Roger Luechinger

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.

A genetic variation of the noradrenergic system is related to differential amygdala activation during encoding of emotional memories

Emotionally arousing events are typically well remembered, but there is a large interindividual variability for this phenomenon. We have recently shown that a functional deletion variant of ADRA2B, the gene encoding the α2b-adrenergic receptor, is related to enhanced emotional memory in healthy humans and enhanced traumatic memory in war victims. Here, we investigated the neural mechanisms of this effect in healthy participants by using fMRI. Carriers of the ADRA2B deletion variant exhibited increased activation of the amygdala during encoding of photographs with negative emotional valence compared with noncarriers of the deletion. Additionally, functional connectivity between amygdala and insula was significantly stronger in deletion carriers. The present findings indicate that the ADRA2B deletion variant is related to increased responsivity and connectivity of brain regions implicated in emotional memory.

Force and Torque Effects of a 1.5‐Tesla MRI Scanner on Cardiac Pacemakers and ICDs

LUECHINGER, R., et al.: Force and Torque Effects of a 1.5‐Tesla MRI Scanner on Cardiac Pacemakers and ICDs. Magnetic resonance imaging (MRI) is a widely accepted tool for the diagnosis of a variety of disease states. However, the presence of an implanted pacemaker is considered to be a strict contraindication to MRI in a vast majority of centers due to safety concerns. In phantom studies, the authors investigated the force and torque effects of the static magnetic field of MRI on pacemakers and ICDs. Thirty‐one pacemakers (15 dual chamber and 16 single chamber units) from eight manufacturers and 13 ICDs from four manufacturers were exposed to the static magnetic field of a 1.5‐Tesla MRI scanner. Magnetic force and acceleration measurements were obtained quantitatively, and torque measurements were made qualitatively. For pacemakers, the measured magnetic force was in the range of 0.05–3.60 N. Pacemakers released after 1995 had low magnetic force values as compared to the older devices. For these devices, the measured acceleration was even lower than the gravity of the earth (< 9.81 N/kg). Likewise, the torque levels were significantly reduced in newer generation pacemakers (≤ 2 from a scale of 6). ICD devices, except for one recent model, showed higher force (1.03–5.85 N), acceleration 9.5–34.2 N/kg), and torque (5–6 out of 6) levels. In conclusion, modern pacemakers present no safety risk with respect to magnetic force and torque induced by the static magnetic field of a 1.5‐Tesla MRI scanner. However, ICD devices, despite considerable reduction in size and weight, may still pose problems due to strong magnetic force and torque.

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

BackgroundMagnetic 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™ SureScan™ and CapSureFix MRI™ 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.MethodsThe 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.ResultsResults will be communicated after approximately 156 and 470 patients have completed 4 months of follow-up.Trial RegistrationClinicalTrials.gov identifier: NCT00433654.

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?

LUECHINGER, R., 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? MRI is established as an important diagnostic tool in medicine. However, the presence of a cardiac pacemaker is usually regarded as a contraindication for MRI due to safety reasons. The aim of this study was to investigate the state of a pacemaker reed switch in different orientations and positions in the main magnetic field of 0.5‐, 1.5‐, and 3.0‐T MRI scanners. Reed switches used in current pacemakers and ICDs were tested in 0.5‐, 1.5‐, and 3.0‐T MRI scanners. The closure of isolated reed switches was evaluated for different orientations and positions relative to the main magnetic field. The field strengths to close and open the reed switch and the orientation dependency of the closed state inside the main magnetic field were investigated. The measurements were repeated using two intact pacemakers to evaluate the potential influence of the other magnetic components, like the battery. If the reed switches were oriented parallel to the magnetic fields, they closed at 1.0 ± 0.2 mT and opened at 0.7 ± 0.2 mT. Two different reed switch behaviors were observed at different magnetic field strengths. In low magnetic fields (< 50 mT), the reed switches were closed. However, in high magnetic fields (> 200 mT), the reed switches opened in 50% of all tested orientations. No difference between the three scanners could be demonstrated. The reed switches showed the same behavior whether they were isolated or an integral part of the pacemakers. The reed switch in a pacemaker or an ICD does not necessarily remain closed in strong magnetic fields at 0.5, 1.5, or 3.0 T and the state of the reed switch may not be predictable with certainty in clinical situations.

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 patients 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.

Safety, feasibility, and diagnostic value of cardiac magnetic resonance imaging in patients with cardiac pacemakers and implantable cardioverters/ defibrillators at 1.5 T

BACKGROUND Recent studies suggest that magnetic resonance (MR) imaging of the brain and spine may safely be performed in patients with pacemakers (PMs) and implantable cardioverter/defibrillators (ICDs), when taking adequate precautions. The aim of this study was to investigate safety, feasibility, and diagnostic value (DV) of MR imaging in cardiac applications (cardiac MR [CMR]) in patients with PMs and ICDs for the first time. METHODS Thirty-two PM/ICD patients with a clinical need for CMR were examined. The specific absorption rate was limited to 1.5 W/kg. Devices were reprogrammed pre-CMR to minimize interference with the electromagnetic fields. Devices were interrogated pre-CMR and post-CMR and after 3 months. Troponin I levels were measured pre-CMR and post-CMR; image quality (IQ) and DV of CMR were assessed. RESULTS All devices could be reprogrammed normally post-CMR. No significant changes of pacing capture threshold, lead impedance, and troponin I were observed. Image quality in patients with right-sided devices (RSD) was better compared with that in patients with left-sided devices (LSD) (P < .05), and less myocardial segments were affected by device-related artefacts (P < .05). Diagnostic value was rated as sufficiently high, allowing for diagnosis, or better in 12 (100%) of 12 patients with RSD, and only in 7 (35%) of 20 patients with LSD. CONCLUSIONS Cardiac MR may be performed safely when limiting specific absorption rate, appropriately monitoring patients, and following device reprogramming. Cardiac MR delivers good IQ and DV in patients with RSD. Cardiac MR in patients with RSD may therefore be performed with an acceptable risk/benefit ratio, whereas the risk/benefit ratio is rather unfavorable in patients with LSD.

Sensitivity-encoded (SENSE) echo planar fMRI at 3T in the medial temporal lobe

Parallel imaging techniques are useful for fMRI studies in light of the increasing susceptibility effects at high magnetic field strength. Yet, spatially varying noise amplification constitutes a challenge for the application of these techniques. The medial temporal lobe is particularly vulnerable to susceptibility effect with increasingly strong signal reduction. We present two fMRI studies comparing SENSE single-shot (ssh) echo planar imaging (EPI) at acceleration factors of 2.0, 2.4, 2.7, and 3.0 with conventional sshEPI at TE of 22 and 35 ms. Data were acquired during a learning task which activates the medial temporal lobe bilaterally. Susceptibility related image distortion was markedly reduced with increasing SENSE acceleration. Moreover, in the group results, statistical power increased in the whole brain with SENSE compared to conventional imaging and with a TE of 35 ms compared to 22 ms. Higher SENSE acceleration factors further improved image quality and increased statistical power in the occipital lobe and fusiform gyrus, but not in the medial temporal lobe. We therefore conclude that an sshEPI acquisition protocol with a moderate SENSE acceleration factor of R = 2.0 and TE 35 ms is suitable for the detection of medial temporal activation at 3T.

The desire for healthy limb amputation: structural brain correlates and clinical features of xenomelia

Xenomelia is the oppressive feeling that one or more limbs of ones body do not belong to ones self. We present the results of a thorough examination of the characteristics of the disorder in 15 males with a strong desire for amputation of one or both legs. The feeling of estrangement had been present since early childhood and was limited to a precisely demarcated part of the leg in all individuals. Neurological status examination and neuropsychological testing were normal in all participants, and psychiatric evaluation ruled out the presence of a psychotic disorder. In 13 individuals and in 13 pair-matched control participants, magnetic resonance imaging was performed, and surface-based morphometry revealed significant group differences in cortical architecture. In the right hemisphere, participants with xenomelia showed reduced cortical thickness in the superior parietal lobule and reduced cortical surface area in the primary and secondary somatosensory cortices, in the inferior parietal lobule, as well as in the anterior insular cortex. A cluster of increased thickness was located in the central sulcus. In the left hemisphere, affected individuals evinced a larger cortical surface area in the inferior parietal lobule and secondary somatosensory cortex. Although of modest size, these structural correlates of xenomelia appear meaningful when discussed against the background of some key clinical features of the disorder. Thus, the predominantly right-sided cortical abnormalities are in line with a strong bias for left-sided limbs as the target of the amputation desire, evident both in our sample and in previously described populations with xenomelia. We also propose that the higher incidence of lower compared with upper limbs (∼80% according to previous investigations) may explain the erotic connotations typically associated with xenomelia, also in the present sample. These may have their roots in the proximity of primary somatosensory cortex for leg representation, whose surface area was reduced in the participants with xenomelia, with that of the genitals. Alternatively, the spatial adjacency of secondary somatosensory cortex for leg representation and the anterior insula, the latter known to mediate sexual arousal beyond that induced by direct tactile stimulation of the genital area, might play a role. Although the right hemisphere regions of significant neuroarchitectural correlates of xenomelia are part of a network reportedly subserving body ownership, it remains unclear whether the structural alterations are the cause or rather the consequence of the long-standing and pervasive mismatch between body and self.

Noninvasive MRI assessment of intracranial compliance in idiopathic normal pressure hydrocephalus

To assess the state and dynamics of the intracranial system in idiopathic normal‐pressure hydrocephalus (I‐NPH), we determined intracranial compliance using magnetic resonance imaging (MRI).