123© R A D C L I F F E C A R D I O L O G Y 2 0 1 4

Device Therapy

Monitoring after implant of patients with cardiac implantable

electronic devices (CIED) forms a part of both device and patient

care, and is the responsibility of the implanting centre. Monitoring

is challenged by the increasing number and technical complexity of

implanted devices coupled with the increasing clinical complexity

of the patient population. Current practice is based on quarterly to

yearly in-office visits with an increased rate when the device approaches

its end of service, or in case of advisories.1–3 In this model, download

of data stored in the device memory, potentially useful for patient

management, is delayed. Telemedicine offers a unique opportunity

to optimise clinic workflow and to improve device monitoring and

patient management.

TechnologyAll major CIED manufacturers have introduced remote monitoring

(RM) systems.4 All of them are based on a patient unit capable

of interrogating the device and downloading the programmed

parameters and the diagnostic data. Information is transmitted to a

central database where it is decrypted and stored on a secure website

on which it can be viewed by the clinical staff. Early wand-based

systems required patient-driven downloads relayed via telephone

connections to following facilities. Currently available systems

are based on automatic transmission mechanisms that are fully

independent of patient or physician interaction. A distinction has to

be made between ‘remote interrogation’ and ‘remote monitoring’. In

the first, device interrogation is performed periodically at home either

by the patient manually or by the monitoring system automatically

at predefined intervals. In the second, continuous device monitoring

may trigger unplanned transmissions in case of programmable alerts.

In spite of major commonalities, different proprietary systems may

differ substantially in connectivity, patient involvement, transmission

scheduling and alert availability and programming.

Impact on Out-patient Clinic WorkloadThe Lumos-T Safely Reduces Routine Office Device Follow-up Trial

(TRUST)5 was the first large randomised trial which demonstrated

that RM may safely reduce the number of in-hospital visits by nearly

50  %. The reduction primarily occurred in scheduled encounters

involving collection of routine measurements and requiring no clinical

intervention. Unscheduled visits slightly increased in the remote arm.

The overall reduction in face-to-face visits was obtained safely, with

no difference between the two study arms in mortality, incidence

of strokes and events requiring surgical interventions. Furthermore,

detection of arrhythmia onset was anticipated by more than 30 days.

Regarding patient adherence to follow-up, the TRUST results6 showed

that patients in the RM arm more effectively and durably attained

follow-up goals of punctual scheduled follow-up and patient retention

compared with conventional methods. Several studies have confirmed

such results and there is now strong evidence that RM significantly

reduces in-hospital visit numbers, time required for patient follow-up,

AbstractFollow-up of patients with cardiac implantable electronic devices is challenging due to the increasing number and technical complexity of

devices coupled to increasing clinical complexity of patients. Remote monitoring (RM) offers the opportunity to optimise clinic workflow and to

improve device monitoring and patient management. Several randomised clinical trials and registries have demonstrated that RM may reduce

number of hospital visits, time required for patient follow-up, physician and nurse time, hospital and social costs. Furthermore, patient retention

and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory

with automatic alerts allows early detection of device malfunctions and of events requiring clinical reaction, such as atrial fibrillation, ventricular

arrhythmias and heart failure. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance

and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. To this purpose, new organisational models have

been introduced. In spite of a favourable cost:benefit ratio, RM reimbursement still represents an issue in several European countries.

KeywordsCardiac implantable electronic devices, implantable cardioverter defibrillator, remote monitoring, follow-up, recall management, atrial

fibrillation, ventricular arrhythmias, heart failure

Disclosure: Renato Pietro Ricci has received minor consultancy fees from Medtronic and Biotronik; Loredana Morichelli has received minor consultancy fees from

Medtronic; Niraj Varma was a consultant to Biotronik for and principal investigator of the TRUST Trial and has received minor consultancy fees from St Jude, Medtronic,

Boston Scientific and Sorin.

Received: 24 July 2014 Accepted: 7 August 2014 Citation: Arrhythmia & Electrophysiology Review 2014;3(2):123–8 Access at: www.AERjournal.com

Correspondence: Renato Pietro Ricci, Department of Cardiology, San Filippo Neri Hospital, Via Martinotti, 20 00135 Rome, Italy; El: renatopietroricci@tin.it

Remote Monitoring for Follow-up of Patients with Cardiac Implantable Electronic Devices

Renato Pietro Ricci , 1 Loredana Morichel l i 1 and Niraj Varma2

1. Department of Cardiology, San Filippo Neri Hospital, Rome, Italy; 2. Cardiac Pacing and Electrophysiology, Cleveland Clinic, Cleveland, Ohio, US

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physician and nurse time and hospital costs.7–11 Furthermore, social

costs for patients and caregivers which include travelling, missed work

and social activities may be reduced by RM.12,13

Device ManagementLead and device performance monitoring is a physician responsibility

and represents a challenge due to the number and complexity of

implanted systems and the increased number of advisories during

the last 10 years. A strategy based on frequent in-hospital follow-up

visits is unsuitable as it places a huge work burden on out-patient

clinics. It is also inefficient since malfunctions are rare and likely to be

missed when developing suddenly in the interval between visits, with

the possibility of causing potentially life-threatening complications.14

RM allows continuous monitoring, with automatic alerts of battery

voltage and impedance, circuit status, charging time, low- and high-

voltage lead impedances, sensing and pacing threshold values, external

interferences, inappropriate detection of arrhythmias due to noise and

double counting or T-wave oversensing (see Figure 1). Clinical studies

have demonstrated that malfunctions are usually asymptomatic and

that RM is superior to a standard strategy for early detection.15–18 Impact

of RM on device longevity is a matter of debate. Concerns have been

raised about the potential negative impact of monitoring itself on

battery drain. On the other hand, continuous monitoring may allow device

programming optimisation with reduction of battery drain. Reduction of

capacitor charges by 75  % in implantable cardioverter defibrillator (ICD)

patients randomised to RM has been demonstrated in the Effectiveness

and Cost of ICD Follow-up Schedule with Telecardiology (ECOST) trial

with a potential major impact on battery longevity.19

Disease ManagementAtrial FibrillationExpected benefits of RM in patients with CIED and atrial fibrillation

(AF) are mainly represented by early arrhythmia detection and patient

continuous monitoring. Early detection of AF may induce prompt

clinical reaction aimed at preventing severe adverse events such as

stroke and heart failure.20 Continuous monitoring allows individual

tailoring of patient treatment and continuous updating of therapeutic

strategy. AF is very common in CIED patients even in those without

any history before implant. Furthermore the majority of events are

asymptomatic.21 CIEDs keep detailed information about AF episodes,

including number and duration, arrhythmia recurrences and burden,

mean and maximum ventricular rate and intracardiac electrogram

strips (see Figure 2).22 RM allows continuous access to stored data,

and alerts may be programmed for specific events. Early detection of

AF by RM has been demonstrated by several trials (for instance five

days versus 31 days in the TRUST trial).5 Clinical evidence for stroke

risk reduction by RM is still awaited. Preliminary studies estimated

that daily monitoring may reduce the two-year stroke risk by 9–18 %

with an absolute reduction of 0.2–0.6 %, compared with conventional

inter-visit intervals of 6–12 months.23,24 In the Comparative Follow-

up Schedule with Home Monitoring (COMPAS) trial, stroke rate was

significantly higher in the control group than in the RM group (3.3 %

vs 0.8  %).8 In the recent Anticoagulation Guided by Remote Rhythm

Monitoring in Patients With Implanted Cardioverter-Defibrillator and

Resynchronisation Devices (IMPACT) study25 of oral anticoagulation

therapy for AF guided by RM (started in the case of AF detection,

stopped in the case of no recurrences), there was no difference in the

outcomes of stroke or all-cause mortality between the intervention

group and controls. As a matter of fact, 92  % of patients who

experienced stroke in the study group were either not anticoagulated

at all or had an international normalised ratio (INR) < 2 at the moment

of the event.

Considering that several trials have demonstrated no temporal

relationship between AF episodes and stroke it should be

recommended that, once started for AF, anticoagulation is not

discontinued in the absence of device-detected AF.26,27

Figure 1: Early Detection of High Voltage Lead Failure by Continuous Remote Monitoring

Figure 2: Alert for Newly Detected Atrial Fibrillation – Internal Atrial Electrogram Confirms Appropriate Detection

Top: intermittent sudden drop in right ventricular (RV) pacing impedance. Bottom: inappropriate detection of self-limited ventricular fibrillation (VF) due to oversensing of spurious signals (noise). Combined data allowed lead replacement before any symptom experienced by the patient. Marker channel: VF = ventricular event sensed in the VF detection window; VS = ventricular sensed event; AS = atrial sensed event. FU = in-person follow-up.

AS = atrial sensed event; AP = atrial paced event; VS = ventricular sensed event; VP = ventricular paced event; AMS = automatic mode switch.

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Ventricular ArrhythmiasThe significant advantage of RM is the prompt evaluation of

appropriateness of detection and efficacy of therapy delivered (see

Figure 3). Wireless devices send a virtually immediate transmission

for review. The physician can evaluate the episode detail on the

website, including internal electrograms and marker chain. With

inductive systems, patients may manually send a transmission to the

service centre and inform the referring physician by phone in case

of perceived shock and/or palpitations or syncope. Ability of RM to

early detect ventricular tachyarrhythmias has been demonstrated by

the TRUST trial5 (one day vs 36 days for ventricular fibrillation and one

day vs 28 days for ventricular tachycardia). Another potential benefit

of RM is prevention of inappropriate shocks and also of appropriate

but unnecessary shocks. Early reprogramming after inappropriate

detection and therapy modulation in the case of slow, well-tolerated

arrhythmias may represent the mechanisms for reaching this goal.

The ECOST trial demonstrated that RM significantly reduced the

number of actual delivered shocks (-72  %), the number of charged

shocks (-76 %) and the rate of inappropriate shocks (-52 %).19,28

Heart FailureIn addition to providing necessary therapies for cardiac arrhythmias

and heart failure (HF), modern implantable devices also provide

diagnostic information that may be useful in monitoring disease

progression and in early detection of deterioration of HF, such

as rest and night heart rate, heart rate variability, patient daily

activity, percentage of right ventricular pacing in single and dual

chamber devices, percentage of actual biventricular pacing in cardiac

resynchronisation therapy (CRT) devices, intrathoracic impedance or

hemodynamic sensors (see Figure 4). A periodic internal electrogram

is available to check actual left ventricular capture (see Figure 5).

A drop in impedance is related to pulmonary congestion and it

may trigger an alert if it reaches a critical threshold. Continuous

monitoring of device diagnostics may allow early identification of HF

progression in the phase in which the patient is still asymptomatic,

but in which filling pressures increase and sympathetic activation

starts. The ultimate goal is to switch clinical reaction from a

‘reactive phase’, delivered when symptoms worsen and weight

increases or when the patient has a pulmonary oedema, to a

‘proactive phase’ delivered when the patient is asymptomatic,

typically two to three weeks in advance. The expected results of this

strategy are prevention of hospitalisations for heart failure and of

disease progression and improvement of patient quality of life (QoL).

Algorithms based on impedance alone showed good sensitivity in HF

early detection, on average two weeks in advance, but specificity was

poor.29–32 The PARTNERS HF (Program to Access and Review Trending

Information and Evaluate Correlation to Symptoms in Patients with

Heart Failure) trial demonstrated that patients with a combined HF

diagnostic algorithm had a 5.5-fold higher risk of HF event within 30

days.33 RM strategies have been associated with reduced unplanned

device-related or cardiac in-hospital visits and reduced emergency

visits for cardiac or device-related events (Evolution of Management

Strategies of Heart Failure Patients with Implantable Defibrillators

[EVOLVO] trial).34 Studies are ongoing to identify a combined score

from device diagnostics with the greatest sensitivity and specificity

for predicting HF events. Pressure-based technologies have been

introduced to improve HF monitoring. Among them, a wireless

implantable pulmonary artery haemodynamic monitoring system, the

CardioMEMS™ (St Jude Medical, MN, US), has been recently approved

by the US Food and Drug Administration (FDA). Pulmonary arterial

pressure is continuously monitored and data may be reviewed by the

physicians via a RM system. In the CardioMEMS Heart Sensor Allows

Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart

Failure Patients (CHAMPION) trial35 (550 patients), patients randomised

to CardioMEMS guided treatment had a 37 % significant reduction in

HF hospitalisation when compared with the control group.

Figure 3: Ventricular Fibrillation Appropriately Detected and Treated at Night During Sleep

Figure 4: Multiparametric Heart Failure Monitoring in Cardiac Resynchronisation Therapy Patient

Shock delivery restored sinus rhythm. The patient did not perceive the shock. Automatic transmission alerted the clinical staff who called the patient for an unscheduled visit. AR = atrial event sensed in the refractory period; AP = atrial paced event; VS=ventricular sensed event; VP=ventricular paced event; VF = ventricular event sensed in the ventricular fibrillation detection window; VT = ventricular event sensed in the ventricular tachycardia detection window; FD = ventricular fibrillation detection; CE = charge end; CD = charge delivery. Deterioration of heart failure is clearly documented by very low cardiac resynchronisation

therapy (CRT) delivery percentage and sudden drop-in thoracic impedance (arrows). CRT = cardiac resynchronisation therapy; BIV = biventricular pacing; VAR PP = heart rate variability; Brd.A = atrial fibrillation burden; IT= thoracic impedance.

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SurvivalEvidence is emerging that RM may improve survival. The ALTITUDE

database (a large observational retrospective, non-randomised,

post-market analysis of real-world data) enrolled about 200,000

patients,36 of whom 30 % were remotely monitored. In the RM group

risk of death was reduced by 50  % both in patients with single/

dual chamber ICDs and in those with CRT defibrillators (CRT-D).

In the prospective randomised IN-TIME (The Influence of Implant-

Based Home Monitoring on the Clinical Management of Heart Failure

Patients with an Impaired Left Ventricular Function) trial,37 after one

year patients in the RM arm, further to a significant improvement in

the composite clinical Packer score (mortality plus HF hospitalisations

plus New York Heart Association [NYHA] class), showed a 60  %

reduction in cardiovascular mortality.

Implementing Remote Monitoring in Daily Practice – The Organisational ModelIn spite of the documented benefits, implementing RM in daily clinical

practice is challenging and is currently offered only to a minority of

potential candidates.38 Reasons for that include reluctance to accept new

technology, concern for legal issues, reimbursement issues, concern for

increased work burden in the transition phase, and the need to develop

new organisational models. Promising results have been demonstrated

by a new model based on ‘Primary Nursing’ in which each patient is

assigned to a nurse responsible for continuity of care.39 The model is

essentially based on a cooperative interaction between the roles of

an expert reference nurse and a responsible physician with an agreed

list of respective tasks and responsibilities. The model includes strict

definition of workflow, early reaction, traceability, continuity of care and

maintaining human relationship with the patient. Nurse duties primarily

include patient training and education, website data entering, data and

alert reviewing, data screening, critical case submission to the physician

for clinical judgement, contacts with the patients, monitoring of patient

compliance and therapy benefits. Written protocols are established in

order to guide nurse reaction to findings and alerts. Physician duties

include obtaining patient consent, analysis of submitted critical events

and medical decisions, and communicating with general practitioners

or other specialists. This model performed remarkably well in the wide

Home Guide Registry which enrolled 1,650 patients.40,41 Sensitivity of

RM in detecting major cardiovascular events was 84 % with a positive

predictive value of 97%. RM required a median manpower less than one

hour per health personnel per month for every 100 patients.

A centralised ‘hub and spoke’ model, in which one monitoring centre

(hub) screened and filtered daily automatic data in pacemaker and ICD

patients from several satellite clinics (spokes), has been suggested

to help smaller centres fully utilise RM technology despite limited

workforce and low patient numbers that may hamper development of

dedicated, experienced, single-centre RM teams.42

The use of external centralised call centres has been suggested to

reduce the work burden of the hospitals and to avoid the need for

on-site dedicated expert teams.43 Personnel at the call centre usually

include expert technicians on duty 24 hours a day, seven days a week,

with electrophysiologists available on call. Potential advantages of

this model may be represented by the 24-hour service and by the

possibility of following thousands of patients in a centralised station.

The main limits are represented by the loss of human relationship

with the patient and potentially decreased patient compliance

and satisfaction. Cost and effectiveness of this strategy could be

unfavourable due to call centre costs and to the risk of repetitious

alerts and duplication of clinical interventions.

Patient Acceptance and SatisfactionSeveral studies have shown high patient satisfaction rates, ease of

use and compliance with the use of RM systems, even when manual

transmission of the data in non-wireless devices is requested.44–46 In

spite of some initial concerns, RM has been demonstrated to be easy

to use and well accepted even for elderly people and for patients

with a low level of education.47 A few patients do not accept RM

mainly due to concerns about technology and about the risk of losing

the human contact with nurses and physicians. Patient education is

critical to overcoming their concerns.48 Poor patient compliance may

complicate workflow efficiency, mainly because of missed scheduled

remote transmissions or duplicate transmissions. Phonecall burden

due to patient noncompliance may negatively impact on personnel

work load.49 Automaticity and reliability of the remote technology used

is important. In the TRUST trial, no patient assigned to RM crossed

over during the study and 98 % elected to retain this follow-up mode

on trial conclusion, indicating patient acceptance and confidence in

follow-up with this technology.50

Legal IssuesRM changes the paradigm of face-to-face visits by gathering electronic

data into a data repository that is remote from the health facility,

yet readily accessed and shared with various healthcare providers

involved in a patient’s care or for research or educational purposes.

There are challenges to maintaining the privacy of patient health

information and potential issues related to liability for RM-related

services. Telemedicine is still a medical act and the patient has to be

appropriately informed about the service and must sign an informed

consent document. In order to ensure privacy, patients have to sign

a ‘Declaration of Privacy Principles’, written according to the local

privacy laws. Responsibility for the data management process lies

with the device manufacturer and RM service provider (usually the

same), hospitals, telecommunication technology and service providers,

physicians and allied professionals and patients. In this scenario the

patient is proactive and asked for their compliance with guidelines

and physician’s prescriptions. Patient compliance is critical for a good

result, and in some cases RM should be denied or withdrawn.

The relationship between the patients and the clinical staff is based on

an atypical contract, reported in the informed consent document signed

by the patient and the physician, in which general rules for patient

RM are defined. In particular, scheduling for alert and transmission

The strip shows intermittent loss of left ventricular capture in the 2nd, 3rd, 6th beat (arrows). VD = right ventricular channel; VS = left ventricular channel; VP = right ventricular pacing; VSP = left ventricular pacing.

Figure 5: Periodic Internal Electrogram in a Non- responder to Cardiac Resynchronisation Therapy

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1. Wilkoff BL, Auricchio A, Brugada J, et al. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations: developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association. Europace 2008;10:707–25.

2. Carlson MD, Wilkoff BL, Maisel WH, et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm 2006;3:1250–73.

3. Maisel WH, Hauser RG, Hammill SC, et al. Recommendations from the Heart Rhythm Society Task Force on lead performance policies and guidelines: developed in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm 2009;6:869–85.

4. Dubner S, Auricchio A, Steinberg JS, et al. ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs). Europace 2012;14:278–93.

5. Varma N, Epstein A, Irimpen A, et al. Efficacy and safety of automatic remote monitoring for ICD follow-up: the TRUST trial. Circulation 2010;122:325–32.

6. Varma N, Michalski J, Stambler B, Pavri BB; TRUST Investigators. Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial – testing execution of the recommendations. Eur Heart J 2014;35:1345–52.

7. Crossley GH, Chen J, Choucair W, et al. on behalf of the PREFER Study Investigators. Clinical benefits of remote

versus transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol 2009;54:2012–9.

8. Mabo P, Victor F, Bazin P, et al. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J 2012;33:1105–11.

9. Elsner C, Sommer P, Piorkowski C, et al. A Prospective Multicenter Comparison Trial of home monitoring against regular follow-up in MADIT II. Comput Cardiol 2006;33:241–4.

10. RCrossley GH, Boyle A, Vitense H, et al. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol 2011;57:1181–9.

11. Hindricks G, Elsner C, Piorkowski C, et al. Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial Eur Heart J. 2014;35:98–105.

12. Raatikainen MJ, Uusimaa P, van Ginneken MM, et al. Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-up Europace 2008;10:1145–51.

13. Ricci RP, Vicentini A, D’Onofrio A, et al. Impact of in-clinic follow-up visits in patients with implantable cardioverter defibrillators: demographic and socioeconomic analysis of the TARIFF study population. J Interv Card Electrophysiol 2013;38:101–6.

14. Kallinen LM, Hauser RG, Lee KW, et al. Failure of impedance monitoring to prevent adverse clinical events caused by fracture of a recalled high-voltage implantable cardioverter defibrillator lead. Heart Rhythm 2008;5:775–9.

15. Neuzil P, Taborsky M, Holy F,Wallbrueck K. Early automatic remote detection of combined lead insulation defect and ICD damage. Europace 2008;10:556–7.

16. Varma N. Remote monitoring for advisories: automatic early detection of silent lead failure. Pacing Clin Electrophysiol 2009;32:525–7.

17. Spencker S, Coban N, Koch L, et al. Potential role of home monitoring to reduce inappropriate shocks in implantable cardioverter defibrillator patients due to lead failure. Europace 2009;11:483–8.

18. Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol 2010;3:428–36.

19. Guédon-Moreau L, Lacroix D, Sadoul N, et al. ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J 2013;34:605–14.

20. Glotzer TV, Hellkamp AS, Zimmerman J, et al. Atrial high rate episodes detected by pacemaker diagnostics predict death and stroke: report of the Atrial Diagnostics Ancillary Study of the MOde Selection Trial (MOST). Circulation 2003;107:1614–9.

21. Orlov MV, Ghali JK, Araghi-Niknam M, et al. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol 2007;30:404–11.

22. Varma N, Stambler B, Chung S. Detection of atrial fibrillation by implanted devices with wireless data transmission capability Pacing Clin Electrophysiol 2005;28:S133–6.

23. Ricci RP, Morichelli L, Santini M. Remote control of implanted devices through home monitoring technology improves detection and clinical management of atrial fibrillation. Europace 2009;11:54–61.

24. Ricci RP, Morichelli L, Gargaro A, et al. Home monitoring in patients with implantable cardiac devices: is there a potential reduction of stroke risk? Results from a computer model tested through monte carlo simulations. J Cardiovasc Electrophysiol 2009;20:1244–51.

25. Martin DT, et al. Randomized trial of anticoagulation guided by remote rhythm monitoring in patients with implanted cardioverter-defibrillator and resynchronization devices. American College of Cardiology Scientific Session, Washington, DC, March 29, 2014.

26. Glotzer TV, Daoud EG, Wyse DG, et al., on behalf of the TRENDS Investigators. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: The TRENDS Study. Circ Arrhythmia Electrophysiol 2009;2:474–80.

27. Healey JS, Connolly SJ, Gold MR, et al. ASSERT Investigators.

revision, including the maximum reaction time, and the hospital service

level agreement have to be understood and signed by the patient.

The patient has to be informed that currently RM is not an emergency

system, but only a tool to improve device surveillance and patient

management. Clear instructions have to be given for emergency

management. The technology provider is asked to respect the privacy

statement and local laws, and to support the hospital centre in all

aspects relating to providing patients with a RM service. Hospital duties

are mainly to define and make available the facilities needed for RM.

Costs and Reimbursement IssuesEconomical analyses have consistently demonstrated CIED RM to

be cost effective.8,10,12,51–55 Mechanisms involved in savings include

reduction of in-hospital visits, reduction of follow-up duration and

physician and nurse time, and a reduction in patient costs related

to travelling and missed work. Further economic benefits may come

from increased device longevity, reduction of hospitalisations and

prevention of clinical adverse events such as stroke. In the US since

2006 Medicare and Medicaid defined reimbursement codes for

remote follow-up of pacemakers and defibrillators. Reimbursement

policies for RM by healthcare systems and insurances vary widely

among different countries in Europe.56 This limits adoption. Some form

of reimbursement does exist in Germany, UK, Netherlands, Norway,

Sweden, Finland, Denmark and Portugal. Although actual fee delivery

to hospitals, doctors and manufacturers differs significantly. The

fee-for-service payment approach and disease management global

budget are the most common systems applied. No reimbursement

exists in Switzerland, Belgium, Greece, Baltic States, Italy and Austria.

This situation is rapidly evolving and soon hopefully homogeneous

reimbursement rules will be established in Europe.

Current GuidelinesSince 2006, the Heart Rhythm Society (HRS)2 recommended that

CIED manufacturers developed and implemented wireless and RM

technologies to early identify abnormal device behaviour and to

reduce under-reporting of device malfunctions. In 2008, the HRS/

European Heart Rhythm Association (EHRA) Expert Consensus on the

Monitoring of Cardiovascular Implantable Electronic Devices1 stated

that the majority of in-person follow-up could be replaced by RM. The

document suggested to maintain face-to-face visits at predischarge

visits, at one-month follow-up and at least once a year. Detail on CIED

RM management recommendations has been published by a joint

committee of the International Society for Holter and Noninvasive

Electrocardiology (ISHNE) and EHRA4 in 2012 and by some national

societies.57–59 In the 2013 European Society of Cardiology Guidelines

on cardiac pacing and cardiac resynchronisation therapy it was

stated that “Device-based RM should be considered in order to

provide earlier detection of clinical problems and technical issues”

(Recommendation class IIa, level of evidence A).60 n

Clinical Perspective

• Remotemonitoringisrapidlybecomingthenewstandardof

care for patients with cardiac implantable electronic devices.

The challenge is to implement remote monitoring in daily

practice.

• Thekeytothesuccessisfromonesidetoinvestonhuman

resource (continuous education of personnel and development

of the organisational model) and from the other to use

technology progress for better interconnectivity and integration

of data in the hospital electronic systems.

• Remotereprogrammingwhichisnotcurrentlyavailable,but

technically feasible, will require great attention to patient safety

prior to implementation.

• Aclearreimbursementpolicyismandatorytodedicate

appropriate resource for a remote monitoring service.

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Subclinical atrial fibrillation and the risk of stroke. N Engl J Med 2012;366:120–9.

28. Guédon-Moreau L, Kouakam C, Klug D, et al. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol 2014; ePub ahead of print. doi: 10.1111/jce.12405.

29. Yu CM, Wang L, Chau E, et al. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation 2005;112:84–8.

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