Emergency bypass surgery
Heart attack
High or low blood pressure
Inadequate supply of blood to the heart
Infection and/or pain at the access site
Injury or tearing of artery
Irregular heartbeat (arrhythmia)
Movement of the stent to an unintended
location
Plugging of the stent with blood clots
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Re-narrowing of the treated artery (restenosis)
Shock/pulmonary edema
Side effects due to contrast dye, heparin or other medications
Stroke or other neurological problems
Total blockage (occlusion) of the artery
Unnatural connection between vein and artery (asterio-venous fistula)
Arterial trauma requiring surgical repair or reintervention
Worsening of heart and lung function
There is a chance that complications may occur
relating to the drug (based on studies of patients
who used the drug for a prolonged period of time)
or the polymer which include:
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Abnormal liver test levels
Allergic or immunologic reaction to the drug
Allergic reaction to the polymer or polymers with similar chemical structures
Anemia
Blood transfusion
Changes in blood profile (decrease in the number of white and red blood cells and platelets)
Changes of the tissue in the arterial wall including inflammation, cell injury and cell death
Disturbances of the gastrointestinal (GI) tract and stomach
Loss of hair
Muscle pain/joint pain
Nerve disease in arms and legs
There may be other potential adverse events that are unforeseen at this time.
Before your coronary artery stenting procedure
Before your coronary artery stenting procedure:
• Tell your doctor about any medications you are taking.
• Let your doctor know about any allergies you have. It is important he or she knows about allergies to contrast dye, iodine, cobalt, chromium, nickel, titanium, stainless steel, platinum or plastics.
• Tell your doctor if you cannot take aspirin or blood thinning medicines. These medications are usually prescribed before and after your procedure.
• Make sure you understand the possible risks and benefits of your coronary stent procedure.
Below is a typical checklist. Your doctor may ask you to go through this
before your procedure:
• Do not eat or drink anything after midnight on the night before your procedure.
• Follow the instructions you receive from your doctor and nurses.
• Take all your medications with you.
• You may be given a sedative to relax you before starting your stent
procedure. The sedative can make you sleepy.
11
During a typical coronary artery stenting procedure
1. You will be taken to an area of the hospital called the Cardiac Catheterization Laboratory. While in the cath lab, you may be given a sedative that will make you feel sleepy during the procedure.
2. A small puncture is made in your arm or groin. A needle is used to gain access to your
artery and a guide catheter and guide wire are fed through the artery and moved up into
the coronary artery. All of this is done using X-rays for a guide.
3. The diseased artery first needs to be enlarged to make room for the stent. To do this, the
doctor places a small, deflated balloon over the guide wire and through the catheter to the
blocked area of the coronary artery. When the balloon is in the correct position, it is inflated. This pushes the plaque buildup aside and reopens the artery to restore blood flow.
4. The balloon is deflated and removed, and a small metal mesh tube called a stent is advanced
into the same blocked area of the artery and expanded against the artery wall to fit the shape
of your artery. Your doctor may choose to expand the stent by using another balloon. This is
to make sure the stent is in better contact with the artery.
5. If your doctor places a drug-eluting stent into your artery, a drug will be released from the
stent over a slow period of time. 6. After the stent is implanted, the catheter and wire are removed and the puncture site is
closed. The stent remains in place permanently and is designed to help keep the artery
open and prevent future narrowing of the coronary artery.
12
After a typical coronary artery stenting procedure
• You may feel sleepy from the sedative given to you. This will wear off over the next few hours.
• You will be taken to a unit where nurses and doctors can monitor you.
• You will be asked to stay in bed for several hours. You will be asked to keep your arm or leg straight so the entry site can heal.
• You may need to stay in the hospital before you can go home.
• You should follow your doctor’s recommendations and let them know if you are experiencing any of the following:
– Chest pain
– Shortness of breath
– Sudden weakness or paralysis of the face, arm or leg
– Pain, bleeding or infection at the entry site in your arm or leg
– Any other unexplained symptoms
• You can return to normal activities gradually. Check with your doctor about physical activities.
• You should not stop taking your medications unless you are asked to stop by the doctor who implanted your stent.
• You should keep all of your follow-up appointments, including blood testing.
• You should carry your Stent Implant Card.
• You should always show your dentist or medical doctor your Stent
Implant Card.
13
Medications
Your cardiologist may prescribe a number of medications to thin the blood and prevent blood
clots from forming and adhering to the surface of the stent. These medications will include
aspirin and blood thinning drugs such as Plavix®, Ticlid® or Effient® (Prasugrel). It is extremely
important that you follow your doctor’s instructions on what medications to take. If you stop
taking these medications before being instructed to do so by your cardiologist, the chances
of blood clot formation on the stent, subsequent heart attack or even death are increased.
If you plan to have any type of surgery or dental work which may require you to stop taking
these medications prematurely, you and your cardiologist should discuss whether or not
placement of a stent is the right treatment for you.
If surgery or dental work is recommended which would require you to stop taking these
medications prematurely after you’ve received the stent, you and your doctor should carefully
consider the risks and benefits of this additional surgery or dental work versus the possible
risks from early discontinuation of these medications.
If you do require premature discontinuation of these medications because of significant
bleeding, then your cardiologist will be carefully monitoring you for possible complications. Once your condition has stabilized, your cardiologist will probably put you back on these
medications.
Follow-Up Examinations
You will need to see the cardiologist who implanted your stent for routine follow-up
examinations. During these visits, your doctor will monitor your progress and evaluate your
medications, the clinical status of your coronary artery disease, and how the stent is working
for you.
14
Frequently Asked Questions
Can the stent move or rust?
Once positioned by your doctor, the stent does
not move on its own. It is manufactured so that it
will not rust.
Can I walk through metal detectors with a stent?
Yes, without any fear of setting them off.
How soon can I go back to work?
The majority of people return to work within a few days following the procedure.
What if I still have pain?
If you experience pain, immediately inform your
cardiologist or the center where the procedure was performed.
Can I undergo MRI or scanner testing
with a stent?
MRI safety testing has shown that the coronary
stent is MR Conditional and that a patient with a
coronary stent may safely undergo an MRI scan
under certain conditions listed on the Stent
Implant Card. Prior to undergoing an MRI scan,
inform your doctor or MR technologist that you
have a coronary stent and show them your Stent
Implant Card.
Can I play sports?
Your doctor will tell you what sports you can play and when you can start them.
What should I change in my diet?
Your doctor may prescribe a low-fat, lowcholesterol diet to help reduce the levels of fat in your blood and reduce your risk.
15
Glossary
Angina Pectoris
Symptoms experienced when the heart
muscle is not receiving adequate oxygen
(may include chest, arm, jaw or back pain,
shortness of breath, nausea, vomiting).
Angioplasty
A minimally invasive treatment to open
blocked coronary arteries. Also known as
percutaneous transluminal coronary
angioplasty (PTCA).
Atherosclerosis
A disease in which the flow of blood to the
heart is restricted with plaque deposits and,
therefore, less oxygen and other nutrients
reach the heart muscle. This may lead to
chest pain (angina pectoris) or to a heart
attack (myocardial infarction).
Balloon Angioplasty
Opening the blocked artery by using a balloon
catheter that is inflated inside the artery. Catheter
A small, thin plastic tube used to provide
access to parts of the body, such as the
coronary arteries.
16
Coronary Angiogram
A test in which contrast dye is injected into
the coronary arteries allowing the doctor to
see the arteries on an X-ray machine.
Coronary Arteries
The arteries that surround the heart and
supply blood containing oxygen and nutrients
to the heart muscle.
Coronary Artery Bypass Graft Surgery (CABG)
Open heart or bypass surgery. A section of an artery or vein from your chest or leg is
harvested and surgically attached to a
coronary artery below the blocked area of the heart.
Coronary Artery Disease (CAD)
Disease affecting the coronary arteries that
surround the heart and supply blood to the
heart muscle. Electrocardiogram (ECG/EKG)
A test that records changes in the electrical
activity of the heart. May show whether
sections of the heart muscle have been
damaged due to insufficient blood or oxygen
flow to the heart.
Glossary continued
In-Stent Restenosis
Recurrent blockage or narrowing of a
previously stented area in an artery.
Restenosis
Recurrent blockage or re-narrowing of a
previously treated artery.
Lumen
The inner channel of an artery.
Stent
An expandable metal tubular structure
(lattice) that supports the vessel wall and
maintains blood flow through the opened
artery.
Magnetic Resonance Imaging (MRI)
A non-invasive way to take pictures of the
body. MRI uses powerful magnets and radio waves, unlike x-rays and computed
tomographic (CT) scans which use radiation.
Myocardial Infarction
Permanent damage to the heart tissue and
muscle due to the interruption of the blood
supply to the area. Commonly referred to as a heart attack.
Stress Test
A test that records the heart’s electrical
activity while the patient exercises. May show
whether parts of the heart muscle have been
damaged and if there is insufficient blood or
oxygen flow to the heart. Percutaneous Transluminal Coronary
Angioplasty (PTCA)
See Angioplasty.
Plaque
Accumulation or buildup of cholesterol, fatty
deposits, calcium and collagen in a coronary
vessel that leads to blockages in the coronary
arteries.
17
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