G Piovaccari

M Marconi

M Mezzetti

S Sermasi

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Remote Patient Management of ICD: Of What Value Is It in
Clinical Practice?
S. SERMASI, M. MARCONI, M. MEZZETTI, G. PIOVACCARI
Introduction
The benefits of the implantable cardioverter-defibrillator (ICD) have been
established in the primary and secondary prevention of ventricular arrhyth-
mias and sudden cardiac death. Patients with ICDs require regular monitor-
ing to ensure that the implanted device is working appropriately. At present
monitoring is undertaken at a pacemaker centre with equipment and experi-
enced staff. The number of ICD implantations is growing rapidly, underlin-
ing the necessity of developing new methods for patient- and doctor-friendly
control of their function. The standard follow-up protocol for patients who
have received ICDs includes a first outpatient check-up 1 month after
implantation and a quarterly device interrogation by radiotelemetry [1]. If
patients experience any problems between check-up visits that may be relat-
ed to the device, they generally have to return to the device clinic.
Most published studies demonstrated a cumulative incidence of adequate
ICD-delivered therapy ranging from 20% to over 60% depending on the
duration of follow-up (6 months to 4 years) [2–4]. In our experience, 73% of
ICD patients implanted in secondary prevention and 42% in primary pre-
vention received appropriate ICD therapy during a 5-year and 4-year follow-
up respectively. The Canadian Implantable Defibrillator Study (CIDS), dur-
ing an 11-year follow-up, showed that 70% of the ICD group had appropriate
therapy [appropriate shock or appropriate antitachycardia pacing (ATP)]
and 50% received inappropriate therapy, including ATP, one shock or more
inappropriate shocks [5]. This cause a high number of event-related or
symptom-related visits to add to routinely scheduled follow-up visits.
Operative Unit of Cardiology, Infermi Hospital, Department of Cardiovascular Diseases,
AUSL Rimini, Italy
Based on the manufacturer’s analysis and/or device interrogation, 72% of
death events in ICD patients were associated with malfunctioning ICDs,
leads, or both [6]. ICD follow-up systems should include methods that can
identify defects before they cause catastrophic events.
In addition, patients who have received ICDs often need to be re-pro-
grammed several times on the basis of changes in their clinical status or con-
comitant anti-arrhythmic therapy that successfully modifies the frequency
and recurrence of ventricular arrhythmias.
Efforts are being made to introduce remote device-based monitoring sys-
tems that can wirelessly transmit device information from the patient to the
pacemaker clinic. Besides the money saving in healthcare costs by reducing
outpatient visits and emergency admissions, the opportunity to follow the
patient over an uninterrupted time period should improve patient care [7].
In addition, so much information, significantly increasing the communica-
tion between physician and patient, is useful for patients who may have con-
cerns about the device or their cardiac health: this too contributes to
improving patients’ quality of life.
Available Technologies
Home Monitoring (HM) Service
Chiodi has described technical characteristics and some clinical benefits of
the HM Service  (Biotronik GmbH & Co., Berlin, Germany) [8]. This system
uses an implanted chip that transmits diagnostic data from the ICD to a
modified GSM mobile phone unit. The ICD is able to send the data over a
distance of about 2.5 m to the receiver. The receiver, which is battery pow-
ered, can be placed in the loading tray beside the patient or can be carried
around with him. The information transmitted includes the number of ven-
tricular tachyarrhythmias detected in each different monitor zone and ATP
and shock therapies delivered, besides data about battery voltage, pacing and
shock impedance, and device status. The message is then forwarded as an
encrypted short message via the standard SMS procedure to the remote
Service Centre, i.e. the central data processing unit to which all implant data
are sent. Data are generated and transmitted either at set times (automatical-
ly every 24 h), following an event (the termination detection after treat-
ment), or as a patient-triggered message. At the Service Centre incoming
messages are automatically decrypted, the contents are collected into a data-
base, and a Cardio Report is then sent to the physician in charge of the
patient. The entire process takes a few minutes and requires no involvement
on the patient’s part.
Several studies have been performed to explore the clinical benefits of
256 S. Sermasi et al.
HM technology in patients who have received Biotronik ICDs [9–11]. Elsner
et al. published an interim analysis of the collected data from 177 ICD
patients followed for 232 ± 109 days [12]. On the basis of daily HM informa-
tion, ventricular tachyarrhythmias were detected in 39% of patients, 36% of
whom received ICD therapy. Detected arrhythmias included 550 ventricular
tachycardia (VT) and 239 ventricular fibrillation (VF) episodes. Nine hun-
dred and eighty-five ATP attempts were documented in 34 patients, with a
mean success rate of 70.2% (one or more attempts). Three hundred and thir-
ty-two shock therapies were initiated in 53 patients, 200 of which were
aborted. The preliminary report from the WAMMI study [13] provided inter-
im data analysis in 180 ICD patients who were followed for a mean of 9
months. Two hundred and fifty-two episodes of VT or VF were detected via
HM, 98 of which were terminated by programmed ATP and 58 by shock.
Additional reports have focused on the use of the HM Service to evaluate
effects of drugs or to detect supraventricular tachyarrhy thmias or
lead/device defects [14–16].
Continuous monitoring of device-delivered therapies as soon as they
occur, appropriate or inappropriate, their success rate, and the incidence of
relevant tachyarrhythmias may contribute to optimising how the device can
work to help modifying programming and drug therapy. Furthermore, the
HM Service may allow prompt detection of lead- or ICD-related technical
failures which can be catastrophic to the patient [17].
CareLink Patient Management Network
The CareLink (CL) monitoring and software package (Medtronic Inc.,
Minneapolis, Minn., USA) allows the physician to collect data via a website
from patients with implanted Medtronic ICDs. The CL includes a portable
monitor used by patients to self-interrogate their ICD. The data are automati-
cally downloaded by the monitor and sent through a standard telephone con-
nection, directly to the secure Medtronic CL Network where doctors view and
analyse patient device data stored on the server [18]. The transmission
includes all data within the device memory: stored episodes, device parame-
ters, and diagnostics. A 10-s rhythm electrogram is available at the time of the
interrogation. Clinicians access their patients’ data by logging onto the clini-
cian website from any internet-connected PC, and patients can also view infor-
mation about their device and condition on their own personal website [19].
In the CareLink trial 59 patients from 10 follow-up clinics across the
United States completed 119 transmissions [18]. Review of the data transmis-
sions revealed several clinically relevant findings such as asymptomatic
episodes of paroxysmal atrial fibrillation, atrial sensing failures, and VT. The
quality of the web-accessed data was comparable to that of in-office device
257Remote Patient Management of ICD: Of What Value Is It in Clinical Practice?
interrogation. As a result, patients enjoy a timely and convenient connection
to their care team and physicians may offer better patient care besides an
improvement in the cost-effectiveness of clinic operations.
Housecall Plus Remote Patient Monitoring System
The Housecall Plus (HP; St. Jude Medical Co., Sylmar, Calif., USA) is a moni-
toring system to transmit complex ICD data: a full, in-office, programmer-
based interrogation (electrograms, surface ECGs, delivered therapies and
stored electrogram, etc.) in real time over standard telephone lines directly
from patient to medical professional [20]. The patient must hold a transmit-
ter over the ICD and the telephone is placed in a special cradle. Information
is transmitted to a processing centre and then compiled and sent to the
physician. During a 12-month study [21], 570 transmissions were received,
revealing 54 delivered ICD therapies, 22 aborted therapies, and 30 episodes
of non-sustained ventricular arrhythmias. In addition, 32 instances of trou-
ble with the ICD or with the leads connected to the heart were revealed.
Patients consider the transtelephonic ICD follow-up provided by HP satisfac-
tory and easy to use, reducing the number of device clinic visits for routine
follow-up and unwarranted trips to the emergency department.
Comment
All studies found high patient and physician satisfaction with the methods
delivering remote monitoring of implanted devices. The ability to transmit
information from any telephone connection means that patients have the
comfort of knowing that their condition can be monitored wherever they
are. Positive benefits include better use of resources including hospital-based
staff, improved patient care, and the economic benefits associated with fewer
unnecessary hospital admissions and patient transport costs [7]. The next
step will be for these systems to allow the doctor to program the device with-
out having the patient present [22].
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Remote Patient Management of ICD: Of What Value Is It in Clinical Practice?

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Remote Patient Management of ICD: Of What Value Is It in Clinical Practice?

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