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About Outpatient ECG
Holter
recording and Event Recorder monitoring are two commonly
used diagnostic tools for long- term outpatient ECG
monitoring, while hospitalized patients are routinely
monitored by hospital Telemetry equipment. Each of these
modalities has different characteristics that influence
their use. For example, Holters are inconvenient for
recording over about 48 hours and the diagnostic data is
delayed by up to several days while Event Recorders can
capture only symptomatic events . Telemetry provides ECG
monitoring with rapid response capability, is routinely
used as a potentially lifesaving measure for essentially
100% of the nation's heart attack victims who are
monitored during their hospital stay , but is not
available on an outpatient basis.
Cardiac Surveillance
As the nature of health care delivery in the United
States changes, one consistent theme is that hospitals
may soon be limited to very sick individuals and more
will be done on an out patient basis and at alternative
lower cost sites. Recently, a new monitoring modality
has been developed and become routinely available,
combining many of the advantages of previous technology.
It provides real time ECG arrhythmia monitoring
(“Cardiac Surveillance”) for any potential expanded
patient sites; taking it all the way to the patient's
home. The system is known as the HEARTLink II, a fully
automatic, real-time cardiac arrhythmia detection and
alarm system that has specifically been designed to
operate in a home environment. It is not intended for
individuals who are at high risk of developing lethal
arrhythmias such as primary ventricular fibrillation or
sustained ventricular tachycardia, but rather those who
might benefit from timely identification of less
malignant arrhythmias. HEARTLink basically operates as
telemetry for the home providing cardiac surveillance
with automatic rapid notification of rhythm
abnormalities. Illustrating its compatibly with
in-hospital telemetry, an essentially identical system,
HEARTtrac, has been cleared by the FDA for use in
hospital step down units.
Monitoring Modes
Operationally, the system monitors and labels
electrocardiogram (ECG) patterns, automatically detects
any rhythm abnormality based on 16 different proprietary
diagnostic algorithms, and automatically transmits them
via a standard telephone to a central monitoring
station. It operates without patient intervention and
has four operational modes: real-time automatic event
mode, real-time display mode, patient activated mode for
symptomatic events, and patient help request. The device
is most commonly left in automatic mode. Any
automatically transmitted rhythm strip is seen within 15
seconds by trained operators at a central location that
is manned 24 hours/day. As occurrences of arrhythmias
are detected, transmitted and displayed at the central
station, they are viewed by medical professionals and
handled per protocol, stored and later merged with trend
data developed at the patient site. This allows a
“Holter Scan” equivalent report to be prepared for any
past 24 hour period that the patient is on the system
providing a parallel to conventional Holter equipment.
Should a patient feel a symptom, a push button is
provided which immediately sends a strip establishing
compatibility with traditional event recorders. The same
push button is used to activate a “Help Request” for use
in a possible non-cardiac emergency. Additionally,
during the real-time display mode, medical technicians
can log on from a remote terminal and display and view
ECG patterns in real time as they occur.
Monitoring Service
HEARTLink II is available to
physicians as a service called “Telemetry @ Home”,
initially targeted for patients who can benefit from its
ability to: 1. provide timely diagnosis and notification
of arrhythmias, 2. detect asymtomatic arrhythmias, 3. be
conveniently worn for a period longer that a
conventional Holter, or 4. operate without patient
intervention. A patient transmitter (Patient Module)
digitally transmits cardiac information to a ruggedized,
computer box (Tele-Link) that monitors, analyzes, stores
and quickly transmits predetermined cardiac events to a
Surveillance Lab (Independent Diagnostic Testing
Facility: IDTF). This analysis is real time and the
analysis/transmission time to the Surveillance Lab is
typically less than 12 seconds. Detection parameters can
be changed per physician instructions from the
Surveillance Lab. The patient’s telephone line works as
a normal telephone line when the Tele-Link processor is
not transmitting data. If the patient is on the phone
when a transmission is initiated, the voice call is
disconnected by the Tele-Link allowing the data call to
proceed. Extensive error detection provisions are made
for most situations that may arise outside of the
surveillance itself (e.g. low battery, leads off,
patient out of range, phone line down, etc.) and a four
(4) hour battery backup is included in the Tele-Link
Processor itself.
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Patient Transmitter
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Tele-Link |
Patient Enrollment
During patient enrollment the physician determines
arrhythmia detection parameters and notification
criteria for the patient. Detection criteria are
programmed into the Tele-Link during the patient setup
process to accommodate for the fact that each patient
situation is unique. Once Cardiac Telecom receives this
information, verification is immediately faxed back to
the physician with dates of the patient surveillance.
The physician has the opportunity to modify any of the
default diagnostic criteria prior to the patient coming
on service (and again, has the ability to change these
during the service as well). As enrollment proceeds, the
Lab contacts the patient, explains the process of the
surveillance to them; and, for the entire surveillance
period, speaks with each patient at least twice a day as
part of normal protocol.
To ensure patient compliance, the system is extremely
easy to use as all the patient needs to do is wear the
transmitting device and change the battery when needed.
Most are even capable of connecting the equipment up in
their home, and for those who cannot; arrangements can
be made to have it done for them. Although the system
performs significant cardiac surveillance and analysis
on a continuous basis, this is done transparently.
Usually, each evening, the Lab will call each
patient’s Tele-Link and download additional information
about the patient’s cardiac activity. Daily diagnostic
reports are sent to each patient’s physician for review.
Although clinicians normally associate telemetry with
“immediate on-site” care, this is not the case with
HEARTLink II. Very high risk patients should be avoided;
however, the Lab is staffed with highly trained EMT-Paramedics
and/or RNs 24/7.
Based on the acuity of the patient local EMS
facilities may be notified upon patient hookup that a
patient is on the system for cardiac surveillance and an
explanation of HEARTLink II™ is given at that time.
Regardless of patient acuity the Lab obtains information
about each patient’s local EMS facility prior to patient
hookup.
How do I provide
Telemetry@Home to my patients?
If you are a physician, or part of a nursing home,
hospital or other medical facility and would like to
evaluate the use of Telemetry@Home for your patients
please call us at (201) 670-9999. See our T@H
service overview for more information on how you and
your patients can benefit from the service.
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