German Roentgen Society Statement on MR Imaging of Patients with Cardiac Pacemakers

Abstract

The aim of this paper is to inform physicians, especially radiologists and cardiologists, about the technical and electrophysiological background of MR imaging of patients with implanted cardiac pacemakers (PM) and to provide dedicated clinical practice guidelines how to perform MR exams in this patient group. The presence of a conventional PM system is not any more considered an absolute contraindication for MR imaging. The prerequisites for MR imaging on pacemaker patients include the assessment of the individual risk/benefit ratio as well as to obtain full informed consent about the off label character of the procedure and all associated risks. Furthermore the use of special PM-related (e. g. re-programming of the PM) and MRI-related (e. g. limitation of whole body SAR to 2 W/kg) precautions is required and needs to be combined with adequate monitoring during MR imaging using continuous pulsoximetry. MR conditional PM devices are tested and approved for the use in the MR environment under certain conditions, including the field strength and gradient slew rate of the MR system, the maximum whole body SAR value and the presence of MR imaging exclusion zones. Safe MR imaging of patients with MR conditional PM requires the knowledge of the specific conditions of each PM system. If MR imaging within these specific conditions cannot be guaranteed in a given patient, the procedure guidelines for conventional PM should be used. The complexity of MR imaging of PM patients requires close cooperation of radiologists and cardiologists.

Key Points:

• Conventional pacemaker systems are no longer an absolute but rather a relative contraindication for performing an MR examination.

• The procedural management of conventional pacemaker includes the assessment of the individual risk/benefit ratio, comprehensive patient informed consent about specific related risks and "off label" use, extensive PM- and MRI-related safety precautions as well as adequate monitoring techniques during the MR exam.

• Decisive for patient safety are precise understanding of, and compliance with, the terms of use for the specific MR-conditional pacemaker system.

• If the electrophysiological and MRI-specific conditions for use of MR-conditional pacemakers are not met or compliance with these conditions for use cannot be guaranteed, the device must be treated like a conventional pacemaker.

Citation Format:

• Sommer T, Luechinger R, Barkhausen J et al. German Roentgen Society Statement on MR Imaging of Patients with Cardiac Pacemakers. Fortschr Röntgenstr 2015; 187: 777 – 787

Zusammenfassung

Ziel dieses Positionspapiers der AG Herz- und Gefäßdiagnostik der Deutschen Röntgengesellschaft ist es, Ärzte aller Fachbereiche – insbesondere die primär involvierten Fachgruppen der Radiologen und Kardiologen – über die Möglichkeiten, Grenzen und Risiken von MRT-Untersuchungen bei Patienten mit konventionellen und bedingt MRT-sicheren Herzschrittmachersystemen (SM) zu informieren und dezidierte Handlungsempfehlungen zur Durchführung von MRT-Untersuchungen bei diesen Patienten auszusprechen. Konventionelle Herzschrittmachersysteme sind nicht mehr als eine absolute, sondern als eine relative Kontraindikation für die Durchführung einer MRT-Untersuchung anzusehen. Entscheidend bei Indikationsstellung und Untersuchungsdurchführung sind die Abschätzung des individuellen Nutzen/Risiko-Verhältnisses sowie eine umfassende Aufklärung über die zulassungsüberschreitende Anwendung („off label use“) als individuelle Einzelfallentscheidung und über die mit der MRT-Untersuchung assoziierten spezifischen Risiken. Des Weiteren sind umfangreiche SM-bezogene (Umprogrammierung des SM) und MRT-bezogene Sicherheitsmaßnahmen (u. a. Limitation der Ganzkörper-SAR-Werte auf 2 W/kg) zur weitestgehenden Reduzierung dieser Risiken sowie adäquate Monitortechniken (insbesondere kontinuierliche pulsoxymetrische Überwachung) während der MRT-Untersuchung erforderlich. Bedingt MRT-sichere („MR conditional“) Herzschrittmachersysteme sind für eine MR-Untersuchung unter dezidierten Rahmenbedingungen getestet und zugelassen („in label use“). Die Hersteller gewährleisten die Sicherheit bei korrekter Anwendung im Rahmen der spezifischen Nutzungsbedingungen, die u. a. Vorgaben bezüglich der Feldstärke des MRT-Systems, der maximalen Anstiegssteilheit („slew rate“) des Gradientensystems, dem maximal erlaubten Ganzkörper-SAR u. dem MR-tomografisch untersuchbaren Bereich (Ganz- vs. Teilkörperzulassung des SM-Systems) beinhalten sowie die Überprüfung diverser elektophysiologischer Parameter (u. a. elektrisch intakte Elektroden, keine gekappten „abandoned“ Elektroden, keine anderweitigen zusätzlichen Elektroden) verlangen. Entscheidend für die Patientensicherheit sind die genaue Kenntnis und die Einhaltung der für das jeweilige Schrittmachersystem spezifischen Nutzungsbedingungen. Sollte dies nicht gewährleistet werden können, wird ein Vorgehen wie bei Patienten mit konventionellen Herzschrittmachern empfohlen. Grundsätzlich erfordert das vorgestellte prozedurale Management von MRT-Untersuchungen bei Patienten mit konventionellen und bedingt MRT-sicheren Herzschrittmachern eine enge Kooperation zwischen Radiologie und Kardiologie.

Key words

safety - magnetic resonance imaging - cardiac - MRI, pacemaker - MRI, implants - MRI, specific absorption rate

• Literatur

• 1 Hundley WG, Bluemke DA, Finn JP et al. ACCF/ACR/AHA/NASCI/SCMR 2010 expert consensus document on cardiovascular magnetic resonance: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. Circulation 2010; 121: 2462-2508
• 2 Schellinger PD, Bryan RN, Caplan LR et al. Evidence-based guideline: The role of diffusion and perfusion MRI for the diagnosis of acute ischemic stroke: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2010; 75: 177-185
• 3 [Anonym]. In Chest Pain of Recent Onset: Assessment and Diagnosis of Recent Onset Chest Pain or Discomfort of Suspected Cardiac Origin. London: 2010
• 4 Achenbach S, Barkhausen J, Beer M et al. Consensus Recommendations of the German Radiology Society (DRG), the German Cardiac Society (DGK) and the German Society for Pediatric Cardiology (DGPK) on the Use of Cardiac Imaging with Computed Tomography and Magnetic Resonance Imaging. Fortschr Röntgenstr 2012; 184: 345-368
• 5 Markewitz A. Annual Report 2011 of the German pacemaker and defibrillator register: Section pacemakers and AQUA-Institute for Applied Quality Improvement and Research in Health Care. Herzschrittmachertherapie & Elektrophysiologie 2013; 24: 249-274
• 6 Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol 2005; 28: 326-328
• 7 Roguin A, Schwitter J, Vahlhaus C et al. Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace 2008; 10: 336-346
• 8 Sommer T, Naehle CP, Yang A et al. Strategy for safe performance of extrathoracic magnetic resonance imaging at 1.5 tesla in the presence of cardiac pacemakers in non-pacemaker-dependent patients: a prospective study with 115 examinations. Circulation 2006; 114: 1285-1292
• 9 Levine GN, Gomes AS, Arai AE et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007; 116: 2878-2891
• 10 Nazarian S, Hansford R, Roguin A et al. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Annals of internal medicine 2011; 155: 415-424
• 11 Nazarian S, Halperin HR. How to perform magnetic resonance imaging on patients with implantable cardiac arrhythmia devices. Heart Rhythm 2009; 6: 138-143
• 12 Roguin A, Zviman MM, Meininger GR et al. Modern pacemaker and implantable cardioverter/defibrillator systems can be magnetic resonance imaging safe: in vitro and in vivo assessment of safety and function at 1.5 T. Circulation 2004; 110: 475-482
• 13 Nazarian S, Beinart R, Halperin HR. Magnetic resonance imaging and implantable devices. Circ Arrhythm Electrophysiol 2013; 6: 419-428
• 14 Sommer T, Vahlhaus C, Lauck G et al. MR imaging and cardiac pacemakers: in-vitro evaluation and in-vivo studies in 51 patients at 0.5 T. Radiology 2000; 215: 869-879
• 15 Luechinger R, Duru F, Scheidegger MB et al. Force and torque effects of a 1.5-Tesla MRI scanner on cardiac pacemakers and ICDs. Pacing and clinical electrophysiology: PACE 2001; 24: 199-205
• 16 Luechinger R, Duru F, Zeijlemaker VA et al. Pacemaker reed switch behavior in 0.5, 1.5, and 3.0 Tesla magnetic resonance imaging units: are reed switches always closed in strong magnetic fields?. Pacing and clinical electrophysiology: PACE 2002; 25: 1419-1423
• 17 Luechinger R, Zeijlemaker VA, Pedersen EM et al. In vivo heating of pacemaker leads during magnetic resonance imaging. European heart journal 2005; 26: 376-383 ; discussion 325–377
• 18 Tandri H, Zviman MM, Wedan SR et al. Determinants of gradient field-induced current in a pacemaker lead system in a magnetic resonance imaging environment. Heart rhythm: the official journal of the Heart Rhythm Society 2008; 5: 462-468
• 19 Nordbeck P, Weiss I, Ehses P et al. Measuring RF-induced currents inside implants: Impact of device configuration on MRI safety of cardiac pacemaker leads. Magnetic resonance in medicine: official journal of the Society of Magnetic Resonance in Medicine / Society of Magnetic Resonance in Medicine 2009; 61: 570-578
• 20 Naehle CP, Meyer C, Thomas D et al. Safety of brain 3-T MR imaging with transmit-receive head coil in patients with cardiac pacemakers: pilot prospective study with 51 examinations. Radiology 2008; 249: 991-1001
• 21 Naehle CP, Strach K, Thomas D et al. Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. J Am Coll Cardiol 2009; 54: 549-555
• 22 Naehle CP, Zeijlemaker V, Thomas D et al. Evaluation of cumulative effects of MR imaging on pacemaker systems at 1.5 Tesla. Pacing Clin Electrophysiol 2009; 32: 1526-1535
• 23 Schmiedel A, Hackenbroch M, Yang A et al. Magnetic resonance imaging of the brain in patients with cardiac pacemakers. Experimental and clinical investigations at 1.5 Tesla. Rofo 2005; 177: 731-744
• 24 Strach K, Naehle CP, Muhlsteffen A et al. Low-field magnetic resonance imaging: increased safety for pacemaker patients?. Europace 2010; 12: 952-960
• 25 Nazarian S, Roguin A, Zviman MM et al. Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla. Circulation 2006; 114: 1277-1284
• 26 Martin ET, Coman JA, Shellock FG et al. Magnetic resonance imaging and cardiac pacemaker safety at 1.5-Tesla. J Am Coll Cardiol 2004; 43: 1315-1324
• 27 Mollerus M, Albin G, Lipinski M et al. Cardiac biomarkers in patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing an MRI scan. Pacing Clin Electrophysiol 2008; 31: 1241-1245
• 28 Mollerus M, Albin G, Lipinski M et al. Magnetic resonance imaging of pacemakers and implantable cardioverter-defibrillators without specific absorption rate restrictions. Europace 2010; 12: 947-951
• 29 Brignole M, Auricchio A, Baron-Esquivias G et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J 2013; 34: 2281-2329
• 30 Medizinische elektrische Geräte Teil 2–33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik, DIN EN 60601-2-33
• 31 Sutton R, Kanal E, Wilkoff BL et al. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials 2008; 9: 68
• 32 Gimbel JR, Bello D, Schmitt M et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart rhythm: the official journal of the Heart Rhythm Society 2013; 10: 685-691
• 33 Wilkoff BL, Bello D, Taborsky M et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart rhythm: the official journal of the Heart Rhythm Society 2011; 8: 65-73