Pacemakers/défibrillateurs et IRM - Estelle Gandjbakhch, Paris Recommandations de l'interface SFR-SFC pour la bonne pratique - Groupe ...
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Pacemakers/défibrillateurs et IRM Recommandations de l’interface SFR-SFC pour la bonne pratique Estelle Gandjbakhch, Paris
PM/ICD implantations in numbers 4 millions worldwide 1.2 millions patients in USA ∾ 400 000 patients in France 60 000-70 000 PM implantations /year 15 000 ICD implantations /year 2% increase /year 50% of PM/ICD carriers would need a MRI during follow-up * Within one year follow-up, 17% of patients with PM/ICD would need a MRI** *Roguin A. Europace 2008; 10: 336–346 **Sakakibara et al., Japanese Heart J 1999
IRM/PM evolution 70 000 examens IRM / million habts 800 PM/million habts - 1000 PM/million habts en France Bhuva AN et al. Eur Radiol 2020; 30:1378-84
Patients with PM/ICD have a difficult access to MRI Exemple with ICDs – Source ACR Turakhia M, Reynolds M, Wolff S, et al. Medtronic Data on File 2013. Data from 2011 MarketScan® Commercial and Medicare database, Truven Analysis, Inc. were used for this research.
Two opposite tendencies Since development of conditional And yet, PM/IRM, – Wrongly referred in France as – Implanted patients are refuted in "compatible" MRI at most MRI centers in – Some trends to trivialize the use Europe of PM/ICD in MRI – An implanted patient is 50 times – Despite a non-zero risk less likely to get an MRI VR than a non-implanted one – especially with the development of high magnetic fields – Increased machine time – No financial recognition Nazarian S et al. J Magn Res Imaging 2016; 43: 115-27
Les risques existent toujours • Les risques sont moindres avec les systèmes MR conditionnels – Dans les conditions d’utilisation recommandées • L’expression pacemaker « IRM- compatible » est impropre • Chaque séquence d’IRM est une nouvelle « expérience » induisant un risque propre – Patient – Matériel implanté – Séquence
Multiparametric interactions Main field (B0) Gradients RF field (B1) Force / Torque Vibration Arrhythmias Potential risk(s) Surdetection Heating Pacing inhibition PM/DAI malfunction (reset mode, battery depletion) ICD Tachycardia detection inhibition
Risks of MRI on PM/ICDs (conditional and non-conditional) For the patient, For the device, • Oversensing • Migrating or moving components – Pacing inhibition (Purely theoretical risk) – Bradycardia in pacing-dependent • Battery depletion patient • Deprogramming – Inappropriate shock • Switching to Reversion Mode (VVI) • Ventricular arrhythmia • Permanent failure – Risk of asynchronous mode VOO, DOO (the main cause of death • Thresholds changes describe) – Non-detection of ventricular arrhythmia (inhibition of ICD therapy) • Burns (RF) – abandoned leads There is no "MR safe" device
Prospective registries of non MRI-conditional devices Magnasafe Regsitry John Hopkins Registry • 1500 patients • 1509 patients • 2/3 PM- 1/3 DAI • 58% PM- 48% DAI • IRM 1.5 T extra thoracic • IRM 1.5 T thoracic /extra thoracic • 0.3% in« back up » mode • 0.5% in« back up » mode • 1 mute ICD change • 1 mute PM (end of life battery) • Sensing/pacing thresholds • Sensing/pacing thresholds modifications : non significant modifications : 4% but non significant Nazarian et al. NEJM 2017 Russo et al. NEJM 2017
The latest reported deaths are related to old models • 6 deaths following MRI in patients with PM • patients not monitored during the examination • Risk contexts (SCA, advanced heart disease, hydro-electrolyte disorders) • examined outside hospital, no cardiological supervision • all not pacing-dependent • Essential cause: VT, VF • All standard field ≤1.5T • The MRI department was not informed of the PM; communication +++ • No deaths reported in selected and monitored patients Irnich W. Europace 2005; 7: 353-365
PM/DAI conditionnels • Les risques sont minorés mais non • Innovations technologiques nuls – Sondes amagnétiques – Surdétection – Nouveaux interrupteurs • Inhibition du pacing ou choc inapproprié – Diminution de la composante ferro – Arythmie magnétique du générateur • Mode asynchrone (VOO, DOO) – Bradycardie • Mode ODO, OOO – Inactivation du DAI: non traitement d’une TV/FV Gandjbakhch E et al. Arch Cardiovasc Dis.2020 Dacher JN et al. Diagn Interv Imaging 2020
Dedicated Protocols +++ Gandjbakhch E et al. Arch Cardiovasc Dis.2020 Dacher JN et al. Diagn Interv Imaging 2020 Prescription Pre-MRI Post-MRI MRI Discussion with cardiologist programming programming • Determine if the system is IRM • What mode? • Monitoring: Who? How? • Restoration of conditional • Where? • Reduce the number of standard settings • Benefit/risk? • Surveillance? sequences to the minimum and device control • Can MRI be substituable? • Who? How? • Never exit the standard • Where? • No contra-indications mode (SAR control) • Who? How? • Indication of PM/DAI • Pacing-dependency? • History of VA (ICD)
Essential data • Lead and can model: MR conditional? • Pacing-dependent +++ • ICD or PM • History of appropriate therapies for ICD • No contra-indications: – Abandoned leads/ epicardial leads/connectors : interrogate the patient, scars, chest Xray if necessary – Device malfunction: elevated pacing thresholds, battery close to end of life • Device implantation > 4-6 weeks (except emergencies) • Clinical state of the patient: no fever or acute medical problem Gandjbakhch E et al. Arch Cardiovasc Dis.2020 Dacher JN et al. Diagn Interv Imaging 2020
Determine if the system is MR conditional www.irm-compatibilite.com
Gandjbakhch E et al. Arch Cardiovasc Dis.2020 Dacher JN et al. Diagn Interv Imaging 2020 PM/ICD MR-conditional
Gandjbakhch E et al. Arch Cardiovasc Dis.2020 Dacher JN et al. Diagn Interv Imaging 2020 PM/ICD non MR-conditional
Check list ++ Gandjbakhch E et al. Arch Cardiovasc Dis.2020 Dacher JN et al. Diagn Interv Imaging 2020
Remaining issues Patients Practitioners Patient Safety/ Organizational problem ++++ Risks associated to lack Time-consuming ++ of access to MRI Availability of device specialists Devices Organization of MR departments Mode auto-detect No financial valuation No patient with implantable electrical cardiac devices should be formally contra-indicated from an MRI because of their device if the MR is vital
• Respecter les indications – Guide de bon usage • http://gbu.radiologie.fr • Substituer l’IRM quand cela est possible (par la TDM en général) • Quand l’IRM doit être faite Que peut faire le – Déterminer l’IRM compatibilité • www.irm-compatibilite.com radiologue pour – Respecter les recommandations constructeurs et se limiter à 1.5T/3T selon les réduire le risque? modèles – Monitorer le patient / médicaliser l’examen – Réduire le nombre de séquences au strict minimum – Ne jamais sortir du mode standard (contrôle du SAR) • Communiquer au mieux avec la cardiologie +++ ( – Détecter les (rares) cas de CI – Evaluer le bénéfice/risque de l’examen
Cas particulier de l’IRM cardiaque • Les artéfacts liés aux DAI rendent illusoire la réalisation d’examens IRM cardiaques de qualité • Une indication de DAI posée peut être une raison de réaliser une IRM en urgence
Perspectives • Généralisation du mode d’auto-activation en mode IRM après détection du champ magnétique limite le risque d’évènement pendant la reprogrammation en mode IRM Facilite le circuit avant/après • Délégation de taches /protocoles de coopération • Simplification du parcours patient a l’échelon de chaque établissement : coordination entre radiologues et cardiologues
Autres données essentielles • Stimulo-dépendance+++ • Absence de sondes abandonnées/épicardiques/ adaptateurs/connecteurs : interroger le patient, cicatrices, RP • DAI: prévention Iaire/II aire • Implantation depuis au moins 6 semaines • Etat clinique du patient: absence de fievre, … • Le carnet de pace maker souvent ne suffit pas quand le patient n’est pas suivi dans le centre
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