Magnetic resonance imaging safety in nonconditional pacemaker and defibrillator recipients: A meta-analysis and systematic review.

BACKGROUND Recommendations regarding performance of magnetic resonance imaging (MRI) in non-MRI conditional pacemaker and defibrillator recipients are evolving. Previous studies have suggested low adverse event rates with MRI in nonconditional cardiac implantable electronic device (CIED) recipients, but low power limits optimal characterization of risk. OBJECTIVE The purpose of this study was to perform a systematic review and meta-analysis to characterize the clinical risk associated with MRI in CIED recipients in order to improve power. METHODS PubMed and CINAHL indexed articles from 1990 to 2017 were queried. A random effects model was used for meta-analysis of continuous variables. Safety outcomes were evaluated with descriptive statistics. RESULTS Seventy studies of non-MRI conditional devices undergoing MRI were identified, allowing for analysis of 5099 patients who underwent a total of 5908 MRI studies. Heterogeneity in lead parameter changes was observed within studies, although smaller variances were noted between studies. All lead characteristics and battery voltages showed very small, clinically insignificant changes when assessed as a pooled cohort, although cases of clinically relevant outcomes were also noted (lead failure 3, implantable cardioverter-defibrillator shock 1, electrical reset 94). Electrical resets were found only in older devices. Defibrillator function was unchanged, and inappropriate shocks were avoided with pre-MRI programming changes. CONCLUSION This review demonstrated low lead failure and clinical event rates in non-MRI conditional pacemaker and defibrillator recipients undergoing MRI. Observed changes were small and interstudy variance was low, suggesting that the composite event rates offer a reasonable estimate of true effect. The observed adverse events reinforce the need for ongoing vigilance and caution, particularly with older devices.

[1]  C. Henrikson,et al.  Malfunction of an MRI-Conditional Pacemaker Following an MRI , 2016, HeartRhythm case reports.

[2]  A. Perucca,et al.  Pseudo "end of life" indication after electromagnetic field exposure: an unusual effect of magnetic resonance imaging on implanted cardioverter defibrillator. , 2012, International journal of cardiology.

[3]  Aharon Turgeman,et al.  MRI-Guided Ventricular Tachycardia AblationClinical Perspective , 2011 .

[4]  Saman Nazarian,et al.  Magnetic resonance imaging and implantable devices. , 2013, Circulation. Arrhythmia and electrophysiology.

[5]  A. Verma,et al.  Canadian Heart Rhythm Society and Canadian Association of Radiologists consensus statement on magnetic resonance imaging with cardiac implantable electronic devices. , 2014, The Canadian journal of cardiology.

[6]  David L. Hayes,et al.  Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. , 2013, Heart rhythm.

[7]  P. Boesiger,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? , 2002, Pacing and clinical electrophysiology : PACE.

[8]  R. Russo,et al.  Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. , 2012, The American journal of cardiology.

[9]  J. Svendsen,et al.  Is modification of the VVI backup mode in implantable cardioverter-defibrillators from St Jude medical required due to increased risk of inappropriate shocks? , 2016, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[10]  D. Bluemke,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 , 2007, Circulation.

[11]  R Core Team,et al.  R: A language and environment for statistical computing. , 2014 .

[12]  El-Sayed H. Ibrahim,et al.  Magnetic resonance imaging in patients with cardiac implanted electronic devices: focus on contraindications to magnetic resonance imaging protocols , 2016, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[13]  Jason C. Rubenstein,et al.  Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. , 2017, The New England journal of medicine.

[14]  H. Heidbuchel,et al.  2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices. , 2017, Heart rhythm.

[15]  Werner Irnich,et al.  Do we need pacemakers resistant to magnetic resonance imaging? , 2005, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[16]  Ronald D Berger,et al.  Determinants of gradient field-induced current in a pacemaker lead system in a magnetic resonance imaging environment. , 2008, Heart rhythm.

[17]  Daniel B Ennis,et al.  Pacemaker lead tip heating in abandoned and pacemaker‐attached leads at 1.5 tesla MRI , 2011, Journal of magnetic resonance imaging : JMRI.

[18]  H. Schild,et al.  Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. , 2009, Journal of the American College of Cardiology.

[19]  Patrick M Colletti,et al.  Magnetic resonance imaging in patients with cardiac pacemakers: era of "MR Conditional" designs , 2011, Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance.

[20]  Peter Hunold,et al.  Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. , 2011, Heart rhythm.

[21]  L. Staib,et al.  Disparities in Care Among Patients With Cardiac Implantable Electronic Devices Undergoing MRI. , 2017, Journal of the American College of Radiology : JACR.

[22]  Jagmeet P. Singh,et al.  Increased Perforation Risk with an MRI‐Conditional Pacing Lead: A Single‐Center Study , 2015, Pacing and clinical electrophysiology : PACE.

[23]  R. Fimmers,et al.  Safety, feasibility, and diagnostic value of cardiac magnetic resonance imaging in patients with cardiac pacemakers and implantable cardioverters/defibrillators at 1.5 T. , 2011, American heart journal.

[24]  B. Demirkan,et al.  High Ventricular Lead Impedance of a DDD Pacemaker after Cranial Magnetic Resonance Imaging , 2012, Pacing and clinical electrophysiology : PACE.

[25]  Lluís Mont,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). , 2013, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[26]  H. Ghanbari,et al.  A protocol for patients with cardiovascular implantable devices undergoing magnetic resonance imaging (MRI): should defibrillation threshold testing be performed post-(MRI) , 2010, Journal of Interventional Cardiac Electrophysiology.

[27]  O. Faris,et al.  Food and Drug Administration perspective: Magnetic resonance imaging of pacemaker and implantable cardioverter-defibrillator patients. , 2006, Circulation.

[28]  I. Olkin,et al.  Meta-analysis of observational studies in epidemiology - A proposal for reporting , 2000 .

[29]  H. Müderrisoğlu,et al.  Inappropriate shock and battery switching to "End of Life" in a patient with biventricular ICD during magnetic resonance imaging. , 2016, Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir.

[30]  H. Halperin,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 , 2006, Circulation.

[31]  C. Blomström-Lundqvist,et al.  Performing magnetic resonance imaging in patients with implantable pacemakers and defibrillators: results of a European Heart Rhythm Association survey. , 2012, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[32]  J. Gimbel.  The safety of MRI scanning of pacemakers and ICDs: what are the critical elements of safe scanning? Ask me again at 10,000. , 2010, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[33]  G. Calcagnini,et al.  Impact of capped and uncapped abandoned leads on the heating of an MR‐conditional pacemaker implant , 2015, Magnetic resonance in medicine.

[34]  Lluís Mont,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). , 2013, European heart journal.