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TOPIC REVIEW

Optimizing Implantable Cardioverter-Defibrillator Remote Monitoring

A Practical Guide

Sylvain Ploux, MD, PHD,a,b Niraj Varma, MD, PHD,c Marc Strik, MD, PHD,a,b,d Arnaud Lazarus, MD,e

Pierre Bordachar, MD, PHDa,b

JACC: CLINICAL ELECTROPHYSIOLOGY CME

Thisarticlehasbeenselectedas themonth’s JACC:ClinicalElectrophysiology

CME activity, available online at www.jacc-electrophysiology.org by

selecting the CME on the top navigation bar.

Accreditation and Designation Statement

The American College of Cardiology Foundation (ACCF) is accredited by

the Accreditation Council for Continuing Medical Education (ACCME) to

provide continuing medical education for physicians.

The ACCF designates this Journal-based CME activity for a maximum

of 1 AMA PRA Category 1 Credit(s). Physicians should only claim credit

commensurate with the extent of their participation in the activity.

Method of Participation and Receipt of CME Certificate

To obtain credit for JACC: Clinical Electrophysiology CME, you must:

1. Be an ACC member or JACC: Clinical Electrophysiology subscriber.

2. Carefully read the CME-designated article available online and in this

issue of the journal.

3. Answer the post-test questions. At least 2 out of the 3 questions

provided must be answered correctly to obtain CME credit.

4. Complete a brief evaluation.

5. Claim your CME credit and receive your certificate electronically

by following the instructions given at the conclusion of the activity.

CME Objective for This Article: Upon completion of this activity, the

learner should be able to: 1) select the appropriate system for VT/VF

From the aIHU Liryc, Electrophysiology and Heart Modeling Institute, FondabBordeaux University Hospital (CHU), Cardio-Thoracic Unit, Pessac, Bordeau

Clinic, Cleveland, Ohio; dPhysiology and Cardiology Department, Maastricht

Institute Maastricht, Maastricht, the Netherlands; and eInParys, A. Paré Pri

received financial support from the French government as part of the “Inv

National Research Agency (ANR), Grant reference ANR-10-IAHU-04. Dr. Str

Foundation and the Netherlands Heart Institute. Dr. Ploux is a consultant fo

and St. Jude Medical. Dr. Varma is a consultant for Biotronik, Boston Scient

has received research funding from Zoll, Medtronic, Biotronik, St, Jude Me

grant from Biotronik. Dr. Lazarus is a consultant for Biotronik, Boston Scie

reported that he has no relationships relevant to the contents of this paper

All authors attest they are in compliance with human studies committe

institutions and Food and Drug Administration guidelines, including patien

visit the JACC: Clinical Electrophysiology author instructions page.

Manuscript received November 4, 2016; revised manuscript received Februa

burden monitoring in a patient with history of VT ablation in order to

shorten time to medical decision; 2) evaluate the benefit of given alert

at the time of device programming to improve sensitivity to problem

detection while limiting message overload; and 3) recommend a system

for remote monitoring of an ICD lead under advisory at the time of

generator change.

CME Editor Disclosure: CME Editor Smit Vasaiwala, MD, has nothing

to declare.

Author Disclosures: This study received financial support from the French

governmentaspart of the“Investmentsof theFuture”programmanagedby

the National Research Agency (ANR), Grant reference ANR-10-IAHU-04. Dr.

Strik has received grant support from the Dutch Heart Foundation and

the Netherlands Heart Institute. Dr. Ploux is a consultant for Biotronik,

Boston Scientific, LivaNova,Medtronic, and St. JudeMedical. Dr. Varma is a

consultant for Biotronik, Boston Scientific,Medtronic, St. JudeMedical, and

LivaNova; and has received research funding from Zoll, Medtronic,

Biotronik, St, Jude Medical, and Boston Scientific. Dr. Strik has received a

grant from Biotronik. Dr. Lazarus is a consultant for Biotronik, Boston

Scientific,Medtronic, and LivaNova. Dr. Bordachar has reported that he has

no relationships relevant to the contents of this paper to disclose.

Medium of Participation: Print (article only); online (article and quiz).

CME Term of Approval

Issue Date: April 2017

Expiration Date: March 31, 2018

tion Bordeaux Université, Pessac, Bordeaux, France;

x, France; cHeart and Vascular Institute, Cleveland

University Medical Center, Cardiovascular Research

vate Hospital, Neuilly sur Seine, France. This study

estments of the Future” program managed by the

ik has received grant support from the Dutch Heart

r Biotronik, Boston Scientific, LivaNova, Medtronic,

ific, Medtronic, St. Jude Medical, and LivaNova; and

dical, and Boston Scientific. Dr. Strik has received a

ntific, Medtronic, and LivaNova. Dr. Bordachar has

to disclose.

es and animal welfare regulations of the authors’

t consent where appropriate. For more information,

ry 13, 2017, accepted February 15, 2017.

Ploux et al. J A C C : C L I N I C A L E L E C T R O P H Y S I O L O G Y V O L . 3 , N O . 4 , 2 0 1 7

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Optimizing Implantable Cardioverter-DefibrillatorRemote Monitoring

A Practical Guide

Sylvain Ploux, MD, PHD,a,b Niraj Varma, MD, PHD,c Marc Strik, MD, PHD,a,b,d Arnaud Lazarus, MD,e

Pierre Bordachar, MD, PHDa,b

ABSTRACT

Remote monitoring (RM) receives a Class I: Level of Evidence: A recommendation for the follow-up of patients with

implantable cardioverter-defibrillators, positioning the technology as standard of care. RM is often seen and sold as a

plug-and-play technology, whereas fundamental differences exist in the philosophy and conception of the 5 main RM

systems. The capabilities and limitations of the different RM systems need to be understood and taken into account when

the decision is made to remotely manage an individual patient. The purpose of this review is to provide to the cardiologist

practical information about RM systems’ specificities with respect to the different technical and clinical alerts. Clinically

based indications and programming suggestions are provided. (J Am Coll Cardiol EP 2017;3:315–28) © 2017 by the

American College of Cardiology Foundation.

A recent international consensus statement rec-ommended that all patients with implantablecardioverter-defibrillator (ICD) should be

offered remotemonitoring (RM) as part of the standardfollow-up management (1). This Class I recommenda-tion was delivered with the highest level of evidenceoriginating frommultiple randomized controlled trials(2–5). A step upstream from the clinician, the cardio-vascular implantable electronic device manufacturershave progressively implemented RM capabilities intheir most recent platforms. Although the differentsystems share a common principle, they differ signifi-cantly in philosophy and practical application, thetype and number of programmable alerts, and someproprietary algorithms. For example, the Biotroniksystem (Biotronik, Berlin, Germany) proposes 42 alertsfor the monitoring of cardiac resynchronization ther-apy (CRT)-defibrillator versus 16 for the LivaNova sys-tem (LivaNova, London, United Kingdom). Nowadays,cardiologists are encouraged to implement RM in theirclinical practice for better efficiency and quality of pa-tient care. This transition implies major organizationalchanges with the replacement of routine appoint-ments to a system of nearly continuous monitoring,with most visits initiated in response to alert notifica-tions communicated by the RM system. The machineis invited to play a major role in the patient care,formerly performed solely by the clinician. The au-thors recognize that not only may this paradigm shiftbe daunting, but selection and activation of any partic-ular RM system may be confusing to any clinicianwishing to adopt RM for patient care. Thismay account

for the fact that only 50% of devices implanted in theUnited States are RM capable, and of those, only 50%are activated (6,7). The capabilities and limitations ofthe different RM systems need to be understood andtaken into account when the decision is made toremotely manage an individual patient. These maydetermine selection before implantation, so that RMmay be enabled soon post-implantation, because thiscarries benefits and conforms with recommendations(1). The purpose of this review is to provide to the cardi-ologist practical information about RM systems’specificities.

TRANSMISSION REQUIREMENT

Radiofrequency transmissions are sent from theimplanted device wirelessly to a transceiver thatmust be in proximity to the patient at the time oftransmission. Size, portability, and need for patientoperation of the transceiver vary considerably amongthe manufacturers. Initiation of the connection iseither achieved by the transceiver or by the device, 2strategies that may affect battery longevity differ-ently. Transmission to the manufacturer’s data re-pository is achieved using either analog or digitallandlines, or wireless data networks. Remote moni-toring of the ICD couples remote systematic in-terrogations with continuous surveillance of devicefunctionalities and clinical events. Automatic remoteinterrogations are performed daily by the Biotroniksystem but at longer pre-specified intervals by theother systems (usually every 3 months, and this may

AB BR E V I A T I O N S

AND ACRONYM S

AF = atrial fibrillation

ATP = antitachycardia pacing

EGM = electrogram

ICD = implantable

cardioverter-defibrillator

LIA = lead integrity alert

LV = left ventricular

NSVT = nonsustained

ventricular tachycardia

RA = right atrial

RM = remote monitoring

RV = right ventricular

SVT = supraventricular

tachycardia

VF = ventricular fibrillation

ventricular tachycardia

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be programmable). A variety of “alerts” can be pro-grammed, either via the programmer (Biotronik,LivaNova, Medtronic [Dublin, Ireland], and St. JudeMedical [St. Paul, Minnesota]) or the website (Bio-tronik, Boston Scientific [Natick, Massachusetts], andSt. Jude Medical), and these define the framework tooperate the remote monitoring function per se. Thecapability to switch on/off or change the range ofalerts remotely from the website avoids alert redun-dancy and the need for an in-clinic device reprog-ramming (inconvenient to patient and clinic alike).Some alerts are linked to transmission of relatedstored electrograms (EGMs) (e.g., ventricular fibrilla-tion [VF]/ventricular tachycardia [VT]/atrial fibrilla-tion [AF] episodes). The EGM transmissioncapabilities vary from 1 EGM per session (Biotronik) tothe complete EGM folder (Boston Scientific, Med-tronic, and St. Jude Medical). A limit to the number ofEGMs transmitted when multiple events occur thesame day incurs a loss of information and may beproblematic. The systems are designed to communi-cate at night (usually between 1:00 AM and 4:00 AM),however, 2 manufacturers (Biotronik and Medtronic)maintain unrestricted transmission of critical alerts(with the corresponding EGM) when the patient isclose enough to the transmitter. These so called

TABLE 1 RM Systems

TransceiverBiotronik279 g

Boston Scienti731 g

Name Biotronik Home Monitoring Latitude NXT

Cellular GPRS/3G 3G

Landline USA only O

Internet O

Direct transmission O

Patient-initiated transmission O

Scheduled follow-up Daily 1w–1y

Transmitted EGM/session 1 All

Remote control of the alerts O O

Remote setting of the alerts All but “long atrial episode” AF burden %CRT%, RV%Weight gain

Special features Mobile Weight scale ablood pressmonitor

Transceiver ¼ indicated weight referred to the cellular version with the charger; Directenough to the transceiver; Scheduled Follow-up ¼ 1 week to 1 year: programmable fromTransmitted EGM/session ¼ For BT: a single EGM is sent in one session at night (the lamission) / “all” refers to all memorized EGM that have not been already sent / For LN, upthe full EGM library of the device can be downloaded from the website, to be read on a Lremotely through the website. Some alerts remain only accessible through the use of aboundaries of an alert. For example, the BT system allows changes in the lower and up

AF ¼ atrial fibrillation; BT ¼ Biotronik; CRT% ¼ cardiac resynchronization therapyLN ¼ LivaNova; RV% ¼ right ventricular pacing percentage.

“direct” transmissions may reduce the timeto medical intervention (for a VT storm or alead alert). Transmission on patient demand(for symptoms) are allowed for Boston Sci-entific, LivaNova, Medtronic, and St. JudeMedical devices. The Biotronik system isentirely automatic and transmits daily, elim-inating dependency on patient activation.

The main technical features are shown inTable 1.

ICD LEAD–RELATED ALERTS

The essential function of an ICD system de-pends on its sensing and defibrillation capa-bilities. These functions rely on lead integrity,which is known to be the weakest part in allICD systems (8). Lead failure may lead to lossof bradycardia pacing, missed treatment of

ventricular arrhythmias (antitachycardia pacing [ATP]or defibrillation), or to inappropriate therapies causedby oversensing. Inappropriate shocks decrease thequality of life and probably the life expectancy of theICD recipients (9). Two manufacturers (Medtronic andSt. Jude Medical) have developed dedicated algo-rithms for lead failure detection in response to the

VT =

fic LivaNova408 g

Medtronic767 g

St. Jude Medical896 g

Smartview CareLink Merlin.net

GPRS GPRS/3G 3G

O O O

USA only O

O

O O O

1d–1y 1w–1y 1w–1y

3 All All

O O

ndure

Intrathoracic Impedancemonitoring

Intrathoracic Impedancemonitoring

Transmission ¼ ability to transmit a critical alert anytime- when the patient is closeevery week to every year; 1 day to 1 year: programmable from every day to every year;st episode), unless the episode occurs in the vicinity of the transmitter (direct trans-to 3 EGM can be sent in one session at night and available on the web site. However,N programmer. Remote control of the alerts ¼ the capability to switch on/off an alertprogrammer; Remote setting of the alerts ¼ the capability to remotely change the

per limits for lead impedances.

pacing percentage; EGM ¼ electrogram; GPRS ¼ General Packet Radio Service;

TABLE 2 RV Lead–Related Alerts

RVU D RVURV

SensingRV

Threshold Shock U

PassiveAlgorithm

ActiveAlgorithm

Biotronik O O O O

Boston Scientific O O O O O Nonphysiologic

LivaNova O O V Oversensing

Medtronic O O O LIA LND

St. Jude Medical O O SecureSense

RVU ¼ RV impedance out of range; D RVU ¼ sudden changes in RV lead impedance (part of the LIA algorithm forMT); Shock U ¼ shock impedance out of range. Passive algorithm ¼ algorithm of lead failure detection that donot interfere with the treatment (see Online Appendix for details). Active algorithm ¼ algorithm of lead failuredetection that may interfere with the treatment. When a superior vena cava (SVC) coil is available, Medtronic andSt. Jude Medical provide a specific impedance alert for this channel.

LIA ¼ lead integrity alert; LND ¼ lead noise discrimination; RV ¼ right ventricular; V ¼ ventricular.

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recall of the Sprint Fidelis and Riata leads (10,11). Thesealgorithms integrated to their respective RM systemconfer significant advantage over the conventionalimpedance monitoring. A large part of the RM alertportfolio is commonly devoted to the ICD lead sur-veillance (Table 2), which includes:

1. A daily check of the pacing and shock impedances.An alert is triggered for each impedance out of thelower and upper bounds (which can remotely bechanged through the Biotronik website). Med-tronic and St. Jude Medical provide dedicatedimpedance alert for the superior vena cava coil.

2. Boston Scientific also checks for lead impedancevariations and sends an alert when 3 large varia-tions have been detected in a 7-day rollingwindow, this alert is available for Wave commu-nicators (models 6288 to 6290) and must be indi-vidually programmed on the website.

3. More sophisticated proprietary algorithms havebeen introduced to detect lead-related oversensingwithout interferingwith treatment delivery. BostonScientific tracks short RR intervals (#160ms) withindetected episodes, whereas LivaNova sends an alertfor accumulation of untreated VF episodes (OnlineAppendix). Medtronic provides a lead integrityalert (LIA) that is triggered by a combination of: 1)relative changes in impedance; 2) transient short RRintervals; and 3) nonsustained VT (NSVT). Thislatter algorithm has been proven to significantlyincrease the detection rate of lead failure comparedwith conventional impedance monitoring (12).

4. Medtronic and St. Jude Medical provide noisediscrimination algorithms that differentiate ICDlead noise from VT/VF by comparing a far-fieldEGM signal to near-field sensing. Once lead noiseis identified, VT/VF detection is withheld, and analert is triggered (Figure 1).

5. Biotronik and Boston Scientific only provide spe-cific alerts for right ventricular (RV) intrinsic

amplitude out of range <2 mV and #3 mV,respectively. These warnings allow early diagnosisof loss of sensing, ICD lead dislodgment, andparadoxically oversensing (Figures 2 and 3).

NB: Following a first impedance alert (either sensingor shock), the RM systems behave differently. Thesespecificities are important to know for those whowould prefer to wait for a recurrence (which is notadvised).

Biotronik: An alert will be sent for any newabnormal measurement (pending that the impedancerecovers in between). However, if the impedance iscontinuously out of range, the alert will only berepeated after 21 days.

Boston Scientific: Latitude delivers a first andunique alert, whatever the number of subsequentabnormal measurements. There will not be anyrecurring alerts until the device has been interrogatedwith a programmer. One exception is the alert for“lead impedance abrupt change,” which can be ret-riggered without a programmer interrogation.

LivaNova: After a first impedance alert, a 1-weekinhibition period is applied during which no alert canbe sent. In case of recurrence, the system will delivera second and last alert (until the device has beeninterrogated with a programmer).

Medtronic: A new alert is sent for every newimpedance out of range.

St. Jude Medical: Merlin delivers a first and uniquealert, whatever the number of subsequent abnormalmeasurements. That alert will not repeat until thedevice has been interrogated with a programmer.

AUTHORS’ ADVICE/SUGGESTIONS.

n Turn ON all the ICD lead–related alerts that do notinterfere with therapy. Boston Scientific “Rightventricular non-physiologic signal detected” and“Right ventricular pacing lead impedance abruptchange” are nominally OFF and must be activatedindividually on the Latitude website because theydo not respond to the patient group default settings.

n Program noise detection alert that may inhibit thetherapy (lead noise discrimination algorithm forMedtronic, and SecureSense for St. Jude Medical).

n The St. Jude Medical SecureSense trigger alert fornonsustained RV/ventricular oversensing must beset to 1 (number of episodes needed before trig-gering and sending the alert).

n Attention must be paid to the scheduled reports onRV lead impedance and R-wave sensing trends,especially in LivaNova, Medtronic, and St. JudeMedical devices, in order to detect a sudden drop inR-wave amplitude or abrupt impedance changes(Figure 2).

FIGURE 1 Lead Fracture Identified Through the Medtronic LIA

Lead warning transmitted as a red CareAlert from a Medtronic Secura DR implanted in secondary prevention in 2011. The observation folder contains a Lead Integrity

Warning related to the association of NSVT and short VV intervals (red arrows). The ICD lead impedances were normal and stable. The recorded EGMs evoke a lead

fracture (part of an EGM containing noise is shown at the bottom). This alert allows early identification of conductor fracture, as well as insulation failure, and therefore

reduces the incidence of inappropriate shocks. Note that the alert was transmitted at 10:08 PM, as soon as the device has found the transmitter (direct transmission).

Confronted with the same technical issue, the 3 Biotronik, Boston Scientific, and LivaNova systems would have remained silent. AF ¼ atrial fibrillation; AT ¼ atrial

tachycardia; bpm ¼ beats per minute; EGM ¼ electrogram; FVT ¼ fast ventricular tachycardia; ICD ¼ implantable cardioverter-defibrillator; LIA ¼ lead integrity alert;

MVP ¼ managed ventricular pacing; NSVT/VT-NS ¼ nonsustained ventricular tachycardia; RV ¼ right ventricular; SVT ¼ supraventricular tachycardia; V ¼ ventricular;

VF ¼ ventricular fibrillation; VP ¼ ventricular pacing; VT ¼ ventricular tachycardia; VT-NS ¼ nonsustained ventricular tachycardia.

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FIGURE 2 Silent Loss of Ventricular Sensing

Ventricular Sense Amplitude Trend from a St. Jude Medical Ellipse VR ICD,

the first month following the addition of a new St. Jude Medical Durata lead.

The graph shows a progressive decrease of the R-wave amplitude (from 12 to

2.4 mV) as indicated by the red arrows related to a delayed right

ventricular wall perforation. No alert was delivered until the patient was

hospitalized for chest pain. A Boston Scientific ICD would have alerted for an

R-wave #3 mV. ICD ¼ implantable cardioverter-defibrillator.

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n At the time of generator change, the preferred RMsystems for surveillance of leads under advisory areMedtronic and St. Jude Medical, which provideactive and passive noise detection algorithms andalerts.

n Patients subjected to a decrease in R-wave ampli-tude (arrhythmogenic RV dysplasia) would benefitfrom a Biotronik system, which has alerts forchanges in sensing (13).

RIGHT ATRIAL, LEFT VENTRICULAR

LEAD–RELATED ALERTS

Although less critical than ICD RV lead failure, a rightatrial (RA) or left ventricular (LV) lead malfunctionmay have clinical consequences. A RA lead malfunc-tion may favor pacemaker-mediated tachycardia,loss of CRT, or supraventricular tachycardia (SVT)-VTdiscrimination errors. An LV lead failure would inter-fere with CRT delivery either by loss of capture oroversensing (for Biotronik and Boston Scientific only).Biotronik and Boston Scientific are the most sensitivein atrial and LV lead failure detection (Table 3).

VENTRICULAR ARRHYTHMIA–RELATED

ALERTS

Ventricular arrhythmia–related alerts are driven bydifferent manufacturer philosophies. Biotronik and

St. Jude Medical offer the highest sensitivity with thepossibility to transmit the range of ventriculararrhythmia episodes (from nonsustained, eventstreated with ATP, to shocked), whereas Boston Sci-entific and Medtronic mostly restrict the alert toshocked arrhythmia episodes (Table 4). The rationalefor adopting a high sensitivity in arrhythmia diag-nosis is as follows:

1. NSVT events are a common source of noise/over-sensing identification. Their early notification byRM may prevent inappropriate shocks andreduce patient morbidity (14). In fact, NSVT is themost sensitive of the 3 LIA criteria (impedancechange þ NSVT þ sensing integrity counter) and ispresent in 96% of the LIA alerts, which have beenfound to be very effective in lead failure detection,especially in combination with remote monitoring(8,12).

2. Non-shocked episode alerts allow reduction intime to medical evaluation for VT and VF events,as shown in the TRUST (Lumos-T Safely ReducesRoutine Office Device Follow-Up) trial (2).

3. Non-shocked VT and VF episodes may relate toSVT, P/R/T-wave oversensing, noise oversensing,or lead dysfunction. Boulé et al. (15) demonstratedthat RM systems that generate alerts following ATPdelivery could reduce emergency presentations forICD shock by 24%.

4. Asymptomatic cancelled shock therapy (whetherfor actual VT or noise) may reduce batterylongevity. Their early identification provides anopportunity for prevention of therapy and batterypreservation (16).

To date, no study has shown the ability of RM toreduce appropriate shocks in comparison to standardfollow-up. However, early RM notification of ventric-ular arrhythmia episodes enables preemptive action toavoid further inappropriate shock therapy and/oraborted shocks, which affects the battery longevity.The ECOST (Benefits of Implantable CardioverterDefibrillator Follow-UpUsingRemoteMonitoring) trialinvolving Biotronik devices has reported a 50%reduction in the proportion of patients who receivedinappropriate shocks (17). In contrast for those systemsthat restrict the alert to the shocked episodes (BostonScientific and Medtronic), the time to diagnosis isdelayed and necessitate a careful examination of thearrhythmia logbook at the time of the scheduledtransmission (Figures 4 to 6).

AUTHORS’ ADVICE/SUGGESTIONS.

n Analyze all transmitted ventricular arrhythmiatracings in order to detect potential sources of

FIGURE 3 Ventricular Sensing Alert Revealing a Diaphragmatic Myopotential Oversensing

Yellow alert for “Right ventricular intrinsic amplitude out of range” sent by a Boston Scientific Incepta ICD 44 days after implantation. The EGM log book contained an

episode labelled NSVT (NonSustV) that shows diaphragmatic myopotential oversensing (high-frequency and low-amplitude oversensed signal interrupted by a sensed

escape rhythm that resets dynamic sensitivity) (magenta arrows). The oversensing was reproducible by forced inspiration, and the RV lead impedance was stable. An

incidental measurement of these diaphragmatic myopotentials has probably been the cause of the “apparent “drop” in the R-wave amplitude (red circle). ATR ¼ atrial

tachycardia response; DMO ¼ diaphragmatic myopotential oversensing; other abbreviations as in Figure 1.

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TABLE 3 RA, RV Lead–Related Alerts

RAU RA Amp RA Threshold LVU LV Amp LV Threshold

Biotronik O O O O O O

Boston Scientific O O O O O O

LivaNova O O

Medtronic O O

St. Jude Medical O O

Amp ¼ amplitude; LV ¼ left ventricular; RA ¼ right ventricular; RV ¼ right ventricular.

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inappropriate shock, or unnecessary shock/abortedshock.

n Biotronik and St. Jude Medical are the preferredsystems to monitor VT burden (e.g., arrhythmo-genic RV dysplasia, ablated VT, history of VTstorm).

n Medtronic ICDs should be programmed with theCareAlert “Number of Shocks Delivered in anEpisode” ON and set to 1.

n LivaNova ICDs should be programmed “all shocks”instead of “Inefficient Max shock.” “ATP deliv-ered” is available since the Platinum series andshould be programmed ON.

n In order to shorten the time to medical interven-tion, we advise reducing the remote interrogationinterval of the Boston Scientific, Medtronic, andLivaNova devices (<3 months) with careful exam-ination of the VT/VF counters and EGM library (18).

n Patient-initiated transmission should be allowedfor Boston Scientific, LivaNova, and Medtronicsystems in order to access nontreated, but symp-tomatic, arrhythmic events.

ATRIAL ARRHYTHMIA–RELATED ALERTS

Current dual-chamber and CRT-ICD RM systemsprovide alerts for AF episodes and/or AF burden(Table 5). Likewise, the new Biotronik Dx and Med-tronic single-chamber ICD also provide alerts for

TABLE 4 Ventricular Arrhythmia–Related Alerts

NSVT VT/VFATP

VT/VFShockedVT/VF

Ineffective MaxEnergy Shock(s)

Biotronik O O O O

Boston Scientific O

LivaNova O O O

Medtronic O O

St. Jude Medical O O O O O

NSVT ¼ for St. Jude Medical: non sustained VT defined as >6 VT intervals but <VT countLIA. VT/VF ¼ VT or VF episode that fulfilled the VT/VF counter (not necessarily treated

ATP ¼ antitachycardia pacing; NSVT ¼ nonsustained ventricular tachycardia; VF ¼ ven

excessive AF burden. RM outperforms standardfollow-up in AF detection because: 1) a large propor-tion of AF episodes are asymptomatic; 2) RM shortensthe time to detection of AF (1 to 5 months earlier); and3) an EGM of an AF episode that has been tele-transmitted may be absent from the ICD records ifoverwritten by more recent episodes (that may not beAF, but rather are noise, for example) (2,3,19). Earlydetection of AF is an important assignment of RM thatmay help to prevent clinical complications:

1. Recognizing AF is important to avoid inappropriateICD therapies, since AF is responsible for the ma-jority of them. The ECOST trial showed a 74%reduction in the number of inappropriate shocksrelated to SVT in the RM arm compared withstandard follow-up (17).

2. AF may trigger hemodynamic instability andworsen congestive heart failure, especially by lossof CRT. The InTIME (INfluence of home moniToringon mortality and morbidity in heart failure patientswith IMpaired lEft ventricular function) studyshowed more favorable outcomes and survival inpatients with heart failure and RM of their ICD.Interestingly, patients with a history of AFbenefited more from RM than did the patientswithout AF. It is also noteworthy that AF was theRM alert that most often led to patient contact.These observations suggest a link between AFmanagement and the RM benefits observed (5).

3. Early detection of AF (sometimes in real time) pro-vides the opportunity to considerwhether to initiateanticoagulation therapy. In the ASSERT trial(Asymptomatic Atrial Fibrillation and Stroke Evalu-ation in Pacemaker Patients and the Atrial Fibrilla-tion Reduction Atrial Pacing Trial), AF episodes asshort as 6minhave been shown to be associatedwithan increased risk of stroke (20). The benefit of treat-ing these with anticoagulation is currently beingevaluated in the ARTESIA (Apixaban for the

>2 StartedShocks

All TherapiesExhausted Acceleration

LongDuration >3 Episodes/24 h

O O O

O

O

O O O

er. For Medtronic: nonsustained tachycardia episodes may be sent in the frame of the).

tricular fibrillation; VT ¼ ventricular tachycardia.

FIGURE 4 Incidental Discovery of an ICD Lead Fracture

Patient implanted in 2011 with a Boston Scientific Incepta cardiac resynchronization therapy defibrillator. The scheduled follow-up displayed no alerts, but NSVT episodes

had been stored. The recorded EGM showed lead-related noise revealing a lead fracture. The ICD lead impedance was stable and in the normal range. This case illustrates

the potential role of NSVT alerts and the need for careful inspection of every stored event. Abbreviations as in Figure 1.

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Reduction of Thrombo-Embolism in Patients WithDevice-Detected Sub-Clinical Atrial Fibrillation)trial.

It is the authors’ opinion that AF detection thresh-olds should be programmed at their lower values(from the programmer, for LivaNova, Medtronic, andSt. Jude Medical; from the website, for Biotronik andBoston Scientific) in patients with no history of AF(21). The default value for AF detection is 3 h for St.

Jude Medical devices, compared with 6 h for othercompanies. The lowest threshold for AF detection is30 min for LivaNova, Medtronic, and St. Jude Medical,and can be lowered in Biotronik and Boston Scientificdevices to>0 h or 0% (Table 5). In patients with knownAF, this detection threshold can be increased and/orreplaced by a high ventricular rate alert. The AFepisode and AF burden alerts are delivered with anEGM, which allows confirmation of the diagnosis. Dueto memory size limitation, the transmitted EGMs are

FIGURE 5 Electromagnetic Interference Diagnosed Through a VF Detection Alert

VF alert originating from a Biotronik Ilesto HF-T CDT-D. Episode details reveal no delivery of ATP and one aborted shock (red circle). The EGM is in favor of electro-

magnetic interference (50 Hz). This untreated episode has allowed the identification and eradication of the contamination source before the delivery of an inappropriate

therapy. For Boston Scientific, LivaNova and Medtronic systems, this kind of event would only be available in the EGM library at the time of the scheduled remote

interrogation, or worse, after an inappropriate shock. ATP ¼ antitachycardia pacing; other abbreviations as in Figure 1.

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the latest, not necessarily the longest, episodes.Furthermore, because atrial undersensing is commonin AF, a continuous, clinical AF episode may bestored as multiple shorter, sequential device-definedepisodes. Thus, the health care provider should scru-tinize the AF burden graph or log and the atrial-modeswitch table (if any) to determine the duration ofthe clinical AF episodes before deciding about anti-coagulation. Additional AF-related alerts are pro-posed for Biotronik and St. Jude Medical devices.

AUTHORS’ ADVICE/SUGGESTIONS.

n Program the AF detection threshold at their lowestvalue in patients free of AF.

n Increase the threshold for an AF alert in patientswith known AF (AF burden >50%, for example) orreplace it with the alert of high ventricular rateduring atrial burden (>110/min during 10% of theday, for example).

n When an AF/mode switch EGM is delivered, alwayspay attention to AF burden/24 h because thetransmitted EGM may not be the longest, but

rather the last. This is particularly true for Bio-tronik and LivaNova devices.

n Apart from the EGM library, duration of the longestatrial episode can be found under “Atr. Arrhythmia”for Biotronik, “Atrial arrhythmia history” for LivaNova,“Clinical status” for Medtronic, and “Diagnosticssummary” for St. Jude Medical.

n LivaNova ICDs send a maximum of 2 AF burdenalerts between 2 programmer interrogations.

n Be aware that a teletransmitted episode loses itspriority in the LivaNova device storage library.

HEART FAILURE–RELATED ALERTS

ICD recipients may be subjected to acute decom-pensated heart failure (especially CRT patients). Withthe exception of Medtronic, all systems can be pro-grammed to deliver a “low CRT” alert, with a pro-grammable %CRT threshold). With the exception ofBiotronik, this alert is delivered with an EGM that canreveal the cause of the lack of CRT (e.g., atrial

FIGURE 6 Silent VT Storm

Content of a scheduled report from a Medtronic Evera XT DR ICD implanted for secondary prevention. There is no alert to display. However, the VT and VT-NS counters

show more than 1,000 episodes, of which 91 were sustained and pace-terminated. This patient had a VT storm at home correctly handled by the device. Time to

diagnosis was 44 days in this case. We advise programming a scheduled report every month for Boston Scientific, Medtronic, and LivaNova (before Platinum) in order to

reduce the time to clinical decision in case of a VT storm or inappropriately paced therapies. Abbreviations as in Figure 1.

TABLE 5 Atrial Arrhythmia–Related Alerts

Episode Long Episode AF Burden High V Rate SVT Atrial Therapy

Biotronik O >30 min >0% O O O

Boston Scientific >0 h

LivaNova >30 min O

Medtronic >30 min O3

St. Jude Medical >30 min >30 min O O

Indicated times are lowest thresholds. An alert is sent when the Biotronik device detects 36 short AA intervals outof 48. Alert when the ventricular rate during an AF episode exceeds the programmed value. Cumulated time in AF>7 min. From the first AF episode. Also available for single chamber (VR) implantable cardioverter-defibrillators.

SVT ¼ supraventricular tachycardia; other abbreviations as in Tables 1 and 2.

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undersensing, T-wave oversensing). Biotronik pro-vides alerts for high ventricular rate and high prema-ture ventricular contraction burden. Medtronic andSt. Jude Medical can provide alerts for a decrease inthe thoracic impedance (OptiVol and Corvue, respec-tively). Though expected to be related to heart failuredecompensation, this was not borne out by the recentOptilink (Optimization of Heart Failure Managementusing OptiVol Fluid Status Monitoring and CareLink)trial, raising doubts about coupling thoracic imped-ance changes to RM (22). Boston Scientific devicesequipped with the weight scale can alert for suddenloss or gain in weight, if patients weigh themselvesdaily (Table 6). Finally, AF alerts may also identify riskof heart failure decompensation in CRT patients.

AUTHORS’ ADVICE/SUGGESTION.

n The effectiveness of fluid status telemedicinealerts to manage congestive heart failure is

currently uncertain (Class IIB recommendation inthe recent guidelines) (1).

n For Biotronik and Boston Scientific, CRT% (CRTpacing percentage) includes LV pacing triggered byRV sensing, which is often higher than the

TABLE 6 HF Monitoring

%CRTMean VHR Rate

Mean VHR Rest % PVC Algorithm

Biotronik O O O O

Boston Scientific O Weight

LivaNova O

Medtronic Optivol

St. Jude Medical O Corvue

HF ¼ heart failure; HR ¼ heart rate; PVC ¼ premature ventricular contraction;other abbreviations as in Tables 1 and 2.

TABLE 7 Summary

YouP

Biotronik

BostonScientific

LivaNova

Medtronic

St. JudeMedical

*When a high sensitivityundetermined source. þ pindication.

ARVC ¼ arrhythmogenicCRT ¼ cardiac resynchrotachycardia burden monit

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biventricular pacing %. We therefore recommendusing the BIV% (biventricular pacing percentage)alert instead of the CRT% alert in Biotronik devices(not available for Boston Scientific).

n

ir

no

PATIENT TRAVELLING

RM while travelling is only possible with transceiverscarrying their own SIM card and depends on theavailability of cellular roaming. Travelling is usuallynot an issue when the shift in time zones is <3 h;likewise, there is no issue with daylight savings time.The different manufacturers have specific contractswith different operating communicators all over theworld. Some transceivers are more compact andportable (Table 1).

Biotronik: The ICD is programmed to transmit oncea day between 01:00 AM and 02:00 AM. The trans-mission attempts will last 3 h. Therefore, it is advisedto reprogram the transmission time if the shift in timezones is more than 3 h. Alternatively, the patient cancarry the Cardiomessenger Smart transmitter to allowdirect transmissions.

g Activeatient

AdvisoryLead

HCMBGDCNLP ARVC/VT

CryptogenicStroke* CRT Traveler

þ þ þ þþ þþ þþ þþ þþ þþ

þ þ þþþ þþ þ þþþ þþ þ þþ þ

n atrial fibrillation detection is needed, for example, in case of embolic stroke ofovides interesting features for this indication. þþ provides specific features for this

right ventricular cardiomyopathy; BGD ¼ Brugada Syndrome; CNLP ¼ channelopathy;ization therapy; HCM ¼ hypertrophic cardiomyopathy; VT ¼ needs of ventricularring.

Boston Scientific: Before the use of the 6290communicator (Autogen and after), RM was notpossible from another continent. With the use of theMedical Implant Communication Service bandwidth,RM is ensured from most parts of the world. Thecommunicator will try to reach the device between00:00 and 05:00 AM (original time zone) and repeatthe search every 10 min during the day. This processis not supposed to affect the battery longevity.

LivaNova: The transmitter will try to reach thedevice at the programmed original time and continuethe search 31 times during 3 consecutive nights. Itis therefore advised to change the transmissiontime through the website (“Enable day timefollow up”).

Medtronic: The transmitter will try to reach thedevice at the original programmed time and performa new search every 3 h during 3 days.

St. Jude Medical: The transmitter will try to reachthe device between 02:00 AM and 04:00 AM (originalMerlin time zone) and continues the search until thetransmission succeeds.

AUTHORS’ ADVICE/SUGGESTIONS.

n Global availability of RM depends on the companyand is subject to changes. Before implanting in apatient who plans to move abroad, it is advised tocheck with the manufacturer that RM is availablein that country.

n For Biotronik and LivaNova, RM transmission re-quires that the cardiac implantable electronic de-vice be reprogrammed according to the foreigntime zone. This can be done remotely for LivaNovadevices through the website. Of course, this timeneeds to be changed back when the patient returnshome.

n Patient equipped with a Biotronik Cardiomes-senger Smart transmitter may benefit from car-rying it during the day to allow permanenttransmission and avoid reprogramming the device.

DISCUSSION

Although RM has recently become a Class I recom-mendation for ICD follow-up regardless of the systemused, major quantitative and qualitative differencesexist between the 5 different RM systems. Equippingthe patient with an automatic RM system must be thepriority. However, the cardiac implantable electronicdevice specialist should be aware of the individualdifferences in RM systems, balance the relativebenefits/limitations for an individual patient, andconsider the transmission loads that need to behandled. The higher the number of proposed alerts,

CENTRAL ILLUSTRATION Tailoring ImplantableCardioverter-Defibrillator Remote Monitoring System toPatient Requirements

Ploux, S. et al. J Am Coll Cardiol EP. 2017;3(4):315–28.

This diagram shows how the Remote Monitoring (RM) system specificities and the

patient’s condition can be integrated in both the choice and the programming of the

implanted device. ASAP ¼ as soon as possible; CRT ¼ cardiac resynchronization therapy;

ERI ¼ elective replacement indicator; ICD ¼ implantable cardioverter-defibrillator;

VT ¼ ventricular tachycardia.

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the better the sensitivity in clinical/technical prob-lems detection. On the other hand, focusing on a fewalerts intends to decrease the noise and the con-sumption of scarce resources, for example, clinicmanpower. For systems that provide a limited num-ber of alerts, it is advisable to allow patient-initiatedinterrogation (for symptoms) and shorten the timebetween scheduled remote follow-ups (every month,for example). We have shown that a specific RM sys-tem may be preferred for a patient-specific condition(Table 7). Medtronic and St. Jude Medical systems areundoubtedly better equipped to detect lead failureand avoid unnecessary shocks. They are thereforeparticularly indicated for surveillance of leads proneto failure: under advisory or implanted in young andactive patients. When a close monitoring of the VTburden is required, in an ischemic patient with his-tory of VT storm, or a patient with arrhythmogenic RVdysplasia, the limitation of the Medtronic and BostonScientific systems, which only alert for shocked epi-sodes, must be borne in mind. One may argue that theoccurrence of VT is expected in an ICD recipient;however, ignoring a VT storm may have adverseconsequences (Figure 6). Similarly, the systems havedifferent capabilities for transmitting NSVT detectionepisodes, which may enable reprogramming to avoidinappropriate therapy, such as for electromagneticinterference and T-wave oversensing. The 5 RM sys-tems have the capability to detect and store AF epi-sodes adequately. However, Biotronik and BostonScientific have enhanced sensitivity and can be pro-grammed to alert for a few seconds of rapid atrialrate. This specificity may be considered whenimplanting a patient with a history of embolic strokeof undetermined source. Biotronik and Boston Sci-entific also provide an attractive combination ofalerts dedicated to CRT monitoring: RA and LV leadcontinuous check with CRT% alert. Additionally, thepatient followed with Latitude can transmit at regularintervals weight and blood pressure using BostonScientific–dedicated material. Finally, the compactsize and the ability of the Biotronik transmitter tocommunicate any time in the day render this suitablefor short and frequent trips, for example, for a com-mercial traveler (Central Illustration).

STUDY LIMITATIONS. We would like to stress thatthe purpose of this document is not to compare andrate the different systems, but rather to optimizetheir use in clinical practice. Suggestions/advicereflect the authors’ clinical experience and opinions.It is the authors’ anticipation that these insightsshould reduce reluctance to adopt and maintain RM.

The present review refers to the latest ICD version ofeach manufacturer.

ACKNOWLEDGMENTS The authors wish toacknowledge the kind collaboration of XavierLaroche (Biotronik, France); Nicolas Charlier (BostonScientific, Europe); Muriel Bon (LivaNova, France);Arthur Schmidt (Medtronic, France); Eve Clédatand Pierre Stiegler (St. Jude Medical, France). Theauthors are especially grateful for the expertopinions offered by Dr. C.D. Swerdlow (Cedars-SinaiHeart Institute, Cedars-Sinai Medical Center, LosAngeles, California).

ADDRESS FOR CORRESPONDENCE: Dr. SylvainPloux, Service Pr Haïssaguerre, Hôpital Cardiologiquedu Haut-Lévêque, Avenue de Magellan, 33600 Pessac,Bordeaux, France. E-mail: sylvain.ploux@gmail.com.

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KEY WORDS arrhythmia, implantablecardioverter-defibrillator, lead failure,remote monitoring, telemedicine

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