a review on remote monitoring technology applied to implantable electronic cardiovascular devices
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Original ResearchA Review on Remote Monitoring Technology Applied to ImplantableElectronic Cardiovascular Devices
Paulo Dias Costa, B.Sc.,1,2 Pedro Pereira Rodrigues, M.Sc.,1,3,4
Antonio Hipolito Reis, M.D.,2
and Altamiro Costa-Pereira, M.D., Ph.D.1,4
1Department of Biostatistics and Medical Informatics—Facultyof Medicine, University of Porto, Porto, Portugal.
2Service of Cardiology, Department of Medicine—Hospital deSanto Antonio, Centro Hospitalar do Porto, Porto, Portugal.
3Laboratory of Artificial Intelligence and Decision Support,University of Porto, Porto, Portugal.
4Center for Research in Health Technologies and InformationSystems, Faculty of Medicine, University of Porto, Porto, Portugal.
AbstractImplantable electronic cardiovascular devices (IECD) include a
broad spectrum of devices that have the ability to maintain rhythm,
provide cardiac resynchronization therapy, and/or prevent sudden
cardiac death. The incidence of bradyarrhythmias and other cardiac
problems led to a broader use of IECD, which turned traditional
follow-up into an extremely heavy burden for healthcare systems to
support. Our aim was to assess the impact of remote monitoring on
the follow-up of patients with IECD. We performed a review
through PubMed using a specific query. The paper selection process
included a three-step approach in which title, abstract, and cross-
references were analyzed. Studies were then selected using previ-
ously defined inclusion criteria and analyzed according to the
country of origin of the study, year, and journal of publication; type
of study; and main issues covered. Twenty articles were included in
this review. Eighty percent of the selected papers addressed clinical
issues, from which 94% referred clinical events identification,
clinical stability, time savings, or physician satisfaction as ad-
vantages, whereas 38% referred disadvantages that included both
legal and technical issues. Forty-five percent of the papers referred
patient issues, from which 89% presented advantages, focusing on
patient acceptance/satisfaction, and patient time-savings. The
main downsides were technical issues but patient privacy was also
addressed. All the papers dealing with economic issues (20%) re-
ferred both advantages and disadvantages equally. Remote moni-
toring is presently a safe technology, widely accepted by patients
and physicians, for its convenience, reassurance, and diagnostic
potential. This review summarizes the principles of remote IECD
monitoring presenting the current state-of-the-art. Patient safety
and device interaction, applicability of current technology, and
limitations of remote IECD monitoring are also addressed. The use
of remote monitor should consider the selection of patients, the type
of disease, and centers’ availability to receive, interpret and re-
spond to device alerts. Before remote IECD monitoring can be
routinely used, technical, procedure, and ethical/legal issues
should be addressed.
Key words: implantable electronic cardiovascular devices, remote
monitoring, artificial pacemaker, cardioverter-defibrillator
Introduction
Device therapy for bradyarrhythmias has been successfully
used in clinical practice for more than 50 years with ob-
jectively proved efficiency, in terms of mortality and
quality of life.1 More recently, other electronic devices
similar to a pacemaker have been introduced in routine clinical
practice for providing cardiac resynchronization therapy (CRT) and/
or preventing sudden cardiac death. These devices, CRT devices and
implantable cardioverter-defibrillators (ICD’s), have the ability to
restore normal cardiac activation sequence and/or to detect and treat
a malignant arrhythmia, by means of electrical therapy, respective-
ly.2 Implantable electronic cardiovascular devices (IECD) include
pacemakers, ICDs and CRTs, as well as loop recorders and implantable
hemodynamic monitors.3
Over the last few years, the development of IECD technology along
with the emergence of new techniques and technologies has tre-
mendously increased the density of analysis and interpretation al-
gorithms. This increased the complexity and duration of follow-up
procedures. The development of battery technology4 along with the
increased patients means that life expectancy has extended not only
the longevity of these devices but also the burden of follow-up
procedures, which became overwhelming in relation with the
extremely vast population currently in follow-up.5 Traditional
follow-up of IECD is still a very resource-consuming activity,
requiring a great deal of time and differentiated human and technical
resources. Traditional follow-up also carries the inconvenience of
prolonged follow-up intervals, in which the physician has no in-
formation about the patient or the device.6
Our aim was to perform a survey of all available remote monitors,
explaining their advantages and inconveniences, along with patient
interaction and compliance. In particular, our objective was to de-
termine whether remote monitoring technology is effective in pro-
viding accurate real-time information regarding device operation
and patient diagnosis/therapies between appointments, while main-
taining patient-safe standards and reducing the burden of follow-up
on the healthcare community.
1042 TELEMEDICINE and e-HEALTH DECEMBER 2010 DOI: 10.1089/tmj .2010.0082
BackgroundRemote monitoring technology has been used since the 1970s,
mainly to overcome great distances between pacing centers and
distant population agglomerates.7 Since then, pacing and remote
monitoring technology have made quite a significant leap.
REMOTE TECHNOLOGY FUNDAMENTALSRemote technologies requirements include, depending on the
relative importance on the practical application, in general (1) low
battery power; (2) safety and reliability; (3) data rate; and (4) data
latency. Based on these requirements, the choice of standards and
regulations to fulfill these needs is necessary.8
RADIO SPECTRUM AVAILABILITYThere are several standards for short range devices. Of these, the
most popular in Europe are those of the European Telecommunica-
tions Standards Institute. Popular frequencies range from 434 to
868 MHz. Nonetheless, a Medical Implants Communication Services
(MICS) band exists worldwide, ranging from 402 to 405 MHz, being
shared only with meteorological aids and specifically designated for
implanted medical devices. MICS systems are classified as class 1
under European directives and, therefore, the frequency band is
available in all European Union member states without license. MICS
is a unique new technology that provides high-speed communica-
tions capability between individuals with implanted devices and
medical practitioners for the purpose of diagnosing and delivering
therapy to individuals with various illnesses. Some committees are
studying future requirements for spectrum up to 3 GHz for medical
applications.8,9
SPECTRUM CHOICEThe choice of any particular spectrum and system has to be made
within the ranges stated above. IECDs have their own particular
problems including large body loss and inefficient antenna. The
400 MHz region offers a good compromise in this respect8 with the
added ability of transmitting radio signals in the human body.9
ULTRA WIDE BANDThis technology has many claimed advantages including high data
rate and low interference potential. However, this technology is not
being implemented in e-health mainly due to its power consumption.
Nonetheless, it has been suggested that it may have some advantages
over ultrasound in terms of in-body imaging.8
SECURITYThis is an area of major importance and difficulty. Although it
was desirable that, from one standpoint, IECDs would be readily
interrogated by means of standard radio interface signal by health
professionals, it has the chance of being maliciously interfered or
even reprogrammed and, therefore, the need to adopt standards.8
Further, MICS users must cooperate in the selection and use of
channels to avoid interference with other MICS transmissions. The
MICS transmitter must incorporate a mechanism for monitoring
the channel or channels that the MICS devices intend to occupy. The
Listen Before Talk protocol instructs the receiver to scan all chan-
nels in the MICS band for other users or noise before establishing a
connection.9 Conventional IECD protocols include encrypted
transmission of data, and MICS additionally provides a restricted
network.9
Available SystemsBefore describing all available systems, we once again remember
that none of the systems allows remote reprogramming of IECDs, a
capability that will probably not be available in the foreseeable future
due to regulatory issues.10 All major device manufacturers have in-
troduced systems for remote patient monitoring that we will now
describe.
HOME MONITORING�
Biotronik (Biotronik GmbH, Berlin, Germany) was pioneer in IECD
remote monitoring technology with the introduction of Home
Monitoring in 2001. It transmits data on a daily basis, at fixed time
intervals, and on the occurrence of a clinically relevant event and is
available in all recently manufactured devices. A cell-phone-like
patient device sends encrypted data automatically via mobile phone
lines to a central database in Europe. On reception, the data are
processed and forwarded to the caregiver. The system rapidly
transmits clinically relevant, symptomatic, or asymptomatic events
regardless of patient location.11
CARELINK� NETWORKMedtronic (Medtronic Inc., Minneapolis, MN) CareLink Network is
available in the newest ICD and CRT and defibrillation (CRT-D) de-
vices as well as pacemakers. The CareLink� monitor collects and
stores information on the device using radio frequency telemetry and
transmits device and patient data via standard phone lines and cell
phones (since 2009) to a secure data repository for processing, stor-
age, and viewing. After a series of confirmations, the system executes
data transfer trough an Internet connection. CareLink is used for
routine IECD checks and automatically checks newer ICDs and CRT-Ds
wirelessly daily and notifies physicians when problems are de-
tected.11
LATITUDE�
Boston Scientifics system Latitude (Boston Scientific, St. Paul, MN)
is not fully available in Europe. The long-range transmissions take
place by standard telephone lines, generally weekly. A patient action
button blinks on the transmitter when the patient needs to initiate
patient-driven communications, for example, on detection of a
clinically relevant event. The Latitude system delivers event notifi-
cations at two levels: Red alert or ‘‘urgent event notifications’’
identify conditions that may pose a real threat to patient’s health and
yellow alerts or ‘‘configurable clinical event notifications’’ send the
physician timely additional information pertaining to patient or
device functions.11
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ª M A R Y A N N L I E B E R T , I N C . . VOL. 16 NO. 10 . DECEMBER 2010 TELEMEDICINE and e-HEALTH 1043
MERLIN.NETTM
Again in the case of St. Jude Medical (St. Jude Medical, Sylmar,
CA) Merlin@Home�, only a wand-operated version is available
outside the United States and is available for almost all ICD and
CRT-D devices. The interrogated data are sent via standard telephone
lines to a central repository for data processing and storage. Mobility
of the system and early detection of asymptomatic events are limited.
On sensing a vibration alert, a patient can manually trigger the
Merlin@Home device to transmit a report.11 The main characteristics
of all systems are summarized in Table 1.
Patient SafetyIn their early studies, Hayes12 and Pinski13 reported susceptibility
of interference from wireless communication devices on IECDs,
namely by cellular telephones and antitheft devices.14 Nevertheless,
they concluded that the use of such technology was safe counting
that some precaution measures were taken (e.g., cellular phone in the
ipsilateral ear or rapid passing by the antitheft devices). More re-
cently, some authors15,16 reported interference between video-cap-
sule endoscopy and some IECDs. One of the studies (in VOO, unipolar
mode) showed significant interference in the recording when the
capsule was near the pacemaker but no change in pacemaker func-
tioning.15 The other study16 showed normal function in all ICDs but
one (Biotronik Belos ICD). Nonetheless, they recommend suspending
ICD therapies in conjunction with close monitoring.
Detected malfunctions include oversensing and under-
sensing, induction of asynchronous ventricular dysrhythmias,
and noise. Interference risk depends on several factors and in-
cludes (1) distance between IECD and source; (2) transmitter pow-
er; and (3) the device itself. These problems are related to direct
IECD malfunction and not to data transfer and programming/
interrogation.16
As described earlier,7–9 remote monitoring uses an encrypted and/
or specific bandwidth reserved to medical devices and, therefore, is
not prone to interference or tampering by conventional wireless
networks.
MethodsAs previously stated, our aim was to establish the effectiveness of
remote monitoring technology applied to device follow-up.
LITERATURE SEARCHWe performed a search in Medline reference database through
PubMed, regardless of the type of publication, using the following
query: artificial pacemaker [MeSH Terms] AND (ICD [MeSH Terms]
OR pacemaker [All Fields] OR ICD [All Fields] OR CRM device [All
Fields] OR cardioverter-defibrillator [All Fields] OR defibrillator
[All Fields] OR implantable cardiovascular devices [All Fields]) AND
remote monitoring [All Fields].
Table 1. Current Commercially Available Patient Management Systems (2008)
HOME MONITORING CARELINK NETWORK LATITUDE MERLIN.NET
FDA approval 2001 2005 2006 2007
Patient device Home monitor Conexus Latitude communicator Merlin@Home
Characteristics Portable/simple Stationary/simple Stationary/interactive Stationary/voice interactive
Home telemetry MICS MICS/wand Wand Wand
Patient trigger Call back light Audio Audio Vibration
Transmission Daily follow-up/event messages
(automatic)
Scheduled follow-up/event
messages (automatic)
Scheduled follow-up/event
messages (automatic)
Scheduled follow-up/patient
initiated (automatic)
Long-range telemetry GSM/GPRS/landline GSM/landline Landline Landline
Information of events Fax/e-mail/SMS E-mail/SMS Fax/phone Fax/e-mail/SMS
Early detection <24 h (all events) <24 h (all events) <24 h (all events) Not available
Data storage Long term Long term Long term Long term
Interface with EMR HL7 HL7/some EMR HL7 HL7/some EMR
Data presentation Event-based Event-based Traffic light-based Event-based guidance
Cognitive interpretation Physician Raytel partnership Raytel partnership Mednet/raytel partnership
Impact on battery longevity Low High High Not available
FDA, U.S. Food and Drug Administration; MICS, medical implants communication services; GSM, global system for mobile communication; GPRS, general packet radio
service; SMS, short message service; EMR, electronic medical records; HL7, health level interface standard.
Note: Adapted from Jung et al.11
COSTA ET AL.
1044 TELEMEDICINE and e-HEALTH DECEMBER 2010
SELECTION PROCESSThe query was performed on December 28, 2008, initially re-
turning 24 papers for analysis. The analysis was performed by a
single investigator in three steps. The first step was done by trying to
relate the title and the object of the study choosing those articles that
were related with our subject. In the next step, we analyzed the ab-
stract of all the selected articles and excluded those that were not
adequate to our purpose. The last step consisted in performing a
cross-linked examination by selecting articles related with those
previously selected in step two.
SELECTION CRITERIASelection criteria were defined before the query and included (1)
study addresses remote monitoring technology, particularly applied
to IECD; (2) description of study design; (3) statistical analysis of
results; and (4) study includes both results and discussion on different
issues.
STUDY VARIABLESThe study variables used for analyzing the papers were country of
origin of the study (first author), year and journal of publication, type
of study, and main issues covered:
. Patient issues: all nonclinic issues that can be perceived by the
patient or have impact on their daily routine;. Clinical issues: all issues related to diagnosis, follow-up, and
treatment that involve staff or routine clinical management,
including legal and ethical aspects of clinical practice;. Economic impact issues: all the issues that imply costs for the
patient, the staff, healthcare providers, or healthcare systems.
For better understanding, the entire selection process is described
in Figure 1.
ResultsAfter applying all of the above criteria, we selected 20 articles on
which we based our review.10,11,17–34 A first overview on the selected
papers allowed us to place them in terms of type, time, and location
while exploring the issues each of them covers.
After a brief analysis, we observed that 30% of the articles were
originated from the United States and 25% were originated from
Italy. If analyzed all together, European countries were responsible
for 70% of the publications. Regarding the field of expertise of the
journal, we observed that the vast majority (95%) was published in
Cardiology related journals, with only one paper appearing in a
Medical Informatics journal.19 More than half (55%) of the articles
were published in 2008 and 2009, as use of these technologies have
increased. The main topics included patient, clinical, and economic
impact issues. Articles include 45% nonrandomized clinical trials,
25% reviews, and two (10%) major ongoing trials, emphasizing the
current interest in this subject. Table 2 summarizes the characteristics
of selected papers.
PATIENT AND CLINICAL ISSUESThe main findings regarding patient and clinical issues are sum-
marized in Tables 3 and 4. Eight of nine patient issues papers pre-
sented advantages with 75% focused on patient acceptance/
satisfaction. Patient time savings were mentioned in four of eight
papers. The main downsides were technical issues in three of four
papers. Ninety-four percent of physician issues papers presented
advantages, focusing on clinical events identification (67%), clinical
stability of patients (40%), time savings (33%), and physician satis-
faction (33%). Six papers referred to disadvantages for physicians,
including legal and technical issues (50%).
The study by Lazarus et al.17 reported that remote monitoring in
devices at risk detects as promptly as currently possible the small
number of device failures, eliminates the need of unnecessary re-
placements, and provides patients with the highest level of reassur-
ance and comfort. In the study by Res et al.,18 a high or very high
satisfaction was claimed by 97% of patients and a small number of
patients, who believe they have experienced a shock, but have not
had one, can be reassured in case they have not had a malignant
tachyarrhythmia. Asymptomatic ventricular dysrhythmias can also
be traced and followed, and patients can be seen for treatment to
improve patient compliance.
Masella et al.,19 using a remote monitoring system in an Italian
population, reported 23 unscheduled contacts by patients, with only
2 requiring clinic visits. The remote monitoring system used in this
study was judged very easy to use by 96% of patients, and 78% of
patients preferred remote monitoring rather than a clinic appoint-
ment.19 Similar results (98%) were observed by Schoenfeld et al.20
Marzegalli et al.21 reported that patients found that remote moni-
toring saved time (travel and appointment) and decreased their costs.
Two major trials to determine clinical outcomes of prolonged re-
mote monitoring and potential benefits to clinic staff are expected to
be completed in the end of 2009.22,23
A retrospective analysis by Heidbuchel et al.24 concluded that
during the vast majority of scheduled visits, no relevant or device-
related problems were detected in 78.2% of patients, and 90% of
patients required no medical treatment or device programming. TheFig. 1. Schematic description of paper selection.
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ª M A R Y A N N L I E B E R T , I N C . . VOL. 16 NO. 10 . DECEMBER 2010 TELEMEDICINE and e-HEALTH 1045
clinical and device-related problems detected in 21.8% of patients
could have been recognized and treated by a general practitioner or
referring cardiologist, or in a scheduled traditional follow-up.
However, unscheduled appointments were much more frequent than
scheduled ones (80.6% vs. 21.7%; p< 0.001) and in 45.7% of un-
scheduled appointments device reprogramming or hospitalization
was required. These results indicate that remote monitoring can di-
agnose the vast majority (99.5%) of arrhythmias and device-related
problems.
Two large studies of CRT-D devices demonstrate that remote
monitoring can alert the clinician to fluid accumulation in the
lungs.25,26 This allows clinicians to call the patient to adjust therapy
and decrease need for admissions for congestive heart failure, a direct
benefit to both the patient and the healthcare system.
Case reports have highlighted the benefits of early detection of
malfunctions and arrhythmias using remote monitoring, particularly
lead insulation or fracture, anomalous impedance risings, battery
depletion, and arrhythmias.27,28
ECONOMIC IMPACTThe main economic advantage of remote monitoring cited was
decreased follow-up costs. Reimbursement issues were considered
the main disadvantage.
Fauchier et al.29 concluded that since recommended follow-up in-
tervals range from 3 to 6 months, remote monitoring can save up to two
visits per year. In terms of savings, this represents a net saving of $948
per patient. Also, regarding transportation, the mean reduction in cost
over a 5 year period was $2,722, with savings beginning at 26 months.
Table 2. General Characteristics of Selected Papers
PATIENT ISSUES CLINICAL ISSUES ECONOMIC IMPACT N
Number of studies 9 (45%) 16 (80%) 4 (20%) —
10,17–21,24,30,32 10,11,17–20,22–28,31,32,34 11,29,30,33 20 (100%)
Country of publication
United States 10,20,32 10,20,22,23,32 33 6 (30%)
Germany — 11,28 11 2 (10%)
France 17 17 29 2 (10%)
Netherlands 18 18,31 — 2(10%)
Italy 19,21 19,25,26,34 — 5 (25%)
Belgium 24 24 — 1 (5%)
Czech Republic — 27 — 1 (5%)
Finland 30 — 30 1 (5%)
Year of publication
2004 20 20,28 — 2 (10%)
2005 32 32 29 2 (10%)
2006 10,18 10,18 — 2 (10%)
2007 17 17,22,25 — 3 (15%)
2008 19,21,24,30 11,19,23,24,27,31,34 11,30,33 10 (50%)
2009 — 26 — 1 (5%)
Type of study
RCT (design) 22,23 2 (10%)
NRCT 17,19,21,24,30,32 17,19,24,26,32,34 29,30 9 (45%)
Review 18,20 11,18,20,25,31 11 5 (25%)
Case report — 27,28 — 2 (10%)
Other 10 10 33 2 (10%)
RCT, randomized clinical trial; NRCT, nonrandomized clinical trial.
COSTA ET AL.
1046 TELEMEDICINE and e-HEALTH DECE MBER 2010
Similarly, Raatikainen et al.30 concluded that the replacement of
traditional follow-up by remote monitoring reduced the direct costs
of ICD follow-up to the healthcare providers by 155e and for patients
by 22e. When compared with traditional follow-up, remote moni-
toring reduced the costs in the studied population from 38.048e to
23.534e (38%). Obviously, these figures have to be put in perspective,
regarding the type of IECD (ICD, CRT, or conventional pacemakers),
the cost of transportation and distance, the cost of appointments, the
inconvenience of unscheduled appointments, and several other fac-
tors. Nevertheless, we can infer that a substantial saving per patient is
attained by the use of remote monitoring.
Reimbursement issues are a complex matter by themselves and
will not be addressed in more depth, with the risk of getting out of
scope. Nevertheless, some residual problems still subside, namely
regarding the relatively slow progress in confirming clinical benefit,
the lack of reliable cost-benefit data11 on remote monitoring, and the
different reimbursement schemes among healthcare systems, with some
countries stressing the need of new models of reimbursement.29,30,33
The information contained in the analyzed papers and regarding
economic impact is summarized on Table 5.
DiscussionMore than three decades have transpired since the inception of
transtelephonic pacemaker monitoring. This modality has proved
useful for tracking the function of early pacemakers, particularly
when both lead and pulse generators longevities were highly un-
predictable. Further, until relatively recently, the complexity of new
devices outpaced the capabilities of transtelephonic monitoring.
Remote monitoring of implanted ICDs is, in contrast to pacers, a
relatively recent development.11,31,32
The demographic increase in mean
age of populations along with the
incremental cost of the provision of
healthcare has a severe impact on
health and, therefore, leads to increas-
ing requirements of technological ap-
plications to reduce costs as well as
improving healthcare. Although these
applications have a widely recognized
value, they cannot entirely replace
human contact, namely in traditional
follow-up and, thus, need to be com-
plementary with each other. We have to
keep in mind that remote monitoring
technologies are not an instrument to
replace traditional follow-up (that
should always be scheduled according
to international guidelines5) but rather
a technology that helps healthcare
professionals to monitor and act on
changes in cardiovascular status of the
patient or the device between scheduled
follow-up. The majority of ICD recipi-
ents are routinely followed from 3 to 6 months.5 Additionally, a
substantial number of patients require additional nonscheduled visits
due to arrhythmic events or system-related complications. The
challenge is to be able to avoid routine follow-up visits such as
integrity check and/or confirmation that no arrhythmic events or
IECD-related issues occurred.31
These systems, while enormously reducing the economic impact
of unscheduled follow-up sessions (and the inherent cost of a
possible admission and treatment), still have some problems re-
garding healthcare provider’s reimbursement.11,29,30,33 Also, re-
motely reprogramming IECDs have additional caveats, both
technical and ethical, that need to be addressed before widespread
implementation will be possible.32–34 This is of particular impor-
tance, as remote monitoring is particularly vulnerable in this field
mainly because the law-making process tends to be outpaced by
technology development and also because of national/European
differences. Additionally, different proprietary technologies for
remote monitoring could pose a major obstacle to data integration,
making it an important premise. Also, the scarce resources of
clinical guidelines may pose a problem to remote monitoring im-
plementation. These issues should be seriously addressed before
remote monitoring can be routinely used and firmly established in
clinical practice.11,25,32–34 Nevertheless, we have to consider that
the economic impact regarding cost estimates and savings must
consider multiple factors, multiple different devices, device costs,
and longevity of different devices. Moreover, issues regarding
reimbursement must be further clarified to show differences in
systems in different countries and must be the subject of future
research. Fully automated remote monitoring capabilities will
probably be included in all upcoming IECDs. Useful new sensors are
Table 3. Patient Issues Regarding Remote Monitoring and Its Main Determinants
ADVANTAGES (N¼ 8) DISADVANTAGES (N¼ 4)
Patient issues (n¼ 9) Patient convenience Technical issues
Reduce patient inconvenience10 Failure to properly handle the system18
Patient acceptance/satisfaction Difficulty in antenna positioning20
Easy/very easy to use10,19–21,30 Transmission problems21
High acceptance18,19,21 Other issues
High/very high level of satisfaction18,21,30 Patient privacy32
Patient reassurance Remote technology: manufacturer specific32
Patient reassurance17,24
Patient calmness19
Time saving
Overall time savings18
Saving in traveling time19,21,30
Saving in waiting time19,21,30
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also expected to soon become available. The evolution of IECD
toward patient monitoring may shift the emphasis from a device-
oriented to a patient-oriented monitoring, allowing a new broader
multidisciplinary approach. That will probably change the follow-
up routines, allowing clinicians to intervene more rapidly,
improving clinical outcomes and reducing costs.
ConclusionsAfter reviewing the issue of remote monitoring, we can conclude
that it is currently a major issue in Europe, reflected by the number of
studies produced in Europe, and probably because this issue has been
addressed in the United States for quite sometime and is currently
being used in clinical practice widely.
Also, based on our analysis, we can infer that remote monitor-
ing is presently a safe technology, widely accepted by the patients
for its convenience and reassurance. It has enormous potential for
the clinician, both for monitoring diseases and treatment and for
identifying potential harmful situations. This is of major importance,
as it can help the physician to perceive any changes of clinical status
of the patient or the device and act on it. Nevertheless, two major
trials are still pending for published conclusions and are expected to
further enlighten this subject.22,23
The fact that in our analysis economic impact disadvantages
match advantages may, in part, explain the delay in the im-
plementation of remote technology. Nevertheless, remote monitoring
has the ability to reduce the direct costs of follow-up, by reducing the
number of in-office visits, transportation costs, and staff-saving
costs.
However, a series of issues should be solved before remote mon-
itoring can be routinely used in Europe and include data integration
Table 4. Clinical Issues Regarding Remote Monitoring and Its Main Determinants
ADVANTAGES (N¼ 15) DISADVANTAGES (N¼ 6)
Clinical issues (n¼ 16) Clinical events Legal issues
Identification of number/type of episodes10,11,17,18,20,25,26,32 Need to establish legal responsibility for an immediate response11
Identification of number/type of delivered
therapies10,11,17,18,20,25,26,32Need to issue guidelines on remote monitoring11,25
Reduce inappropriate delivered therapy18 Need to inform patient on purpose, use, and limitations of remote
monitoring11
Silent arrhythmias discovery10,18,20,24–26,28,32 Patients’ privacy32
Assessment of antiarrhythmic drug
efficacy10,18,20,24–26,28Technical characteristics
Identifying abnormal device functions10,11,17,20,24–27,31,32 Does not allow remote reprogramming17,19,24
Patients’ clinical stability Most current remote systems do not allow determination of
pacing threshold24
Prediction of hospitalization10,26,31,32
Changes in patients’ clinical status11,17,26
Helping in the design of individualized follow-up11,31
Time savings
Overall time savings for physicians19,34
Follow-up clinic optimization17,19,23,24
Physician satisfaction
High physician satisfaction working with remote monitoring19
Assessing patient data20
Ability to provide comparable to in-office interrogation data20
Timely identification of clinically important
issues20,22,23,31
Reprogramming
Makes reprogramming less frequent34
Postshock interrogations can be done remotely34
COSTA ET AL.
1048 TELEMEDICINE and e-HEALTH DECEMBER 2010
of different proprietary technologies, the scarce resources of clinical
guidelines, and ethical and legal issues.
We can conclude that remote monitoring technology is effective in
providing accurate real-time information regarding device operation
and patient diagnosis/therapies between appointments while main-
taining patient-safe standards and reducing the burden of follow-up
on the healthcare community.
While we were writing this article, two important reviews were
published, further substantiating our conclusions.35,36 Nevertheless,
our work has a broader approach on remote monitoring technology,
therefore providing additional contributions on this subject.
Despite all these considerations, nowadays all major companies
have remote monitoring systems applied to IECDs, and several devices
are available for clinical use. The type of device should be carefully
selected depending on the patient, the type of disease, and the centers’
availability to receive, interpret, and respond to device alerts.
Authors’ ContributionsPaulo Dias Costa was responsible for the conception and design of
the paper and for drafting the article. Pedro Pereira Rodrigues was
responsible for drafting and critically revising the article. Antonio
Hipolito Reis and Altamiro Costa-Pereira were responsible for criti-
cally revising the manuscript.
Disclosure StatementNo competing financial interests exist.
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Table 5. Economic Impact of Remote Monitoring and Its Main Determinants
ADVANTAGES (N¼ 4) DISADVANTAGES (N¼ 4)
Economic impact (n¼ 4) Savings in follow-up Reimbursement issues
Overall reduction of follow-up costs29,30 Lack of reimbursement issues11,29
Time-saving tool11,30 Slow progress in confirming clinical benefit11
Resource-saving tool11 Lack of reliable cost-benefit data11
Transportation costs29,30 Requirement for new models of reimbursement33
Reduction of number of visits29 Reimbursement schemes different healthcare systems29,30,33
Staff costs reduction 29,33
Patient working days savings33
REMOTE MONITORING APPLIED TO CARDIOVASCULAR DEVICES
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Address correspondence to:
Paulo Dias Costa, B.Sc.
Service of Cardiology
Department of Medicine—Hospital de Santo Antonio
Centro Hospitalar do Porto
Largo do Prof. Abel Salazar
Porto 4099-001
Portugal
E-mail: paulocosta.cardiologia@hgsa.min-saude.pt
Received: May 25, 2010
Revised: July 20, 2010
Accepted: July 25, 2010
COSTA ET AL.
1050 TELEMEDICINE and e-HEALTH DECEMBER 2010
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