Diagnostic and Interventional Imaging (2017) 98, 203—215

RECOMMENDATIONS /Professional Information

Pacemakers and MRI: A protocol in line withinternational guidelines and approved bythe SFICV (French Society of CardiovascularImaging)

Y. Cruypenincka, B. Dubourga,b, P. Michelina,B. Godinc, C. Savoye-Colleta, E. Gérardina,J.-N. Dachera,b,∗

a Department of Radiology, University Hospital of Rouen, 76031 Rouen, Franceb Inserm U1096, University of Rouen, 76000 Rouen, Francec Department of Cardiology, University Hospital of Rouen, 76031 Rouen, France

The rate of pacemaker implantation is increasing each year. It has been estimated thatabout 1 person in 1000 in the Western world has received a pacemaker worldwide [1].Despite major advances in pacemaker technology, notably with the advent of ‘‘magneticresonance imaging (MR)-compatible’’ pacemakers, it should be borne in mind that thesemedical devices still contain ferromagnetic material and remain a relative contraindicationfor MRI. Nonetheless, when the risk—benefit ratio is favorable, imaging may be performedunder specific safety conditions. In all cases, MRI in a patient with a pacemaker must be

closely supervised by cardiology (cardiac rhythm disorder specialists) and radiology teams[2]. To ensure such conditions are fulfilled, this kind of imaging should only be performed inhospitals that have implemented efficient interdepartmental protocols and collaborationprocedures.

∗ Corresponding author at: Department of Radiology, University Hospital of Rouen, 1, rue de Germont, 76031 Rouen cedex, France.E-mail address: jean-nicolas.dacher@chu-rouen.fr (J.-N. Dacher).

http://dx.doi.org/10.1016/j.diii.2016.06.0242211-5684/© 2016 Editions francaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

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At the same time, the use and scope of MRI has expandedreatly with, for example, 5.3 million MRI scans performedn France in 2012 [3]. To continue considering pacemakerss an absolute contraindication for MRI when this modal-ty’s indications are steadily expanding, could result inissed opportunities for these patients. A Japanese studyemonstrated that 17% of pacemaker patients were likely toequire MRI in the year following implantation [4]. Similarly,oguin et al. estimated that the likelihood of pacemakeratients requiring MRI during the lifespan of the deviceanged from 50% to 75% [5]. Finally, a two-fold increase inhe likelihood of needing MRI is observed in patients agedver 65.

The indications for MRI keep expanding. For the pace-aker patient age group, the main indications are for

eurological disorders (stroke, dementia, Parkinson’s dis-ase, etc.) and neurosurgery (tumors, hematoma, abscess,tc.), although MRI examinations for cancer and cardiovas-ular disorders are also steadily increasing [6,7].

The aim of the present article is to suggest rules ofood practice when performing MRIs in pace maker patientsegardless the device’s compatibility. This recommendationas endorsed by the SFICV (French Society of Cardiovascular

maging).

acemakers, implantable automaticefibrillators: basic principles

chematically, pacemaker insertion is indicated for patientsith atrioventricular conduction abnormalities. An inter-ational three-letter code describes the pacing mode andettings. The first letter indicates which chamber(s) aretimulated [A atrium, V ventricle, D (dual) atrium and ven-ricle, O none], the second which chamber(s) are detectedA, V, D, O), and the third the mode of response of the pace-aker (I inhibited, T triggered, D inhibited and triggered, O

one). For example, a pacemaker programmed to the VOOode performs simple asynchronous ventricular pacing.An implantable automatic defibrillator is a pacemaker

hat can deliver shocks. Such pacemakers are indicatedor patients at risk for ventricular rhythm disorders, cer-ain patients with cardiomyopathy or cardiac failure with aeduced ejection fraction of less than 30—35%.

he new ‘‘MRI-compatible’’ pacemakers

hese recently marketed devices consist in a pacing boxnd leads that are immediately recognizable on X-ray exam-nations due to the radiopaque markers they contain. In010, a study on the first commercially released device con-rmed that MRI could be performed without harm to theatients or damage to the device [8]. The study included 464atients with this pacemaker from 41 different sites. Twoundred and forty-four of these patients underwent non-ardiac MRI 9 to 12 weeks after pacemaker implantation.he control group included 206 patients. No immediate or

elayed complications attributable to MRI were observed.o differences were found between the threshold param-ters measured for the pacemakers having undergone MRInd control pacemakers.

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Y. Cruypeninck et al.

MRI-compatible pacemakers are not non-magnetic;herefore, they are categorized as ‘‘MR conditional’’ by theoods and Drugs Administration, not ‘‘MR Safe’’. This impliesaintaining a high safety standard. All pacemaker manufac-

urers provide their own recommendations for MRI on theirebsites (Table 1).

In practice, MRI teams should implement the sameafety conditions, whether the patient has a MRI-compatibleacemaker or not. The main differences are in fact the indi-ations for MRI and the applicable legal framework. Theanufacturer’s warranty guaranteeing the absence of inci-ents means that the indications for MRI can be extended.or example, a patient with a MRI-compatible pacemakerith dementia, brain metastases, extrapyramidal symptomsr meniscus injury may benefit from MRI, even if the proce-ure is not vital for patient care. However, MRI would mostikely be contraindicated in the same clinical setting if theacemaker is not MRI-compatible.

Contraindications for implantable defibrillators are moretringent than for pacemakers, except for the new ‘‘MRI-onditional’’ models. Still, imaging may be performed in theame rigorous safety conditions as for pacemakers, if thexpected benefit exceeds by far the potential risk.

otential risks

he risk of harm to the patient or device during a MRI scans not negligible. Multiple interactions occur when a patientith a pacemaker is placed within a MRI machine. A largeumber of patient, pacemaker and MRI parameters need toe taken into account to minimize the risks associated withRI scans. Each additional sequence, each additional minute

hat the scan lasts represents a new risk, hence the need toeep the procedure to the bare minimum.

Potentially interfering factors are: B0 static field and gra-ient intensities, the spatial magnetic field gradient, theadiofrequency used (pulse type), the specific absorptionate (SAR), the anatomical region investigated, the positionnside the magnet, the implanted material (leads and pac-ng box), the patient’s dependence on the pacemaker, leadength, loops and direction, and the duration of the scan.

isks for the pacemaker

lacing a pacemaker in a MRI system may result in dam-ge to the pacing box or leads. Potential risks includeremature deterioration of the battery, heating of stimu-ation leads with possible endocardial burns, device switcho asynchronous mode, stimulator deprogramming or inhi-ition, permanent device failure, and stimulator or leadigration.

isks for the patient

he potential risks for the patient are variable, depending on

ow much the patient relies on his/her pacemaker. Althoughhe risks are different, both dependent and non-dependentatients are subject to potentially dangerous incidents, and

Pacemakers

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Table 1 MRI-compatible pacemakers.

Models Field Patientposition

Exclusion zone SAR Slew rate Spatialgradient

Totalexposuredurationallowed

Leads

BIOTRONIK Evia SR-DR 1.5 T or 3 T(for somecombina-tionpace-maker/leads)

Strictsupineposition

Isocenter ofthe reelexcludedbetweenthe level ofeyes andtop of hips

Full body≤ 2 W/kg

Slew rate ≤216 T/m/sper axis

Notspecified

30 min totalactiveimaging bysession

Safio S 53,S60Siello S 53,S 60, S45Solia S 45,S & T 53, S& T 60Setrox S 53,S60

EntovisSR-DR

Up to theserialnumber66237094included,maximumslew rate of125 T/m/sper axis

EstellaSR-DREcuroSR-DR

Overexclusionzone fromthe serialnumber66237095

Slew rate ≤200 T/m/sper axis

Eluna 8Epyra 6 et 8Etrinsa 6 et8

Full body Head < 3.2 W/kg 10 hours forthe life ofthe system

BOSTONSCIENTIFIC

AccoladeMRIEssensioMRIProponentMRIAdvantioMRIFormio MRIIngenio MRIVitalio MRI

1.5 T Prone orsupineposition

Full body Fullbody ≤ 4 W/kg ifINGEVITY leadsotherwise2 W/kgHead < 3.2 W/kgFullbody ≤ 2 W/kgHead < 3.2 W/kg

Slewrate ≤ 200 T/m/sper axis

Notspecified

Notspecified

INGEVITYMRI,FINELINE IISterox,FINELINE IISterox EZ

206

Y. Cruypeninck

et al.

Table 1 (Continued)

Models Field Patientposition

Exclusion zone SAR Slew rate Spatialgradient

Totalexposuredurationallowed

Leads

St JUDEMEDICAL

AssurityMRIAccent MRI

1.5 T Strictsupineposition

Consult SJMweb siteFull bodyorIsocenter ofthe reelexcludedbetweenthe eyes (or10 cmsabove) andthevertebra L4depends onthePM/leadsassociation

Fullbody ≤ 2 W/kgor ≤ 4 W/kgbased onPM/leadsassociationHead < 3.2 W/kg

Slewrate ≤ 200 T/m/sper axis

Notspecified

30 min ofactiveimaging bysession.30 min ofwaitbetweenthe sessions

Tendril MRI,Tendril STS,IsoFlexOptimEndurity

MRI

EndurityEnduritCoreNanostimleadless

1.5 T Prone orsupineposition

Full body Full body ≤4 W/kgHead ≤3.2 W/kg

≤ 19 T/m or1900gauss/cm

None

SORIN Kora 100 1.5 T Prone orsupineposition

Isocenter ofthe reelexcludedbetweenthe level ofeyes andtop of hips

Full body ≤2 W/kgHead <3.2 W/kg

Slew rate ≤200 T/m/sper axis

Notspecified

40 min ofactiveimagingexceptthorax bysession.20 minthoracicregion

Beflex52 cmRF45D — 58 cmRF46D

Pacemakers

and M

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207

Table 1 (Continued)

Models Field Patientposition

Exclusion zone SAR Slew rate Spatialgradient

Totalexposuredurationallowed

Leads

Kora 250 Full body Fullbody ≤ 2 W/kg(1 W/kg inthoracic regionif body massindex < 23)Head < 3.2 W/kg

MEDTRONIC Revo 1.5 T Prone orsupineposition

Isocenter ofthe reelexcludedbetween C1et T12

Full body ≤2 W/kgHead < 3.2 W/kg

Slew rate ≤200 T/m/sper axis

≤ 20 T/m or2000gauss/cm

Notspecified

CapSureFixNovusMRITM

SureScan®

5076(models5076-35,5076-45,5076-52,5076-58,5076-65,5076-85)

EnrythmAdvisaEnsura

Norestrictions

Micra 1.5 or 3 T Fullbody ≤ 4 W/kgHead < 3.2 W/kg

≤ 25 T/m or2500gauss/cm

None

MRI: magnetic resonance imaging. These recommendations are for illustration only and do not exclude to check accurately the recommendations given by the manufacturers.

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on-dependent patients are not apparently at less risk thanependent patients [9].

For dependent patients, the risk is over-detection result-ng in inhibition of stimulation (bradycardia, cardiac arrest).ndeed, the pacemaker can wrongly detect radiofrequencyaves as a signal mimicking cardiac activity and stop stim-lating the patient’s ventricles. The clinical outcome isradycardia, or even cardiac arrest.

For non-dependent patients, the risk is inappropriatesynchronous stimulation that can result in tachycardia orentricular fibrillation. This basically means that the stimu-ator no longer receives external input and stimulates theeart regardless of its real physiological activity.

However, many studies have reported successful MRIcans for patients with standard pacemakers without anyarm to either the patient or the device. Martin et al.eported a series of 62 MRI scans for 49 patients withoutny clinical incidents [10]. In the same way, Nazarian et al.eported that no complications had occurred during the55 scans they performed on 438 patients with pacemak-rs. It should be noted nevertheless that devices implantedefore 1998 were excluded. In three cases, the pacemakerseverted to transient back-up programming mode withoutonsequences either for the patients or the devices [11]. Inhe study by Roguin et al., no thermal injury was observednd the levels of magnetic attraction and torsion remainedow. However, the authors reported that devices manufac-ured before 2000 were more subject to damage than moreecent models [12].

Devices implanted after 2000 are smaller in size andontain less ferromagnetic components explaining theirmproved MRI-compatibility. So, the date the device wasmplanted should also be taken into account when makingecisions. The year 2000, a date that is easy to remember,s a key element of the decision tree.

In the same way, the anatomical region that requiresnvestigation and pacemaker manufacturer recommenda-ions should also be taken into account, since the risk isigher if the pacemaker is located in the imaged region.

Any clinical incident (malaise, palpitations or evenatient asking to stop the scan), electrical anomaly (espe-ially bradycardia or tachycardia) should result in immediateiscontinuation of the MRI scan and removal of the patientrom within the magnet as quickly as possible. ECG readoutuality should be monitored, in particular during the emis-ion of radiofrequency waves. ECG artifacts can occur andust not be mistaken for heart rhythm problems. We suggest

sing both external monitoring and the imager’s onboardonitoring system (ECG, heart rate monitoring).

rench and international guidelines

n 2005, the French Agency for the Safety of Health Prod-cts (AFSSAPS now known as ANSM) issued guidelines on thenteractions between MRI and active implantable devicespacemakers, implantable defibrillators, neurostimulators).

ome of the contraindications for these devices are theame, such as the minimum time after implantation andhe maximum magnetic field intensity. As far as possible,omputed tomography (CT) should be preferred over MRI.

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Y. Cruypeninck et al.

ll three kinds of devices are considered to be relative con-raindications for MRI with a field of not more than 1.5 Tesla.

The decision to go ahead with MRI must be discussedmong the physician asking for the scan, the cardiac rhythmpecialist and the radiologist. These three clinicians shouldeview the indication and consider alternatives to MRI.

If MRI is to be performed, the following conditions muste fulfilled without fail:presence of a clinician at the patient’s bedside during thescan;quickly available crash cart and external defibrillator;permanent ECG monitoring during the scan with a MRI-compatible ECG system;correct pacemaker programming prior to entering the MRIenvironment and pacemaker operation checked beforeand after the scan by the cardiologist;pacemaker implanted at least 6 weeks before the MRIscan;if necessary, chest X-ray to verify the absence of dam-aged, abandoned or epicardial leads;immediate discontinuation of the scan upon occurrenceof an incident.

In the AFSSAPS guidelines, 3 Teslas MRI scans weretrictly contraindicated. However, certain new generationRI-compatible pacemakers are eligible for 3-Tesla staticelds. The American Heart Association (AHA) advises againsterforming MRI for patients with pacemakers, with a higher-evel contraindication for pacemaker-dependent patients,nless the benefit of MRI be significantly higher than theisk [13].

Pacemaker-dependent and non-dependent patients areanaged in the same way as regards to MRI (Fig. 1) [14],

he only difference is how the pacemaker is programmed.

acemakers and MRI: a strictly monitoredrocess

he present protocol for managing pacemaker patients is inine with international guidelines and has been approved byhe executive committee of the Société francaise d’imagerieardiovasculaire (SFICV, French society for cardiovascularmaging).

MRI scans for patients with pacemakers should only beonsidered in public or private hospitals for which the imag-ng department and cardiology department, as well as aardiac emergency unit, are located on the same campus.RI-compatible vital signs monitoring equipment, an exter-al defibrillator and an adequately stocked crash cart muste available in the MRI environment to deal with poten-ial emergency situations. MRI staff must be appropriatelyrained in basic resuscitation techniques.

Given the significant rise in the number of requests forRI scans for patients with pacemakers and the relativeonfusion regarding ‘‘MRI-compatible’’ and ‘‘non-MRI-ompatible’’ devices, healthcare facilities should definetandardized procedures for performing MRI scans in

atients with pacemakers, regardless MR compatibility.

Such procedures should describe responsibilities andesource persons, how the patient is prepared before,uring and after the scan, and should provide technical

Pacemakers and MRI 209

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Figure 1. Recommendations regarding the use of magnetic resonpacemaker; ICD: implantable cardioverter defibrillator. Adapted fro

recommendations as regards to how the scan is performed,how the patient is monitored and how MRI is prescribed, aswell as information on the patient circuit.

The document can be made available to all staff usinga hospital document management system. Drawing up suchprocedures requires multidisciplinary cooperation. All theinformation provided in the procedure must be in line withANSM and AHA guidelines.

In addition to this procedure, we propose a communica-tion sheet to be filled in by the cardiac rhythm specialist(Fig. 2). This sheet is completed when the patient consultsprior to MRI and is then sent to the imaging department(Fig. 3). It provides proof that the patient has actuallyattended the pre-MRI visit. The cardiac rhythm specialist

can also provide, via this sheet, specific recommendationsas to patient care after the MRI scan and before the post-MRIvisit.

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imaging (MRI) for patients with implantable cardiac devices. PM:ference [14].

In order to differentiate requests for patients withacemakers from the usual MRI request procedure, a spe-ific pacemaker patient form (Fig. 4) should be used andhould be processed separately (Fig. 5). Without a specificrocess, pacemaker patients may make it to their appoint-ent only to see the scan postponed and rescheduled

ubsequently.The specific request form, to be completed by the physi-

ian requesting the MRI, will provide specific details as tohy MRI is requested and the potential clinical benefit for

he patient. It also involves the requesting physician person-lly in the decision to proceed with MRI. For both cardiachythm specialists and radiologists, the form ensures trace-bility from the very start of the process. It also provides

hem with the possibility of reviewing the patient recordrior to imaging, to discuss the request’s relevance and per-aps suggest an alternative method. The request must be

210 Y. Cruypeninck et al.

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igure 2. Magnetic resonance imaging (MRI)-cardiology communi

alidated sequentially first by the radiologist, then by theardiologist, before MRI can be performed.

To summarize, healthcare facilities with a MRI servicehould use:

a specific MR imaging request form;a standardized procedure stating all the necessary rec-ommendations on prescribing MRI, the patient circuit,patient care and technical recommendations for scanning;

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n sheet.

a communication sheet to liaise between the cardiologydepartment and the medical imaging department.

The previously described procedure is only feasible as

art of a scheduled process (non-emergency). In emergencyases, tripartite dialogue (requesting physician, cardiolo-ist, and radiologist) is required to assess the benefit—riskatio. If MRI is vital, the cardiologist, radiologist and on-call

Pacemakers and MRI 211

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Figure 3. Pacemaker patient circuit on the day of the magnetic r

MRI operator can proceed with imaging in accordance withour recommendations (see Clinical case).

Role of each staff member

The successful management of patients with pacemakers isconditional upon multidisciplinary collaboration. The multi-disciplinary team including prescribing physician, radiologistand cardiologist, assesses the benefit—risk ratio and, ifpossible, considers using an alternative modality. The car-diologist evaluates the feasibility of imaging based on the

patient’s cardiac status. He/she examines the patients dur-ing the pre- and post-MRI visits and fills in the MRI-Cardiologycommunication sheet. If necessary, the cardiologist monitorsthe patient during MRI. The radiologist ensures that there

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ance imaging (MRI) scan.

re adequate medical grounds for MRI and that it cannot beeplaced by another imaging modality. He/she monitors theatient during the scan, limits the acquisition scans to thetrict minimum, and ensures the patient’s safety and compli-nce of the procedure with the pacemaker manufacturer’secommendations.

The MRI technician reviews the cardiac rhythm spe-ialist’s instructions on the MRI-Cardiology communicationheet and ensures that appropriate medical attention isvailable throughout the scan. He/she prepares the MRI-ompatible monitoring equipment, resuscitation materialcrash cart) and external defibrillator. During acquisition,

e/she ensures that the SAR is as low as possible (nor-al operating mode or level 0). After the scan, he/she

nsures that the patient returns safely to the cardiologyepartment.

212 Y. Cruypeninck et al.

Figure 4. Request form for magnetic resonance imaging (MRI) for patients with pacemakers or defibrillators.

Pacemakers and MRI 213

resonance imaging (MRI) for patients with pacemakers or defibrillators.

Figure 6. Antero-posterior chest X-ray prior to magneticresonance imaging (MRI) showing the pacemaker and leads (non-c

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Figure 5. Discussion/approval process for requests for magnetic

Conclusion

Although MRI is still nowadays contraindicated for patientswith pacemakers, it may be performed under specificconditions, following multidisciplinary assessment and orga-nization of the scan by a three-member team comprisingthe radiologist, a cardiac rhythm specialist and the physi-cian requesting the scan. MRI is facilitated in patients withthe new ‘‘MRI-compatible’’ pacemakers, provided that thewhole device (pacing box and leads) be MRI-compatible.Nevertheless, MRI scans of patients with such new gener-ation pacemakers must still be performed with the samehighest level of precaution as for patients with standardpacemakers. Whatever the case, MRI should only be per-formed in specialized facilities where all the potentiallyrequired resources are immediately available. In no instanceshould MRI of patients with pacemakers be considered astrivial.

Clinical case

This 55-years old man with a non-MRI-compatible pacemaker(Fig. 6) complains of brutal onset neurological deficit fol-lowing recent implementation of anticoagulation therapy.Clinical examination reveals incomplete paresis of all fourlimbs and a sensory level C6. After discussion between theprescribing physician, radiologist and cardiologist, MRI ofthe cervical spine is approved. Close cardiac monitoring isensured during the scan and the patient’s vital signs aremonitored using a MRI-compatible system.

The artifacts caused by the pacing box are clearly visibleon the scout image in the axial plane (Fig. 7). T2-weightedimages and T1-weighted images of the cervical spine areacquired in the sagittal plane. T1-weighted images reveal

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pidural injury with central iso-signal intensity and higheripheral signal intensity, and T2-weighted images showidespread high signal intensity from C5 to T2 (Figs. 8 and 9)s well as anterior displacement of the cord with high cen-romedullar signal intensity. Taken together, these findingsuggest subacute compressive epidural hematoma compli-ated by spinal cord injury.

The patient did not complain about pacemaker heatinguring the procedure. No rhythm or conduction anomaliesere observed. A neurosurgical approach, guided by MRI,as attempted and confirmed diagnosis. Unfortunately, theatient did not recover neurological function. No cardiac

omplications were observed, either immediately or some-ime after MRI, for this patient with a non-MRI-compatibleacemaker.

214 Y. Cruypeninck et al.

Figure 7. Metal artifacts caused by the pacing box on the scoutimage (arrows).

Figure 8. Magnetic resonance imaging (MRI) of spinal cord: mid-line T2-weighted image in the sagittal plane. Posterior epiduralhematoma (arrows).

Figure 9. Magnetic resonance imaging (MRI) of spinal cord:T1-weighted image in the axial plane. Right posterior epiduralhematoma (arrows) with iso-signal intensity on T1-weighted imagese

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isclosure of interest

he authors declare that they have no competing interest.

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