Implantable Defibrillator System Shock Function, Mortality, and Cause of Death After Magnetic Resonance Imaging.

BACKGROUND: Studies have shown that magnetic resonance imaging (MRI) does not have clinically important effects on the device parameters of non-MRI-conditional implantable cardioverter-defibrillators (ICDs). However, data on non-MRI-conditional ICD detection and treatment of arrhythmias after MRI are limited. OBJECTIVE: To examine if non-MRI-conditional ICDs have preserved shock function of arrhythmias after MRI. DESIGN: Prospective cohort study. (ClinicalTrials.gov: NCT01130896). SETTING: 1 center in the United States. PATIENTS: 629 patients with non-MRI-conditional ICDs enrolled consecutively between February 2003 and January 2015. INTERVENTIONS: 813 total MRI examinations at a magnetic field strength of 1.5 Tesla using a prespecified safety protocol. MEASUREMENTS: Implantable cardioverter-defibrillator interrogations were collected after MRI. Clinical outcomes included arrhythmia detection and treatment, generator or lead exchanges, adverse events, and death. RESULTS: During a median follow-up of 2.2 years from MRI to latest available ICD interrogation before generator or lead exchange in 536 patients, 4177 arrhythmia episodes were detected, and 97 patients received ICD shocks. Sixty-one patients (10% of total) had 130 spontaneous ventricular tachycardia or fibrillation events terminated by ICD shocks. A total of 210 patients (33% of total) are known to have died (median, 1.7 years from MRI to death); 3 had cardiac arrhythmia deaths where shocks were indicated without direct evidence of device dysfunction. LIMITATIONS: Data were acquired at a single center and may not be generalizable to other clinical settings and MRI facilities. Implantable cardioverter-defibrillator interrogations were not available for a subset of patients; adjudication of cause of death relied solely on death certificate data in a subset. CONCLUSION: Non-MRI-conditional ICDs appropriately treated detected tachyarrhythmias after MRI. No serious adverse effects on device function were reported after MRI. PRIMARY FUNDING SOURCE: Johns Hopkins University and National Institutes of Health.

The Relationship between MRI Radiofrequency Energy and Function of Nonconditional Implanted Cardiac Devices: A Prospective Evaluation.

Background The risks associated with MRI in individuals who have implanted cardiac devices are thought to arise from the interaction between the implanted device and static, gradient, and radiofrequency magnetic fields. Purpose To determine the relationship between the peak whole-body averaged specific absorption rate (SAR) and change in magnetic field per unit time (dB/dt), maximum specific energy dose, imaging region, and implanted cardiac device characteristics and their function in patients undergoing MRI. Materials and Methods This prospective observational cohort study was conducted from October 16, 2003, to January 22, 2015 (https://ClinicalTrials.gov, NCT01130896). Any individual with an implanted cardiac device who was referred for MRI was included. Clinical MRI protocols without SAR restriction were used. Exclusion criteria were newly implanted leads, abandoned or epicardial leads, and dependence on a pacemaker with an implantable cardioverter defibrillator without asynchronous pacing capability. For each MRI pulse sequence, the calculated whole-body values for SAR, dB/dt, and scan duration were collected. Atrial and ventricular sensing, lead impedance, and capture threshold were evaluated before and immediately after (within 10 minutes) completion of each MRI examination. Generalized estimating equations with Gaussian family, identity link, and an exchangeable working correlation matrix were used for statistical analysis. Results A total of 2028 MRI examinations were performed in 1464 study participants with 2755 device leads (mean age, 67 years ± 15 [standard deviation]; 930 men [64%]). There was no evidence of an association between radiofrequency energy deposition, dB/dt, or scan duration and changes in device parameters. Thoracic MRI was associated with decreased battery voltage immediately after MRI (ß = -0.008 V, P < .001). Additionally, right ventricular (RV) lead length was associated with decreased RV sensing (ß = -0.012 mV, P = .05) and reduced RV capture threshold (ß = -0.002 V, P < .01) immediately after MRI. Conclusion There was no evidence of an association between MRI parameters that characterize patient exposure to radiofrequency energy and changes in device and lead parameters immediately after MRI. Nevertheless, device interrogation before and after MRI remains mandatory due to the potential for device reset and changes in lead or generator parameters. © RSNA, 2020 See also the editorial by Shellock in this issue.

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.

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 .).