Download a Patient`s Guide to Transcatheter Aortic

PATIENT
BOOKLET
Medtronic
Transcatheter Aortic
Valve Replacement
(TAVR) System
medtronic.com/TAVR
IS THE
MEDTRONIC
TAVR VALVE
RIGHT
FOR YOU?
The Medtronic TAVR
valve is for people
with severe aortic
stenosis (AS) and are
at high risk or greater
risk for surgical aortic
valve replacement.
Your doctor can help
you decide if this
device is right for
you. This booklet will
help you learn more
about the Medtronic
TAVR valve.
medtronic.com/TAVR
Table of Contents
About the Heart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Aortic Stenosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Treatment Options for Your Severe Aortic Stenosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Treatment of Your Severe Aortic Stenosis Using a Medtronic TAVR Valve . . . . . . . . . 5
Understanding the Medtronic TAVR Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
After the Medtronic TAVR Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Benefits and Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Warnings and Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Frequently Asked Questions (FAQs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Medtronic TAVR Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Other Potential Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back Cover
medtronic.com/TAVR
About the Heart
1
How the Heart Works
A healthy heart beats around 100,000
times a day. The heart’s job is to supply
the body with oxygen-rich blood.
The heart has four chambers. Blood is
pumped through the four chambers with
the help of four heart valves.
Left Upper
Chamber
(Left Atrium)
Aortic Valve
Pulmonary Valve
Right Upper Chamber
(Right Atrium)
Tricuspid Valve
Right Lower Chamber
(Right Ventricle)
Mitral Valve
Left Lower
Chamber
(Left Ventricle)
About the Heart
2
What Heart Valves Do
Heart valves open when the heart pumps to allow blood to flow. They close quickly
between heartbeats to make sure blood does not flow backward. Any trouble in this
normal flow will make it hard for the heart to pump the blood where it needs to go.
The pulmonic valve controls the flow
of blood to the lungs to get oxygen
The aortic valve controls the flow
blood as it exits the heart and is
pumped to the rest of the body.
The mitral and tricuspid valves control blood flow as it moves between
the chambers of the heart
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Severe Aortic Stenosis
3
Severe Aortic Stenosis (Severe AS) of Your Native Valve
Your native valve is the valve you were born with. Severe AS occurs when
your aortic valve does not open as it should. This makes your heart work
harder to pump blood through your body. This affects your health and limits
your normal daily activities.
Severe AS may be caused by the following:
· Age
· Calcium buildup that narrows the aortic valve
· Radiation therapy
· Infection of the heart
Left untreated, severe AS can lead to heart failure or even sudden death.
Normal Valve
Failing Surgical Aortic Valve
Some people have had their own valve replaced with surgery. Surgical
valves wear out over time. The surgical valve can start to fail. The
Medtronic TAVR valve might be an option for these people.
Signs of Severe Aortic Stenosis
Severe AS may cause you to feel:
· Chest pain
· Faint
· Dizzy
· Tired
· Out of breath
· Irregular heart beat
Stenotic Valve
Treatment Options for Your Severe Aortic Stenosis
4
Medication and Balloon Valvuloplasty (BAV)
Your doctor may give you medicine to help ease the symptoms of your disease. A procedure called BAV may also be
done. BAV is not surgery. This is where a balloon is placed in the aortic valve and inflated. This may help the valve
function better, but is only a temporary fix. Without valve replacement you could feel worse over time.
Surgical Aortic Valve Replacement (SAVR)
SAVR is an option for some people with severe AS. The native valve is removed and replaced with a new valve.
SAVR often includes the following:
· Your chest is opened to access the heart.
· Your heart is stopped.
· A machine pumps blood through your body.
· Your diseased valve is removed.
· The new valve is sewn into place.
· You may be in the hospital for more than a week.
The risks of SAVR are listed on pages 16-19.
medtronic.com/TAVR
Treatment of your Severe Aortic Stenosis using the
Medtronic TAVR System
5
Medtronic Transcatheter Aortic
Valve Replacement
The Medtronic TAVR valve is another option for people
with severe AS. It does not require open heart surgery.
It is implanted using an artery that leads to the heart.
The Medtronic TAVR valve is made from pig heart tissue.
This tissue valve is held by a metal frame. It is designed to
work like your own heart valve.
The Medtronic TAVR valve is recapturable, allowing your
doctor to accurately position your new heart valve.
Your physician may refer to your heart valve by a few
different names including CoreValve™, Evolut™ R or Evolut™
PRO. These are all Medtronic TAVR valves and your doctor
can help you decide which is best for you.
Metal frame
(nickel-titanium alloy)
Three tissue leaflets and
outer wrap (made from
pig heart tissue)
Image is bigger than actual valve.
Image shown is Evolut PRO Valve.
Understanding the TAVR Procedure
6
3
How Does the Medtronic TAVR Valve
Get to My Heart?
The arteries in your body are like a system of roads. They
branch out from the heart. There are different “routes” that
your doctor can use to get to your heart.
These include:
· An artery in your leg 1
· An artery in your neck 2
· A space between your ribs 3
· Or another entry point determined by your doctor
Each route has risks. Discuss them with your doctor.
1
medtronic.com/TAVR
2
7
A Typical Medtronic TAVR Valve Procedure
1. B
ecause each patient is different, your doctor will determine if you should
be fully asleep during the 1-2 hour procedure.
2. T
he doctor will make a cut and guide a long tube (sheath) into your artery.
3. Y
our doctor will place the Medtronic TAVR valve in position within your own
diseased heart valve or your failing surgical valve. (Figures 1 and 2)
4. Y
our new Medtronic TAVR valve will begin opening and closing. (Figure 3)
The doctor will conduct a test to confirm it is working properly.
5. T
he thin, flexible tube will be removed, the cut will be closed, and the
operation will be complete.
During the procedure, your doctor will use machines that use sound waves or
x-rays to look at your heart and arteries.
Figure 1
Catheter with
Compressed Valve
Figure 2
Valve Starting to Expand
Figure 3
Valve Fully Expanded
After the Medtronic TAVR Procedure
8
Follow-up Care
When you leave the hospital your doctor will give
you care instructions. You may have to limit certain
activities. You will need to take medicine and have your
heart checked from time to time. Talk to your doctor any
time you have questions or concerns about your new
heart valve.
If you require an MRI* scan, tell the doctor that you have
a Medtronic TAVR valve. Tell your doctor if you have a
Medtronic TAVR valve inside a surgical valve. Not doing so
could result in injury or death. Your dentist and all doctors
need to know about your valve.
You will get a card with your TAVR heart valve information.
Keep this card with you. Show it to any doctors who
may be treating you. If you do not get a card, contact
your doctor.
The lifespan of the Medtronic TAVR valve will vary from
patient to patient. It has been tested to mimic 5 years of
use without failure.
Keep appointments with your doctor. Follow all care
instructions to ensure the best possible results.
Hospital Stay
You will stay in the hospital until your doctor
decides you are able to leave. Patients are
often walking in a day or two.
*Magnetic Resonance Imaging
medtronic.com/TAVR
The Medtronic TAVR System Benefits and Risks
9
Benefits
You should start feeling better right away. This is
because your heart valve is now working properly.
Some patients may take longer to feel better.
Most patients felt less pain and less anxious. They
could take care of themselves better and go back to
everyday activities.
If you are interested, ask your doctor for more
information on additional clinical studies.
Risks
Most medical procedures have risks. The Medtronic
TAVR procedure’s most serious risks are:
· Death
· Stroke
· Serious damage to the arteries
· Serious bleeding
The Medtronic TAVR Procedure is Not Right for Everyone
10
The Medtronic TAVR Valve Should NOT be Used for the Following People:
Patients who:
· Have an infection
· Have a mechanical valve
· Cannot take blood thinning medicines
· Have a reaction to some metals
· Have a reaction to some imaging solutions
If the Medtronic TAVR valve is used in the patients mentioned above, it may not work properly.
This could make you feel very sick or even cause death.
For some patients, the risk of the Medtronic TAVR procedure may outweigh the benefits.
See page 9 for the risks and benefits associated with the Medtronic TAVR procedure.
medtronic.com/TAVR
Warnings and Precautions
11
Warnings
Some patients may have a disease that results in more
calcium in their blood. This may cause early wear.
The Medtronic TAVR valve is only for certain patients.
This includes patients with severe AS or failing surgical
valves that:
· Cannot have surgery
· Are at high risk for surgery
Precautions
· At some point the Medtronic TAVR valve may need to be
replaced. How long it lasts varies from patient to patient.
· It has been tested to mimic 5 years of use without failure.
Keep appointments with your doctor. Follow all care
instructions to ensure the best possible results.
· Antibiotics are recommended for patients who are at risk
of infections.
· Patients should stay on blood-thinning medicines after
the procedure as instructed. Patients who do not, are
more likely to have a stroke.
· If you require an MRI scan, tell the doctor that you have
a Medtronic TAVR valve. Tell your doctor if you have a
Medtronic TAVR valve inside a surgical valve. Not doing so
could result in injury or death. Your dentist and all doctors
need to know about your Medtronic TAVR valve.
The Medtronic TAVR valve has not been studied in patients:
· Who are not sick from AS
· Who are children
· With an aortic valve that has only one or two leaflets
· Who have a blood clot
· With an abnormal growth in the heart or arteries
· Who have an infection
· Who have AS in their own valve and a condition that
allows blood to leak backwards through the aortic valve
· Who have severe mitral valve disease
· With poor left ventricle function
· Whose diseased valve is too small or too big
· Whose arteries are too small for the device
· Whose arteries that deliver blood to the heart may
be blocked by the device
· Whose arteries that deliver blood to the heart need to
be treated
· Whose arteries that deliver blood to the brain need to
be treated
· Who have severe problems with bleeding or
blood clotting
· Who have specific types of surgical valves implanted in
the pulmonary valve
· Who have specific types of surgical valves implanted in
the mitral valve
· Who have thick heart muscles making it difficult for the
heart to pump blood
· Who have thick heart muscles that blocks the heart from
pumping blood
If the Medtronic TAVR valve is used in these patients, it may not work right.
This could make you feel sick or cause death.
For some, the risks of the Medtronic TAVR valve procedure may outweigh the benefits.
See page 9 for the risks and benefits.
12
medtronic.com/TAVR
FAQs
13
Frequently Asked Questions
Q) Are physical activities safe?
A) Discuss this with your doctor. They can help decide what is best for you.
Q) Is it safe to have an x-ray with a Medtronic TAVR valve?
A) Yes. The a Medtronic TAVR valve is safe for x-rays.
Q) Is it safe to have a MRI with a Medtronic TAVR valve?
A) Yes, under certain conditions. If you require an MRI scan, tell the doctor that you have a
Medtronic TAVR valve. Tell your doctor if you have a Medtronic TAVR heart valve inside a
surgical valve. Not doing so could result in injury or death.
Q) How will I know if my Medtronic TAVR valve is working right?
A) Attend regular follow-up doctor visits to check your valve.
Clinical Studies
14
Medtronic TAVR System Clinical Studies
The Medtronic TAVR heart valve has been tested in many
studies.The results of 2 studies are summarized on pages
15-17 - The Evolut R System Study and the Evolut PRO
System Study.
Ask your doctor for more information on the clinical studies
on the following patient groups:
· High Risk Patients
· Extreme Risk Patients
· Failing Surgical Valve Patients
· Severe Renal Disease Patients
· Low-Flow/Low-Gradient (LFLG) Patients.
Evolut R System Study Overview
These patients were at high risk or were too sick
for surgery. This group included 166 patients at
24 hospitals in the US, Australia, New Zealand and the
United Kingdom.
Patients were seen at 30 days and 1 year.
Yearly checkups will continue for 5 years.
The Evolut R valve works like the previous generation
CoreValve valve. The CoreValve TAVR System study results
at 1 year showed:
· The CoreValve procedure was a safe and effective
alternative to surgery.
· More CoreValve heart valve patients were alive than
surgical patients.
Quality of Life Improvements
A standard tool* was used to assess health at 30 days.
Most Evolut R valve patients:
· Felt less pain
· Had improved health
· Were less anxious
· Could take care of themselves better
· Went back to everyday activities
The improvement in the patients was similar to the first
generation Medtronic TAVR valve patients at 1 year.
* This quality of life tool is called the Kansas City Cardiomyopathy Questionnaire (KCCQ)
medtronic.com/TAVR
Evolut R Patients | Risks You Should Know
15
What are the Potential Risks 30 Days or
1 Year After an Evolut R System Procedure?
Most medical procedures have risks. The Evolut R
procedure’s most serious risks are:
· Death
· Stroke
· Serious damage to the arteries
· Serious bleeding
Potential risks at 30 days are listed in the table. Almost all
received the Evolut R heart valve through a leg artery. This
is a common access site. Few used the space between
their ribs or an artery in the neck. These sites are not often
used. Therefore the results are grouped together. Access
site is selected by your doctor. Talk to your doctor about
these risks.
Evolut R System Clinical Study Outcomes
Risks Within 30 Days
Risks Within 1 Year
Death from any cause
1 out of 100 Patients
8 out of 100 Patients
Death from a heart related cause
1 out of 100 Patients
7 out of 100 Patients
All stroke
4 out of 100 Patients
6 out of 100 Patients
New permanent device to help regulate the heart (pacemaker)
16 out of 100 Patients
19 out of 100 Patients
Major vascular access site complication
7 out of 100 Patients
7 out of 100 Patients
Heart attack
1 out of 100 Patients
1 out of 100 Patients
Valve inflammation or infection (endocarditis)
0 out of 100 Patients
0 out of 100 Patients
16
Evolut PRO System Study Overview
Quality of Life Improvements
These patients were at high risk or were too sick
for surgery. This group included 45 patients at
8 hospitals in the US.
Patients were seen at:
· 30 days
Patients will be seen at:
· 6 months
· 1 year
Yearly checkups will continue for 5 years.
A standard tool* was used to assess health at
30 days. Most Evolut PRO valve patients:
· Felt less pain
· Had improved health
· Were less anxious
· Could take care of themselves better
· Went back to everyday activities
The Evolut PRO valve works like the previous generation CoreValve and Evolut R heart valves. It was
also found reasonably safe and effective.
* This quality of life tool is called the Kansas City Cardiomyopathy Questionnaire (KCCQ)
medtronic.com/TAVR
Evolut PRO Patients | Risks You Should Know
17
What are the Potential Risks 30 Days
After Evolut PRO valve?
Most medical procedures have risks. The Evolut PRO
procedure’s most serious risks are:
· Death
· Stroke
· Serious damage to the arteries
· Serious bleeding
Potential risks at 30 days are listed in the table. Almost all
received the Evolut PRO valve through a leg artery. This is
a common access site. Few used the space between their
ribs or an artery in the neck. These sites are not often
used. Therefore the results are grouped together. Access
site is selected by your doctor. Talk to your doctor about
these risks.
Evolut PRO System Clinical Study Outcomes
Risks Within 30 Days
Death from any cause
2 out of 100 Patients
Death from a heart related cause
2 out of 100 Patients
All stroke
0 out of 100 Patients
New permanent device to help regulate the heart (pacemaker)
11 out of 100 Patients
Major vascular access site complication
9 out of 100 Patients
Heart attack
0 out of 100 Patients
Valve inflammation or infection (endocarditis)
0 out of 100 Patients
Other Potential Risks Associated with Medtronic
TAVR System Procedures
· Cardiogenic shock - failure of the heart to pump
enough blood to the body organs
· Perforation of the myocardium or vessel - a hole in
the heart muscle or a blood vessel
· Cardiac Tamponade - the constriction or inability
of the heart to pump due to buildup of blood or fluid
around the lining of the heart
· Ascending aorta trauma - injury to the large blood
vessel leading blood away from the heart
· Embolism - an abnormal particle (air, blood clots)
floating in the blood stream or attached to an
object, including the valve
· Thrombosis (including valve thrombosis) - blood clot,
including a blood clot on the valve
· Valve migration - upward or downward movement of
the device from where it was originally placed
medtronic.com/TAVR
· Dysfunctions of a Medtronic TAVR valve including but
not limited to:
- Break (fracture) in the valve frame
- Bending of the valve frame
- Valve frame does not open (expand) all the way
- Buildup of calcium on the valve
- Pannus - the formation of scar tissue that may
cover or block the valve from functioning normally
- Wear, tear or movement forward (prolapse) or
backward (retraction) from the normal position
of the valve leaflets
- Valve leaflets do not close together
- A break in the stitches (sutures) of the valve frame
or leaflets
-L
eakage through or around the valve or valve frame
- Incorrect size of the valve implanted
- Incorrect position of the valve, either too high
or too low
- Regurgitation - backward flow of blood through
the valve
- Stenosis - narrowing of the opening of the valve
18
19
· Mitral valve regurgitation - blood leaking backwards
through the valve between the left lower chamber of
the heart to the left upper chamber of the heart
· Hypotension or hypertension - low or high
blood pressure
· Unfavorable reaction by the body (allergic reaction) to:
- Antiplatelet agents - blood thinning medicines that
keep blood clots from forming
- Contrast medium - a substance used to increase
the visualization of body structures such as
x-ray dye
· Bowel ischemia - decreased blood supply to
the intestines
· Complications at the area where the doctor cut
the skin or related to cutting the skin, including
but not limited to:
- Pain
- Bleeding
- Hematoma - blood collecting under the skin
-P
seudoaneurysm - blood collecting on the outside
of a vessel wall causing a balloon-like widening
- Irreversible nerve damage - permanent damage
to nerves
- Compartment syndrome - squeezing of nerves and
muscles in a closed space that could cause muscle
or nerve damage
- Stenosis - narrowing of a blood vessel (artery)
In addition, you may experience other problems that
have not been previously observed with this procedure.
Resources
For More Information on the Medtronic TAVR Procedure
Please contact your doctor or nurse for more information.
For product information, visit www.medtronic.com/TAVR.
For Technical Support Information
Toll-free phone number in the USA: 1-877-526-7890
Phone number from outside the USA: 1-763-526-7890
Email address: [email protected]
Caution: Federal law (USA) restricts this device to sale by or
on the order of a physician.
Medtronic TAVR systems have been approved by FDA for
specific patient populations only. Refer to the Instructions
for Use for a full list of warnings, precautions, indications,
and adverse events.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax:(763) 514-4879
Toll-free: (800) 328-2518
Medtronic.com/TAVR
LifeLine
CardioVascular Technical Support
Tel: (877) 526-7890
Tel: (763) 526-7890
Fax:(763) 526-7888
[email protected]
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All rights reserved.
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and Further, Together are
trademarks of Medtronic.
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of a Medtronic company.
UC201708422 EN
01/2017