Download All About Your Heart Failure Device

Cardiac Rhythm Therapy // Patient Manual
All About Your H
eart
Failure Device
A manual for patients with heart failure devices
Content
Introduction............................................................ 1
Questions and answers about your
heart failure device................................................ 4
Why do I need a heart failure device?.................... 6
What exactly is heart failure?................................. 7
Why am I receiving a heart failure device if I do
not have heart failure?........................................... 8
What kind of heart failure do I have?..................... 8
Are there other types of heart failure
I should know about?............................................. 9
How does a heart failure device help people with
dilated cardiomyopathy
or HOCM?.............................................................. 11
Are there different types of heart
failure devices?..................................................... 12
What kind of heart failure device do I have? Is one
more common than another?.............................. 12
i
What does it mean that some heart failure
devices offer “defibrillation”?............................... 13
Why do I need an ICD in my
heart failure device?............................................. 13
What causes these rhythm disorders?............... 15
How does a heart failure device help people with
heart failure?......................................................... 16
How does the healthy heart beat?....................... 16
Do people with heart failure always have rhythm
disorders?.............................................................. 19
What kinds of very fast heart rhythms are there?..
19
What is VF?............................................................ 20
What does VF feel like?........................................ 21
What is VT?............................................................ 21
ii
What does VT feel like?........................................ 23
How does the heart failure device with
defibrillation know whether a rhythm is
dangerous?........................................................... 23
How does the heart failure device with
defibrillation treat VT and VF?............................. 24
Is ATP an effective therapy?................................. 25
What if ATP does not work?................................. 25
How does a doctor know how much shock I
should receive?..................................................... 26
How does the heart failure device with
defibrillation treat VF?.......................................... 27
How does electrical energy reset the heart cells?.
27
How can the heart failure device with
defibrillation get enough energy to shock the
heart back into a normal rhythm?...................... 28
iii
What does a shock feel like?............................... 29
How quickly can a person recover from
a high-energy shock?........................................... 29
If defibrillation is so important,
why would a person get a heart failure device
without defibrillation?........................................... 30
Are there other types of tachyarrhythmias?....... 31
Would a heart failure device help me if
I have atrial fibrillation?........................................ 33
Why is it important to treat atrial fibrillation?.... 34
Are there other types of rhythm disorders?....... 35
What causes bradycardia?................................... 36
What does it feel like to have bradycardia?........ 38
Are there different types of bradycardia?............ 38
Are there different types of heart block?............ 40
How do I know what kind of
iv
arrhythmias I have?.............................................. 41
What does it feel like when the heart failure
device paces the heart to treat
my mechanical dyssynchrony?............................ 42
Is there any other way to treat heart failure?..... 42
Will I still have to take heart failure medications
after I get a heart failure device?......................... 43
Will my heart failure ever go away
on its own?............................................................ 44
I have never had a dangerous
arrhythmia before. Why does my doctor want me
to get a heart failure device
with defibrillation?................................................ 45
I have survived a dangerous arrhythmia before.
Why does my doctor think I need a heart failure
device with defibrillation?.................................... 48
v
What if my heart condition changes
in the future?......................................................... 48
How can the doctor adjust the heart failure
device once it is implanted in
my body?................................................................ 49
How does my heart failure device pace my heart?.
50
Why is one of the leads placed outside the heart
and not inside it?................................................... 53
Are there different types of leads?...................... 54
If my heart failure device
defibrillates, does it defibrillate
only in the right ventricle?.................................... 54
How does the heart doctor know whether I need
a heart failure device?.......................................... 55
Should I get a second opinion before getting a
heart failure device?............................................. 55
vi
What is the surgery like when a heart failure
device is implanted?............................................. 56
How long does the surgery take?........................ 57
Is it painful to be awake during the surgery?..... 57
What will go on during the device surgery?........ 58
How will they actually perform the implant
surgery?................................................................. 59
Is lead testing the same as the testing the
doctors do when they cause a rhythm disorder
(defibrillation testing)?......................................... 61
How long is the recovery time after surgery?..... 62
What should I do right after surgery?................. 63
What should I do during the recovery period?.... 64
Which activities might I need to give up now that I
have a heart failure device?................................. 66
Can I still drive?.................................................... 68
vii
Why would there be any problem with driving if I
have a heart failure device with defibrillation?... 68
Are there driving restrictions for people who have
a heart failure device without defibrillation?...... 68
What does it feel like to have a heart failure
device?................................................................... 69
How many shocks can I expect to
receive if I have a heart failure device with
defibrillation?........................................................ 70
Where does the device get all the energy to pace
the heart and even shock it?................................ 71
How long does this battery-operated device last?.
71
Is there any warning before the battery runs out?.
72
What is a replacement?....................................... 72
viii
Why can’t they just replace the battery?............. 73
How often do I need to have checkups?.............. 73
Why do I need to go to so many checkups?........ 74
What should I tell my heart doctor during my
routine checkup?.................................................. 74
What should I tell my family about my heart
failure device?....................................................... 75
Sometimes I hear the doctors or nurses calling
my device a pacemaker. Isn’t a pacemaker
something different than a heart failure device?...
76
Is it safe to be near a microwave oven?.............. 77
Can I still use a computer?.................................. 77
Can I still use a cell phone?................................. 77
Can I go through airport security or other
checkpoints?......................................................... 78
ix
BIOTRONIK Home Monitoring®.......................... 79
Resources............................................................. 82
Websites................................................................ 82
BIOTRONIK..........................................................83
HRSOnline...........................................................83
FDA.......................................................................83
Pacemaker Club.................................................84
Support Groups.................................................85
Important information......................................... 86
Contraindications................................................. 86
Risks, warnings and precautions........................ 90
Risks...................................................................... 91
Warnings............................................................... 93
Precautions........................................................... 98
x
Initial precautions
(First three months after implant)....................98
Cell phones.........................................................99
Metal detectors and security
checkpoints.......................................................100
Electromagnetic interference..........................101
Other healthcare providers............................ 106
Changes in your health and condition........... 115
Shock therapy.................................................... 85
Glossary.............................................................. 119
Index.................................................................... 138
xi
Introduction
This booklet was prepared for you by
BIOTRONIK to help you better understand your
heart failure device. The best source of
information for your health questions is your
physician, since every person is unique and
many factors affect your overall health. It is our
goal at BIOTRONIK to give you a good overview
of heart failure device therapy and share with
you what we have found to be the general
experiences of most patients.
We have divided this booklet into four main
sections:
1. Questions and answers about your heart
failure device
2. BIOTRONIK Home Monitoring®
3. Resources
4. Important information
The “Important information” section tells you
some of the information that the U.S. Food and
1
Drug Administration (FDA) wants you to know
about your device.
The section called “Questions and answers about
your heart failure device” tells you about how
these devices work, why you need a heart failure
device, and how it will affect your life. We
compiled this information based on questions
that people frequently ask about their heart
failure devices and how they work. This is
probably the most interesting portion of the
booklet if this is your first heart failure device and
you do not know what to expect.
2
Many BIOTRONIK devices offer Home Monitoring®.
To learn what this is and how important it can be
in your overall care, refer to the “Home
Monitoring®” section. If you are not sure whether
your heart failure device has Home Monitoring®,
ask your doctor.
The “Resources” section shares with you some
sources of information that can help you learn
more about heart failure devices.
Throughout the booklet, we will sometimes use
medical terms. These terms might be long or
confusing, but it is important for you to know the
correct medical terms for certain procedures
and conditions. You will notice a bluish shaded
box with these words defined in ordinary
language near where the words appear in the
text. You can also look up these words in the
“Glossary” section at the end of this booklet.
3
Questions and answers about
your heart failure device
If you have just learned that you need a heart
failure device, or you have just had your device
implanted, you probably have many questions
and a lot of different emotions. Many people who
get a heart failure device get the news that they
need a device suddenly, before they ever realized
they had heart problems. This can be a confusing
time, but let us look at a few facts you may not
have known about heart failure devices.
Heart failure devices are actually similar in
technology to pacemakers (which have been
around for more than 50 years) and sometimes
have a built-in defibrillator (which has been
around for decades). The technology used in
these systems is well established.
Many hundreds of thousands of people all over
the world have an implanted cardiac rhythm
4
management device right now. You are joining a
very large group.
If you have a certain type of heart failure, heart
failure devices have been shown to help your
heart function better by bringing it back to a
more natural rhythm.
There are two main types of heart failure
devices; both types provide pacing-type therapy
at low energy levels to help your heart failure,
but one has a built-in defibrillator. Many people
with heart failure are at high risk for dangerous
arrhythmias, and the defibrillator can help
protect them. Ask your doctor to find out if your
heart failure device has defibrillation.
BIOTRONIK has been at work for more than a
half a century making implantable devices to
treat heart rhythm disorders, and we have
5
gathered some of the most common questions to
help you better understand your new heart
failure device.
Why do I need a heart failure device?
Your doctor has decided that your kind of heart
failure may be helped by implanting an electronic
device that will help your heart beat more
efficiently. Not all people with heart failure
benefit from such a device, but many do.
Heart Failure
A syndrome characterized by the heart’s
inability to pump blood efficiently. Heart failure
is a pumping disorder, not an electrical
disorder. It may be mild or severe, and it tends
to get worse over time. People with heart
failure are at risk for dangerous arrhythmias.
There are different types of heart failure.
6
What exactly is heart failure?
Heart failure means that your heart is not
pumping blood as efficiently as it could. The term
“heart failure” is a bit misleading because it does
not mean the heart fails or stops, but rather that
it no longer pumps blood as well as it used to.
This means you are not getting the benefits of
adequate circulation. There are many types of
heart failure, each of which is defined by the
reason the heart is not pumping efficiently. Heart
failure may put you at risk for abnormal heart
rhythms called arrhythmias.
Arrhythmia
Any type of abnormal heart rhythm and / or
rate. Other terms for this are dysrhythmia
and rhythm disorder.
7
Why am I receiving a heart failure device
if I do not have heart failure?
Your doctor may have talked with you about your
symptoms and health condition without using the
term “heart failure”. In order to prescribe a heart
failure device, your doctor has made sure that your
condition could be treated by this kind of device.
Heart failure is a condition that will not go away.
It will get worse over time. However, early and
effective intervention can slow the progression of
symptoms. You may be at an early stage of this
condition. Please speak with your doctor about
your specific health condition and prognosis.
What kind of heart failure do I have?
If your doctor recommends that you should have
a heart failure device, then you have the kind of
heart failure that involves the right and left sides
of your heart not beating at the same time.
Doctors call this condition mechanical
8
dyssynchrony because the right and left sides of
the heart are out of sync with each other.
Mechanical Dyssynchrony
A heart condition that involves the right and
left sides of the heart not contracting at the
same time, or where the lower chambers of
the heart do not contract as a whole.
Mechanical dyssynchrony can cause the heart
to pump less efficiently. Some – but not
all – people with heart failure have mechanical
dyssynchrony.
Are there other types of heart failure
I should know about?
You may sometimes hear the term
“cardiomyopathy,” which means that there is a
problem with the heart muscle itself. People with
dilated cardiomyopathy have hearts that can
9
grow abnormally large and become flabby. A
flabby heart cannot pump efficiently. Another
term you may hear, called hypertrophic
obstructive cardiomyopathy (abbreviated HOCM
and pronounced “hokem”), is a very different
problem. With HOCM, the heart walls become
abnormally thick and stiff. This reduces the size
of the pumping chamber inside so the heart can
still beat, but it cannot pump as much blood as
before. Many people with heart failure have
either dilated cardiomyopathy or HOCM; you
cannot have both at the same time.
Cardiomyopathy
A disorder of the heart muscle.
Dilated Cardiomyopathy
A disorder of the heart muscle that causes
it to become enlarged and flabby.
10
Hypertrophic Obstructive Cardiomyopathy,
also called HOCM. A disorder of the heart
muscle that causes the heart walls to thicken
abnormally, causing the pumping chambers
to become smaller.
How does a heart failure device help
people with dilated cardiomyopathy
or HOCM?
If you have either dilated cardiomyopathy or
HOCM, there is a good chance the right and left
sides of your heart are not working together as
they should. In other words, many people with
these conditions also have mechanical
dyssynchrony. The heart failure device will help
synchronize the right and left sides of your heart
and keep it beating fast enough to pump as
efficiently as it can.
11
Are there different types of heart
failure devices?
Yes. All heart failure devices offer low-energy
pacing to help the right and left sides of the
heart beat together in a coordinated way. Some
heart failure devices also have defibrillation
ability, which means they can deliver highenergy shocks to the heart to correct a
dangerous rhythm.
What kind of heart failure device do I
have? Is one more common than
another?
You should ask your doctor about the type of
heart failure device you have. In the United
States, there are more heart failure devices with
defibrillation than without.
12
What does it mean that some heart
failure devices offer “defibrillation”?
Every heart failure device uses low-voltage
energy, delivered to the right and left sides of the
heart, to help it beat in a more coordinated
fashion. This is the same type of energy that
pacemakers use, except pacemakers pace only
one side of the heart. Many heart failure devices
have a built-in defibrillator. This is the same as
an implantable cardioverter-defibrillator (ICD).
The ICD part of the heart failure device is on
standby, but will deliver a shock if it detects a
dangerous rhythm.
Why do I need an ICD in my
heart failure device?
If you have a heart failure device with a built-in
ICD, it is because your physician has determined
that you have an electrical problem in your heart
that keeps it from functioning properly and could
13
even be life-threatening. This electrical problem
causes or could cause your heart to beat too
rapidly. If your heart tries to beat very rapidly, it
cannot pump efficiently.
Try this experiment. Open your hand and then
curl it up to make a fist. Think of this as one
heartbeat. To pump blood, your heart has to relax
(so blood fills the heart) and then squeeze (so
that blood pumps out into the body). If you can
open and close your fist one time each second,
that corresponds to a heart rate of about 60
beats per minute – which is normal. Now try to
open and close your fist twice per second; that
corresponds to 120 beats per minute. Now try to
open and close your fist five times a second; that
corresponds to 300 beats per minute. You will
see that you cannot completely open and close
your fist if you try to go too fast. The same is true
of your heart. If it tries to beat 300 beats per
14
minute, it cannot fully fill with blood, and it
cannot completely pump the blood out. In fact,
when your heart beats dangerously fast, it just
quivers and stops pumping blood. This state
results in a condition called sudden cardiac
arrest. It sounds like the heart has stopped, but
actually the opposite is true – the heart is trying
to go too fast.
Sudden Cardiac Arrest (SCA)
A heart rhythm in which the heart is trying to
beat so fast that it merely quivers and can no
longer pump blood effectively. Sudden cardiac
arrest is a dangerous and life-threatening
condition.
What causes these rhythm disorders?
There are many things that can cause your heart
to beat in an irregular fashion, including
problems with your heart’s electrical system,
15
disease, a family history of rhythm disorders, as
well as other factors. People with heart failure
are at risk for rhythm disorders.
How does a heart failure device help
people with heart failure?
Most people with heart failure have mechanical
dyssynchrony, which means the right side of the
heart is not coordinated with the left side of the
heart. This makes the heart pump less efficiently.
A heart failure device paces the right and left
lower chambers of the heart together so that
they beat together as one unit.
How does the healthy heart beat?
Your heart has four chambers: two upper
chambers (the right atrium and the left atrium)
and two lower chambers (the right ventricle and
the left ventricle). The upper chambers are much
smaller than the lower chambers. The healthy
16
heartbeat begins with the heart at rest. It is
completely relaxed and blood flows into the
heart. The valves that separate the atria from the
ventricles are open.
Lung
Left atrium
Right atrium
Left ventricle
Right ventricle
Oxygen-poor blood
Oxygen-rich blood
Body
Oxygen-enriched blood
Oxygen-depleted blood
Then the valves between the atria and ventricles
close. Blood continues to flow into the atria.
A healthy heart in the center of the bloodstream
Together the atria contract and the valves open,
17
6|7
squeezing blood into the ventricles. The valves
close and, after a fraction of a second, the two
large ventricles squeeze at the same time and
the blood is pumped out into the body.
A healthy heart rhythm has one atrial beat for
each and every ventricular beat. This is called
One-To-One AV Synchrony. Sometimes electrical
problems affect one-to-one AV synchrony or
cause the atria and the ventricles to beat in a
disorganized way. If you have this type of problem
in addition to mechanical dyssynchrony, a heart
failure device may be able to help.
One-To-One AV Synchrony
Also written 1:1 AV synchrony. The healthy
heart rhythm in which there is one atrial
contraction or beat for every ventricular beat.
18
Do people with heart failure always have
rhythm disorders?
Not necessarily, although many people with heart
failure do have rhythm disorders. Heart failure is
mainly a pumping disorder (not a rhythm
disorder) and the heart failure device helps to
correct mechanical dyssynchrony, which many
(but not all) heart failure patients have.
Mechanical dyssynchrony is not a rhythm
disorder. However, many heart failure patients
are considered to be at risk for developing
arrhythmias – particularly very fast rhythms.
What kinds of very fast heart rhythms
are there?
There are several kinds of very fast rhythms
known as tachyarrhythmias or tachycardias. If
your heart is at risk of beating too quickly and
this abnormal rhythm starts from the lower
chambers (the ventricles), you have a ventricular
19
tachyarrhythmia. There are two main types of
ventricular tachyarrhythmia: those that are
extremely fast (ventricular fibrillation [VF]) and
those that are “slower” but still very fast
(ventricular tachycardia [VT]).
Tachycardia
Also called a tachyarrhythmia. Any heart rate
that is too fast for the person’s activity.
What is VF?
Ventricular fibrillation is the most dangerous
heart rhythm and can be life-threatening. It
occurs when the heart tries to beat very rapidly
and can no longer pump effectively. During VF,
the heart may try to beat 300 times a minute or
even faster. This condition is sometimes called
Sudden Cardiac Arrest (SCA).
20
Ventricular Fibrillation (VF)
A potentially life-threatening arrhythmia
originating in the ventricles in which the heart
tries to beat so quickly that it can no longer
pump effectively. During ventricular
fibrillation, the heart may try to beat 300 beats
per minute or faster. Sometimes called V-fib.
What does VF feel like?
People with VF experience a sudden, usually
unexpected lack of blood flow to the brain that
causes them to feel weak and then pass out. Left
untreated, VF can be fatal in a matter of minutes.
What is VT?
Ventricular tachycardia occurs when a
dangerous heart rhythm originates in the lower
chambers and causes the heart to beat too
rapidly. The exact rate of VT depends on your age
21
and overall health, and even then not all doctors
agree as to the rate range of VT. Generally
speaking, VT can range from more than 100
beats per minute to up to 200, or even 250, beats
per minute.
Ventricular Tachycardia (VT)
A potentially dangerous and sometimes lifethreatening arrhythmia originating in the
ventricles in which the heart tries to beat very
quickly and can no longer pump blood
effectively. Ventricular tachycardia can occur
at rates of 100 to 250 beats per minute. What
defines ventricular tachycardia is not so much
the rate, but that the patient does not tolerate
it well. The rate zones for ventricular
tachycardia vary by age, disease and fitness
levels. Sometimes called V-tach.
22
What does VT feel like?
People with VT usually experience a sense of a
pounding or racing heart and may have other
symptoms such as being out of breath, sweating,
blurred vision, dizziness and a feeling of being
unwell. Some people with VT faint or feel like
they might faint. VT can last a few moments or
several hours. A person with VT experiences a
very fast heart rate, even if he or she is resting.
VT is a potentially dangerous arrhythmia and can
even be life-threatening. A heart failure device
with defibrillation can help change a dangerous
rhythm into a safer rhythm.
How does the heart failure device with
defibrillation know whether a rhythm is
dangerous?
The device monitors every single beat of your
heart and detects unusual rhythms and high
rates. Your doctor can program how the heart
23
failure device with defibrillation, defines VT and
VF. When it detects such a rhythm, it confirms
the rhythm and then delivers treatment.
How does the heart failure device with
defibrillation treat VT and VF?
Your doctor can program your heart failure
device with defibrillation to treat a VT in different
ways. One way is using low-energy pulses called
antitachycardia pacing or ATP. In this approach,
the device will send a stream of rapid but very
small electrical pulses (perhaps less than one
volt) at the heart in an effort to reset it.
Antitachycardia Pacing (ATP)
Delivery of a series of rapid, low-voltage
pulses to the heart in an effort to stop an
arrhythmia.
24
Is ATP an effective therapy?
ATP does not work well for everyone, but it can
be an effective way to stop certain ventricular
arrhythmias in some people. The advantage of
ATP is that it uses low energy. Some people
experience a fluttering sensation in their chest
during ATP, but many people feel nothing
unusual at all.
What if ATP does not work?
If the device delivers ATP, it keeps monitoring the
heart. If the device detects that the dangerous
arrhythmia is still going on, it will deliver more
therapy, or it will then deliver a shock. In some
cases, the doctor can program the heart failure
device with defibrillation so that each new therapy
is stronger than the one before, up to the
maximum therapy. If ATP does not work, the
device may then deliver a shock.
25
How does a doctor know how much
shock I should receive?
Doctors usually set up shocks in terms of joules
or units of energy. The doctor can adjust the
amount of energy in these shocks at the time of
the implant or at follow-up visits. The amount of
shock needed varies and is determined by a
number of factors: the device you have, the
condition you have, the medications you take, and
the amount of energy your heart doctor
determines is needed to treat your condition.
Joule (J)
A unit of energy that is commonly used
to describe how much energy is in a
defibrillation shock. Technically, it is the
amount of energy needed to pass an electric
current of one ampere through a resistance
of one ohm for one second.
26
How does the heart failure device with
defibrillation treat VF?
When VF occurs, the device delivers its
maximum shock energy. ATP, or lower-energy
shocks, are not appropriate to treat VF since VF
is a potentially life-threatening condition that
must be stopped as soon as possible. A highenergy shock can reset the heart rhythm.
How does electrical energy reset the
heart cells?
The heart is a muscle made up of highly
specialized cells. These cells respond to electrical
energy. Most of the time, electricity travels
through the heart – that is, electrical energy
stimulates some cells, passes through, and then
stimulates new cells while the previously
stimulated cells recover. A defibrillation shock
causes all heart cells to be stimulated at once,
essentially “resetting” them to zero. After a
27
second or two, the heart muscle recovers and
the heart generates a new electrical impulse,
which can now travel through the heart normally.
How can the heart failure device with
defibrillation get enough energy to shock
the heart back into a normal rhythm?
The device contains a battery, as well as some
special components known as capacitors. The
capacitors store a charge. When the device
prepares to deliver a shock, it starts to send
electrical energy from the battery to the
capacitors, which hold it until all at once the
device delivers a high-energy shock. Capacitors
can charge in a matter of seconds.
Capacitor
A component within the heart failure
device with defibrillation designed to
hold and release an electrical charge.
28
What does a shock feel like?
That depends on how bad the rhythm disorder is
and how powerful the shock is. For a “slow” VT
and a low-energy shock, you may experience a
thump in your chest. For a high-energy shock,
the sensation may feel more like being kicked in
the chest. If you have a very dangerous rhythm,
you may faint or become unconscious before the
shock is delivered. Some people do not feel a
high-energy shock, but those who do say it is
painful. However, the shock lasts only a fraction
of a second and could save your life.
How quickly can a person recover from
a high-energy shock?
This depends. After you get a shock, you should
find a safe place to sit and rest; contact your
heart doctor and, if unavailable, summon
emergency medical help. Some people get back
to normal very quickly. Other people may feel
29
uneasy for hours. If you have trouble recovering
from a shock, talk to your heart doctor.
If defibrillation is so important,
why would a person get a heart failure
device without defibrillation?
Many people have a heart failure device that has
no ability to defibrillate. These devices are
implanted in patients who are considered to be at
low risk for the kind of dangerous arrhythmias
that require defibrillation. For other patients,
medication may be enough to reduce the risk of
dangerous arrhythmias. A heart failure device
with defibrillation is larger than a heart failure
device without defibrillation and may have to be
replaced more frequently. If you are concerned
about the type of device you have or may receive,
discuss this with your heart doctor.
30
Are there other types of
tachyarrhythmias?
Yes, there are also tachyarrhythmias that originate
in or near the atria. These are called atrial
tachycardia, atrial fibrillation and atrial flutter.
Atrial fibrillation is the most serious of these, but
it is not life-threatening. Atrial fibrillation is
sometimes referred to as A-fib or AF.
Atrial Flutter
A tachycardia that originates in the heart’s
upper chambers, or atria, and causes a rapid
atrial rate. The ventricles, or lower chambers,
try to keep up with the atria and also beat
too quickly, but without 1:1 AV synchrony. This
causes the heart to pump inefficiently.
Atrial flutter is often intermittent, that is, it may
come and go for no apparent reason. People with
atrial flutter may experience the sensation of a
31
racing or pounding heart, palpitations,
clamminess, fatigue or a feeling of being unwell.
Atrial fibrillation
(also known as A-fib or AF)
A very rapid atrial rate (300 beats per minute
or higher) that causes a loss of 1:1 AV
synchrony. The ventricles try to keep up with
the atria and end up beating too fast as well,
but their rate is erratic. Atrial fibrillation
may stop and start suddenly or it may be
longer lasting – even permanent.
Atrial fibrillation causes the upper chambers of
the heart to beat so fast (300 or 400 beats a
minute) that they cannot actually contract and
relax. They are trying to pump and relax about
5 or 6 times per second. That means instead of
pumping, the atria quiver and blood is not
32
effectively pumped out. Atrial fibrillation keeps
the heart from pumping blood efficiently and can
cause symptoms of a pounding or racing heart,
fatigue, dizziness, shortness of breath,
palpitations, a feeling of being unwell, and pain
or discomfort in the chest. A big concern with
atrial fibrillation is the risk of stroke. Since the
upper chambers do not pump efficiently, blood
collects in the upper chambers where it may clot.
If a clot breaks free, it can cause a stroke.
Would a heart failure device help me if
I have atrial fibrillation?
Atrial fibrillation can be a challenging arrhythmia
to treat. While your heart failure device does not
specifically treat atrial fibrillation, it may help you
if you have this condition. A BIOTRONIK device
can monitor the heart and can alert your heart
doctor if it sees evidence that you have atrial
fibrillation. Your heart doctor can then adjust
33
your heart failure device and prescribe
medications to help with the atrial fibrillation.
Why is it important to treat atrial
fibrillation?
Atrial fibrillation is not life-threatening, but it can
be dangerous. If you have atrial fibrillation, your
risk of having a stroke increases by a factor of five.
Atrial fibrillation can also cause uncomfortable
symptoms, such as shortness of breath,
weakness, dizziness and even fainting. Atrial
fibrillation is what doctors call a “progressive”
disorder, which means that, if left untreated, it
tends to get worse over time. For that reason, it is
important to find out if you have atrial fibrillation
so that your heart doctor can help you manage it.
In many cases, atrial fibrillation is treated with
drug therapies or medications.
34
Are there other types of rhythm
disorders?
Yes, your heart can also beat too slowly. Any type
of too-slow heart rate is called a bradyarrhythmia
or bradycardia. It is not unusual for one person to
have both too-fast and too-slow rhythm disorders.
Bradycardia
Any heart rate that is too slow to support the
person’s activity. Another term for bradycardia
is bradyarrhythmia.
People with bradycardia may feel overly tired, be
short of breath, or have other symptoms because
the heart does not beat fast enough to pump
enough blood to meet their needs. A heart
failure device can help a person with bradycardia
because the heart failure device will keep the
heart beating at an appropriate rate. Many (but
35
not all) people with heart failure devices have
bradycardia at least some of the time.
What causes bradycardia?
To understand bradycardia, you have to know a
little bit about the heart’s natural electrical
system. To know when to pump, your heart relies
on electrical pulses generated by a small
area of tissue called the sinoatrial node
(SA or sinus node).
Sinoatrial Node
Also called the sinus node, the sinus, or SA
node. This is an area of highly specialized
tissue on the upper area of the right side of
your heart (the so-called “high right atrium”).
The sinoatrial node generates electrical
pulses and drives the heart rate. In fact, the
sinoatrial node is nicknamed the “heart’s
natural pacemaker.”
36
In the healthy heart, the SA node generates a
small electrical signal that travels across the
upper chambers of the heart (the atria), down
to the center of the heart to the
atrioventricular node or AV node, and then
continues down to the two larger lower
chambers of the heart (the ventricles).
Atrioventricular Node
Also called the AV node. Located in about the
middle of the heart, below the upper
chambers and above the lower chambers, the
atrioventricular node is an important stop on
the electrical conduction pathway through the
heart. In the healthy heart, the atrioventricular
node slows the electrical pulse slightly
(fractions of a second) so that the upper
chambers can fully pump and relax before the
lower chambers pump.
37
Sometimes, however, problems can occur in the
heart’s electrical system, such as bradycardia.
What does it feel like to have
bradycardia?
People with bradycardia may feel overly tired, be
short of breath, or have other symptoms because
the heart does not beat fast enough to pump
enough blood to meet their needs.
Are there different types of bradycardia?
There are a couple of different ways in which
bradycardia can occur. You might have
bradycardia because your SA node fires too
slowly or does not fire regularly. This is
sometimes called sinus bradycardia because it
is caused by the sinus node (SA node).
38
Sinus Bradycardia
A type of too-slow heart rate that occurs
because the SA node does not fire quickly
enough or because it is erratic or unreliable.
Another type of bradycardia occurs when the
electrical pulse traveling through the heart
travels too slowly or is somehow delayed or even
blocked along its pathways through the heart.
This is called heart block. The SA node may
function perfectly well, but the electrical energy
does not travel reliably through the heart.
Heart Block
A type of too-slow heart rate that occurs
because the electrical pulses from the
SA node are delayed or even blocked at
the AV node.
39
Are there different types of heart block?
There are three main types of heart block that
are identified by degrees. In first-degree heart
block, the electrical pulse from the SA node is
delayed at the AV node. First-degree heart block
may be mild and cause you few or no
symptoms. In many cases, first-degree heart
block may be intermittent.
Intermittent
A medical term that describes a condition
that comes and goes. A person with
intermittent AV block experiences it some
of the time but not continually.
Second-degree heart block is more severe. In
this case, some (but not all) of the impulses from
the SA node are blocked at the AV node. This
results in a too-slow heart rate and a loss of AV
synchrony. People with second-degree heart
40
block may have symptoms that include dizziness,
lightheadedness, shortness of breath and a
feeling of being unwell; they can even faint.
Third-degree heart block is also called complete
heart block. In this case, all of the electrical
impulses from the SA node are blocked
completely at the AV node. The lower chambers
of the heart continue to beat on their own, but
they beat at a much slower rate. People with
third-degree heart block have a very slow heart
rate and a loss of 1:1 AV synchrony. They can
have severe symptoms.
How do I know what kind of
arrhythmias I have?
Ask your doctor about the type of arrhythmia that
you have. On the one hand, you may not have any
or you may have only intermittent arrhythmias.
On the other hand, you may be at risk for severe
arrhythmias. It is not unusual for a person with
41
one arrhythmia to develop another arrhythmia
over time or to have more than one kind of
arrhythmia. Your doctor may ask you to undergo
some testing or monitoring to determine the
exact type of arrhythmia that you have.
What does it feel like when the heart
failure device paces the heart to treat
my mechanical dyssynchrony?
Your heart failure device uses such little energy
to pace the heart, you probably will not be able
to feel it at all. It is highly unusual for patients to
report “feeling” the device at work.
Is there any other way to treat heart
failure?
There are many things your doctor can prescribe
or recommend that can be helpful to you if you
have heart failure. Most people with heart failure
take medications. You may be asked to watch
42
your fluid intake. However, a heart failure device
is the only way to correct mechanical
dyssynchrony.
Will I still have to take heart failure
medications after I get a heart failure
device?
Only your doctor can tell you for sure, but most
people with heart failure devices also take heart
failure medications. Heart failure is a complex
condition and often requires several
medications and a device to address all of the
symptoms involved.
43
Will my heart failure ever go away
on its own?
While some health problems can clear up on
their own, it is unlikely that your heart failure will
go away. In fact, heart failure can become
progressively worse over time. There is some
evidence from clinical studies that heart failure
device pacing over time can help your heart
resume a more healthy shape. This process is
44
called remodeling, and it has been observed with
long-term heart failure pacing in some patients.
As the heart remodels, it gets healthier and
stronger and your heart failure may improve, but
it does not go away.
Remodeling
A change in the shape of the heart to a more
normal shape after heart-failure-type pacing.
I have never had a dangerous
arrhythmia before. Why does my doctor
want me to get a heart failure device
with defibrillation?
It is unusual for a person to have experienced a
dangerous arrhythmia before because these
arrhythmias can oftentimes be fatal. In an effort
to save lives, doctors have studied people with
rhythm disorders and found that there are risk
45
factors for dangerous arrhythmias. These
include having right and left ventricles that do
not contract at the same time (mechanical
dyssynchrony), having heart failure or having a
low ejection fraction. Some people are at very
high risk for a life-threatening arrhythmia, even
though they have no symptoms and no history of
arrhythmia. For such people, defibrillation is a
preventative treatment. This type of therapy is
sometimes called primary prevention.
Risk Factors
Conditions that make it more likely that a
particular disease or rhythm disorder will
occur. For example, smoking is a risk factor
for cancer. Some risk factors cannot be
changed, such as age or family history.
46
Ejection Fraction
The amount of blood, stated as a percentage,
that the heart can pump out in one beat.
Nobody has an ejection fraction of 100 %.
A normal ejection fraction is around 60 %
(meaning that in one beat, the heart pumps
out 60 % of the blood it contains). An ejection
fraction below 35 % may be considered a risk
factor for arrhythmias.
Primary Prevention
An approach to defibrillation therapy in which
a device is implanted in a patient at high risk
for dangerous arrhythmias even if he or she
has not yet had such an arrhythmia.
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I have survived a dangerous arrhythmia
before. Why does my doctor think I need
a heart failure device with defibrillation?
If you have had a dangerous arrhythmia and
survived, you are very fortunate, but you are also
at high risk for having another dangerous
arrhythmia in the future. Your device will help
protect you should that occur.
What if my heart condition changes
in the future?
Your heart condition may change over time. A
heart failure device can be individually
programmed for you by adjusting dozens of
specific settings. If your condition changes, your
doctor can adjust the device to new settings to
meet your new needs.
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How can the doctor adjust the heart
failure device once it is implanted in
my body?
The clinical team (doctors, nurses) can
communicate with the implanted heart failure
device by using a special device called a
programmer. A programmer is a computer that
uses special radio waves to share information back
and forth with the implanted heart failure device.
49
Programmer
A special computer that a doctor can use to
communicate back and forth with an
implanted heart failure device. The
programmer can obtain information stored in
the device and can also change its settings.
Communicating with the device is a simple and
painless procedure. With the programmer, your
clinician can get information stored in the heart
failure device and also change how the device is
set. For example, it is possible to change the rate
for pacing.
How does my heart failure device pace
my heart?
The heart failure device system consists of a
pulse generator (running on a battery) plus at
least two and sometimes three wires called leads.
50
The leads are plugged into the heart failure device
at one end and the other ends are maneuvered to
the heart. One lead will be placed in the inside of
the right ventricle. Another lead will be placed in
a coronary artery on the outside of the heart so
that it can pace the left ventricle. In some cases, a
third lead is placed inside the right atrium or
upper chamber of the heart. Electrical pulses
from the pulse generator travel via the leads to
the heart. This electrical pulse causes the heart
muscle to contract. By pacing the right and left
ventricles so that they contract at the same time,
the device can resynchronize them. In fact,
doctors call this kind of pacing cardiac
resynchronization therapy (CRT).
51
Lead
Also called pacing wire, or wire. A thin,
flexible, insulated wire with one or more
electrodes at the end. One end of the lead is
plugged into the heart failure device, and the
other end (with the electrode) is attached to
the heart. Electrical pulses from the device
travel via the lead into the heart to pace. The
device also uses the leads to sense what is
going on in the heart.
52
Cardiac Resynchronization Therapy
Pacing the right and left ventricles of the
heart at the same time so that they beat
together as one unit.
Why is one of the leads placed outside
the heart and not inside it?
The left lead in a heart failure device system is
always placed in a blood vessel on the outside of
the heart, but in a location where it can pace the
left ventricle. This has to be done this way
because the left ventricle is the heart’s main
pumping chamber that pumps blood out of the
heart into the rest of the body. It is much larger
and stronger than the right ventricle, which only
has to pump blood from the heart across the
lungs. The powerful force of the pumping action
makes it impossible to secure a lead inside the
left ventricle. However, the left ventricle can be
53
reliably paced by delivering the pacing pulse to
the outside of the heart.
Are there different types of leads?
Yes, there are many types of leads. For example,
if your heart failure device offers defibrillation,
you will need a defibrillation type of lead in the
right ventricle. There is a special lead designed
for pacing the left ventricle as well. Leads may
also be distinguished by their length and how
they attach to the heart.
If my heart failure device
defibrillates, does it defibrillate
only in the right ventricle?
Yes, but the shock energy is large enough to
defibrillate the whole heart.
54
How does the heart doctor know
whether I need a heart failure device?
The heart doctor will base the conclusion on your
overall health, your medical history and the
results of tests. Some of these tests may involve
procedures to observe your heart’s rate and
rhythm. Every patient is unique, so your doctor
will base his or her decision on the factors
specific to you. If a heart failure device is
recommended, your heart doctor can answer
your questions and schedule your surgery.
Should I get a second opinion before
getting a heart failure device?
If you ever feel that you need more information,
or if you are unsure about your heart doctor’s
recommendations, it is wise to consult another
specialist for a second opinion. Your heart doctor
will not be offended if you want a second opinion.
55
What is the surgery like when a heart
failure device is implanted?
The physician will implant the device in your body.
For most people, the device is implanted in the
upper chest below the collarbone, but in some
cases, the heart doctor may decide it is better to
implant the device in the abdomen. The doctor
will make a small cut in a nearby vein and then
advance the leads gently through the vein. This is
done using a device called a fluoroscope, which is
like a video X-ray. Once the lead is in place in or
on the heart, it is plugged into a testing device to
be tested for proper placement and function.
Most heart failure devices are implanted with
three leads. Once all of the leads are in place and
have been tested to show they are working
properly, the leads are then plugged into the heart
failure device. At that point, the area where the
device is implanted is sewn up. This procedure is
often done under a local anesthetic. You will be
56
given some medication to help relax, and your
chest area will be numbed, but most patients are
awake during the procedure.
Fluoroscope
A device that allows for real-time X-rays to be
taken, creating a sort of X-ray movie. A
fluoroscope is used during device implantation
so the physician can observe the lead
advancing through the vein and into the heart.
How long does the surgery take?
While that depends on your particular case,
it generally lasts about one to two hours.
Is it painful to be awake during the
surgery?
If your doctor decides that you should be awake
during surgery, you will be given some medication
to numb the area where the heart failure device is
57
implanted. If you feel pain or even discomfort, tell
the clinical team at once. They can adjust your
medication so that you are not in any pain or
discomfort, although you may feel some pressure
at times. You will be draped so you cannot see
what the clinicians are doing. However, you will
likely be aware of what is going on around you.
What will go on during the device
surgery?
You may be surprised that several clinicians are
in the room. There is one doctor who performs
the surgery, but another physician may be
present to assist. There will likely be at least one
nurse in the room. A technician may be present
to operate some of the monitors and technical
equipment. During the procedure, these
clinicians talk to each other, and you may hear
some loud voices around you. Do not be alarmed,
this is very normal. During the operation, they
58
may call out numbers or other information to
each other. They may also occasionally talk to
you to check that you are comfortable. If you have
a heart failure device with defibrillation, in some
cases your device will be tested during the
implantation procedure. The doctor will apply
some electrical energy to your heart to cause a
rhythm disorder, then the device will be tested to
see if it can identify and stop the rhythm disorder
and change your heart rhythm back to normal.
You may be given some extra medicine, and the
clinical team will tell you what to expect.
How will they actually perform the
implant surgery?
The physician will make an incision to create a
pocket where the device is placed. For most
people, this is in the upper chest below the
collarbone, but in some cases, the doctor will
make the pocket in the abdomen.
59
Pocket
A small area that the physician forms in
the upper chest (or sometimes abdomen)
that is just large enough to hold the
implanted device.
This pocket is typically formed above the muscle,
and it is only large enough to contain the device.
Once the pocket is formed, the clinicians will
drench it in antibiotics to prevent infection.
Meanwhile, the physician will make a small
incision in a nearby vein. Through this tiny cut he
or she will insert the leads. Each lead is
temporarily stiffened for this procedure by the
insertion of a very thin wire called a stylet. Using
a fluoroscope, or video X-ray machine, the
physician will gently advance the lead with stylet
through the vein and into the heart.
60
Once the lead is in position, the other end is
plugged into a special device used for testing.
The physician will test the lead to make sure that
it functions properly. It is sometimes necessary
for the clinical team to detach the lead and
reposition it to get it to work better. This is not
unusual. Once the clinical team has the lead in
the best possible position, the lead is unplugged
from the test device, plugged into the
implantable heart failure device and tested again.
After making sure it is working properly, the
heart failure device is placed into the pocket, and
the pocket is sewn closed.
Is lead testing the same as the testing
the doctors do when they cause a
rhythm disorder (defibrillation testing)?
No. Each lead will be checked to make sure it
can pace and sense and that it is located properly
in the heart. For heart failure devices with
61
defibrillation, the doctor may also want to test
whether the device can stop a rhythm disorder.
This is a different kind of test. It is not always
necessary to do this test for all patients, even if
they have heart failure devices with defibrillation.
When it is done, it is to make sure that the device
can identify a dangerous rhythm disorder, stop it,
and change the heart rhythm back to normal.
How long is the recovery time after
surgery?
The recovery time depends on your overall
health, your condition, the type of procedure you
had and your age. While some heart failure
devices are implanted on an outpatient basis,
many people stay one or two nights in the
hospital. When you are discharged from the
hospital, you will be given specific instructions
about how to care for yourself.
62
What should I do right after surgery?
In the first days after your heart failure device
surgery, you may find the implant site to be
tender and slightly swollen. The clinical team will
advise you how to keep the implant site clean
and dry. If you notice any redness or extreme
soreness at the implant site, contact your heart
doctor immediately or go to the emergency
room, as these are possible signs of infection.
You may soon feel some of your symptoms are
gone or are reduced. In the first few days after
surgery, avoid all strenuous activity and exercise,
and do not lift your arms over your head. Moving
your arms can place a strain on the implanted
lead(s). In a few weeks, the leads will be firmly
attached to the heart, but in the first weeks after
surgery, strenuous activity may move the leads
out of their proper place.
63
What should I do during the recovery
period?
You will likely need a few weeks, possibly even a
few months, to fully recover from surgery. You
should feel better and better with each passing
week. During this time there are a few
recommendations to speed your healing:
Do not wear clothing that binds or is tight over
the implant site.
Avoid touching the implant site as much as
possible.
Do not lift or carry heavy objects, and do not
carry anything heavy on your shoulder (such as
a heavy bag, purse or backpack).
Avoid strenuous exercise and “big” or twisting
motions. This would include, for example,
swinging a golf club or baseball bat, picking up
a child or gardening.
64
Do not raise your arms up over your head for
the first few weeks after surgery.
Your heart doctor will tell you when you can
resume your normal activities and which
activities you might have to modify or give up.
65
Which activities might I need to give up
now that I have a heart failure device?
Your heart doctor will give you specific advice
about what you can and cannot do now that you
have a heart failure device. In general, people
who have a heart failure device can do most of
what they used to do – and may even find that
they have more energy and feel better so that
they can resume doing things that they had
previously given up. That being said, if you have a
heart failure device, you should avoid
participating in sports that might cause you to
suffer a blow to chest, such as football or boxing.
Do not fire a rifle with the gun butt directly over
the implant site. You will likely be able to resume
most regular activities, such as:
Returning to work
Traveling
66
Playing sports (with the exception of contact
sports, during which the implant site could
be hit)
Bathing, swimming and showering
Normal sexual activity
Moderate exercise, as your overall health
permits
If you find that any particular activity makes you
feel worse, tell your doctor at once.
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Can I still drive?
Some areas may have laws or regulations about
whether a person with a heart failure device with
defibrillation can still drive. Ask your doctor
about driving and the laws in your area.
Why would there be any problem with
driving if I have a heart failure device
with defibrillation?
You have a heart failure device with defibrillation
because you are at risk for a dangerous rhythm
disorder. The concern is that you might have
such a rhythm disorder and suffer symptoms or
have a shock while driving. Your doctor can help
determine if and when you can resume driving.
Are there driving restrictions for people
who have a heart failure device without
defibrillation?
No.
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What does it feel like to have a heart
failure device?
At first, you may be very aware of the device, and
you may want to touch the implant site. After a
few weeks, you will get used to this. If you have a
heart failure device without defibrillation, you will
soon not notice it at all. On the other hand, if your
heart failure device has defibrillation and it treats
a dangerous heart rhythm, you may feel it. If the
device delivers antitachycardia pacing (ATP), you
may not feel anything, or you may feel a sort of
fluttering in your chest. If the device delivers a
shock, what you experience will depend on your
rhythm disorder and how much electricity the
shock sends to the heart. Shocks can be painful,
but they last only a fraction of a second. Some
people with dangerous rhythm disorders are
unconscious when the shock is delivered and do
not feel it.
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How many shocks can I expect to
receive if I have a heart failure device
with defibrillation?
That depends. Some people with heart failure
devices with defibrillation never get a shock.
Some people will receive several shocks a year. If
you receive frequent shocks, your heart doctor
may prescribe some medications that can help
reduce the number of arrhythmias you
experience. These medications do not guarantee
that you will never have any rhythm disorders, but
they may make them less frequent. Your heart
doctor may be able to adjust the device to reduce
the number of shocks you get. Of course, if you
have a heart failure device without defibrillation,
you will never get a defibrillation shock.
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Where does the device get all the energy
to pace the heart and even shock it?
Your heart failure device is battery-powered. In
fact, the battery takes up most of the space
inside a heart failure device. This is a very special
long-life battery that is designed to alert the
physician when it is running low.
How long does this battery-operated
device last?
How long the battery lasts depends on how much
energy the device needs to resynchronize your
heart and, if it has defibrillation, whether or not
the device delivers shocks. Unlike pacemakers,
which may pace the heart only some of the time,
a heart failure device is designed to provide
pacing all of the time – what doctors call “100 %
pacing.” Your heart failure device should last a
couple of years; it may last far longer than that.
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When you go for your checkup, your physician can
estimate how much longer your device will last.
Is there any warning before the battery
runs out?
Yes. Heart failure device batteries are different
from car batteries or other batteries that deplete
suddenly. A heart failure device battery signals
when it is nearing depletion but still runs for
many months at full capacity. Your heart doctor
will alert you when the battery is nearing
depletion – but you will still likely have weeks or
even months to schedule a replacement.
What is a replacement?
When the battery wears out, the entire device is
removed and a new heart failure device is
inserted in place of the old one. This involves a
new surgical procedure, but it is usually faster
and easier than the original procedure. In most
72
cases, the leads stay in place. They are just
unplugged from the old device and then plugged
into the new device.
Why can’t they just replace the battery?
Your heart failure device is hermetically sealed to
prevent fluids in your body from entering the
device and interfering with the circuits. There is
no way to open it up and remove the battery. For
that reason, the entire heart failure device is
removed and replaced.
How often do I need to have checkups?
Most heart failure device patients need to see
their doctor from two to four times a year, but
some may have more checkups than that. How
often the doctor wants to see you depends on
many factors. During most visits, the doctor or
nurse will examine you, ask you some questions,
and then check your device using a special
73
computer called a programmer that can
communicate with the implanted heart failure
device. This is completely painless.
Why do I need to go to so many
checkups?
It is important for the clinical team to monitor
your device. Each time you come in for a
checkup, they will see how much energy is left in
the battery. They can also check to make sure
that the leads are working properly and that the
device is doing what it is supposed to do. While
many of these visits will be routine, it is
important to know that your device is always
working properly.
What should I tell my heart doctor
during my routine checkup?
Report to your physician any unusual symptoms
such as redness at the implant site, difficulty
74
breathing, swelling of legs or hands, chest pain,
dizziness, lightheadedness, shortness of breath,
fainting spells, persistent hiccups or abnormal
heart rates (such as a very slow, very fast or
abnormal pulse). Also tell your doctor about any
changes in your health, new medications you are
taking and medications you have discontinued.
What should I tell my family about my
heart failure device?
Chances are that unless you tell others that you
have a heart failure device, they will never know.
Most people with heart failure devices live
normal, active lives. While your medical privacy is
important, you should consider that in the event
of an emergency, those around you should be
able to inform the medical team that you have a
heart failure device. If you have a device with
defibrillation, they should also know what to do
in the event you have a shock. For that reason,
75
we recommend that you share this information
with your family and those close to you.
Sometimes I hear the doctors or nurses
calling my device a pacemaker. Isn’t a
pacemaker something different than a
heart failure device?
Yes and no. The electronics of both devices are
very similar because they both pace and sense
the heart. A heart failure device and a pacemaker
look alike and share many functions. Your heart
doctor and nurses can communicate with both
heart failure devices and pacemakers using the
same programmer. There are, however, several
differences. The main difference is that a
pacemaker paces only the right side of the heart,
while a heart failure device paces both the right
and left sides of the heart. Another difference is
that only a heart failure device has a left-heart
lead. Most people who get pacemakers have
76
hearts that beat too slowly, at least some of the
time. People get heart failure devices to treat
mechanical dyssynchrony, which they have all of
the time. For that reason, pacemakers pace only
when needed, while heart failure devices pace all
of the time.
Is it safe to be near a microwave oven?
Yes. Normal household appliances in good
condition will not interfere with your heart
failure device.
Can I still use a computer?
Yes. A computer or tablet computer will not
interfere with your heart failure device.
Can I still use a cell phone?
In general, most cell phones in good condition
are safe around heart failure devices. It is
recommended that you do not place the phone
77
over the implanted heart failure device (even if
the phone is turned off) and that you hold the
phone on the side of the body opposite your heart
failure device.
Can I go through airport security or
other checkpoints?
There are many different types of security
systems in use today and it is difficult to make
any general recommendation. Instead, we
recommend that you present your BIOTRONIK ID
card to the security personnel, request a patdown and follow their instructions. Whether or
not you can go through security machinery, you
should have no problem traveling. Airport and
other personnel are trained to assist people with
all kinds of implantable devices so that they can
safely clear security checkpoints.
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BIOTRONIK Home Monitoring®
BIOTRONIK Home Monitoring® is an
important feature available in BIOTRONIK
heart failure devices. Your heart doctor’s
office may set up Home Monitoring for you. If
you have questions about Home Monitoring
capabilities, ask your heart doctor directly.
You may be given a separate transmitter system
along with your heart failure device. Together,
your heart failure device and the transmitter can
share information with your doctor about your
heart and your device and how they are working
together. In simple terms, the heart failure device
communicates automatically to the transmitter,
and the transmitter then sends information to a
secure computer server that your doctor can
access. This happens without any special action
on your part. It is painless. In fact, you will not
even be aware that it is happening.
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BIOTRONIK Home Monitoring® has changed heart
failure device therapy. With Home Monitoring, your
heart failure device can report directly to the
doctor about any unusual heart rhythms you have
experienced, or if the device battery is low, or if a
lead is not functioning properly. If you have a heart
failure device with defibrillation that delivers a
shock to treat a dangerous arrhythmia,
BIOTRONIK Home Monitoring® will automatically
alert your heart doctor.
80
In some cases, the heart failure device can
detect and identify a problem before you even
know it is there. But most of the time, Home
Monitoring just confirms to your heart doctor’s
office that everything is working fine.
BIOTRONIK Home Monitoring® provides you with
an automatic connection to your physician, even
as you go about your ordinary daily activities. Your
heart doctor can help you decide if Home
Monitoring is right for you.
Please note that the transmitter is NOT an
emergency system. It is for monitoring only.
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Resources
You may want to learn more about your heart
failure device or want to meet other people who
have similar devices to share experiences.
There are a number of resources that may be
helpful to you.
Websites
Please note that websites change frequently, and
the ways to access patient information may
change with time. Visit the sites, and seek the
sections designated for patients.
With the exception of the BIOTRONIK site,
BIOTRONIK is not responsible for the content of
the sites referenced, but has examined them at
the time of printing and found them to be of
potential interest to you.
BIOTRONIK
BIOTRONIK maintains a large website with high
quality information for patients about its
82
products and pacing in general. Visit
biotronik.com and click on the tab marked
“Patients.” You will find information about the
heart, heart failure, rhythm disorders, cardiac
resynchronization therapy, defibrillation and
heart failure devices.
HRSOnline
The Heart Rhythm Society is a large nonprofit
organization for clinicians who specialize in
cardiac rhythm management devices. Visit them
online at HRSOnline.org. Locate the tab marked
“Patient Resources.” They have information
about the heart, electrical problems with the
heart, heart failure and cardiac
resynchronization therapy.
FDA
The U.S. Food and Drug Administration (FDA)
has an extensive website that contains a
83
significant amount of consumer information.
The FDA information is more likely to be topical
and based on new research, new products or
potential product problems. Visit them at
FDA.gov and then select “Medical Devices.”
Look for resources for consumers.
Pacemaker Club
The Pacemaker Club is an organization run by
individuals who have implanted cardiac rhythm
management devices like pacemakers or heart
failure devices. It operates as a message board
where people with devices can share
experiences, ask questions and find support
and encouragement. It is important to know
that the Pacemaker Club is not run by medical
experts or monitored by physicians. This site
84
should not be taken as a source for medical or
health information, but it is a great way to
connect informally with other people who have
devices. Visit them at the pacemakerclub.com.
You will need to register to participate, but
registration is free.
Support Groups
Some hospitals hold regular support group
meetings for people with cardiac rhythm
management devices. Ask your heart doctor if
there are such meetings in your community or
contact local hospitals. These groups bring
together patients and their loved ones to share
experiences and offer encouragement. They may
also periodically offer educational sessions or
guest speakers.
85
Important information
Contraindications
In the United States, the law requires this
manual to describe the contraindications
for the device.
Contraindication
A condition or situation in which it may not
be appropriate for you to have this device.
This heart failure device may be contraindicated
in certain people. Your physician has evaluated
these contraindications for you. If you have
questions about whether or not a heart failure
device is appropriate for you, please talk to your
physician.
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This heart failure device is contraindicated:
If your anatomy does not allow it to be properly
placed.
If you have a mechanical heart valve.
If you have other implanted medical devices
that are not compatible with this heart failure
device.
If you have a heart rhythm known as constant
or incessant ventricular tachycardia or
ventricular fibrillation.
87
If you have certain heart rhythm disorders.
The type of rhythm disorder you have is a very
important consideration. Heart failure devices
are not appropriate for all rhythm disorders.
The type of rhythm disorder you have may
determine which type of heart failure device is
indicated.
If the dangerous heart rhythms you have are
considered temporary or reversible.
Your heart rhythm might be considered
temporary or reversible if it occurs because of
some condition or event and it is expected that
when you heal, your heart rhythm will go back
to normal. These kinds of temporary or
reversible dangerous heart rhythms may
happen:
Right after a heart attack.
If you take too much of certain medications.
88
After nearly drowning or receiving an electric
shock.
If you have an electrolyte imbalance.
If you have sepsis.
If certain areas of your body are starved for
oxygen.
Heart Attack
Also called a myocardial infarction (MI). A
medical event that occurs when one or more of
the arteries that supply the heart muscle with
oxygen are clogged or blocked. This results
in a portion of the heart muscle being starved
for oxygen. This tissue dies. Depending on
how much tissue dies, the heart attack may
be major or minor. It is not unusual for people
to have dangerous abnormal heart rhythms
immediately after a heart attack.
89
Sepsis
A severe condition characterized by a wholebody infection.
Special wires, also called leads, are used with the
heart failure device. Certain leads may be
contraindicated if you cannot tolerate a small
dose of steroid medication. In such cases you
may still be able to have a heart failure device, but
it must use a different type of lead.Your doctor will
check on this before implanting your device.
Risks, warnings and precautions
As with any medical device, there are certain
risks and safety concerns associated with having
a heart failure device.
90
Risks
The following lists some rare but possible
adverse events associated with a heart failure
device.
Adverse Events
Sometimes called “side effects,” these are
negative occurrences and / or symptoms
that may be associated with the heart failure
device.
These adverse events may be unpleasant,
uncomfortable or painful. Some of these risks
may require you to undergo surgery again to
replace, remedy or remove the entire heart
failure device system. Your physician can explain
these risks to you in more detail and may be able
to take steps to minimize these risks. If you
experience any of these adverse events, or other
unusual problems that may or may not be
91
related to the heart failure device, please tell
your physician at once.
Bleeding around the heart
Damage to the heart
Collection of air or gas in the chest cavity
Death, if the device is not able to function
properly
The device moving from its original location
and / or protruding through the skin
Infection
Problems with the device lead(s)
Blood clots
Blocked blood vessels
Rejection of the device by the body
Muscle or nerve stimulation that may
cause hiccups
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Fluid accumulation around the heart
failure device
Faster heart rates
Unnecessary shocks
Vein closure
Some of these conditions may occur without your
being aware of them. For that reason, you should
see your heart doctor for all regular checkups.
Warnings
Warnings advise you about certain situations that
can put you at serious risk and may damage your
health. There are some important warnings for
people with heart failure devices.
Strong magnetic fields can interfere with your
device. This includes industrial magnets, heavy
industrial equipment and certain amusement
park rides. If you know you are near a strong
93
magnet, move away from the magnetic field as
soon as you can. The heart failure device is
designed to withhold treatment when in a
strong magnetic field, so your device may not
deliver the therapy you need if you are around
strong magnets. Some heart failure device
patients (but not all) may also experience
dizziness, lightheadedness or a feeling of being
unwell when they are in a magnetic field.
Magnetic resonance imaging (MRI) can
interfere with the device, damage the device
and / or lead(s), and may harm you. Avoid MRI
procedures. If an MRI is ever recommended,
tell the clinical team that you have a heart
failure device. Always carry your BIOTRONIK
identification (ID) card with you in case you
cannot speak for yourself.
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This warning does not apply to BIOTRONIK
ProMRI® systems.
Some devices may be approved as safe for
certain kinds of MRI procedures. If yours is one
of these, your patient ID card from BIOTRONIK
will have a MR symbol on it.
Magnetic Resonance Imaging (MRI)
A procedure to painlessly take a picture of the
soft tissue in the body using magnetic waves.
95
Defibrillation
The use of high-energy shocks to “shock” the
heart out of cardiac arrest and restore the
heart to normal rate and rhythm. Not all heart
failure devices have defibrillation, but many do.
Defibrillation Function Testing
The use of the newly implanted heart failure
device with defibrillation to identify and treat
a potentially dangerous heart rhythm that
the doctor induces in the hospital setting.
This test makes sure the device can detect
dangerous heart rhythms and treat them
quickly and effectively.
Defibrillation function testing may be
necessary for some heart failure devices to
test the system. Defibrillation function testing
96
is only done for heart failure devices with
defibrillation, and then only at your heart
doctor’s request (not all heart failure devices
offer defibrillation). If such testing is necessary,
it will be done during the implant surgery. Your
heart doctor will electrically cause your heart
rhythm to become fast and irregular and then
use the device to detect and treat the rhythm
to bring your heart back to normal. The
purpose of the test, which is safely conducted
by the clinical team in the hospital, is to be
sure that your device is able to identify
dangerous heart rhythms and treat them
effectively. The defibrillation function test is
usually only performed when the device is
implanted, but it may be necessary to test the
device more than once.
During a defibrillation function test, you may
experience discomfort and pain. Although rare,
97
in some cases the heart failure device with
defibrillation will not be able to treat the
dangerous heart rhythm provoked by the doctor.
If this happens, the clinical team may use an
external defibrillator to bring your heart back to
normal. External defibrillation can be painful.
Defibrillation function testing can give your
doctor important information so he or she can
program your device to work effectively for you.
Precautions
Precautions are advice to you to protect you from
minor injury and to keep your heart failure device
in good working condition.
Initial precautions
(First three months after implant)
Right after the implantation procedure takes
place, avoid making sudden and / or very large
movements or doing strenuous activities. Avoid
98
lifting or carrying heavy objects. These kinds of
vigorous activities can delay healing of the
implant site or even cause your wound to reopen.
Vigorous movement can also put stress on the
device leads. Avoid wearing tight clothes or
anything that might put pressure on the implant
site. Take care that nothing bumps or hits the
implant site. If you are worried or concerned
about any of these restrictions, contact your
heart doctor.
Cell phones
You may use a cell phone with a heart failure
device provided you take some simple
precautions.
Keep the phone at least 6 inches (15 cm) away
from the device at all times, even when the
phone is turned off.
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Hold the phone to the ear opposite the heart
failure device. For example, if your heart failure
device is implanted on your left side, hold your
cell phone to your right ear.
Do not put the phone over the heart failure
device or carry it in a breast pocket so it is over
the heart failure device, even if the phone is
turned off.
Metal detectors and security checkpoints
Avoid both walk-through and handheld metal
detectors. If you need to pass through a security
checkpoint (at the airport or a courthouse, for
example), tell the security personnel that you
have a heart failure device and show your
BIOTRONIK ID card. Security professionals are
trained to check people with implanted devices
without the use of the metal detectors. You may
be subject to a pat-down search.
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Electromagnetic interference
People with heart failure devices should try to
avoid electromagnetic disturbance which may
cause electromagnetic interference (EMI).
Electromagnetic Interference (EMI)
Electronic disturbances are invisible signals,
sometimes called “static” or “noise” that can
interfere with certain medical devices, including
heart failure devices. Power tools, heavy
101
machinery, theft detection systems and security
systems may all produce electromagnetic
emissions, which can create electromagnetic
disturbances. These disturbances may result in
electromagnetic interference (EMI).
Your heart failure device was designed with
special filters to keep out and reduce unwanted
electromagnetic disturbances which may cause
EMI. If your heart failure device senses EMI, it
may “think” that these signals are coming from
your heart and cause your heart failure device to
respond inappropriately. Your device may not
work as your doctor programmed it and/or it may
not give you the therapy you need. If your heart
failure device has defibrillation, EMI may cause
the device to deliver an unnecessary shock which
can be painful and may even start a dangerous
heart rhythm. EMI can also cause the heart
102
failure device with defibrillation to withhold
defibrillation when you do need it, which puts you
at risk during a dangerous heart rhythm. For
these reasons, people with heart failure devices
should try to avoid sources of electromagnetic
disturbance as much as possible.
EMI may interfere with the heart failure device,
but it will not damage it permanently. If your
device is sensing EMI, some (but not all) people
may have symptoms such as feeling lightheaded,
dizzy or unwell. If this occurs – or if you know you
are near a source of electromagnetic disturbance,
even if you do not have symptoms – move out of
the area. This should allow the heart failure
device to go back to normal operation.
Most household appliances (including microwave
ovens) are safe to operate around heart failure
devices. Appliances in good working order will
not interfere with your heart failure device.
103
Electrical tools, power tools or other electrical
devices may interfere with your heart failure
device if they are not properly shielded or not in
good repair. If these affect your heart failure
device, turn them off or move away from them.
104
Many stores use theft detection systems, and
sometimes this equipment can affect your heart
failure device. If you know you are passing through a
theft detection system, simply walk through it at a
normal pace. This should not interfere with your
device. Some stores conceal these theft detection
systems, which may be located anywhere within the
store. If you think that a theft detection system is
affecting your device, move out of the area quickly. It
may be necessary for you to leave the store.
Some equipment is known to produce
electromagnetic disturbance and should be
avoided or used with caution. This includes:
Electric welding equipment
Electric melting furnaces
Radio and TV transmitters, including
commercial stations
Radar transmitters
105
Power plants
High-voltage lines
Walkie-talkies and other two-way
communication systems, including emergency
vehicle two-way radios
Microwave transmitters
TV satellite dishes
Paging transmitters
Satellite towers
Electrical starting systems of gasoline engines,
if not properly shielded
Electrical tools and power tools
Electrical appliances not in good working
condition
Some amusement park rides, such as
bumper cars
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Other healthcare providers
Always tell other healthcare professionals that
you have a heart failure device (this includes
doctors, dentists, X-ray technicians, nurses and
emergency room staff). Carry your BIOTRONIK
ID card with you at all times. Some people with
heart failure devices wear a special medical
alert bracelet; while this is not required, it may
communicate this information for you if you ever
need emergency medical care and cannot
speak for yourself. These are available from
other vendors; you may ask at your pharmacy,
for example.
If you ever need surgery, make sure the clinical
team knows about your heart failure device.
High doses of radiation or X-rays can damage
the device, so everyone caring for you must
know about your heart failure device. If you need
surgery, your heart doctor may be consulted to
107
take the necessary steps to protect you and the
device. Since some types of procedures can
cause a heart failure device with defibrillation to
deliver therapy you do not need – or to withhold
therapy you do need – it is important that your
heart doctor be able to discuss your case with
the other physicians. In most cases, your heart
failure device will be turned off for the duration
of the procedure. After the operation, the heart
failure device will be turned back on. This step
is completely painless and usually takes only a
few minutes.
Once you have a heart failure device, there are
certain procedures and operations that may
possibly harm you or the device. Tell the clinical
team that you have a heart failure device, and
they can help to evaluate the risks and benefits
and discuss them with you. There may be
protective steps to help make the procedure safe
108
for you and/or protect the heart failure device
from possible damage. If you undergo any type of
procedure, your doctor should test the heart
failure device both before and after the procedure
to make sure it is working properly. Some
procedures can damage the heart failure device
system. This damage may not be detected right
after the procedure, but could cause a
malfunction or device failure in the future.
The following are some procedures that should
be avoided if you have an implanted heart failure
device. In some cases, it may be possible for you
to undergo the procedure by taking special
precautionary steps. If you might need to undergo
any of these procedures, discuss the possible
risks and your safety with your physician.
109
Diathermy
Diathermy
Heat produced by electricity and used
on tissue in the body, usually as a form
of physical or occupational therapy and
in surgery.
Diathermy may cause heating of the heart failure
device, leads or implant site. If diathermy must
be used, it should be used as far from your
device as possible.
110
Transcutaneous electrical nerve
stimulation
Transcutaneous Electrical Nerve
Stimulation (TENS)
The use of electrical energy to stimulate
muscles. The energy is produced by a
TENS device and is carried by wires through
electrodes stuck onto the skin.
TENS devices are often used to treat pain. They
are not implanted in the body and can be easily
removed or turned off.
Magnetic resonance imaging (MRI),
see pages 94-95.
111
Electrical cautery
Electrical Cautery
The use of heat from an electrical device
to seal a wound or remove tissue.
Electrical cautery is usually performed during surgery.
External defibrillation
External Defibrillation
Defibrillation that is administered via paddles
applied to the chest (“external” to the body).
In an emergency situation, first responders may
deliver external defibrillation by placing large
paddles on the chest and sending electrical energy
to change your heart rhythm from a dangerous
rhythm to a more normal one. During external
defibrillation, very large amounts of energy will be
sent through the skin to your heart. External
defibrillation can be effective in restoring a normal
112
heart rhythm, but in rare cases, the electrical
energy could damage your device. After external
defibrillation, the amount of energy your device
needs to pace your heart may increase for a
short time or permanently. If external
defibrillation is required, the medical team
should place the defibrillator paddles in a way
that affects your implanted device as little as
possible. If you ever receive external
defibrillation, alert your heart doctor at once so
that your heart failure device can be checked.
Radiation therapy
There are different types of radiation treatments
used in medicine. An X-ray is a type of radiation
therapy, and so are devices that send
concentrated radiation energy to specific areas of
the body (called “radiotherapy”). It may be
possible for a person with a heart failure device
to undergo radiation therapy, but your heart
doctor should be consulted.
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Lithotripsy
Lithotripsy
A procedure during which sound waves
are used to break up kidney stones.
Lithotripsy may damage the heart failure device or
interfere with its function. If your doctor decides
you may undergo lithotripsy, the procedure should
be performed as far from the device as possible.
Cardiac ablation
Cardiac Ablation
A surgical procedure during which very tiny
sections of cardiac tissue are destroyed, either
by surgically cutting them out or destroying them
with heat energy or freezing cold.
Cardiac ablation is often performed using a
catheter and a very small incision. Although it may
114
be considered minor surgery, it may damage the
heart failure device. Cardiac ablation using heat or
radiofrequency energy may overheat the
implanted leads. This can damage the leads,
possibly damage the device, and could even harm
you. If cardiac ablation is necessary, your heart
doctor should be consulted to make sure proper
precautions are taken. It may be possible to
perform the ablation far from the device leads; the
device should be turned off during the ablation.
Changes in your health and condition
Your health and physical condition are always
changing. Because you have a heart failure
device, changes in your overall health and
fitness, the drugs you take and illnesses you
might have, may all affect your therapy. For these
reasons, you should see your heart doctor
regularly and tell him or her about your current
health and all of the drugs you are
115
taking – including those prescribed by other
clinicians. You should also tell your doctor about
any over-the-counter drugs, vitamins and
supplements you are taking – since these may
also affect your heart. Some drugs can have an
effect on your heart that may change the way
your heart failure device should be programmed.
Shock therapy
Some heart failure devices provide defibrillation
as well as heart failure therapy. If you do not
know whether your heart failure device has
defibrillation, you can ask your doctor. Only a
heart failure device with defibrillation can provide
shock therapy. A heart failure device with
defibrillation is designed to deliver a large
amount of electrical energy (shock) to your heart
to help change a dangerous rhythm into a
normal one. This is not a common occurrence;
some patients never receive a shock, and others
116
may receive only a few shocks during their entire
lifetimes. Some people feel symptoms before
they are shocked, but others do not. If you ever
get a shock or think you might have had a shock,
call your heart doctor immediately or call 9-1-1.
If you received a shock, your heart doctor may
need to make some adjustments to your heart
failure device.
If you got a shock because you had a dangerous
heart rhythm, your doctor may want to better
assess your condition. This can sometimes be
done using BIOTRONIK Home Monitoring® so
that you do not have to come into the clinic. On
the other hand, your doctor may want to see you
in person to evaluate your condition.
It is possible that you may get more than one
shock. Your heart failure device with defibrillation
will continue to deliver therapy if it detects that
117
the dangerous rhythm is still going on. In such
cases, you should seek emergency medical help.
If you have a heart failure device with defibrillation,
it may be a good idea for you and your family and
friends to develop a “shock plan.” Discuss what
should happen in the event that your device
delivers a shock. A shock plan might include:
Finding a quiet place where you can safely rest.
Contacting your doctor (have his or her phone
number handy).
Being able to get to the nearest emergency room
in the event that your doctor asks you to go there.
Being prepared to seek emergency medical
help in the event your device delivers more
than one shock.
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Glossary
Adverse events
Sometimes called “side effects,” these are
negative occurrences and/or symptoms that may
be associated with a particular form of
treatment, such as your heart failure device.
Antitachycardia pacing
Delivery of a series of rapid, low-voltage pulses
to the heart in an effort to stop an arrhythmia.
Abbreviated ATP.
Arrhythmia
Any type of abnormal heart rhythm and/or rate.
Other terms for this are dysrhythmia and rhythm
disorder.
Atria (singular: atrium)
The two upper chambers of the heart.
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Atrial fibrillation, also known as A-fib or AF
A very rapid atrial rate (300 beats per minute
or higher) that causes a loss of one-to-one AV
synchrony. The ventricles try to keep up with
the atria and end up beating too fast and their
rate is erratic. Atrial fibrillation may stop and
start suddenly, or it may be longer
lasting – even permanent.
Atrial flutter
A tachycardia (too-fast heart rate) that originates
in the heart’s upper chambers (atria) and causes
a rapid atrial rate. The lower chambers
(ventricles) try to keep up with the atria and also
beat too quickly, but without one-to-one AV
synchrony. This causes the heart to pump
inefficiently.
120
Atrioventricular node (AV node)
A specialized area of cardiac tissue located in
about the middle of the heart (below the upper
chambers and above the lower chamber) that is
an important part of the electrical conduction
pathway through the heart. In the healthy heart,
the atrioventricular node slows the electrical
pulse slightly (fractions of a second) so that the
upper chambers can fully pump and relax before
the lower chambers pump.
Atrioventricular synchrony (AV synchrony)
The healthy heart rhythm in which there is one
atrial contraction or beat for every ventricular
beat – often called one-to-one atrioventricular
synchrony.
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Bradycardia
Any heart rate that is too slow to support the
person’s activity. Bradycardia is a type of
arrhythmia. This is sometimes called
bradyarrhythmia.
Capacitor
A component within the heart failure device with
defibrillation designed to hold and release an
electrical charge.
Cardiac ablation
A surgical procedure in which very tiny sections
of cardiac tissue are destroyed, either by
surgically cutting them out or destroying them
with heat energy or freezing cold.
Cardiac resynchronization therapy
Pacing the right and left ventricles of the heart
at the same time so that they beat together as
one unit.
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Cardiomyopathy
A disorder of the heart muscle.
Cardioversion
The use of lower-energy shocks to stop
tachyarrhythmias and restore the heart to a
normal rhythm.
Contraindication
A condition or situation in which it may not be
appropriate for you to have a particular
treatment or medical device.
Defibrillation
The use of high-energy shocks to “shock” the
heart out of cardiac arrest and restore the heart
to its normal rate and rhythm.
123
Defibrillation function testing
The use of the newly implanted heart failure device
with defibrillation to identify and treat a potentially
dangerous heart rhythm that the doctor induces in
a hospital setting. This test makes sure the device
can detect dangerous heart rhythms and treat
them quickly and effectively.
Diathermy
Heat produced by electricity and used on tissue
in the body, typically during a surgical procedure.
Dilated cardiomyopathy
A disorder of the heart muscle that causes it to
become enlarged and flabby.
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Ejection fraction (EF)
The amount of blood, stated as a percentage,
that the heart can pump out in one beat. No one
has an ejection fraction of 100%. A normal
ejection fraction is approximately 60% (meaning
that in one beat, the heart pumps out 60% of the
blood it contains). An ejection fraction below 35%
may be considered a risk factor for arrhythmias.
Electrical cautery
The use of heat from an electrical device to seal
a wound or remove tissue, typically during a
surgical procedure.
125
Electromagnetic interference (EMI)
Electronic disturbances are invisible signals,
sometimes called “static” or “noise” that can
interfere with certain medical devices, including
heart failure devices. Power tools, heavy
machinery, theft detection systems and security
systems may all produce electromagnetic
emissions, which can create electromagnetic
disturbances. These disturbances may result in
electromagnetic interference (EMI).
External defibrillation
The use of large amounts of energy, administered
via paddles applied to the chest (“external” to the
body), to “shock” the heart out of cardiac arrest
and restore its normal rate and rhythm.
Fluoroscope
A device that allows for real-time X-rays to be
taken, creating a sort of X-ray movie. A
126
fluoroscope is used during heart failure device
implantation so the physician can observe the lead
advancing through the vein and into the heart.
Heart attack, also known as a myocardial
infarction or MI
A medical event that occurs when one or more of
the veins that supplies the heart muscle with
oxygen is clogged or blocked. This starves a
portion of the heart muscle of oxygen so that this
tissue dies. Depending on how much tissue dies,
the heart attack may be major or minor. It is not
unusual for people to have dangerous abnormal
heart rhythms immediately after a heart attack.
Heart block
Any type of too-slow heart rate that occurs
because the electrical pulses from the sinus
node (SA node) are delayed or even blocked
at the AV node.
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Heart failure (HF)
A syndrome characterized by the heart’s inability
to pump blood efficiently. Heart failure is a
pumping disorder, not an electrical disorder. It
may be mild or severe, and it tends to get worse
over time. People with heart failure are at risk for
dangerous arrhythmias. There are different types
of heart failure.
Hypertrophic obstructive cardiomyopathy
(HOCM)
A disorder of the heart muscle that causes the
heart walls to thicken abnormally, causing the
pumping chambers to become smaller.
Implantable cardioverter-defibrillator (ICD)
An electronic device implanted in the body that
can cardiovert or defibrillate the heart in an
emergency. Some heart failure devices have a
built-in ICD.
128
Intermittent
A medical term that describes a condition that
comes and goes. An intermittent arrhythmia is
one that occurs at times but not continuously. An
intermittent arrhythmia can still be very
dangerous.
Joule (J)
A unit of energy commonly used to describe how
much energy is in a defibrillation shock.
Technically, it is the amount of energy needed to
pass an electric current of one ampere through a
resistance of one ohm for one second.
129
Lead
A thin, flexible, insulated wire with one or more
electrodes at the end. One end of the lead is
plugged into the device and the other end (with
the electrode) is located in or on the heart.
Electrical energy from the heart failure device
travels via the lead into the heart to pace;
electrical energy from the heart travels via the
lead into the heart failure device to sense.
Lithotripsy
A procedure during which sound waves are used
to break up kidney stones.
Magnetic resonance imaging (MRI)
A procedure to painlessly take a picture of soft
tissue in the body using magnetic waves.
130
Mechanical Dyssynchrony
A heart condition that involves the right and left
sides of the heart not contracting at the same
time, or where the lower chambers of the heart
do not contract as a whole. Mechanical
dyssynchrony can cause the heart to pump less
efficiently. Some – but not all – people with heart
failure have mechanical dyssynchrony.
One-to-one AV synchrony
The healthy heart rhythm in which there is one
atrial contraction or beat for every ventricular beat.
Pacing
The ability of a heart failure device (or pacemaker)
to generate and deliver a small electrical output
pulse to the heart, causing it to beat.
131
Pocket
A small area in the body, usually the upper
chest, that the physician forms to hold the
implanted heart failure device.
Primary prevention
An approach to heart failure device therapy
where a heart failure device with defibrillation is
implanted in a patient at high risk for dangerous
arrhythmias even if he or she has not yet had
such an arrhythmia.
Programmer
A special computer that a doctor can use to
communicate back and forth with an implanted
heart failure device. The programmer can obtain
information stored in the heart failure device and
can change the settings of the implanted heart
failure device.
132
Remodeling
A change in the shape of the heart to a more
normal shape after heart failure type pacing.
Risk factor
Any condition that makes it more likely that a
particular disease or rhythm disorder will occur.
For example, smoking is a risk factor for cancer.
Some risk factors cannot be changed, such as
age or family history.
Sensing
The ability of a heart failure device to pick up
electrical signals from within the heart and
interpret them.
Sepsis
A severe condition characterized by a whole-body
infection.
133
Sinoatrial node, also known as the SA node
An area of highly specialized tissue on the upper
right side of the heart (the “high right atrium”).
The sinoatrial node generates electrical pulses
and drives the heart rate. In fact, the sinoatrial
node is nicknamed the “heart’s natural
pacemaker.” Sometimes called the sinus node or
just the sinus.
Sinus bradycardia
Any type of too-slow heart rate that occurs
because the SA node (sinus node) does not fire
quickly enough or because it is erratic or
unreliable.
134
Sudden cardiac arrest (SCA)
A heart rhythm in which the heart is trying to
beat so fast that it merely quivers and can no
longer pump blood effectively. Sudden cardiac
arrest, sometimes called sudden cardiac death,
is a dangerous and life-threatening condition.
Tachycardia
Any heart rate that is too fast for the person’s
activity. Also called tachyarrhythmia.
Transcutaneous electrical nerve stimulation
(TENS)
The use of electrical energy to stimulate
muscles. The energy is produced by a small
device and is carried by wires through
electrodes stuck onto the skin.
135
Ventricles
The two lower chambers of the heart.
Ventricular fibrillation, also known as
V-fib or VF
A potentially life-threatening arrhythmia
originating in the ventricles in which the heart
tries to beat so quickly that it can no longer pump
effectively. During ventricular fibrillation, the heart
may try to beat 300 beats per minute or faster.
136
Ventricular tachycardia, also known as
V-tach or VT
A potentially dangerous and sometimes lifethreatening arrhythmia originating in the
ventricles in which the heart tries to beat very
quickly and can no longer pump blood effectively.
Ventricular tachycardia can occur at rates of
100 to 250 beats per minute. What defines
ventricular tachycardia is not so much the rate,
but that the patient does not tolerate it well; the
rate zones for ventricular tachycardia vary by
age, disease and fitness levels.
137
Index
A
Ablation............................................................... 115
Antitachycardia pacing........................... 24, 69, 119
Arrhythmia......................................... 5, 6, 7, 19, 21,
22, 23, 24, 25, 30, 33, 41, 42, 45, 46, 47, 48, 70, 80,
119, 122, 125, 128, 129, 132, 136, 137
Atrial fibrillation.......................... 31, 32, 33, 34, 120
Atrial flutter................................................... 31, 120
Atrial tachycardia.................................................. 31
Atrioventricular synchrony................................. 121
Atrium.................................. 16, 17, 36, 51, 119, 134
AV node................................ 37, 39, 40, 41, 121, 127
AV synchrony................................................. 40, 121
B
Bath....................................................................... 67
138
Battery............................... 28, 50, 71, 72, 73, 74, 80
BIOTRONIK.................1, 3, 5, 33, 79, 82, 83, 95, 150
BIOTRONIK Home Monitoring®.... 1, 79, 80, 81, 117
BIOTRONIK ID card.............................. 78, 100, 107
Blood Clot.............................................................. 92
Bradycardia................................. 35, 36, 38, 39, 122
C
Capacitor....................................................... 28, 122
Cardiac ablation.................................. 114, 115, 122
Cardiac arrest....................................... 96, 123, 126
Cardiac resynchronization therapy..... 51, 53, 83, 122
Cell phones..................................................... 77, 99
Chest pain............................................................. 75
Complete heart block........................................... 41
Computer.............................. 49, 50, 74, 77, 79, 132
139
Conduction pathway..................................... 37, 121
Contraindications................................................. 86
D
Defibrillation.....5, 12, 13, 23, 24, 25, 26, 27, 28, 30,
45, 46, 47, 48, 54, 59, 61, 62, 68, 69, 70, 71, 75, 80,
83, 96, 97, 98, 102, 103, 108, 112, 116, 117, 118,
122, 123, 124, 129, 132
Defibrillation function test............... 96, 97, 98, 124
Diathermy.................................................... 110, 124
Difficulty breathing............................................... 74
Dizziness................................. 23, 33, 34, 41, 75, 94
Driving................................................................... 68
E
Ejection fraction...................................... 46, 47, 125
Electrical cautery........................................ 112, 125
Electromagnetic interference............ 101, 102, 126
140
EMI....................................... 101, 102, 103, 105, 126
Exercise..................................................... 63, 64, 67
External defibrillation................... 98, 112, 113, 126
F
Fainting............................................................ 34, 75
Fatigue............................................................. 32, 33
FDA.............................................................. 2, 83, 84
First-degree heart block...................................... 40
Fluoroscope.............................. 56, 57, 60, 126, 127
Follow-up.............................................................. 26
G
Guns....................................................................... 66
141
H
Heart....4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,
19, 20, 21, 23, 24, 25, 27, 28, 32, 33, 35, 36, 37, 38,
39, 40, 41, 42, 44, 45, 48, 50, 51, 53, 54, 55, 56, 59,
60, 61, 63, 69, 71, 75, 76, 77
Heart attack............................................ 88, 89, 127
Heart block.............................................. 39, 40, 127
Heart doctor....26, 29, 30, 33, 34, 55, 56, 63, 65, 66,
70, 72, 74, 76, 79, 80, 81, 85, 93, 97, 99, 108, 113,
115, 117
Heart electrical system.................................. 15, 38
Heart failure......................... 5, 6, 7, 8, 9, 10, 16, 19,
42, 43, 44, 45, 46, 83, 116, 128, 131, 133
142
Heart failure device................. 1, 2, 3, 4, 5, 6, 8, 11,
12, 13, 16, 18, 19, 23, 24, 25, 27, 28, 30, 33, 34, 35,
36, 42, 43, 44, 45, 48, 49, 50, 51, 52, 53, 54, 55, 56,
57, 59, 61, 62, 63, 66, 68, 69, 70, 71, 72, 73, 74, 75,
76, 77, 78, 79, 80, 81, 82, 83, 84, 86, 87, 88, 90, 91,
92, 93, 94, 96, 97, 98, 99, 100, 102, 103, 104, 105,
107, 108, 109, 110, 113, 114, 115, 116, 117, 118,
119, 122, 124, 127, 128, 130, 131, 132, 133
Heart rhythm........................ 5, 7, 15, 18, 19, 20, 21,
27, 59, 62, 69, 80, 87, 88, 89, 96, 97, 98, 102, 103,
112, 113, 117, 119, 121, 124, 127, 131, 135
Heart Rhythm Society.......................................... 83
Hiccups............................................................ 75, 92
HRSOnline............................................................. 83
I
ID card............................................. 78, 95, 100, 107
Implant surgery.............................................. 59, 97
143
Incision.................................................... 59, 60, 114
Infection....................................... 60, 63, 90, 92, 133
L
Lead.......................50, 51, 52, 53, 54, 56, 57, 60, 61,
63, 73, 74, 76, 80, 90, 92, 94, 99, 110, 115, 127, 130
Lightheadedness...................................... 41, 75, 94
Lithotripsy................................................... 114, 130
M
Magnetic field.................................................. 93, 94
Magnetic resonance imaging........ 94, 95, 111, 130
Magnets........................................................... 93, 94
Mechanical dyssynchrony..................... 8, 9, 11, 16,
18, 19, 42, 43, 46, 77, 131
Metal detectors................................................... 100
Microwave oven............................................. 77, 104
144
MRI................................................... 94, 95, 111, 130
Myocardial infarction.................................... 89, 127
N
Natural pacemaker...................................... 36, 134
O
One-to-One (1:1) AV synchrony............... 18, 31, 32,
41, 120, 131
P
Pacemaker Club................................................... 84
Patient ID card...................................................... 95
Power tools................................................. 104, 106
Precautions....................................... 90, 98, 99, 115
Primary prevention................................. 46, 47, 132
Programmer............................... 49, 50, 74, 76, 132
Pulse generator.............................................. 50, 51
145
R
Radiation..................................................... 108, 113
Radio waves.......................................................... 49
Replacement......................................................... 72
Risk factors............................................. 45, 46, 133
Risks................................................ 90, 91, 109, 110
S
SA node................... 36, 37, 38, 39, 40, 41, 127, 134
Second-degree heart block................................. 40
Sepsis...................................................... 89, 90, 133
Sexual activity....................................................... 67
Shock................................ 12, 13, 25, 26, 27, 28, 29,
30, 54, 68, 69, 70, 71, 75, 80, 89, 93, 96, 102, 116,
117, 118, 123, 126, 129
Shock plan........................................................... 118
146
Showering............................................................. 67
Sinoatrial node.............................................. 36, 134
Sinus node............................................... 36, 38, 134
Sports.............................................................. 66, 67
Stroke.............................................................. 33, 34
Sudden cardiac arrest............................ 15, 20, 135
Support group....................................................... 85
Symptoms.............................. 23, 33, 34, 35, 38, 40,
41, 43, 46, 63, 68, 74, 91, 103, 117, 119
T
Tachyarrhythmia....................... 19, 20, 31, 123, 135
Tachycardia............................... 19, 20, 31, 120, 135
Theft detection system....................................... 105
Third-degree heart block..................................... 41
Transcutaneous electrical nerve (TENS).. 111, 135
147
Transmitter............................................. 79, 81, 106
V
Ventricle.................................. 16, 17, 18, 19, 21, 22,
31, 32, 37, 46, 51, 53, 54, 120, 122, 136, 137
Ventricular fibrillation...................... 20, 21, 87, 136
Ventricular tachyarrhythmia.......................... 19, 20
Ventricular tachycardia.............. 20, 21, 22, 87, 137
W
Warnings......................................................... 90, 93
X
X-ray........................... 56, 57, 60, 107, 108, 113, 126
148
Notes
149
All About Your Heart Failure Device
A manual for patients with heart failure devices
© BIOTRONIK SE & Co. KG
All rights reserved. Specifications
are subject to modification,
revision and improvement.
M4180-A 09/15
© 2015 BIOTRONIK, Inc. All rights reserved.
MN055r1 9/22/2015
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035, USA
Technical Services:
1-800-284-6689
Home Monitoring Help Line:
1-800-889-9066
www.biotronik.com