Role and Prospective of Remote Monitoring in Management of

Patients with Cardiac Implantable Devices

Emanuela T. Locati, Sara Vargiu, Ederina Mulargia, Corrado Ardito, Franca Negrini

and Maurizio Lunati

Cardiology 3 - Electrophysiology, Cardiovascular Department, Niguarda Hospital, Milan, Italy

Keywords: Home Monitoring, Implantable Cardioverter Devices, Heart Failure, Ventricular Arrhythmias.

Abstract: Many studies have now shown that remote control of implantable devices (Home Monitoring, HM) is

beneficial for the patient, making very strict and custom controls, allowing an earlier identification of

potential problems and avoiding unnecessary visits. HM is also beneficial for the hospitals, which reduce

progressively the resources used in routine checks, often not necessary, instead dedicating resources to the

management of critical patients in the moment in which real clinical problems arise. According to the

current guidelines Italian and European HM can replace the standard ambulatory monitoring, thereby

reducing the amount of outpatient visits to be made in the individual patient (instead of testing every 6

months, it is possible to schedule one annual overall clinical evaluation of the patient, while intermediate

checks are performed by remote transmissions. To date however, HM, although recommended by the Italian

and European guidelines, do not yet have a specific reimbursement charge within the NHS and therefore

HM cannot be carried out as an institutional activity within the hospital. Furthermore, many critical issues

must yet be resolved before a full utilization of HM system can be used for the clinical management of

patients, particularly in patients with heart failure at higher risk of cardiac death.

1 CURRENT STATUS OF

REMOTE MONITORING OF

IMPANTABLE DEVICES

According to current guidelines both International

(HRS / EHRA Expert Consensus) (Wilkoff et al.,

2008); (Dubner et al., 2012) and Italian (Consensus

Conference AIAC) (Ricci et al., 2009) remote

control (Home Monitoring, HM) can now integrate

and sometimes replace the traditional ambulatory

monitoring the patient with an ICD. The feasibility,

safety and efficacy of remote control have now been

repeatedly demonstrated in an increasing number of

patients followed in the world with this method: to

date more than 800,000 patients worldwide, and also

in Italy more than 15,000 patients in 180 hospitals,

for a total of more than 100,000 transmissions.

Many studies have now shown that remote control

of the holders of implantable devices, especially

implantable cardioverter defibrillators (ICD) is

beneficial both for the patient, allowing closer and

personalized controls, with earlier identification of

possible problems avoiding unnecessary visits, and

for the Hospital, which progressively reduces the

resources used in routine control, often not

indispensable, devoting themselves instead to the

management of patients in the moment in which

they arise real clinical problems.

Several randomized trials have not only

confirmed the equivalence of the remote control

with respect to ambulatory control standard in terms

of safety (Varma et al., 2010), but have even

demonstrated the superiority of the management of

the patient with a remote control with respect to the

traditional control, resulting in a reduction of

planned and unplanned visits, a reduction of access

to the ER and the average duration of hospitalization

for cardiovascular causes, an increased ability to

identify clinically relevant events, and a reduction in

the time between the occurrence of an adverse event

and the subsequent clinical treatment (Crossley et

al., 2009); (Crossley et al., 2011); (Spencker et al.,

2009).

The remote control produces a more efficient

management of health care resources, both hospital

admissions and optimizing the use of time and

health professionals, which reduces transportation

T. Locati E., Vargiu S., Mulargia E., Ardito C., Negrini F. and Lunati M..

Role and Prospective of Remote Monitoring in Management of Patients with Cardiac Implantable Devices.

DOI: 10.5220/0004647600670070

In Proceedings of the International Congress on Cardiovascular Technologies (CRM-2013), pages 67-70

ISBN: 978-989-8565-78-5

 2013 SCITEPRESS (Science and Technology Publications, Lda.)

costs and expenses for accompanying persons (Ricci

et al., 2008). In general, the remote control makes it

possible to reduce the load of outpatient controls to

be carried out in the individual patient (instead of

checks every 6-9 months, it is thus possible to

perform an ambulatory monitoring every 12 months

for a global clinical assessment of the patient, while

intermediate checks are carried out remotely).

Remote control also involves an optimization of

timing: from an average of 25-30 min for traditional

in-hospital control to an average 4-5 min in the

remote control (Ricci et al., 2008); (Klersy et al.,

2009).

It is important to distinguish models of remote

device control (which is related to the problems of

the device, such as breakage of leads or battery

depletion), from actual remote surveillance, which

instead is focused on clinical problems, such as

ventricular arrhythmias, shocks delivered, episodes

of atrial fibrillation, fluid accumulation or other.

Currently five of the leading manufacturers of

ICD (Biotronic, Medtronic, St. Jude Medical,

Boston Scientific and Sorin), have developed

different systems for ICD HM. All systems are

based on sending of the remote query of the ICD to a

central server, which processes the reports and sends

them back to the individual clinical centers, where

data from the remote control are controlled and

integrated with the patient's clinical data. The

differences between the various systems are both on

the mode of remote interrogation of the ICD (off-

line for most of the systems, generally by non-

portable systems that query the implantable device at

night during sleep), and on the mode of trans-

telephonic transmission from the remote modem to

the central server (both via analogic lines and

increasingly Mobile via GSM or GPRS).

To date, in Italy, as in many other European

countries, projects for the control of HM ICDs,

although recommended by the Guidelines Italian and

European, not yet have a specific reimbursement

charge within the NHS, therefore cannot be

institutional activities carried out officially within

the Hospitals.

2 EXPERIENCE OF HOME

MONITORING OF ICDS AT

MILAN NIGUARDA HOSPITAL

Since June 2011, we initiated a project called Project

CareLink Niguarda (PCLN) for remote control of

patients with implantable devices, especially

implantable cardioverter defibrillators (ICD). The

project uses the remote control system of Medtronic

CareLink called, through which it is possible to

transmit a series of electrical parameters and clinical

results from devices (ICDs, pacemakers and

recorders loop recorder "Reveal"), directly from the

patient's home to a secure service to the Hospital.

The CareLink system had been since 2009 under the

project EVOLVO (research project of the Lombardy

Region). (Landolina et al., 2012)

To date, the PCLN has enrolled over 350 patients

(out of more than 1000 patients with ICDs followed

by Electrophisiology Unit). The operational phase of

the PCLN was preceded in the first half of 2011 by a

phase of planning and preparation, in which we

identified potential critical problems and developed

operational flows, contracts and certifications

needed to start HM activities safely, given the clear

organizational difficulties and implications of

medical-legal liability.

The participation of individual patients to PCLN

is bound to a specific individual contract, which

specifies the terms and obligations of the respective

parties. In particular, according to the contract of

participation, the patient is made aware of the fact

that PCLN does not handle on-line real-time alarm

or emergency situations (absolutely does not replace

the 118 or access in PS) and that any transmissions

will not be handled immediately but only within 5

working days later.

In the initial phase, patients were enrolled in the

first carriers with Medtronic ICD with SprintFidelis

electrocatheters (subject to recall due to the high risk

of sudden rupture of the catheter) patients who

cannot hear audible alarms, patients who live outside

the province / region outside and pediatric patients.

In the second phase, were enrolled all patients with

ICD device equipped with a wireless connection and

the holders of implantable loop recorders Reveal (for

a total approximately 350 patients). In this phase, the

remote control system was activated simultaneously

to the implant of the device, training the patient and

signing the related consents before discharge from

hospital. In the next phase, starting from January

2014 we will extend the HM to the vast majority of

patients with implantable devices both ICD

pacemaker, implantable devices including the other

houses, as well as Medtronic, Biotronic, St. Jude,

Boston and Sorin.

For the revision of transmission we used the

approach defined as "Primary Nurse Model" (Ricci

et al., 2008), which provides a critical role in the

management to the Nurse, who is responsible of

making telephone contacts with patients and in

CARDIOTECHNIX2013-InternationalCongressonCardiovascularTechnologies

controlling the flow of transimssions, in particular

by identifying lost transmissions, and by making the

first revision of the transmissions themselves. The

medical coordinator is in charge of the verification

and reporting of data transmission, the organization

and any necessary actions to manage the problems

detected during transmission, such as arrhythmias

and severe malfunctioning of the device or leads,

which require ambulatory monitoring or any

hospitalization.

The data transmission takes place through the

appropriate modem CareLink delivered to the

patient, which serves as the station detection and

transmission trans-telephone, both in manual mode

(that is activated by the patient), or in automatic

mode (through a wireless connection between the

modem CareLink and ICD). CareLink modem

transmits the recorded data to a central server

(located in the Netherlands), which sends the

processed data to a single hospital of reference,

which analyzed the data for the clinical management

of patients.

The timing used for the controls provided a

check every 1-3 months, with monthly checks in

pediatric patients in the first 3 months after

implantation in carriers of devices in recall or low

and in patients with any clinical complications

To date, in approximately 350 patients enrolled,

we handled over 1000 transmsiion per year,

including scheduled transmissions and transmissions

generated by CareAlert, and in about 10% of cases

the programs have highlighted the problems that led

to both the admission (for severe or recurrent

arrhythmias or related problems such as the ICD

battery depletion or malfunction or repositioning of

the leads) that outpatient visits for reprogramming of

recognition or optimization of medical therapies.

One of the main objectives of PCLN was to

integrate as much as possible the remote monitoring

of ICDs to classic ambulatory clinic visit, in order to

anticipate future forms of clinical management of

patients when this type of management will be

recognized and made payable inside the institutional

flow-chart of the Hospital.

Among the priorities of PCLN was also to

identify operational synergies with other Divisions

of the Department, in particular the Unit of care for

heart failure, to which belonged many of the patients

with ICD (ICD-CRT in particular) with heart failure

already enrolled in the project, and which is already

running at an additional model of remote monitoring

of patients with heart failure, and with the

CardioPediatricians (with whom we already co-

managed 5 small patients with ICD).

3 NEW ISSUES AND PROSPECTS

FOR THE CONTROL OF

REMOTE ICD

There are many critical issues that must be

addressed and resolved once the HM systems

actually become the universal system of remote

monitoring of implantable systems, in particular ICD

and CRT. Among the main problems include:

1. Changes to billing systems of HM service by the

NHS. To date, the NHS only provides

reimbursement for outpatient visits for the control of

devices made in the presence of the patient. The

billing systems of HM may be based on either the

repayment of the reporting of individual

transmissions, or more probably on some sort of

"canon" of annual assistance for single patient with a

device, regardless of the number of transmissions

performed. Such fees may be different according to

the complexity of the implantable device (e.g. could

be greater in the case of patients with an ICD-CRT

compared with single-chamber ICD): in particular,

should be ideal to have different billings for remote

device control, compared to the more comprehensive

remote patient surveillance. To date, the Lombardy

Region, based on the results of the project EVOLVO

is developing a pilot system of reporting, which

could come into force by 2014 (the conditional is a

must).

2. Uniformity and a standardization of the models

of HM. While taking into account the specificities

and characteristics of each company hospital, also in

view of a forthcoming charging by the NHS, it must

be identified and shared a reference standard pattern

for remote control involving:

a. Well-defined roles for doctors and nurses (the

shared framework of reference is currently the

"Primary Nurse Model"), in particular with

respect to their responsibilities medico-legal

b. Minimum precise timing for remote controls

with respect to outpatient controls, also taking

into account the characteristics of individual

devices (first installation, replacements, devices

subject to recall, etc.).

c. Forms reference in particular as regards the

informed consent, explaining in particular the

limits of the remote control with respect to the

management of emergency situations (the system

of HM is not an emergency service and does not

replace the 118!)

d. Minimum reporting deadlines and the need

for specific reporting for single transmission

RoleandProspectiveofRemoteMonitoringinManagementofPatientswithCardiacImplantableDevices

(through special note fields with signature and

date unique and can not be changed afterwards).

3. Integration of HM Systems with Hospital

Informatic Systems To date, the systems of HM the

various companies are worlds unto themselves who

do not interact with each other and especially not

interact with the hospital portals. Given the

increasing number use of "paperless" hospitals high

computerization, will be needed more integration of

systems of HM the device with hospital portals, so

that data transmissions are integrated into the

medical records of the patient and thus available to

all members of the hospital (for example, First Aid,

Care Unit Heart Failure etc). In this sense, it is

desirable that individual manufacturers are available

to communicate with the computer systems of the

hospitals to implement such a complex integration.

4. Remote management of patients with heart

failure. The current HM systems of implantable

device are currently able to provide numerous

clinical parameters very important for the

management of patients with heart failure, such as

the loading of supraventricular arrhythmias (in

particular atrial fibrillation) and ventricular, the level

of heart rate and its variability, the percentage of

ventricular pacing in carriers of CRT, and changes in

thoracic impedance, possible evidence of intra-

thoracic fluid accumulation. The evaluation and

integration of these parameters may allow an

effective monitoring the hemodynamic situation of a

patient with heart failure. However, to date accurate

models for the real remote management of patients

with heart failure, in particular for the specific

medical-legal implications, are still lacking.

5. Coordinating HM systems with other health

care professionals within and outside the hospital.

The HM systems following by definition very

critically ill patients must identify operational

synergies with other professionals who are in charge

of these patients, in particular the Unit of care for

heart failure, to which belong many of the patients

with ICDs (particularly ICD-CRT). Another critical

aspect is to engage in the systems of HM also

territorial care professionals (general practitioners or

specialists outside), to realize the concept of

"continuity of care" really crucial towards patient

extremely fragile and at high risk of fatal

arrhythmias, "the sickest of the sick".

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