Remote Device Monitoring: Understanding What’s Right For You 1 C9-114-1108

Remote Device Monitoring:
Understanding What’s Right For You
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Disclaimer
This presentation is provided with the understanding
that the slide content must not be altered in any manner
as the content is subject to FDA regulation. If portions
of the slide presentation are used, the appropriate
indications, contraindications, warnings, precautions,
and adverse events must be included.
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Imagine the possibilities
• Your doctor may be getting important information from your
device while you are relaxing at home.
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Remote Device Monitoring Overview
• Remote Device Monitoring
– Factors that determine the type of monitoring you may have
– Types of remote device monitoring systems
• Trans-telephonic monitoring
• Scheduled remote follow-up
• Daily/weekly checks
– Remote device monitoring systems
• The LATITUDE® Patient Management System
– An example of a remote device monitoring system
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What is remote device monitoring?
• “Remote" because you don't
need to be at your doctor's
office to have your device
checked.
• "Monitoring" because the
remote system can check
your device for specific
information per your doctor’s
orders (for example, if the
battery status and event
information) and as
scheduled by your doctor.
• How often your device is
monitored is determined by
your doctor.
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What is remote device monitoring?
All patients should have regular
monitoring of their device and
health.
Why are there so
many types of
monitoring
systems?
Three factors determine what
type of monitoring system your
doctor will prescribe for you:
1. The type of device you have.
2. The manufacturer of your
device.
3. What you and your doctor
decide is the best approach for
you.
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Why do I use one
monitoring system
for my device, while
someone else I
know uses a
different system?
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1. Type of Device You Have
• If you have a pacemaker (Pacemaker
or CRT-P):
– Trans-telephonic monitoring (TTM)
offers real-time transmission of heart
rate sent over phone line.
– In-home remote monitoring as
scheduled (manufacturer dependent)
offers real-time device and heart
data sent over phone line to webbased system.
• If you have an implanted cardioverter
defibrillator (ICD, CRT-D):
– In-home remote monitoring as
scheduled by physician with data
sent over a secure phone line to
web-based system.
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2. The Device Manufacturer
• Each device manufacturer or
company uses its own
proprietary technology.
• One company’s system will not
monitor a device from another
company.
• Some systems allow you to use
additional in-home equipment
(such as weight scales and
blood pressure measurement
devices).
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3. Best Approach for You
• You and your doctor will decide what
monitoring system is the best for you.
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Trans-telephonic Monitoring Overview
• Trans-telephonic Monitoring
(TTM)
– Transmits through a standard
phone line.
– Use of TTM is arranged by
your doctor.
– Services not typically
provided by pacemaker
manufacturer.
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Remote Device Monitoring Overview
Common features of remote device monitoring systems include
the following:
Scheduled Remote
Follow-Up
• May replace some inclinic follow-ups
• Implanted device
interrogation at a
predetermined time set
by your doctor
• Checks specific device
and heart health
information
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Remote Device Monitoring
Daily and Weekly
Device Checks
• Interrogations between
follow-ups
• Daily and/or weekly
device interrogations set
by your doctor
• Checks specific device
information
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What is a scheduled remote follow-up?
• Routine scheduled follow-up:
– Gathers data from your
implanted device:
• Real-time picture of your
heart rate (EGM)
• Specific information about
your device and heart health
(manufacturer specific)
– Appears on a secure website for
review
• If you have a wireless system:
– The monitor will perform the
follow-up automatically.
• If you have a wanded system:
– You will participate in the followup at the scheduled time.
• You may get a note from your
clinic before or after your inhome follow-up appointment.
• You may get a bill for the inhome follow-up.
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How are daily and/or weekly checks done?
• Your doctor sets a schedule determining
when your device will be checked.
• Depending on the device you have:
– A wireless communicator will
automatically receive information, or
– You will hold “wand” over your device
to allow your monitor to receive your
device information.
• Information from your device is collected
by your monitor then sent by a phone
line to your doctor’s secure web site.
• Your doctor/nurse then checks your
information which they have received.
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How is information sent?
• Most in-home monitoring systems
use standard land lines to
connect to the internet.
– If you have DSL (digital phone lines),
you may need an adapter for your
phone system.
– Some systems use cellular
technology.
• Keep the monitor connected to a
power outlet and a phone line at
all times, unless otherwise
directed by the manufacturer.
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What information is checked?
• Your doctor will set the
monitoring system to check:
– Battery status
– Leads
– Certain device settings
– Certain device conditions
that need immediate
attention
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What can’t remote monitoring do?
• Does not eliminate contact with
your doctor.
– Always contact your doctor about
symptoms you are experiencing.
• Does not replace emergency
response (911).
– Always call 911 or activate EMS for
medical emergencies or a change in
your health status.
• Cannot change device settings.
• Does not replace all visits with
your doctor.
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Benefits of remote monitoring
• Doctor has access to specific
device information.
• Doctor can manage your care
and respond more efficiently to
any health changes
communicated by your
monitoring system.
• System will alert doctor of certain
device conditions needing
attention.
• System is portable if you travel.
• Patient support representatives
available to assist you in your
communications.
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In an emergency…
• Remote monitoring does not
replace physician contact!
• Always call 911 in an
emergency.
• Always call your doctor
if your health changes suddenly
or dramatically.
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Remote Device Monitoring Systems
• Systems commonly available in the US:
– Medtronic Carelink®
– St. Jude Merlin™@Home and HouseCall Plus™
– Biotronik CardioMessenger®
– Boston Scientific LATITUDE® system
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Remote Monitoring Systems
Medtronic CareLink Network
• The patient monitor enables you to “connect” your
implanted device to your clinic via a standard phone line.
• Available for Medtronic ICDs, CRT, pacemakers and
implantable cardiac monitors in the United States.
www.carelinknetwork.com/
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Remote Monitoring Systems
St. Jude [email protected]
• The patient monitor enables you to “connect” your
implanted device to your clinic via a standard
phone line.
• For use with CurrentTM RF ICD and PromoteTM RF
CRT-D devices.
St. Jude Housecall Plus
• The patient monitor enables you to “connect” your
implanted device to your clinic via a standard
phone line.
• For use with AtlasTM and EpicTM ICDs and Atlas HF
and Epic HF CRT devices.
www.sjm.com/
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Remote Monitoring Systems
Biotronik CardioMessenger
• A portable unit that receives data from the implanted
device. It is the link that connects you to the Biotronik
service center.
• Available for Biotronik ICDs, CRT and pacemakers in
the continental United States and in over 50 countries.
www.biotronik.com/en/us/
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Remote Monitoring Systems
Boston Scientific LATITUDE System
• The patient monitor enables you to “connect” your
implanted device to your clinic via a standard phone
line.
• Available for Boston Scientific ICDs and CRT devices in
the United States, Puerto Rico and the Virgin Islands.
www.aboutlatitude.com
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LATITUDE Patient Management System
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3
You are
implanted with
a cardiac
device
2
The clinic enters your name
into the remote patient
management system
4
Clinic receives
implant form
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You set up
the equipment
at home.
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Boston Scientific ships
equipment to your
home
Clinic begins
managing patients
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LATITUDE Patient Management System
When the in-home equipment arrives
at your home:
• Information to help you set up your
equipment:
– A video setup guide (in both VHS and
DVD formats)
– A detailed patient manual
– A one-page sheet with instructions
and illustrations
– LATITUDE Patient Support number
• Set up your equipment as soon
as you receive it based on manufacturer’s
instructions.
• After set-up, your doctor can begin
monitoring your device.
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LATITUDE Patient Management System
To set up your equipment:
• Place your equipment where
your sessions will take place,
such as by the bedside.
• The Communicator plugs into
your regular phone line and
electrical outlet.
• Instructions are provided to
guide you through the set-up
process.
If you have a phone jack in your bedroom,
you may want to put the in-home monitor on
the nightstand next to your bed.
Your doctor decides how often to collect the
data, and the remote monitoring system
does the rest.
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LATITUDE Patient Management System
• If your in-home equipment is the LATITUDE Wanded Communicator:
– A blinking white action button reminds you
when it is time to send your
information.
– Simply hold the wand over your
device.
– Press the blue interrogation button
to send information from your device.
– Remote monitoring, on average,
takes 10 to 15 seconds to complete
but may take more time if
additional information needs to be
collected.
– The Communicator screen will indicate
when the session is over.
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LATITUDE Wanded Communicator
Interrogate Button
Communicator Wand
Action Button
Menu Selection Buttons
Volume Control
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LATITUDE Patient Management System
• If your in-home equipment is the LATITUDE Wireless Communicator:
– It is recommended that your LATITUDE Communicator stay near your
bedside.
– After it is set up, the Communicator
can be configured by your doctor over the phone line.
– Your doctor will determine
when monitoring will occur.
– You typically do not need
initiate any action.
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LATITUDE Wireless Communicator
Wireless antenna
Interrogate Button
Action Button
Menu Selection Buttons
Volume Control
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Other in-home monitoring tools
• Your doctor may prescribe additional in-home equipment,
such as a weight scale and blood pressure cuff, to enhance
your follow-up care.
• These tools also make it easy for you to take an active role
in managing your health.
LATITUDE
Communicator
Wireless weight scale
Wireless blood
pressure cuff
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How does this equipment work?
• Measure your weight and blood
pressure as instructed by your
doctor.
• Your weight and blood pressure
readings are automatically and
wirelessly sent to the
Communicator.
• The Communicator sends this
information to a secure
computer system that your
doctor can access.
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LATITUDE Patient Management System
Think of daily or weekly remote monitoring like a smoke detector.
It will only notify you if there is an alert.
Would you put the batteries in your smoke detector only
once or twice a month?
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LATITUDE Patient Management System
• Ask your doctor about remote monitoring while
planning your trip. Some of the scheduled events
may need to be temporarily changed.
• The in-home monitor may be used while away
from home for an extended period of time – just
pack it up and take it with you.
• The LATITUDE system may be used outside the
50 United States, Puerto Rico and the Virgin
Islands.
We recommend packing the LATITUDE Communicator in your
carry-on luggage. Other monitoring equipment – weight scale
and blood pressure cuff – may be checked if well packed
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Questions?
What questions do you have about
remote device monitoring?
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Important Safety Information
Cardiac Resynchronization Therapy Devices
• Cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D) are used to treat heart failure
patients who have symptoms despite the best available drug therapy. These patients also have an electrical condition
in which the lower chambers of the heart contract in an uncoordinated way and a mechanical condition in which the
heart pumps less blood than normal. CRT-Ps and CRT-Ds are not for everyone including people with separate
implantable cardioverter-defibrillators (CRT-P only) or certain steroid allergies. Procedure risks include infection, tissue
damage, and kidney failure. In some cases, the device may be unable to respond to your heart rhythm (CRT-P only)
or may be unable to respond to irregular heartbeats or may deliver inappropriate shocks (CRT-D only).
Implantable Cardioverter Defibrillators
• An implantable cardioverter defibrillator (ICD) can protect you from the effects of sudden cardiac arrest by reviving
your heart rhythm. An ICD is not for everyone, including people with certain steroid allergies. Procedure risks include
infection and tissue damage. In some cases, the device may not respond to irregular heartbeats or may deliver
inappropriate shocks.
Pacemakers
• A pacemaker system can monitor and treat your heart rhythm by delivering electrical energy to pace your heart when
it senses a slow rhythm. A pacemaker is not for everyone, including patients with certain steroid allergies. Patients
who have additional medical conditions that may not allow the pacemaker to function appropriately should not receive
a device. Procedure risks include infection, tissue damage and kidney failure. In some cases, the device may not
respond to your heart rhythm.
For All Devices
• In rare cases severe complications or device failures can occur. Electrical or magnetic fields can affect the device.
Only your doctor knows what is right for you. These devices are available by prescription only. Individual results may
vary.
Device Quality and Reliability
• It is Boston Scientific’s intent to provide implantable devices of high quality and reliability. However, these devices may
exhibit malfunctions that may result in lost or compromised ability to deliver therapy. Refer to Boston Scientific’s CRM
product performance report on www.bostonscientific.com for more information about device performance, including
the types and rates of malfunctions that these devices have experienced historically. While historical data may not be
predictive of future device performance, such data can provide important context for understanding the overall
reliability of these types of products. Also, it is important that you talk with your doctor about the risks and benefits
associated with the implantation of a device.
(Rev. B)
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Important Safety Information
The LATITUDE Patient Management system is used to remotely communicate with a compatible pulse generator
device from BSC CRM and send data to a central database. The LATITUDE system is contraindicated for use
with any pulse generator other than a device from BSC CRM.
The LATITUDE system is designed to tell your doctor within 24 hours if alert conditions are detected by the
Communicator. However, alert notification cannot occur if:
– The Communicator is unplugged or is not able to connect to the LATITUDE system through an active phone line.
– Your device and the Communicator cannot establish and complete a communication session. This session must be initiated
by you if you have a device that uses inductive telemetry (Communicator that has a wand).
– The Communicator becomes damaged or it malfunctions
Up to two weeks may go by before the LATITUDE system detects the events mentioned above, and additional
time may be required for notification and resolution of the condition.
The wanded and wireless Communicator uses a radio frequency (RF) communication system to communicate
with an optional weight scale and blood pressure monitor. This communication can be disrupted by
electromagnetic interference. Avoid placing your Communicator next to or in the immediate vicinity of other
wireless products and sources of electromagnetic energy. The wireless Communicator uses RF to also send and
receive signals from the implanted device (RF enabled devices only). Using the blue Interrogate button more than
as prompted by your Communicator or as instructed by your physician may lead to a decrease in the battery life
of your implanted device. Your communicator is designed to be used in the continental US, Alaska, Hawaii, and
Puerto Rico. These devices are available by prescription only.
(Rev. I)
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Thank you!
This presentation was sponsored by
Boston Scientific
Cardiac Rhythm Management
We work to improve the quality of life for cardiac patients and
those who care for them.
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