Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator

Russo, Robert J.; Costa, H. S.; Silva, Patricia D.; Anderson, Jeffrey L.; Arshad, Aysha; Biederman, Robert W; Boyle, Noel G.; Frabizzio, Jennifer V.; Birgersdotter‐Green, Ulrika; Higgins, Steven L.; Lampert, Rachel; Machado, Christian; Martin, Edward T.; Rivard, Andrew L.; Rubenstein, Jason; Schaerf, Raymond; Schwartz, Jennifer; Shah, Dipan J.; Tomassoni, Gery; Tominaga, Gail T.; Tonkin, Allison; Uretsky, Seth; Wolff, Steven

doi:10.1056/nejmoa1603265

Cited by 306 publications

(249 citation statements)

References 35 publications

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“…1 Small studies have reported on the safety of MRI in patients who have a pacemaker or ICD 2–20 ; a recent larger study evaluated only nonthoracic examinations. 21 Other studies have specifically investigated the safety of MRI in patients who have pacemakers that, according to the Food and Drug Administration (FDA), have been shown to pose no known hazard under certain specified conditions of use; such devices are termed “MRI-conditional.” 22–25 However, the vast majority of pacemaker and ICD systems in current use are not labeled specifically as MRI-conditional and are termed “legacy” systems. The presence of a legacy system is considered by the FDA 26,27 and device manufacturers 28–30 to be a contraindication to MRI.…”

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confidence: 99%

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices

et al. 2017

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BACKGROUND Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed “MRI-conditional” devices). METHODS We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter–defibrillator (42%) that was not considered to be MRI-conditional (termed a “legacy” device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient’s device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter– defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials.gov number, NCT01130896.)

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Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices

et al. 2017

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“…42 Both studies used similar protocols, with the notable exception of exclusion of ICD patients who are pacemaker dependent and those undergoing thoracic MRI in the MagnaSafe study. Tachycardia therapies were programmed off, and pacemaker-dependent patients were programmed to pace asynchronously.…”

Section: Mri In Patients With Cardiac Implantable Electronic Devicementioning

confidence: 99%

Year in Review in Cardiac Electrophysiology

Tzou

Hussein

Madhavan

et al. 2018

Circ: Arrhythmia and Electrophysiology

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1 In the past year, there have been key advances in our understanding of arrhythmia mechanisms and diagnosis and important new therapies. We have seen advances in basic cardiac electrophysiology with demonstration of optogenetic targeting of atrial fibrillation (AF) rotors, induced pluripotent stem cell-based biological pacemakers, small-conductance Ca 2+ -activated K + (SK) channels as targets for AF treatment, and reductions in inward rectifier potassium current in promoting ventricular fibrillation. Hand-held ECG devices and implantable loop recorders have been shown to detect subclinical AF. Catheter ablation of AF in patients with left ventricular dysfunction improves outcomes compared with medical therapy. Both hybrid thoracoscopic surgical and catheter ablation procedures and off-pump surgery for AF have demonstrated efficacy. Anticoagulation with uninterrupted dabigatran had a lower major bleeding rate compared with uninterrupted warfarin after AF ablation. Studies have examined optimizing access to automatic external defibrillators by identifying optimal locations for placement and possibility of using a drone delivery network. In long-QT syndrome, there are advances in understanding of ECG predictors of arrhythmic events, the role of the role of gene variants in conferring arrhythmic risk, and effect of age and sex on QTc interval. There are numerous advances in the treatment of ventricular tachycardia, including noninvasive cardiac radiation. Catheter ablation and implantable devices continue to demonstrate effectiveness in patients with congenital heart disease.In the past year, there have been numerous ground-breaking discoveries and observations that illustrate the vibrancy and promise of our field. In this review, we have tried to capture articles published in the year 2017 of particular interest to cardiac electrophysiologists. Although we have focused on articles from our journal, we have captured many of the most impactful articles in numerous other journals. We apologize for omitting a large number of other important articles that cannot be included in this review because of space limitations. We have placed some of these in our Data Supplement. BASIC ELECTROPHYSIOLOGY BradyarrhythmiasThe search for new biological therapies for bradycardia met with recent progress as human keratinocytes genetically reprogrammed into electrically unstable cardiomyocytes were shown to persist and provide continued catecholaminergic-responsive pacing for 13 weeks after subepicardial injection into immunosuppressed dogs at the time of atrioventricular (AV) node ablation.1 Although only 40% to 80% of the beats matched the site of cell injection, this is first study to test a human induced pluripotent stem cell-based biological pacemaker in a large animal model of heart block and represents an important step forward in biological pacing.

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“…MagnaSafe-studien inkluderte 1 000 undersøkelser med pacemaker og 500 med implanterbar defibrillator (6). Det var ingen alvorlige komplikasjoner.…”

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