MR Imaging in Patients with Cardiac Pacemakers and Implantable Cardioverter Defibrillators.

This joint consensus paper of the German Roentgen Society and the German Cardiac Society provides physical and electrophysiological background information and specific recommendations for the procedural management of patients with cardiac pacemakers (PM) and implantable cardioverter defibrillators (ICD) undergoing magnetic resonance (MR) imaging. The paper outlines the responsibilities of radiologists and cardiologists regarding patient education, indications, and monitoring with modification of MR sequences and PM/ICD reprogramming strategies being discussed in particular. The aim is to optimize patient safety and to improve legal clarity in order to facilitate the access of SM/ICD patients to MR imaging. Key Points: · Conventional PM and ICD systems are no longer an absolute but rather a relative contraindication for performing an MR examination. Procedural management includes the assessment of the individual risk/benefit ratio, comprehensive patient informed consent about specific risks and "off label" use, extensive PM/ICD-related and MR-related safety precautions to reduce these risks to the greatest extent possible, as well as adequate monitoring techniques.. · MR conditional pacemaker and ICD systems have been tested and approved for MR examination under specific conditions ("in-label" use). Precise understanding of and compliance with the terms of use for the specific pacemaker system are essential for patient safety.. · The risk for an ICD patient during MR examinations is to be considered significantly higher compared to PM patients due to the higher vulnerability of the structurally damaged myocardium and the higher risk of irreversible damage to conventional ICD systems. The indication for a MR examination of an ICD patient should therefore be determined on a stricter basis and the expected risk/benefit ratio should be critically reviewed.. · This complex subject requires close collaboration between radiology and cardiology.. Citation Format · Sommer T, Bauer W, Fischbach K et al. MR Imaging in Patients with Cardiac Pacemakers and Implantable Cardioverter Defibrillators. Fortschr Röntgenstr 2017; 189: 204 - 217.

Impact of magnetic resonance imaging on ventricular tachyarrhythmia sensing: Results of the Evera MRI Study.

BACKGROUND: Studies have shown that magnetic resonance imaging (MRI) conditional pacemakers experience no significant effect from MRI on device function, sensing, or pacing. More recently, similar safety outcomes were demonstrated with MRI conditional defibrillators (implantable cardioverter-defibrillator [ICD]), but the impact on ventricular arrhythmias has not been assessed. OBJECTIVE: The purpose of this study was to assess the effect of MRI on ICD sensing and treatment of ventricular tachyarrhythmias. METHODS: The Evera MRI Study was a worldwide trial of 156 patients implanted with an ICD designed to be MRI conditional. Device-detected spontaneous and induced ventricular tachycardia/ventricular fibrillation (VT/VF) episodes occurring before and after whole body MRI were evaluated by a blinded episode review committee. Detection delay was computed as the sum of RR intervals of undersensed beats. A ≥5-second delay in detection due to undersensing was prospectively defined as clinically significant. RESULTS: Post-MRI, there were 22 polymorphic VT/VF episodes in 21 patients, with 16 of these patients having 17 VT/VF episodes pre-MRI. Therapy was successful for all episodes, with no failures to treat or terminate arrhythmias. The mean detection delay due to undersensing pre- and post-MRI was 0.60 ± 0.59 and 0.33 ± 0.63 seconds, respectively (P = .17). The maximum detection delay was 2.19 seconds pre-MRI and 2.87 seconds post-MRI. Of the 17 pre-MRI episodes, 14 (82%) had some detection delay as compared with 11 of 22 (50%) post-MRI episodes (P = .03); no detection delay was clinically significant. CONCLUSION: Detection and treatment of VT/VF was excellent, with no detection delays or significant impact of MRI observed.

Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment.

BACKGROUND: Recently, magnetic resonance (MR)-conditional implantable cardioverter defibrillator (ICD) systems have become available. However, associated cardiac MR image (MRI) quality is unknown. The goal was to evaluate the image quality performance of various cardiac MR sequences in a multicenter trial of patients implanted with an MR-conditional ICD system. METHODS AND RESULTS: The Evera-MRI trial enrolled 275 patients in 42 centers worldwide. There were 263 patients implanted with an Evera-MRI single- or dual-chamber ICD and randomized to controls (n=88) and MRI (n=175), 156 of whom underwent a protocol-required MRI (9-12 weeks post implant). Steady-state-free-precession (SSFP) and fast-gradient-echo (FGE) sequences were acquired in short-axis and horizontal long-axis orientations. Qualitative and quantitative assessment of image quality was performed by using a 7-point scale (grades 1-3: good quality, grades 6-7: nondiagnostic) and measuring ICD- and lead-related artifact size. Good to moderate image quality (grades 1-5) was obtained in 53% and 74% of SSFP and FGE acquisitions, respectively, covering the left ventricle, and in 69% and 84%, respectively, covering the right ventricle. Odds for better image quality were greater for right ventricle versus left ventricle (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P<0.0001) and greater for FGE versus SSFP (odds ratio, 3.5; 95% confidence interval, 2.5-4.8; P<0.0001). Compared with SSFP, ICD-related artifacts on FGE were smaller (141±65 versus 75±57 mm, respectively; P<0.0001). Lead artifacts were much smaller than ICD artifacts (P<0.0001). CONCLUSIONS: FGE yields good to moderate quality in 74% of left ventricle and 84% of right ventricle acquisitions and performs better than SSFP in patients with an MRI-conditional ICD system. In these patients, cardiac MRI can offer diagnostic information in most cases. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02117414.

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

BACKGROUND: Magnetic resonance imaging (MRI) of patients with conventional implantable cardioverter-defibrillators (ICD) is contraindicated. OBJECTIVES: This 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. METHODS: Subjects 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. RESULTS: In 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. CONCLUSIONS: This 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).

Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.

BACKGROUND: Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system. OBJECTIVE: The purpose of this study was to use preclinical computer modeling, animal studies, and bench and scanner testing to demonstrate the safety of an ICD system developed for 1.5-T whole-body MRI. METHODS: MRI hazards were assessed and mitigated using multiple approaches: design decisions to increase safety and reliability, modeling and simulation to quantify clinical MRI exposure levels, animal studies to quantify the physiologic effects of MRI exposure, and bench testing to evaluate safety margin. RESULTS: Modeling estimated the incidence of a chronic change in pacing capture threshold >0.5 V and 1.0 V to be less than 1 in 160,000 and less than 1 in 1,000,000 cases, respectively. Modeling also estimated the incidence of unintended cardiac stimulation to occur in less than 1 in 1,000,000 cases. Animal studies demonstrated no delay in ventricular fibrillation detection and no reduction in ventricular fibrillation amplitude at clinical MRI exposure levels, even with multiple exposures. Bench and scanner testing demonstrated performance and safety against all other MRI-induced hazards. CONCLUSION: A preclinical strategy that includes comprehensive computer modeling, animal studies, and bench and scanner testing predicts that an ICD system developed for the magnetic resonance environment is safe and poses very low risks when exposed to 1.5-T normal operating mode whole-body MRI.

Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results.

BACKGROUND: The Advisa MRI system is designed to safely undergo magnetic resonance imaging (MRI). Its influence on image quality is not well known. OBJECTIVE: To evaluate cardiac magnetic resonance (CMR) image quality and to characterize myocardial contraction patterns by using the Advisa MRI system. METHODS: In this international trial with 35 participating centers, an Advisa MRI system was implanted in 263 patients. Of those, 177 were randomized to the MRI group and 150 underwent MRI scans at the 9-12-week visit. Left ventricular (LV) and right ventricular (RV) cine long-axis steady-state free precession MR images were graded for quality. Signal loss along the implantable pulse generator and leads was measured. The tagging CMR data quality was assessed as the percentage of trackable tagging points on complementary spatial modulation of magnetization acquisitions (n=16) and segmental circumferential fiber shortening was quantified. RESULTS: Of all cine long-axis steady-state free precession acquisitions, 95% of LV and 98% of RV acquisitions were of diagnostic quality, with 84% and 93%, respectively, being of good or excellent quality. Tagging points were trackable from systole into early diastole (360-648 ms after the R-wave) in all segments. During RV pacing, tagging demonstrated a dyssynchronous contraction pattern, which was not observed in nonpaced (n = 4) and right atrial-paced (n = 8) patients. CONCLUSIONS: In the Advisa MRI study, high-quality CMR images for the assessment of cardiac anatomy and function were obtained in most patients with an implantable pacing system. In addition, this study demonstrated the feasibility of acquiring tagging data to study the LV function during pacing.

Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla.

BACKGROUND: Magnetic 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. OBJECTIVE: To confirm the safety and effectiveness of a pacemaker system designed for safe whole body MRI without MRI scan positioning restrictions. METHODS: Primary 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. RESULTS: There 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. CONCLUSIONS: This 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.

Cardiomyopathies (hypertrophy and failure): what can offer cardiac magnetic resonance imaging?

In routine, cardiomyopathy, confirmed or not, is a frequent reason for cardiac MRI evaluation. Step by step, by using a wide panel of sequences, cardiac MRI is able to characterize cardiomyopathies by their morphologic and functional phenotype as well as by tissue characterization. Cardiac-MRI is also considered as the most appropriate technique for the follow-up of this disease. The purpose of this article is to browse an overview of the main MRI features of cardiomyopathy, focusing the purpose on hypertrophic forms and myocardial diseases leading to cardiac failure.

Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment.

BACKGROUND: Magnetic resonance imaging (MRI) of pacemaker patients is contraindicated due to documented potential risks to the patient from hazardous interactions between the MRI and pacemaker system. OBJECTIVE: The purpose of this prospective, randomized, controlled, worldwide clinical trial was to evaluate the safety and effectiveness of a pacemaker system designed for safe use in MRI for any bradycardia indicated patient. METHODS: Patients (n = 464) were randomized to undergo an MRI scan between 9 and 12 weeks postimplant (MRI group, n = 258) or not to undergo MRI (control group, n = 206) after successful implantation of the specially designed dual-chamber pacemaker and leads. Patients were monitored for arrhythmias, symptoms, and pacemaker system function during 14 nonclinically indicated relevant brain and lumbar MRI sequences. Sequences were performed at 1.5 T and included scans with high radiofrequency power deposition and/or high gradient dB/dt exposure. Clinical evaluation of the pacemaker system function occurred immediately before and after MRI, 1 week and 1 month post-MRI, and at corresponding times for the control group. Primary endpoints for safety analyzed the MRI procedure complication-free rate and for effectiveness compared capture and sensing performance between MRI and control groups. RESULTS: No MRI-related complications occurred during or after MRI, including sustained ventricular arrhythmias, pacemaker inhibition or output failures, electrical resets, or other pacemaker malfunctions. Pacing capture threshold and sensed electrogram amplitude changes were minimal and similar between study groups. CONCLUSION: This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function.

Low-field magnetic resonance imaging: increased safety for pacemaker patients?

AIMS: The number of low-field (<0.5 T) magnetic resonance (MR) scanners installed worldwide is increasing due to a favourable cost and safety profile and improved patient comfort using an open-scanner design. Therefore, the aim of our study was to evaluate a strategy for the safe performance of magnetic resonance imaging (MRI) at a field strength of 0.2 T, in pacemaker (PM) patients without limitations on scan region, PM dependency, or the presence of abandoned leads. METHODS AND RESULTS: One hundred and fourteen PM patients, including PM-dependent patients and patients with abandoned leads, examined at a 0.2 T MR scanner due to an urgent clinical need for an MRI examination, were evaluated. All PMs were reprogrammed before MRI: if heart rate was <60 bpm, the asynchronous mode (with a rate of 80 bpm) was programmed to avoid MR-induced inhibition; if heart rate was >60 bpm, sense-only mode (ODO/OVO/OAO) was used to avoid MR-induced competitive pacing and potential proarrhythmia. Patients were monitored with electrocardiogram (ECG) and pulse oximetry. All PMs were interrogated before and after MRI, including measurement of lead impedance, pacing capture threshold (PCT), and battery voltage. All MRI scans were completed safely. No induction of arrhythmias or inhibition of PM output occurred. There were no statistically significant changes in lead impedance, PCT, or battery voltage (P>0.05). CONCLUSION: Low-field MRI of PM patients, including high-risk PM patients and MRI scan regions, can be performed with an acceptable risk-benefit ratio under controlled conditions.

Incidence and predictors of silent cerebral embolism during pulmonary vein catheter ablation for atrial fibrillation.

AIMS: Left atrial catheter ablation of the pulmonary veins (PV) has evolved as an important therapeutic option for the treatment of atrial fibrillation (AF). We aimed to investigate the incidence and predictors of silent cerebral embolism associated with PV catheter ablation, detected by diffusion-weighted magnetic resonance imaging (DW-MRI). METHODS AND RESULTS: We performed a prospective analysis of 53 consecutive patients with persistent or paroxysmal AF that underwent PV ablation and post-procedural cerebral MRI 1 day after lasso catheter-guided ostial PV ablation. Patients were analysed for possible demographical, medical, echocardiographical, and procedural predictors of embolic events. A mean of 3.5 +/- 0.5 PVs were ablated per patient. In six patients, DW-MRI depicted new clinically silent microembolism after PV ablation (11%). The number of ineffective medical antiarrhythmic agents prior to ablation procedure was significantly higher in the embolism group (3.3 +/- 0.5 vs. 2.2 +/- 1.4, P = 0.014). Coronary heart disease (CAD) was more frequent in patients with cerebral embolisms (33 vs. 2%, P = 0.031); left ventricular volume (130 +/- 12 vs. 103 +/- 26 mL, P = 0.002), and septal wall thickness (13.0 +/- 1.4 vs. 7.9 +/- 4.8 mm, P = 0.025) were significantly increased. CONCLUSION: This study shows a high incidence of silent micro-embolic events after PV ablation. CAD, left ventricular dilatation, and hypertrophy were potential predictors of this complication.

Evaluation of cumulative effects of MR imaging on pacemaker systems at 1.5 Tesla.

BACKGROUND: The purpose of this study was to evaluate possible cumulative effects of repeated magnetic resonance imaging (MRI) examinations on pacemaker systems in patients with cardiac pacemakers. METHODS AND RESULTS: The records of pacemaker patients who underwent repetitive MRI examinations in our institution were reviewed to identify patients who underwent two or more MRI examinations at 1.5T of any anatomical region. Using these criteria, a total of 47 patients who underwent a total 171 MRI examinations were identified and included in this study. Institutional Review Board approval for all pacemaker investigations was obtained. Written informed consent was obtained from all patients. Pacemakers were interrogated immediately before and after MR imaging, and after 3 months, including measurement of pacing capture threshold (PCT), lead impedance (LI), and battery voltage (BV). PCT, LI, and BV were analyzed for changes dependant on the number of MRI exams performed. Mean changes over time and changes between first and last pacemaker interrogation of PCT, LI, and BV were calculated. A statistically significant (P < 0.05), but clinically irrelevant trend for decrease in PCT and BV was found. No significant or clinically relevant changes in LI were observed. CONCLUSION: In this first study, no clinically relevant, cumulative changes in PCT, LI, or BV could be detected in PM patients who underwent two or more MRI examinations. However, a careful benefit/risk evaluation, among other MRI- and pacemaker-related safety precautions, remains mandatory, as clinically relevant alterations to the PM system cannot be excluded by all means.

Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators.

OBJECTIVES: Our aim was to establish and evaluate a strategy for safe performance of magnetic resonance imaging (MRI) at 1.5-T in patients with implantable cardioverter-defibrillators (ICDs). BACKGROUND: Expanding indications for ICD placement and MRI becoming the imaging modality of choice for many indications has created a growing demand for MRI in ICD patients, which is still considered an absolute contraindication. METHODS: Non-pacemaker-dependent ICD patients with a clinical need for MRI were included in the study. To minimize radiofrequency-related lead heating, the specific absorption rate was limited to 2 W/kg. ICDs were reprogrammed pre-MRI to avoid competitive pacing and potential pro-arrhythmia: 1) the lower rate limit was programmed as low as reasonably achievable; and 2) arrhythmia detection was programmed on, but therapy delivery was programmed off. Patients were monitored using electrocardiography and pulse oximetry. All ICDs were interrogated before and after the MRI examination and after 3 months, including measurement of pacing capture threshold, lead impedance, battery voltage, and serum troponin I. RESULTS: Eighteen ICD patients underwent a total of 18 MRI examinations at 1.5-T; all examinations were completed safely. All ICDs could be interrogated and reprogrammed normally post-MRI. No significant changes of pacing capture threshold, lead impedance, and serum troponin I were observed. Battery voltage decreased significantly from pre- to post-MRI. In 2 MRI examinations, oversensing of radiofrequency noise as ventricular fibrillation occurred. However, no attempt at therapy delivery was made. CONCLUSIONS: MRI of non-pacemaker-dependent ICD patients can be performed with an acceptable risk/benefit ratio under controlled conditions by taking both MRI- and pacemaker-related precautions. (Implantable Cardioverter Defibrillators and Magnetic Resonance Imaging of the Heart at 1.5-Tesla; NCT00356239).

Combined myocardial stress perfusion imaging and myocardial stress tagging for detection of coronary artery disease at 3 Tesla.

BACKGROUND: Adenosine stress perfusion is very sensitive for detection of coronary artery disease (CAD), and yields good specificity. Standard adenosine cine imaging lacks high sensitivity, but is very specific. Myocardial tagging improves detection of wall motion abnormalities (WMAs). Perfusion and tagging cardiovascular magnetic resonance (CMR) both benefit from high field imaging (improved contrast to noise ratio and tag persistence). We investigated the diagnostic impact of a combined stress perfusion-tagging protocol for detection of CAD at 3 Tesla. METHODS: Stress perfusion and tagging images were acquired in 3 identical short axis locations (slice thickness 8 mm, FOV 320-380 mm, matrix 256(2)). A positive finding at coronary angiography was defined as stenosis or flow limiting restenosis > 50% in native and graft vessels. A true positive CMR - finding was defined as > or = 1 perfusion deficit or new WMA during adenosine-stress in angiographically corresponding regions. RESULTS: We included 60 patients (males: 41, females: 19; 21 suspected, 39 known CAD). Myocardial tagging extended stress imaging by 1.5-3 min and was well tolerated by all patients. Sensitivity and specificity for detection of significant CAD by adenosine stress perfusion were 0.93 and 0.84, respectively. The sensitivity of adenosine stress tagging was less (0.64), while the specificity was very high (1.0). The combination of both stress perfusion and stress tagging did not increase sensitivity. CONCLUSION: The combined adenosine stress perfusion-tagging protocol delivers high sensitivity and specificity for detection of significant CAD. While the sensitivity of adenosine stress tagging is poor compared to perfusion imaging, its specificity is very high. This technique should thus prove useful in cases of inconclusive perfusion studies to help avoid false positive results.

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 MRI(TM) SureScan(TM) and CapSureFix MRI(TM) 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.

Safety of brain 3-T MR imaging with transmit-receive head coil in patients with cardiac pacemakers: pilot prospective study with 51 examinations.

PURPOSE: To evaluate the safety and feasibility of 3-T magnetic resonance (MR) imaging of the brain in patients with implanted cardiac pacemakers (PMs) by using a transmit-receive head coil. MATERIALS AND METHODS: The study protocol was approved by the institutional review board. Signed informed consent was obtained from all subjects. In vitro testing at 3 T was performed with 32 PMs and 45 PM leads that were evaluated for force and torque (by using a floating platform) and radiofrequency (RF)-related heating by using a transmit-receive head coil (maximum specific absorption rate, 3.2 W/kg). Patient examinations at 3 T were performed in 44 patients with a cardiac PM and a strong clinical need; patients underwent a total of 51 MR examinations of the brain by using a transmit-receive head coil to minimize RF exposure of the PM system. An electrocardiograph and pulse oximetry were used for continuous monitoring during MR imaging. The technical and functional PM status was assessed prior to and immediately after MR imaging and at 3 months thereafter. Serum troponin I level was measured before and 12 hours after imaging to detect myocardial thermal injury. PM reprogramming was performed prior to MR imaging depending on the patient's intrinsic heart rate (< 60 beats per minute, asynchronous pacing; > or = 60 beats per minute, sense-only mode). RESULTS: For in vitro testing, the maximum translational force was 2150 mN (mean, 374.38 mN +/- 392.75 [standard deviation]), and maximum torque was 17.8 x 10(-3) N x m (mean, [2.29 +/- 4.08] x 10(-3) N x m). The maximum temperature increase was 2.98 degrees C (mean, 0.16 degrees C +/- 0.45). For patient examinations, all MR examinations (51 of 51) were completed safely. There were no significant (P < .05) changes in lead impedance, pacing capture threshold level, or serum troponin I level. CONCLUSION: MR imaging of the brain at 3 T in patients with a cardiac PM can be performed safely when dedicated safety precautions (including the use of a transmit-receive head coil) are taken.

Clinical, genetic, and cardiac magnetic resonance imaging findings in primary desminopathies.

We report the clinical, genetic and cardiac magnetic resonance imaging (MRI) findings in 11 German patients with heterozygous E245D, D339Y, R350P and L377P desmin mutations and without cardiac symptoms. Clinical evaluation revealed a marked variability of skeletal muscle, respiratory and cardiac involvement even between patients with identical mutations, ranging from asymptomatic to severely affected. While echocardiography did not show any pathological findings in all 11 patients, cine MRI revealed focal left ventricular hypertrophy in 2 patients and MR delayed enhancement imaging displayed intramyocardial fibrosis in the left ventricle in 4 patients indicating early myocardial involvement. Our data argue against distinct genotype-phenotype correlations and suggest that comprehensive cardiac MRI is superior to conventional echocardiography for the detection of early and clinically asymptomatic stages of cardiomyopathy in desminopathy patients. Therefore, cardiac MRI may serve as a screening tool to identify patients at risk, which might benefit from early pharmacological and/or interventional (e.g. implantable cardioverter-defibrillator devices) therapy.

Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices.

Magnetic resonance (MR) imaging has unparalleled soft-tissue imaging capabilities. The presence of devices such as pacemakers and implantable cardioverter-defibrillators (ICDs), however, was historically considered a contraindication to MR imaging. We summarize the potential hazards of the device-MR environment interaction, and present updated information regarding in vitro and in vivo experiments suggesting that certain pacemaker and ICD systems may indeed be MR-safe. Recent reports on several hundred patients with implantable pacemakers and ICDs who underwent MR scan safely indicate that, under certain conditions, individuals with these implanted systems may benefit from MR imaging. We believe that, on a case-by-case basis, the diagnostic benefit from MR imaging outweighs the presumed risks for some pacemaker and ICD patients. Thus for some patients, the risks presented by MR imaging under specific, characterized scanning and monitoring conditions may be acceptable given the diagnostic benefit of this powerful imaging modality. This may have major clinical implications on current imaging practice. A strategy for the performance of MR imaging in these individuals is proposed.

High-resolution myocardial stress perfusion at 3 T in patients with suspected coronary artery disease.

To implement a high-resolution first-pass myocardial perfusion imaging protocol (HRPI) at 3 T, and to evaluate the feasibility, image quality and accuracy of this approach prospectively in patients with suspected CAD. We hypothesized that utilizing the gain in SNR at 3 T to increase spatial resolution would reduce partial volume effects and subendocardial dark rim artifacts in comparison to 1.5 T. HRPI studies were performed on 60 patients using a segmented k-space gradient echo sequence (in plane resolution 1.97 x 1.94 mm(2)). Semiquantitative assessment of dark rim artifacts was performed for the stress studies on a slice-by-slice basis. Qualitative visual analysis was compared to quantitative coronary angiography (QCA) results; hemodynamically significant CAD was defined as stenosis >or=70% at QCA. Dark rim artifacts appeared in 108 of 180 slices (average extent 1.3 +/- 1.2 mm representing 11.8 +/- 10.8% of the transmural myocardial thickness). Sensitivity, specifity, and test accuracy for the detection of significant CAD were 89%,79%, and 85%. HRPI studies at 3 T are feasible in a clinical setting, providing good image quality and high accuracy for detection of significant CAD. The presence of dark rim artifacts does not appear to represent a diagnostic problem when using a HRPI approach.

Triggered replenishment imaging reduces variability of quantitative myocardial contrast echocardiography and allows assessment of myocardial blood flow reserve.

Assessment of replenishment kinetics (RK) following ultrasound-induced destruction of contrast microbubbles allows quantification of myocardial blood flow reserve (MBFR) applying the model f (t) = A (1 - e(-betat)), with parameter beta describing mean flow velocity and parameter A representing blood volume. However, few data on the variability and reproducibility of RK in a clinical setting are available. Therefore, we examined 30 patients in a rest-adenosine protocol in one center. Off-line quantification of real-time perfusion imaging (RTPI) and triggered replenishment imaging (TRI) was performed at two sites and compared with coronary angiography and flow reserve measurements. Parameter A was found to be robust in all investigated segments (coefficient of variation (CV) < 7.2%+/- 5.1). Variability was lowest for parameter beta using TRI in apical segments (CV 6.5%+/- 5.2, P < 0.01). Highest CV was found with RTPI in lateral segments (CV : 39.8%+/- 40.6). Concerning day-to-day reproducibility both methods revealed similar results within range of heterogeneity of myocardial blood flow. Both sites obtained significantly lower MBFR in patients with flow-limiting CAD, compared to subjects without (P < 0.01). Correlation of both sites showed close relationship (y = 0.88x + 0.45, r = 0.83, P < 0.0001), without systematic bias. TRI significantly reduces variability of RK in quantitative MCE. Assessment of MBFR allows investigator-independent evaluation of CAD.