Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design

BACKGROUND: Magnetic Resonance Imaging (MRI) of patients with implanted cardiac devices is currently considered hazardous due to potential for electromagnetic interference to the patient and pacemaker system. With approximately 60 million MRI scans performed worldwide per year, an estimated majority of pacemaker patients may develop an indication for an MRI during the lifetime of their pacemakers, suggesting that safe use of pacemakers in the MRI environment would be clinically valuable. A new pacing system (Medtronic EnRhythm MRItrade mark SureScantrade mark and CapSureFix MRItrade mark leads) has been designed and pre-clinically tested for safe use in the MRI environment. The EnRhythm MRI study is designed to confirm the safety and efficacy of this new pacing system. METHODS: The EnRhythm MRI study is a prospective, randomized controlled, unblinded clinical trial to confirm the safety and efficacy of MRI at 1.5 Tesla in patients implanted with a specifically designed pacemaker and lead system. The patients have standard indications for dual chamber pacemaker implantation. Successfully implanted patients are randomized in a 2:1 ratio to undergo MRI (MRI group) or to have no MRI scan (control group) at 9-12 weeks after pacemaker system implantation. Magnetic resonance (MR) scanning includes 14 head and lumbar scan sequences representing clinically relevant scans while maximizing the gradient slew rate up to 200 T/m/s, and/or the transmitted radiofrequency (RF) power up to SAR (specific absorption rate) levels of 2 W/kg body weight (upper limit of normal operating mode). Full interrogation of all device information and sensing and capture function are measured at device implantation, every follow-up and before and immediately after MRI in the MRI group and at the same time points in the control group. Complete pacemaker and lead evaluations are also done at one week and one month after the scan for the MRI and control group patients.The primary endpoint is safe and successful completion of the MRI scan as measured by freedom from both MRI-procedure related complications and clinically significant changes in the sensing and capture function of the leads. RESULTS: Results will be communicated after approximately 156 and 470 patients have completed 4 months of follow-up. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00433654

Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator Primary Results of a Randomized Study

AbstractBackgroundMagnetic resonance imaging (MRI) of patients with conventional implantable cardioverter-defibrillators (ICD) is contraindicated.ObjectivesThis multicenter, randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency. The primary safety objective was >90% freedom from MRI-related events composite endpoint within 30 days post-MRI. The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude.MethodsSubjects received either a single- or dual-chamber ICD. In a 2:1 randomization, subjects either underwent MRI at 1.5-T of the chest, cervical, and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis (MRI group, n = 175), or they underwent a 1-h waiting period without MRI (control group, n = 88). A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function.ResultsIn 42 centers, 275 patients were enrolled (76% male, age 60.4 ± 13.8 years). The safety endpoint was met with 100% freedom from the composite endpoint (p < 0.0001). Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a ≤0.5 V increase in ventricular pacing capture threshold (100% MRI vs. 98.8% control, noninferiority p < 0.0001) or a ≤50% decrease in R-wave amplitude (99.3% MRI vs. 98.8% control, noninferiority p = 0.0001). A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes (20 induced; 14 spontaneous) occurred in 24 subjects post-MRI, with no observed effect on sensing, detection, or treatment.ConclusionsThis is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T. These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy. (Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access; NCT02117414

Randomized Trial of Pacemaker and Lead System for Safe Scanning at 1.5 Tesla

BackgroundMagnetic resonance imaging (MRI) of pacemakers is a relative contraindication because of the risks to the patient from potentially hazardous interactions between the MRI and the pacemaker system. Chest scans (ie, cardiac magnetic resonance scans) are of particular importance and higher risk. The previously Food and Drug Administration-approved magnetic resonance conditional system includes positioning restrictions, limiting the powerful utility of MRI.ObjectiveTo confirm the safety and effectiveness of a pacemaker system designed for safe whole body MRI without MRI scan positioning restrictions.MethodsPrimary eligibility criteria included standard dual-chamber pacing indications. Patients (n = 263) were randomized in a 2:1 ratio to undergo 16 chest and head scans at 1.5 T between 9 and 12 weeks postimplant (n = 177) or to not undergo MRI (n = 86) post-implant. Evaluation of the pacemaker system occurred immediately before, during (monitoring), and after MRI, 1-week post-MRI, and 1-month post-MRI, and similarly for controls. Primary end points measured the MRI-related complication-free rate for safety and compared pacing capture threshold between MRI and control subjects for effectiveness.ResultsThere were no MRI-related complications during or after MRI in subjects undergoing MRI (n = 148). Differences in pacing capture threshold values from pre-MRI to 1-month post-MRI were minimal and similar between the MRI and control groups.ConclusionsThis randomized trial demonstrates that the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system is safe and effective in the 1.5 T MRI environment without positioning restrictions for MRI scans or limitations of body parts scanned

ACR guidance document on MR safe practices: 2013

Because there are many potential risks in the MR environment and reports of adverse incidents involving patients, equipment and personnel, the need for a guidance document on MR safe practices emerged. Initially published in 2002, the ACR MR Safe Practices Guidelines established de facto industry standards for safe and responsible practices in clinical and research MR environments. As the MR industry changes the document is reviewed, modified and updated. The most recent version will reflect these changes. J. Magn. Reson. Imaging 2013;37:501–530. © 2013 Wiley Periodicals, Inc.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/96674/1/24011_ftp.pd

Totally Accessible MRI: A User's Guide to Principles, Technology, and Applications

This is a practical guide that offers a lucid introduction to the principles of MRI physics. The author, recognized in the imaging community for his exceptional teaching methods and lectures, has written an easy to understand text. Each chapter explains the "why" and "how" behind MRI physics. Readers will understand how altering MRI parameters will have many different consequences for image quality and the speed in which images are generated. Practical topics, selected for their value to clinical practice, include progressive changes in key MRI parameters, imaging time, and signal to noise ratio. A wealth of high quality illustrations, complemented by concise text, enables readers to gain a thorough understanding of the subject without requiring prior in-depth knowledg

Assessment of rates of acute adverse reactions to gadobenate dimeglumine: review of more than 130,000 administrations in 7.5 years

OBJECTIVE: The purpose of this study was to determine the incidence of adverse events associated with gadobenate dimeglumine over 7.5 years in a major hospital system consisting of both academic and community hospitals. SUBJECTS AND METHODS: As part of a regular and continuous prospective quality assurance project, MRI technologists contemporaneously recorded all gadolinium-based contrast administrations and any associated adverse reactions, including type of reaction and treatment rendered, between August 1, 2005, and March 14, 2013. Weekly data review was performed by the director of MRI services, who evaluated data both by individual site and by comparison among the participating hospitals and sites within the hospital system. Comparison between reaction rates at different sites was performed with a chi-square test. RESULTS: Over 7.5 years, 132,252 doses of gadobenate dimeglumine were administered, and 236 reactions were recorded (0.18% of contrast-enhanced examinations). Of these, 133 (56.4% of all adverse reactions) required treatment and 12 (5.1%) qualified as serious. Reaction rates were significantly different between academic (0.23%) and community (0.07%) hospitals (p\u3c0.001). Reaction rates were higher in the initial years of the study, tapering to a lower baseline rate, which was maintained over more than 5 years. The findings were consistent with the Weber and Lalli effects reported in the literature on other pharmaceutical agents. CONCLUSION: Rates of adverse reactions to gadobenate dimeglumine recorded over 7.5 years were comparable to those reported for other gadolinium-based contrast agents examined over smaller time ranges and populations. The findings reinforce the relatively robust safety profile of this agent