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Definition
of Treatment.
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Enhanced External Counterpulsation () treatment is a noninvasive,
outpatient procedure to relieve angina by improving perfusion
in areas of the heart deprived of adequate blood supply.
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Clinical
Benefits
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Clinical
trials have confirmed the benefits of EECP® treatment. They
include: symptomatic relief of angina unresponsive to medical
therapy, improved blood flow to deprived areas of heart muscle
demonstrated by the results of thallium stress testing, elimination
or reduction of nitrate use, improved ability to exercise.
In a 3-year, follow-up study, the majority of patients remained
free of angina and showed persistent improvements in their thallium
scans. Patients and their families usually report noticeably
greater ability to engage in daily activity.
Patients
usually receive EECP® treatment for 35 hours divided into one
or two 60-minute treatment sessions five days per week. Patients
who undergo two treatment sessions in one day rest between sessions.
EECP® treatment uses unique equipment to inflate and deflate
a series of pneumatic compressive cuffs around the lower extremities.
Treatment is administered on a padded table where three sets
of electronically controlled inflation and deflation valves
are located. These valves are connected to specially designed
adjustable cuffs that are wrapped firmly, but comfortably around
the patient's calves, lower thighs, and upper thighs, including
the buttocks. The design of the cuffs permits significant pressure
to be applied to the arteries and veins at relatively low air
pressures. Timing for inflation and deflation is regulated by
running electrocardiogram signals through a microprocessor that
monitors the treatment process.
While the heart is at rest the cuffs are inflated in rapid sequence
from the calves upward, creating a pressure wave that increases
diastolic pressure, coronary artery perfusion pressure, and
blood flow to the heart muscle. This compression of the blood
vessels in the legs also increases the volume of blood returned
to the right side of the heart via the venous system. Instantaneous
deflation of all cuffs at the onset of the heart's contraction
lowers the resistance the heart must pump against, decreasing
the heart's work load. This latter effect, when coupled with
increased venous return, significantly raises cardiac output.
The overall effect is to increase the oxygen supply of the heart,
while decreasing its oxygen demand.
Significant obstruction in one or more coronary arteries can
create a pressure difference between areas of the heart muscle
that receive and those that do not receive enough blood. Repeated
and pulsed increases in pressure during diastole may stimulate
opening collateral channels across this pressure gradient within
the heart muscle, resulting in increased blood supply to deprived
tissues.
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Answers
to Frequently Asked Questions
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How
does the heart work?
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A
muscular organ, the heart has two pumps that are divided into
an upper chamber (atrium) and lower chamber (ventricle). These
chambers are linked by passageways with valves to ensure blood
flow in one direction. The lower left ventricle works the
hardest, pumping blood into the body through the aorta, the
largest artery in the body. In turn, this chamber of the heart
has the greatest need for oxygenated blood.
The blood's cycle through the body begins when oxygen-depleted
blood returns to the heart, entering the upper right atrium
via the largest veins (venae cavea). Blood passes through
a valve from the right atrium to the lower right ventricle.
The blood is then pumped through the pulmonary artery into
the lungs where it receives oxygen.
Freshly oxygenated blood then flows from the lungs through
the pulmonary veins into the left atrium and then into the
left ventricle. From the left ventricle, blood is pumped through
the aorta to supply the body. |
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What
is angina?
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| Angina
literally means "strangling in the chest". It is
the most common symptom of coronary artery disease, which
occurs when vessels that carry blood to the heart muscle become
narrowed and blocked by deposits of calcified fatty tissue
(atheroma). |
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Is
angina life threatening?
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| Angina
signals heart disease, the number one killer in the industrialized
world. Two to four percent of people with angina die from
heart disease. More than 7 million people in the United States
suffer with angina. An estimated 350,000 new cases occur each
year. Of this number, approximately 1 million will have invasive
procedures; 6 million patients who are maintained on drug
therapy live in varying degrees of discomfort. Angina is frequently
crippling and disabling; patients are often unable to maintain
their lifestyles. |
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What
does it feel like?
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| The
majority of patients with angina complain of chest discomfort
provoked by mental, physical, or emotional stress. Discomfort
can vary widely among patients who report shortness of breath,
fatigue, indigestion, faintness, jaw pain, and other symptoms.
Angina can also feel like a pressing or squeezing pain, usually
in the chest under the breast bone, and sometimes in the shoulders,
arms, neck, jaws, or back. |
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What
triggers angina?
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| Angina
occurs when the heart needs more oxygen from the blood. Physical
activity often triggers angina. Other triggers include emotional
stress, extreme cold or heat, heavy meals, alcohol, and cigarette
smoking. |
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How
does angina affect people?
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| Angina
restricts the activities of many patients. They are able to
walk, but not uphill or carrying packages. For some patients,
angina is disabling, interfering with their ability to work
or engage in various activities. |
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How
is angina avoided?
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| Doctors
recommend controlling the risk factors that contribute to
underlying coronary artery disease. These risk factors include
high blood pressure, cigarette smoking, high blood cholesterol
levels, and obesity. |
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What
is the first line of treatment for angina?
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| Angina
is usually controlled by medication that helps increase the
supply of oxygen to the oxygen-deprived heart muscle by dilating
coronary vessels or decreasing the demand for oxygen. Unfortunately,
in most patients, medication becomes less effective over time. |
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When
should EECP® treatment be used for patients with angina?
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| EECP®
treatment may be used to treat any patient with chronic stable
angina, but it is usually reserved for patients taking medication
that is losing its effectiveness. |
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What
is EECP® treatment?
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| The
EECP® procedure is a noninvasive outpatient treatment that
is used to relieve or eliminate angina. It is believed to
create new pathways around blocked arteries in the heart by
expanding networks of tiny blood vessels that help increase
blood flow to the heart muscle. |
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What
are the advantages of EECP® treatment?
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| Unlike
procedures such as bypass surgery and balloon angioplasty,
EECP® treatment can be administered in outpatient sessions,
carries little or no risk, and is relatively comfortable. |
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Will
EECP® treatment eliminate the need for bypass surgery?
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| No.
Some patients with more extensive disease or those who have
disease of the left main coronary artery require bypass surgery.
EECP® treatment is an option for patients who are unsuitable
for or unwilling to undergo, invasive procedures. For patients
who have undergone multiple invasive procedures and for whom
additional surgery carries excessive risk, EECP® treatment
may be the only way to obtain relief from crippling angina. |
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What
are the clinical benefits of treatment?
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| EECP®
treatment can reduce or eliminate the frequency and intensity
of chest pain, decrease the need for medication, and greatly
improve the ability to participate in activities of daily
living. After receiving EECP® treatment, patients often are
able to enjoy moderate exercise for the first time since developing
angina. |
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Are
there any downsides to the procedure?
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| The
length of treatment may be a consideration for some people.
It can take between four to seven weeks to complete a course
of EECP® treatment. During that time, patients must visit
an outpatient clinic and receive treatment for one to two
hours per day. Some patients with more extensive disease may
require more than one course of therapy to achieve optimal
relief. |
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What
have studies shown about EECP® and its effect on angina?
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| In
1989, the Health Sciences Center, State University of New
York at Stony Brook, began clinical studies with EECP® treatment
for patients with chronic angina. These studies demonstrated
a number of positive effects that are maintained after treatment
for at least three years after completing a full course of
EECP® treatment. |
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How
is EECP® treatment performed?
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| During
treatment, patients lie on a padded table in which sets of
electronically-controlled inflation and deflation valves are
located. These valves are connected to specially designed
adjustable cuffs that are wrapped firmly, but comfortably,
around the patient's calves, lower thighs, and upper thighs,
including the buttocks. While the heart is in its resting
phase, the cuffs are inflated sequentially and rapidly from
the calves toward the buttocks. The cuffs are then deflated
instantaneously just before the heart beats. This causes the
heart muscle to receive an increased blood supply while reducing
the heart's work load. |
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How
does EECP® treatment work?
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The body has its own solution to an inadequate blood supply
caused by blocked or partially blocked arteries. When an artery
is severely narrowed, the body can increase the amount of
blood flowing to the heart muscle by opening up small branches
of nearby arteries. Known as collateral circulation, these
networks of blood vessels create new routes for blood to detour
around clogged arteries.
The development of a collateral circulation is particularly
important in the heart muscle where it may be life saving.
However, the development of collateral circulation is a gradual
process, and not everyone has the same ability to develop
these networks. |
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History
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Kantrowitz
brothers in 1953
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The
state-of-the art angina treatment has evolved from a principle
described in 1953 by the Kantrowitz brothers at Harvard. The
phase-shift, diastolic augmentation principle, led to a better
understanding of the myocardial oxygen consumption differences
between "flow work" and "pressure work."
This new understanding on improving blood flow to the ischemic
myocardium by increasing coronary perfusion became the research
objective.
Many attempts were made to develop effective means of providing
mechanical cardiac assistance for patients with low, cardiac
output syndromes.
One of the first techniques developed was the Intra-Aortic
Balloon Pump (IABP). The IABP consists of an inflatable balloon
catheter that is inserted into the femoral artery and advanced
to the descending aorta. Modified and refined over the last
40 years, this device remains a primary therapy for assisting
the heart function of patients in cardiogenic shock. |
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Soroff,
Birtwell, and others at Harvard in the mid-60s
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In
the mid-60s, Soroff, Birtwell and others at Harvard developed
a device for external counterpulsation. It was a hydraulic
system that pumped water in and out of cuffs applied to the
lower extremities. It was clear that Soroff and Birtwell's
device had advantages over the IABP. It was noninvasive, and
also increased venous return as it boosted coronary perfusion
pressure.
Though cumbersome, this early hydraulic device increased survival
rates of patients with acute myocardial infarction and cardiogenic
shock and relieved angina. However, in the United States,
external counterpulsation was eclipsed by the emergence of
coronary bypass surgery and angioplasty.
While physicians in the United States turned their attention
to these dramatic new developments in invasive treatments,
physicians in China adopted the concept of external counterpulsation
and refined the technology. Treatment was made easier to administer
and more comfortable for patients by using pneumatic cuffs
instead of hydraulic cuffs. |
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Researchers
in the 1970s and Late 1980s
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In
the 1970s, a group of researchers, led by Dr. Zeng Sheng
Zheng at the Sun Yat-sen University of Medical Sciences
in the People's Republic of China, began to develop more
sophisticated counterpulsation systems. They devised a system
in which the pneumatic cuffs inflated sequentially, not
simultaneously as they had before.
The Chinese researchers in collaboration with researchers
at the State University of New York at Stony Brook continued
to refine the technique of external counterpulsation. In
1989, researchers at Stony Brook began clinical studies
of enhanced external counterpulsation (EECP®) treatment.
These studies demonstrated that the treatment produces a
number of positive effects that are maintained for at least
three years after a full course of treatment.
Multi-center clinical trials have confirmed the Stony Brook
results. The trials also showed the extent of treatment
benefit with greater accuracy, determined the patients who
gained the most from treatment, and measured the effect
of treatment on medication requirements, exercise capability,
and quality of life.
EECP® treatment has evolved and is being used with no reported
complications as an outpatient treatment of chronic angina
patients. References to the treatment appear in medical
literature and are presented at medical conferences. EECP®
treatment does not require the adoption of new medical practices;
it is an improvement of existing medical practices made
possible by the advanced technology of a new delivery system.
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Treatment
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When
patients have angina, their bodies are telling them that
their heart is not receiving enough oxygen. A treatment,
in harmony with patients heart, can improve circulation
to the heart muscle. EECP® treatment appears to stimulate
the opening of new, natural pathways around narrowed or
blocked arteries. After EECP® treatment, patients may find
that:
- they
can walk farther, carry heavier packages, and be more
active without having angina
- they
have fewer attacks of angina
- their
episodes of angina are less intense
- they
need less anti-anginal medication
- they
can return to work, go out to dinner, garden, travel,
or enjoy golf, tennis, or bowling once again
- they
no longer restrict their social lives, volunteer activities,
or exercise because they are worried that they will cause
angina.
If patients
are one of more than seven million people in the United
States with angina, they may be all too familiar with angina.
Angina signals that a part of the heart muscle is not receiving
an adequate supply of blood and oxygen. The heart requires
a particularly rich blood supply because of its heavy workload,
and receives this nourishment through the coronary arteries.
When these vessels are narrowed or blocked, restricting
blood flow, they fail to supply adequate oxygen.
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Detours
around blocked arteries
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The body has a response to pain and problems caused
by narrowed arteries. The body often can increase the amount
of blood flowing to the muscle by opening up tiny branches
of nearby vessels. This network of tiny blood vessels --;
known as collateral circulation --; makes it
possible for blood to detour around blocked or narrowed
arteries. The development of collateral circulation is particularly
important in the heart muscle where it may be life-saving.
However, the development of collateral circulation is a
gradual process and not everyone has the same natural ability
to develop these networks at a rate that will relieve angina.
Enhanced
External Counterpulsation may stimulate the opening of small
branches of blood vessels (collaterals) to create a natural
bypass around narrowed or blocked arteries.
The
term Enhanced External Counterpulsation describes
what will happen during treatment.
Enhanced
refers to the equipment that has evolved over decades of
research and development to become the state-of-the-art
treatment delivery system now used in EECP® treatment centers.
External
means treatment happens outside of the patients body
and doesnt require surgery.
Before
we can understand the term Counterpulsation,
we have to understand the cardiac cycle, the period from
the beginning of one heartbeat to the beginning of the next.
The cardiac cycle includes diastole when the heart relaxes
and fills with blood, and systole when the heart contracts
and pumps blood out to the body.
The
EECP® system compresses a patients lower limbs to
increase blood flow toward the heart. Each wave of pressure
is electronically timed to a heartbeat, so that the increased
blood flow is delivered to the heart at the precise moment
it is relaxing. When the heart pumps again, pressure is
released instantaneously. This lowers resistance in the
blood vessels of the legs so that blood may be pumped more
easily from the heart, decreasing the amount of work required
of the heart muscle.
During
counterpulsation the EECP® system pumps when the heart is
resting and releases pressure when the heart is working.
Your
doctor will evaluate you to determine if you may be eligible
to receive EECP® treatment. You may be a candidate for EECP®
treatment if:
- you
have angina
- nitroglycerin
does not provide adequate relief from your angina
- you
have been told that you are not a candidate for bypass
surgery or angioplasty
- you
underwent bypass surgery or angioplasty in the past, and
angina has returned
- you
want to explore all treatment options
Some
people may not be candidates for EECP® treatment because
of their medical conditions. Only a physician can make a
decision regarding whether or not you are a candidate for
EECP® treatment.
Once
you are eligible to receive EECP® treatment, it is important
that you understand the treatment schedule. Patients typically
attend one-hour treatment sessions once a day, five days
a week for seven weeks. Many people receive treatment, without
interruption to their employment, by scheduling their sessions
before or after work.
To make
sure the treatment goes smoothly, please follow your Pre-Treatment
Instructions, which will be similar to those at the back
of this booklet. You may wish to bring a book, a magazine,
or a portable CD or tape player with earphones. You also
may wish to invite a family member or friend to accompany
you.
At the
EECP® center, your therapist will explain each step as you
go through treatment. You may be given a pair of stretch
pants to wear at each treatment session. Although treatment
usually takes one hour, you should plan to spend approximately
1-1/2 hours at the treatment center.
Once
patients have changed clothes, a therapist will weigh them,
and take their blood pressure. Patients will lie on a padded
table in a treatment room. Three electrodes will be applied
to the patients chest to take a constant ECG reading during
treatment. A finger sensor, called a plethysmograph, will
be placed over patients finger like a thimble. This
sensor records tracings that represent blood pressure.
The
therapist will wrap a set of inflatable cuffs around patients
calves, thighs, and buttocks. Patients are likely to feel
a sensation of a strong hug moving upwards from
the calves to thighs to buttocks during inflation followed
by the rapid release of pressure on deflation.
Synchronized
with your heartbeat
Inflation and deflation are electronically synchronized
with the heartbeat using the ECG signal. By monitoring the
ECG reading and the plethsmograph (blood pressure) tracing,
your EECP® therapist can time counterpulsation accurately.
Clinical
studies indicate that EECP® treatment may create a natural
bypass around narrowed or blocked portions of
arteries. These channels or collaterals may eventually become
permanent pathways for blood to reach heart muscle that
was previously deprived of adequate nourishment.
A controlled,
randomized, blinded study showed a significant increase
in the length of time that participants who had received
active treatment were able to exercise. Additionally, participants
who received active treatment experienced fewer attacks
of angina.
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Medical
research
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Studies
conducted at numerous university medical centers and published
in peer-reviewed medical
journals have demonstrated benefits including:
- elimination
or decrease in exercise-induced signs of lack of oxygen
to the heart muscle (ischemia)
- increased
exercise tolerance
- elimination
or decrease in episodes of chest pain
- decrease
in need for anti-anginal medication
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What
are the clinical benefits of treatment?
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For
many patients, EECP® treatment can reduce the frequency
and intensity of chest pain or eliminate it altogether,
decrease the need for medication, and greatly improve the
ability to participate in activities of everyday life. After
receiving EECP® treatment, patients often are able to enjoy
moderate exercise for the first time since they developed
angina.
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How
will I feel after treatment?
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| You
may feel a little tired after your first treatment session,
but you are unlikely to experience any unpleasant aftereffects.
You may be given an Angina Diary in which you can record any
episodes of angina and your use of nitroglycerin. This record
may be helpful in tracking your progress. |
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How
soon can I expect to feel an improvement in my condition?
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| Because
each individuals condition is unique, there is no special
time when you can expect to feel an improvement. Experience
has shown that some patients tend to report some improvement
about halfway through their course of treatment. |
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Are
there any drawbacks to the procedure?
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| The
length of treatment may be a consideration for some people.
A course of EECP® treatment typically takes seven weeks to
complete. During that time, patients must visit an outpatient
clinic and receive treatment for one hour per day. Some patients
may require more than one course of therapy to achieve an
optimal level of relief. |
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What
are the risks of EECP® treatment?
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| Some
patients have experienced minor skin irritation due to the
pressure of the cuffs. You should consult with your physician
regarding any risk and complication factors. |
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What
are the advantages of EECP® treatment over other treatments
for angina?
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Unlike procedures such as bypass surgery and balloon angioplasty,
EECP® treatment is administered on an outpatient basis and
does not involve any period of post-treatment recuperation. |
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Are
there other treatment options to consider?
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| There
are several other treatment options including bypass surgery,
balloon angioplasty, and drug treatments. Discuss options
with a physician to determine which course of treatment is
most suitable for you. |
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Are
there any drawbacks to the procedure?
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| The
length of treatment may be a consideration for some people.
A course of EECP® treatment typically takes seven weeks to
complete. During that time, patients must visit an outpatient
clinic and receive treatment for one hour per day. Some patients
may require more than one course of therapy to achieve an
optimal level of relief. |
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What
are the risks of EECP® treatment?
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| Some
patients have experienced minor skin irritation due to the
pressure of the cuffs. You should consult with your physician
regarding any risk and complication factors. |
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What
are the advantages of EECP® treatment over other treatments
for angina?
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| Unlike
procedures such as bypass surgery and balloon angioplasty,
EECP® treatment is administered on an outpatient basis and
does not involve any period of post-treatment recuperation. |
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Are
there other treatment options to consider?
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There are several other treatment options including bypass
surgery, balloon angioplasty, and drug treatments. Discuss
options with a physician to determine which course of treatment
is most suitable for you. |
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Glossary
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Angina
pectoris
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| Angina
pectoris -- which literally means "pain in the chest"
-- refers to a set of symptoms, characterized by a "crushing"
sensation or pain that may be felt in the chest, back, and
sometimes radiating down the left arm. Often referred to as
angina, it occurs when regions of the heart muscle do not
receive the amount of blood (oxygen) needed when exercise
or other forms of stress increase oxygen demand. Usually,
the reason for this oxygen deficit is coronary artery disease,
in which one or more of the heart's blood vessels are narrowed
or blocked. |
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Balloon
angioplasty
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| This
procedure, known in medical terms as Percutaneous Transluminal
Coronary Angioplasty (PTCA), is used to expand blocked arteries
by inserting a slim hollow tube (catheter) through a major
artery in an arm or leg and into the obstructed vessel. A
small balloon at the tip of the catheter is inflated alongside
the obstructing tissues, flattening them against the vessel
wall, thereby restoring normal blood flow. About 405,000 initial
and repeat angioplasties are performed in the United States
each year at an average cost of $21,113. |
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Bypass
surgery
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| Also
called Coronary Artery Bypass Graft (CABG), it is the surgical
transplant of one or more blood vessels to carry (pipe) blood
around the blocked portion of a coronary artery. This is a
major operation that involves opening the chest and stopping
the heart. About 485,000 such operations take place every
year in the United States at an average cost of $32,347. |
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Collateral
circulation
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| This
phrase refers to an auxiliary or supplemental network of tiny
channels that usually lie dormant in muscular tissues and
can be recruited to carry blood around obstructed main vessels.
Collateral vessels begin to open or enlarge when a blockage
in an artery produces a pressure differential across the well-supplied
and poorly-supplied parts of the muscle. Over time, these
accessory vessels can be transformed into significant conduits
substituting for the blocked arteries. Probably because pressure
differentials are lower, collateral circulations form less
readily in the heart but can be life-saving when they do.
The clinical benefits of EECP® are believed to
stem from enhanced development of collateral circulation to
oxygen-deprived regions of the heart. |
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Diastole
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| The
period in the pumping cycle of the heart when the heart muscle
relaxes, the chambers fill with blood, and the heart receives
about 80% of its own supply of oxygen and other nutrients. |
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EECP®
- Enhanced External Counterpulsation
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| A
non-surgical procedure that can relieve or eliminate the symptoms
of angina pectoris. It increases the amount of blood flowing
to heart muscles. |
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Systole
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The period when the heart contracts to force blood onward.
The pumping action of the heart raises the blood pressure
throughout the body to increase perfusion of tissues, but
the heart muscle itself receives only about 20% of its supply
at this time because the heart's contraction squeezes and
closes off many of its own blood vessels.
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