Download living a fuller life

Harald, 2014 HeartMate 3™ recipient
LIVING A
FULLER LIFE
every step of the way
Astrid, 2014 HeartMate 3 recipient
Understanding advanced
heart failure
When your heart is working well, you usually don’t notice it.
When you have advanced heart failure, it may often seem like
it’s all you can think about.
With advanced heart failure, the left side of your heart has
become too weak to pump the normal amount of oxygen-rich
blood throughout your body.1 As a result, you may be too
exhausted to take part in your usual activities of daily life—
walking, climbing stairs, eating, even just lying down may be
an overwhelming challenge.
Now you can move from understanding to hope.
This information is only intended for distribution
in countries with CE Mark approval.
2
“My goal was to lead an active
life again. Thanks to my doctors
and HeartMate 3, I have met
that goal.”
–Astrid, 2014 HeartMate 3 recipient
3
About HeartMate 3
HeartMate 3 is a left ventricular assist device, or LVAD,
that helps your heart pump blood throughout your body and
increase the supply of oxygen to your organs.2 It is placed in
your chest by an experienced cardiac surgeon and has parts
that also exist outside of your body.
HeartMate 3 is designed with Full MagLev™ flow technology,
which helps protect the blood as it flows through the pump.
HeartMate 3 is from the makers of HeartMate II®, the
world’s most widely used and extensively studied LVAD.3,4
HeartMate 3 is approved for use in patients for short-term
or long-term support.
4
“I felt very positive about going
ahead with the HeartMate 3
implant, and the more I learned
about it, the more positive I became.”
–Harald, 2014 HeartMate 3 recipient
5
Living with heart failure
can mean living well
Moving ahead with HeartMate 3
In a clinical study, people with advanced heart failure who
received HeartMate 3 could walk an average of 373 metres
in 6 minutes, 6 months after implantation.3 That’s almost the
length of 4 football pitches.
Before receiving HeartMate 3, those patients could walk only
179 metres in 6 minutes, on average.3
Improvement in 6-minute walk distance for
HeartMate 3 patients3*
On average, HeartMate 3
allowed patients to walk
more than twice as far
as before.
108%
Before HeartMate 3
increase
6 months after receiving HeartMate 3
0
metres
*
179
metres
P < 0.0001
373
metres
esults from a multicentre clinical study of 50 adult patients with
R
advanced heart failure who received HeartMate 3.
6
“I’m able to do the things
I love again, like hiking,
riding my bike, and doing
volunteer work.”
–Astrid
7
Living a more active life
Living well means returning to an active life
with fewer limits*
Many HeartMate 3 patients find that they can get
back to doing the things they love, including:
•
Playing golf
•
Fishing
•
Dancing
•
Gardening
•
Walking
•
Traveling
•
Bicycling
•
Enjoying family time
You cannot swim or play water sports or contact sports
because some parts of the HeartMate 3 device are located
outside the body.
*
8
“My family and I noticed a
big improvement in my energy
just 2 weeks after I received
HeartMate 3.”
–Harald with his wife
9
Getting to know
the HeartMate 3 system
1
Heart pump (LVAD). It is connected to the left side of your
heart and moves blood from your heart to the rest of your body.
2
Batteries. Provide up to 17 hours of uninterrupted power.
3
Driveline. Transfers power and information between the
controller and the heart pump.
4
Controller. Powers and checks the pump and driveline.
This easy-to-wear controller weighs only 500 grams and
discreetly slips into a front pocket.
The controller uses alerts to tell you how the system
is working and includes 15 minutes of emergency
backup power.
10
1
2
2
3
4
11
Powering a better life
Rechargeable batteries. These light and long-lasting
batteries weigh only 500 grams each. A pair of batteries offers
up to 17 hours of uninterrupted support—almost twice as long
as batteries in similar devices.
Mobile Power Unit. The Mobile Power Unit (MPU) can
be plugged into an electrical socket to provide power while
you are indoors, at rest, or asleep. Small, light, and as mobile
as you are, the unit is designed to be extremely durable.
Battery charger. For your convenience and confidence,
HeartMate 3 batteries are rechargeable.
12
“I was very positively surprised
at how easy it was to adapt
to the equipment. It was not
a problem at all.”
–Harald
13
Important safety information
HeartMate 3 is approved for short-term or long-term support
in people who have advanced heart failure. It is from the makers
of HeartMate II, the world’s most widely used and extensively
studied LVAD.3,4
A high rate of success
In a recent clinical study, HeartMate 3 showed the highest rate
of success ever experienced in an LVAD trial leading to CE Mark
approval within the European Union.* In addition, not a single
pump malfunctioned or had to be replaced.5
*
Success defined as survival and incidence of adverse events.
“My family say I seem
10 years younger.”
–Astrid
14
Before you decide
It is important that you understand the risks of LVAD
implantation.
HeartMate 3 should not be used in patients who cannot tolerate
or are allergic to anticoagulation therapy.
Common side effects of HeartMate 3 include death, bleeding,
cardiac arrhythmia, infection, respiratory failure, device
malfunction, sepsis, right heart failure, renal failure, stroke,
neurologic dysfunction, psychiatric episode, peripheral or
device-related thromboembolic event, haemolysis, hepatic
dysfunction, and myocardial infarction.
Talk to your doctor to make sure you completely understand
the risks of having a HeartMate 3 implant.
15
Frequently asked questions
Is HeartMate 3 safe and effective? HeartMate 3 is
approved for use in patients for short-term and long-term
support. It is from the makers of HeartMate II, the world’s
most widely used and extensively studied LVAD.3,4
What kind of relief does HeartMate 3 provide to
people with advanced heart failure? In a clinical study,
people with advanced heart failure who received HeartMate 3
could walk an average of 373 metres in 6 minutes, 6 months
after implantation.3 That’s almost the length of 4 football pitches.
Before receiving HeartMate 3, those patients could walk only
179 metres in 6 minutes.3 HeartMate 3 also provided significant
relief of heart failure symptoms and improved quality of life in
many patients in the study.5
Are there other risks? Like any major surgery, getting
an LVAD comes with risks, including bleeding, infection,
stroke, device malfunction, and death. Talk to your doctor
to understand the risks and benefits.
16
“I know I have heart
failure, but I don’t
feel sick anymore.”
–Harald
17
Frequently asked questions
How long does HeartMate 3 last? HeartMate 3 is approved
for use in patients for both short-term and long-term support.
What happens if HeartMate 3 fails? HeartMate 3 is
designed to work for a long time. The controller is always
checking the system operation. It will let you know if there is
a problem, and you will learn what to look for, too. The system
will be checked during your regular medical visits.
What about a power outage? Having extra batteries
charged and ready will keep you prepared for a power outage.
The Mobile Power Unit (MPU) is portable, so you can connect
your HeartMate 3 system wherever power is available. When
you leave the hospital, your local power company will be told
of your medical device. This is a precaution in the event of a
power outage. If an outage occurs, you would be placed on
a high-priority list to have your power restored.
18
“Losing control was my
biggest concern. Now I feel
in charge again.”
–Astrid
19
How to learn more
The information in this brochure is provided for educational
purposes. Individual experiences, symptoms, situations, and
circumstances may vary. Please consult your physician or
qualified health provider regarding your condition and
appropriate medical treatment.
Remember, the more you know, the more confident you can
be about your decision. Some people find it helpful to talk with
local support groups. Your medical team may be able to put
you in touch with groups in your area.
And don’t hesitate to ask questions. The more you know,
the better off you’ll be.
20
Questions you may have
for your medical team
1. What has been the survival rate with HeartMate 3?
2. What’s the longest time that HeartMate 3 can help someone?
3. H
ow do complications with HeartMate 3 compare to those
of other, similar devices?
4. What can I expect before the procedure?
5. What can I expect after the procedure?
6. Will I be able to return to work?
7. How will my life change with HeartMate 3?
21
Notes
References: 1. Mayo Clinic website. http://www.mayoclinic.org/diseases-conditions/heartfailure/basics
/definition/con-20029801. Accessed April 30, 2015. 2. HeartMate 3 Patient Handbook. Document
10002833.B. Published September 2015. 3. Data on file. November 2014. Pleasanton, CA. Thoratec
Corp. 4. Rodriguez LE, Suarez EE, Loebe M, Bruckner BA. Ventricular assist devices (VAD) therapy: new
technology, new hope? Methodist Debakey Cardiovasc J. 2013;9:32-37. 5. Netuka I, et al. HeartMate 3
fully magnetically levitated LVAD for the treatment of advanced heart failure: results from the CE Mark
Trial. Presented at 19th Annual Meeting of the Heart Failure Society of America; September 26-29,
2015; Washington, DC.
22
Notes
IMPORTANT INFORMATION
This information is provided for educational purposes. Individual experiences,
symptoms, situations, and circumstances may vary. Please consult your physician or
qualified health provider regarding your condition and appropriate medical treatment.
This information is only intended for distribution
in countries with CE Mark approval.
Not approved for commercial sale in the US.
23
Move ahead
toward a more
enjoyable life
© 2015 Thoratec Corporation.
All rights reserved.
GL-HM3-09150353
Thoratec, the Thoratec logo, and
HeartMate II are registered trademarks
and HeartMate 3 and Full MagLev are
trademarks of Thoratec Corporation.