: ICD Monitoring Device
August 1, 2014
The need
There is a need to develop a notification system that alerts emergency medical services when
an implantable cardiac defibrillator triggers a defibrillation.
The problem
Patients with heart arrhythmias are treated with an implantable cardioverter defibrillator (ICD).
This device administers an electrical shock to the patient’s heart to control the arrhythmias or to
restart the heart after sudden cardiac arrest (SCA). The side effects of the defibrillation can lead
to further injuries, such as fall injury, or can incapacitate the patient, meaning the patient has the
inability to seek medical attention. Patients with an ICD are recommended to seek medical
attention after a defibrillation. Physical inability and non-compliance can lead to further injuries,
complications and even death. The defibrillation is a violent event, caused by apporixmately 25
joules applied to the heart. This electrical shock can be a stressful experience that can lead to
stress disorders, present in nearly a third of ICD patients [3].
The burden
● Patients can experience inappropriate corrective arrhythmia therapy (a shock)
○ Inappropriate ICD intervention occurred 3.7% / year [10]
● Before receiving corrective arrhythmia therapy, patients can be expected to feel dizzy or
faint [1].
○ After receiving two or more shocks, most patients are instructed to seek
immediate medical attention [2].
○ If patients are incapacitated they are unable to seek medical attention.
○ Mortality rate in patients who experience syncope is greater than those who
remain conscious, 36.7% vs 17.4% [4].
● Patients with ICDs commonly experience post traumatic stress disorder (PTSD).
○ Some sources approximate 20% of patients have the condition [3].
○ 2 years after implant, 30.8% of patients had PTSD, and this increased to 36.4%
at 4 years after implant [3]
● As of February 2012, the Registry has collected data from more than 800,000 implants
in the United States, a rate of 10,000 ICD implants per month. [5]
Existing solutions
Existing solutions are detailed below. All devices use proprietary radio frequency (RF) and are
not compatible with devices made by other companies or outside of the “device family”. The
majority of these devices are designed for the cardiologist to monitor the ICD and check its
functionality. Some solutions, such as the CardioMessenger (Biotronik, Berlin, Germany),
generate an “alert” which notifies the patient's cardiologist of a defibrillation event. This device,
however, does not communicate the event to emergency medical services (EMS).
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Current products on market:
● Remote Monitoring of Pacemakers and ICDs [6]
○ Home Monitoring™ (Biotronik, Berlin, Germany)
○ CareLink Network™ (Medtronic, Inc., MN, USA)
○ Latitude Patient Management system™ (Boston Scientific, St Paul, USA)
○ Merlin.net™ (St Jude Medical, Sylmar, USA).
● CardioMessenger (Biotronik, Berlin, Germany) [7]
○ Each implanted device is designed to transmit diagnostic, therapeutic and
technical data to the external CardioMessenger
○ Device is only compatible with Biotronik ICD/Pacemakers(PC)
○ Does not alert EMS
● Merlin@home™ Transmitter (St Jude Medical, Sylmar, USA). [8]
○ The Merlin@home™ transmitter allows efficient remote care management of
patients with implanted cardiac devices through scheduled transmissions and
daily alert monitoring.
○ Better remote patient follow-up compliance through automatic uploads of data on
the scheduled date with RF devices and transmitters.
○ No EMS notification
● Latitude Patient Management system™ (Boston Scientific, St Paul, USA) [9]
○ Boston Scientific implanted cardiac device, and additional equipment from the
wireless weight scale and blood pressure cuff if prescribed. It sends the
information over a standard phone line based on a schedule set by your
healthcare team.
○ No EMS notification
○ Only at when the patient is in the home
● Medtronic CareLink Network [11]
○ The Medtronic CareLink® Home Monitor allows patients to send data from their
cardiac device over a standard phone line for you or your clinic to review. The
unit is small, portable, and very easy to use
○ Not designed for detection of sudden defibulation
○ No EMS notification
○ Only at usable when the patient is in the home
Stakeholders
Patient
● Reduction in mortality rate from sudden cardiac arrest (SCA) due to EMS
● Increased comfort of knowing EMS will be notified after an ICD defibrillation event
○ Potential reduction in PTSD
● Increases comfort in notification of family members
Health Care Provider
● Notification of patient defibrillation event
○ Adjustment of ICD and medication
● Psychiatric evaluation of patient after defibrillation event
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○
Treatment of PTSD
Insurance
● Reduction in cost related to complications associated with patient noncompliance in
seeking medical attention after an defibrillation
Emergency medical services
● Provided with patient location, status and medical history ensuring medical attention can
be provided accurately and timely
Need Criteria for Success
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The device must be able to monitor the patient without patient action
○ The device must interface with the patient in a noninvasive manner
○ The device must be compatible with all ICD makes and models
The application must notify a third party of the defibrillation event without patient
interface or action
○ The application must be able to open a communication link between the patient
and a healthcare professional
The device and application should be portable so that the use of the device does not
interfere with the patients lifestyle
The device and application should be accessible to individuals with all levels of computer
ability
The call center should be able to contact the patient through cell phone or through the
device to determine the following:
○ syncope vs non-syncope
○ appropriate defibrillation or inappropriate defibrillation
○ mental status of patient
○ Notify EMS of the patients location, age, and status
The device should have complete compatibility with all ICD makes and model
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Sources:
[1] http://www.uihealthcare.org/pacemakers-and-defibrillators-frequently-asked-questions/
[2] http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000108.htm
[3] http://circep.ahajournals.org/content/4/2/242.full
[4] http://search.proquest.com/docview/1506574475/citation?accountid=13605
[5] http://www.hrsonline.org/Practice-Guidance/Quality-Outcomes-Reporting/ICDRegistry#ixzz37AKOiAK1
[6] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2686319/
[7]
http://www.biotronik.com/wps/wcm/connect/en_nl_web/biotronik/sub_top/healthcareprofessional
s/products/home_monitoring/HM_Products?p=http://www.biotronik.com/wps/wcm/connect/en_nl
_web/biotronik/sub_top/healthcareprofessionals/products/home_monitoring/HM_Products/produ
ct_page_CardioMessenger&pw=974&pt=
[8] http://professional.sjm.com/products/crm/connectivity-remote-care/remote-care/merlin-hometransmitter
[9] http://www.bostonscientific.com/lifebeat-online/live/latitude-questions.html?
[10] http://www.medscape.com/viewarticle/810926
[11] http://www.medtronic.com/for-healthcare-professionals/products-therapies/cardiacrhythm/patient-management-carelink/medtronic-carelink-network-for-cardiac-devicepatients/index.htm#tab2
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