Search

Aims Persistent reluctance to perform magnetic resonance imaging (MRI) in patients with abandoned and/or epicardial leads of cardiac implantable electronic devices is related to in vitro studies reporting tip heating. While there is a plethora of data on the safety of MRI in conditional and non-conditional implantable devices, there is a clear lack of safety data in patients with abandoned and/or epicardial leads. Methods and results Relevant literature was identified in Medline and CINAHL using the key terms 'magnetic resonance imaging' AND 'abandoned leads' OR 'epicardial leads'. Secondary literature and cross-references were supplemented. For reporting guidance, the Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 was used. International Prospective Register of Systematic Reviews (PROSPERO) registration number 465530. Twenty-one publications with a total of 656 patients with 854 abandoned and/or epicardial leads and 929 MRI scans of different anatomical regions were included. No scan-related major adverse cardiac event was documented, although the possibility of under-reporting of critical events in the literature should be considered. Furthermore, no severe device dysfunction or severe arrhythmia was reported. Mainly transient lead parameter changes were observed in 2.8% in the subgroup of patients with functional epicardial leads. As a possible correlate of myocardial affection, subjective sensations occurred mainly in the subgroup with abandoned epicardial leads (4.0%), but no change in myocardial biomarkers was observed. Conclusion Existing publications did not report any relevant adverse events for MRI in patients with abandoned and/or epicardial leads if performed according to strict safety guidelines. However, a more rigorous risk–benefit calculation should be made for patients with epicardial leads. [ABSTRACT FROM AUTHOR]

The application of cardiac magnetic resonance (CMR) imaging in clinical practice has grown due to technological advancements and expanded clinical indications, highlighting its superior capabilities when compared to echocardiography for the assessment of myocardial tissue. Similarly, the utilization of implantable cardiac electronic devices (CIEDs) has significantly increased in cardiac arrhythmia management, and the requirements of CMR examinations in patients with CIEDs has become more common. However, this type of exam often presents challenges due to safety concerns and image artifacts. Until a few years ago, the presence of CIED was considered an absolute contraindication to CMR. To address these challenges, various technical improvements in CIED technology, like the reduction of the ferromagnetic components, and in CMR examinations, such as the introduction of new sequences, have been developed. Moreover, a rigorous protocol involving multidisciplinary collaboration is recommended for safe CMR examinations in patients with CIEDs, emphasizing risk assessment, careful monitoring during CMR, and post-scan device evaluation. Alternative methods to CMR, such as computed tomography coronary angiography with tissue characterization techniques like dual-energy and photon-counting, offer alternative potential solutions, although their diagnostic accuracy and availability do limit their use. Despite technological advancements, close collaboration and specialized staff training remain crucial for obtaining safe diagnostic CMR images in patients with CIEDs, thus justifying the presence of specialized centers that are equipped to handle these type of exams. [ABSTRACT FROM AUTHOR]

Copyright of Die Gynäkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: After epicardial cardiac implantable electronic devices are implanted in pediatric patients, they become ineligible to receive MRI exams due to an elevated risk of RF heating. We investigated whether simple modifications in the trajectories of epicardial leads could substantially and reliably reduce RF heating during MRI at 1.5 T, with benefits extending to abandoned leads. Methods: Electromagnetic simulations were performed to assess RF heating of two common 35‐cm epicardial lead trajectories exhibiting different degrees of coupling with MRI incident electric fields. Experiments in anthropomorphic phantoms implanted with commercial cardiac implantable electronic devices confirmed the findings. Both electromagnetic simulations and experimental measurements were performed using head‐first and feet‐first positioning and various landmarks. Transfer function approach was used to assess the performance of suggested modifications in realistic body models. Results: Simulations (head‐first, chest landmark) of a 35‐cm epicardial lead with a trajectory where the excess length of the lead was looped and placed on the inferior surface of the heart showed an 87‐fold reduction in the 0.1 g–averaged specific absorption rate compared with the lead where the excess length was looped on the anterior surface. Repeated experiments with a commercial epicardial device confirmed this. For fully implanted systems following low–specific absorption rate trajectories, there was a 16‐fold reduction in the average temperature rise and a 28‐fold reduction for abandoned leads. The transfer function method predicted a 7‐fold reduction in the RF heating in 336 realistic scenarios. Conclusion: Surgical modification of epicardial lead trajectory can substantially reduce RF heating at 1.5 T, with benefits extending to abandoned leads. [ABSTRACT FROM AUTHOR]

This study focused on the potential risks of radiofrequency-induced heating of cardiac implantable electronic devices (CIEDs) in children and adults with epicardial and endocardial leads of varying lengths during cardiothoracic MRI scans. Infants and young children are the primary recipients of epicardial CIEDs, though the devices have not been approved as MR conditional by the FDA due to limited data, leading to pediatric hospitals either refusing the MRI service to most pediatric CIED patients or adopting a scan-all strategy based on results from adult studies. The study argues that risk–benefit decisions should be made on an individual basis. We used 120 clinically relevant epicardial and endocardial device configurations in adult and pediatric anthropomorphic phantoms to determine the temperature rise during RF exposure at 1.5 T. The results showed that there was significantly higher RF heating of epicardial leads than endocardial leads in the pediatric phantom, but not in the adult phantom. Additionally, body size and lead length significantly affected RF heating, with RF heating up to 12 °C observed in models based on younger children with short epicardial leads. The study provides evidence-based knowledge on RF-induced heating of CIEDs and highlights the importance of making individual risk–benefit decisions when assessing the potential risks of MRI scans in pediatric CIED patients. [ABSTRACT FROM AUTHOR]

Aims To describe safety and feasibility of magnetic resonance imaging (MRI) in patients with transvenous temporary external pacemakers and whether artefacts affect the diagnostic image quality during cardiac MRI. Methods and results We reviewed records of all patients treated with temporary external pacing between 2016 and 2020 at a tertiary centre. Temporary pacing was established using a transvenous standard active fixation pacing lead inserted percutaneously and connected to a MRI-conditional pacemaker taped to the skin. All patients undergoing cardiac or non-cardiac MRI during temporary transvenous pacing were identified. Before MRI, devices were programmed according to guidelines for permanent pacemakers, and patients were monitored with continuous electrocardiogram during MRI. Of 827 consecutive patients receiving a temporary external pacemaker, a total of 44 (5%) patients underwent MRI (mean age 71 years, 13 [30%] females). Cardiac MRI was performed in 22 (50%) patients, while MRI of cerebrum, spine, and other regions was performed in the remaining patients. Median time from implantation of the temporary device to MRI was 6 (3–11) days. During MRI, we observed no device-related malfunction or arrhythmia. Nor did we detect any change in lead sensing, impedance, or pacing threshold. We observed no artefacts from the lead or pacemaker compromising the diagnostic image quality of cardiac MRI. MRI provided information to guide the clinical management in all cases. Conclusion MRI is feasible and safe in patients with temporary external pacing established with a regular MRI-conditional pacemaker and a standard active fixation lead. No artefacts compromised the diagnostic image quality. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety of MRI in patients with fragmented retained leads (FRLs) through numerical simulation and phantom experiments. Methods: Electromagnetic and thermal simulations were performed to determine the worst‐case RF heating of 10 patient‐derived FRL models during MRI at 1.5 T and 3 T and at imaging landmarks corresponding to head, chest, and abdomen. RF heating measurements were performed in phantoms implanted with reconstructed FRL models that produced highest heating in numerical simulations. The potential for unintended tissue stimulation was assessed through a conservative estimation of the electric field induced in the tissue due to gradient‐induced voltages developed along the length of FRLs. Results: In simulations under conservative approach, RF exposure at B1+ ≤ 2 µT generated cumulative equivalent minutes (CEM)43 < 40 at all imaging landmarks at both 1.5 T and 3 T, indicating no thermal damage for acquisition times (TAs) < 10 min. In experiments, the maximum temperature rise when FRLs were positioned at the location of maximum electric field exposure was measured to be 2.4°C at 3 T and 2.1°C at 1.5 T. Electric fields induced in the tissue due to gradient‐induced voltages remained below the threshold for cardiac tissue stimulation in all cases. Conclusions: Simulation and experimental results indicate that patients with FRLs can be scanned safely at both 1.5 T and 3 T with most clinical pulse sequences. [ABSTRACT FROM AUTHOR]

Summary: Background: Many patients with cardiac implantable electronic devices (CIED) undergo magnetic resonance imaging (MRI); however, a relevant proportion have a CIED system that has not been classified as MRI-conditional because of generators and leads from different brands (mixed-brand group). The available data concerning the outcome of these mixed patients undergoing MRI is limited. Methods: A retrospective single center study, including all patients with CIEDs undergoing MRI between January 2013 until May 2020, was performed. Primary endpoints were defined as death or any adverse event necessitating hospitalization or CIED revision. Secondary endpoints were the occurrence of any sign for beginning device or lead failure or patient discomfort during MRI. Results: A total of 227 MRI examinations, including 10 thoracic MRIs, were carried out in 158 patients, with 1–9 MRIs per patient. Of the patients 38 underwent 54 procedures in the mixed-brand group and 89 patients underwent 134 MRIs in the MRI-conditional group. Of the patients 31 were excluded since the MRI conditionality could not be determined. No primary endpoints occurred within the mixed-brand group but in 2.2% of the MRI-conditional group (p = 1.000), with 2 patients developing new atrial fibrillation during MRI, of whom one additionally had a transient CIED dysfunction. No secondary endpoints were met in the mixed-brand group compared to 3.4% in the MRI-conditional group (p = 0.554). No complications occurred in the excluded patients. Conclusion: The complication rate of CIED patients undergoing MRI was low. Patients with a mixed CIED system showed no signs of increased risk of adverse events compared to patients with MRI-conditional CIED systems. [ABSTRACT FROM AUTHOR]

Copyright of Der Kardiologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

As access to MRI in pediatrics increases, the radiologist needs to become acquainted with the basic principles of MRI safety. As part of the image acquisition, the static magnetic field, gradient system, and the radiofrequency transmit-receive coil interact with medical and non-medical implants and can result in serious injury. The main stage of risk triage is based on the determination of whether the implant is MRI-safe, conditional, unsafe or unknown. Guiding principles include the strict adherence to manufacturer specifications for MRI-conditional implants and the assumption that an unknown implant is MR-unsafe. In this article we review considerations for common medical implants encountered in pediatrics including ventriculoperitoneal shunts, orthopedic hardware, orthodontic hardware, pacemakers, vascular stents, vagal nerve stimulators and cochlear implants. Finally, we review a set of high-yield considerations, including the non-communicative patient (sedated or non-verbal), susceptibility artifacts from unclear source, and the approach to an unknown implant. [ABSTRACT FROM AUTHOR]

Magnetic resonance imaging (MRI) has become a commonly used non‐ionizing radiation dependent imaging modality which has an excellent spatial resolution with the capability to provide physiological information. Cardiac implantable electronic devices (CIEDs) are used in modern cardiology with a frequency of 1:50 over 75 years of age and nearly one in three people in this population required MRI during their lifetime. Changes in the CIED structure, electronics, and algorithms paired with changes in the protocol design of MRI have created a relatively safe environment for performing MRI in patients with CIED. Despite their documentation in literature and a guideline document from a professional society, significant skepticism exists in doing MRI in patients with CIEDs. We intend to give an overview of interactions between MRI and CIEDs, including the evidence available in this regard and conclude with the suggestion of a protocol for safely carrying out an MRI in patients with CIEDs. [ABSTRACT FROM AUTHOR]

Purpose: In this work a simulation study is performed to gain insights in the patterns of induced radiofrequency (RF) currents for various implant‐like structures at 1.5 T. The previously introduced transfer matrix (TM) is used to determine why certain current patterns have a tendency to naturally occur. This can benefit current safety assessment techniques and may enable the identification of critical exposure conditions. Theory and Methods: The induced current on an elongated implant can be determined by multiplication of the incident electric field along the implant with its TM. The eigenmode spectrum of the TMs for various lengths and various types of implants are determined. The eigenvector with the highest eigenvalue describes the incident electric field pattern that induces the highest current which in turn will lead to highest heating. Subsequently, a statistical probability analysis is performed using a wide range of potential incident electric field distributions in a representative human subject model during a 1.5 T MR exam which are determined by means of electromagnetic FDTD simulations. These incident electric field distributions and the resulting induced current patterns are projected onto eigenvectors of the TM to determine which eigenmodes of the implant dominate the current patterns. Results: The eigenvectors of the TM of bare and insulated wires resemble sinusoidal harmonics of a string fixed at both ends similar to the natural‐current distribution on thin antennas(1). The currents on implants shorter than 20 cm are generally dominated by the first harmonic (similar to half a sine wave). This is firstly because for these implant lengths (relative to the RF wavelength), the first eigenvalue is more than three times bigger than the second showing the ability of an implant to accommodate one eigenmode better than another. Secondly, the incident electric fields have a high likelihood (≳95,7%) to project predominantly on this first eigenmode. Conclusion: The eigenmode spectrum of the TM of an implant provides insight into the expected shape of induced current distributions and worst‐case exposure conditions. For short implants, the first eigenvector is dominant. In addition, realistic incident electric field distributions project more heavily on this eigenvector. Both effects together cause significant currents to always resemble the dominant eigenmode of the TM for short implants at 1.5 T. [ABSTRACT FROM AUTHOR]

Aim: To examine the clinical and histopathological consequences of MRI in sheep implanted with non-MRI-conditional cardiac pacemakers. Materials and methods: Under general anesthesia, active fixation leads of two dual-chamber, non-MRI-conditional cardiac pacemakers (St. Jude Medical and Medtronic) were implanted either at the right ventricular apex or at the right atrium of two male sheep and connected to the V and A channels of the pacemakers, respectively. The generators were placed in cervical subcutaneous pockets. On day 5, both sheep underwent 1.5 T cervical and chest MRI with continuous electrocardiogram monitoring. Obtained sequences were T1-weighted (T1W), T2-weighted (T2W), T2-gradient echo and diffusion weighted (DW). The employed modes were OVO, VOO and VVI for one sheep and OAO, AOO and AAI for the other (unipolar and bipolar configuration of pacing and sensing for both). Battery impedance, pacing lead impedance, intrinsic amplitude and capture thresholds were checked at baseline and after each sequence, as well as 48 h after imaging. Histopathological examination of the cardiac tissue around the lead tip was performed 4 weeks post-imaging. Results: No significant changes in device position or configuration were observed during or after MRI. Clinical outcome was uneventful in both sheep. Minor inflammatory and necrotic changes were reported after histopathological examination of the cardiac tissue around the lead tip. Conclusion: 1.5 T MRI of two implanted non-MRI-conditional pacemakers was found safe in terms of device configuration and stability, clinical outcome and cardiac tissue histopathological findings. [ABSTRACT FROM AUTHOR]

The use of magnetic resonance imaging (MRI) is increasing globally, and MRI safety issues regarding medical devices, which are constantly being developed or upgraded, represent an ongoing challenge for MRI personnel. To assist the MRI community, a panel of 10 radiologists with expertise in MRI safety from nine high-volume academic centers formed, with the objective of providing clarity on some of the MRI safety issues for the 10 most frequently questioned devices. Ten device categories were identified. The panel reviewed the literature, including key MRI safety issues regarding screening and adverse event reports, in addition to the manufacturer's Instructions For Use. Using a Delphi-inspired method, 36 practical recommendations were generated with 100% consensus that can aid the clinical MRI community. Level of Evidence: 5 Technical Efficacy Stage: 5 J. Magn. Reson. Imaging 2020;51:657-674. [ABSTRACT FROM AUTHOR]

Aims: Cardiovascular magnetic resonance (CMR) imaging has long been a contraindication for patients with a cardiac implantable electronic device (CIED). Recent studies support the feasibility and safety for non-thoracic magnetic resonance imaging, but data for CMR are sparse. The aim of the current study was to determine the safety in patients with magnetic resonance (MR)-conditional or non-MR-conditional CIED and to develop a best practice approach.Methods and Results: All patients with a CIED undergoing CMR imaging (1.5 T) between April 2014 and April 2017 were included in the study. Devices were programmed according to the standardized protocol directly before and after the CMR examination. Follow-up interrogation was performed 6 months after CMR examination. Results were compared with a large, reference cohort of CIED patients not undergoing any MR examination. A total of 200 consecutive patients with a CIED (non-MR-conditional, n = 103) were included in the study. Directly after CMR imaging, one device failure (0.5%, battery status = end of service) was noted necessitating premature generator replacement. In three patients (2%) of pacemaker/implantable cardioverter-defibrillator (ICD) carriers a sustained ventricular tachycardia (VT) occurred during CMR imaging. Ten ICD showed a decrease in battery capacity immediately after CMR. Overall, the reference cohort showed comparable changes of CIED function during follow-up.Conclusion: With adherence to a standardized protocol and established exclusion criteria CMR imaging could safely be performed in patients with a CIED. The potential risks of device malfunction necessitate the presence of a device trained individual during the entire CMR examination. If there is a history of VT storm the attendance of an experienced cardiologist, should be mandatory. [ABSTRACT FROM AUTHOR]

Copyright of Der Kardiologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: To evaluate the local specific absorption rate (SAR) and heating around retained cardiac leads during MRI at 64 MHz (1.5T) and 127 MHz (3T) as a function of RF coil type and imaging landmark. Methods: Numerical models of retained cardiac leads were built from CT and X‐ray images of 6 patients with retained cardiac leads. Electromagnetic simulations and bio‐heat modeling were performed with MRI RF body and head coils tuned to 64 MHz and 127 MHz and positioned at 9 different imaging landmarks covering an area from the head to the lower limbs. Results: For all patients and at both 1.5T and 3T, local transmit head coils produced negligible temperature rise (ΔT<0.1°C) for ‖‖B1+‖‖≤3 μT. For body imaging with quadrature‐driven coils at 1.5T, ΔT during a 10‐min scan remained < 3°C at all imaging landmarks for ‖‖B1+‖‖≤3 μT and <6°C for ‖‖B1+‖‖≤4 μT. For body imaging at 3T, ΔT during a 10‐min scan remained < 6°C at all imaging landmarks for ‖‖B1+‖‖≤2 μT. For shorter pulse sequences up to 2 min, ΔT remained < 6°C for ‖‖B1+‖‖≤3 μT. Conclusion: For the models based on 6 patients studied, simulations suggest that MRI could be performed safely using a local head coil at both 1.5T and 3T, and with a body coil at 1.5T with pulses that produced ‖‖B1+‖‖≤4 μT. MRI at 3T could be performed safely in these patients using pulses with ‖‖B1+‖‖≤2 μT. [ABSTRACT FROM AUTHOR]

Copyright of Herz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Cardiac implanted electronic devices (CIEDs) have historically been regarded as a contraindication for performing magnetic resonance imaging (MRI), limiting the availability of this exam for large numbers of patients who may have otherwise benefited from the unique diagnostic capabilities of MRI. Interactions between CIEDs and the magnetic field associated with MRI systems have been documented, and include potential effects on CIED function, lead heating, and force/torque on the generator. Several device manufacturers have developed "MR-Conditional" CIEDs with specific hardware and software design changes to optimize the device for the MR environment. However, a substantial body of evidence has been accumulating that suggests that MRI may be safely performed in patients with either conditional or nonconditional CIEDs. Institutional policies and procedures, including preexam screening and assessment by skilled electrophysiology personnel and intraexam monitoring, allow MRI to be safely performed in CIED patients, as evidenced by at least two, large multicenter prospective studies and multiple smaller, single-institution studies. Cross-departmental collaboration and a robust safety infrastructure at sites that perform MRI should allow for the safe imaging of CIED patients who have a clinical indication for the study, regardless of the conditionality status of the device.Level Of Evidence: 5 Technical Efficacy: Stage 5 J. Magn. Reson. Imaging 2018;47:595-603. [ABSTRACT FROM AUTHOR]

Driving behaviors play an important role in accident involvement. Concretely speaking, aberrant driving behaviors would cause more accidents, and oppositely positive driving behaviors would promote to build safety traffic environment. The main goals of this study were to explore the positive driving behavior and its relationship with personality in a Chinese sample. A total of 421 licensed drivers (286 male and 135 female) from Beijing, China completed the Positive Driver Behavior Scale (PDBS), the Driver Behavior Questionnaire (DBQ), the Dula Dangerous Driving Index (DDDI) and the Big Five Inventory (BFI) on a voluntary and anonymous basis. The results showed that the Chinese version of the PDBS has both reliability and validity and that the PDBS was significantly correlated with the BFI. Specifically, the PDBS was negatively correlated with neuroticism (r = -0.38) and positively correlated with extraversion, agreeableness, conscientiousness and openness to experience (the correlation coefficient ranged from 0.36 to 0.55). In contrast with previous research, age was negatively correlated with the PDBS (r = -0.38) in our sample, which may have resulted from less driving experience or a lack of available cognitive resources. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses various reports within the issue on topics including growing confidence regarding safety of magnetic resonance imaging (MRI); and growing use of non-MRI-conditional devices.

Aims: Increasing need for magnetic resonance imaging (MRI) has driven the development of MR-conditional cardiac implantable electronic devices (CIEDs; pacemakers and defibrillators); however, patients still report difficulties obtaining scans. We sought to establish current provision for MRI scanning of patients with CIEDs in England.Methods and Results: A survey was distributed to all hospitals in England with MRI, to assess current practice. Information requested included whether hospitals currently offer MRI to this patient group, the number and type of scans acquired, local safety considerations, complications experienced and perceived obstacles to service provision in those departments not currently offering it. Responses were received from 195 of 227 (86%) of hospitals surveyed. Although 98% of departments were aware of MR-conditional devices, only 46% (n = 89) currently offer MRI scans to patients with CIED's; of these, 85% of departments perform ≤10 scans per year. No major complications were reported from MRI scanning in patients with MR-conditional devices. Current barriers to service expansion include perceived concerns regarding potential risk, lack of training, logistical difficulties, and lack of cardiology support.Conclusion: Provision of MRI for patients with CIEDs is currently poor, despite increasing numbers of patients with MR-conditional devices and extremely low reported complication rates. [ABSTRACT FROM AUTHOR]

The transmit-receive (Tx/Rx) birdcage head coil is often used for excitation instead of the body coil because of the presumably lower risk of heating in and around conductive implants. However, this common practice has not been systematically tested. To investigate whether the Tx/Rx birdcage head coil produces less heating than the body coil when scanning individuals with implants, we used a 3T clinical scanner and made temperature measurements around a straight 15 cm conductor using either the Tx/Rx body or the head coil for excitation. Additionally, the transmitted fields of a Tx/Rx head coil were measured both in air and in gel using a resonant and a non-resonant B field probes as well as a non-resonant E field probe. Simulations using a finite-difference time domain solver were compared with the experimental findings. When the body coil was used for excitation, we observed heating around the 15 cm wire at various anatomical locations (both within and outside of the active volume of the head coil). Outside its active area, no such heating was observed while using the Tx/Rx head coil for excitation. The E and B fields of the Tx/Rx birdcage head coil extended well-beyond the physical dimensions of the coil. In air, the fields were monotonically decreasing, while in gel they were more complex with local maxima at the end of the ASTM phantom. These experimental findings were line with the simulations. While caution must always be exercised when scanning individuals with metallic implants, these findings support the use of the Tx/Rx birdcage head coil in place of the body coil at 3T in order to reduce the risk of heating in and around conductive implants that are remote from the head coil. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to evaluate the safety and efficacy of the Lumax 740(®) Implantable Cardioverter Defibrillator (ICD) system in patients undergoing a defined 1.5 Tesla (T) MRI.Materials and Methods: Between November 2013 and April 2014, eighteen patients (age range, 41-78 years; mean age, 64 years) implanted with a Lumax 740(®) ICD system for at least 6 weeks before an MRI were enrolled into this single-center feasibility study. The local ethics committee approved the study before patients gave written informed consent. Patients underwent defined MRI 1.5T of the brain and lower lumbar spine with three safety follow-up evaluations obtained during the 3-month study period. Data were analyzed descriptively. Study endpoints were the absence of either MRI and pacing system related serious adverse device effects (SADE), or of a ventricular pacing threshold increase >0.5V, or of an R-wave amplitude attenuation < 50%, or of an R-wave amplitude < 5.0 mV at 1-month follow-up. The assessment of safety and efficacy was supported by recording of all adverse events, changes in pacing threshold, R-wave sensing, pacing impedances and in battery status.Results: Sixteen patients completed the MRI and the follow-up period. As no SADE occurred, the SADE free rate was 100%. Freedom from ventricular pacing threshold increase was 100% (16/16; 95%CI: 82.9%; 100.0%). There were no significant differences between baseline and follow-up measurements of sensing amplitudes (-0.58 ± 2.07 mV, P = 0.239, -0.41 ± 1.04 mV, P = 0.133, and -0.25 ± 1.36 mV, P = 0.724, for immediately after, 1 month and 3 months after MRI scan, respectively) and pacing thresholds (-0.047 ± 0.18 V, P = 0.317, -0.019 ± 0.11 V, P = 0.490, and 0.075 ± 0.19 V, P = 0.070, for immediately after, 1 month and 3 months after MRI scan, respectively). Lead impedances after the MRI scan were significantly lower as compared with baseline values (-22.8 ± 21.69 Ω, P = 0.001, -21.62 ± 39.71 Ω, P = 0.040, and -33.68 ± 57.73 Ω, P = 0.018, for immediately after, 1 month and 3 months after MRI scan, respectively).Conclusion: MRI scans in patients with MRI conditional ICD system (Lumax 740(®) ) are feasible and can be performed safely under defined conditions in a hospital setting. [ABSTRACT FROM AUTHOR]

The authors reflect on the use, safety, and access of magnetic resonance imaging (MRI) conditional products. Topics discussed include the concerns on the potential safety risks of MRI when being performed off-label, the response of power-on-reset (POR) to electromagnetic interference, and the advantage of implantable cardioverter-defibrilaltor (ICD).

Implantable pulse generators and de brillators have traditionally been considered contraindications to MRI. However, recent data have challenged this paradigm and demonstrated that patients with newer generation devices can safely undergo MRI, including cardiac MRI, provided basic precautions are taken. Indeed, the introduction of MRI conditional systems has led to a conceptual shift in clinical decision making--'can this patient undergo MRI safely?' is being superseded by 'should this patient be implanted with an MRI conditional device?'. This review outlines the risks associated with MRI in patients with implanted cardiac devices, and discusses practical measures to minimise risks and facilitate safe and diagnostic scanning. [ABSTRACT FROM AUTHOR]

Use of both magnetic resonance imaging (MRI) and pacing devices has undergone remarkable growth in recent years, and it is estimated that the majority of patients with pacemakers will need an MRI during their lifetime. These investigations will generally be denied due to the potentially dangerous interactions between cardiac devices and the magnetic fields and radiofrequency energy used in MRI. Despite the increasing reports of uneventful scanning in selected patients with conventional pacemakers under close surveillance, MRI is still contraindicated in those circumstances and cannot be considered a routine procedure. These limitations prompted a series of modifications in generator and lead engineering, designed to minimize interactions that could compromise device function and patient safety. The resulting MRI-conditional pacemakers were first introduced in 2008 and the clinical experience gathered so far supports their safety in the MRI environment if certain conditions are fulfilled. With this technology, new questions and controversies arise regarding patient selection, clinical impact, and cost-effectiveness. In this review, we discuss the potential risks of MRI in patients with electronic cardiac devices and present updated information regarding the features of MRI-conditional pacemakers and the clinical experience with currently available models. Finally, we provide some guidance on how to scan patients who have these devices and discuss future directions in the field. [ABSTRACT FROM AUTHOR]

Magnetic resonance imaging (MRI) is the imaging modality of choice in many clinical situations, and its use is likely to grow due to expanding indications and an ageing population. Many patients with implantable devices are denied MRI except in cases of urgent need, and when scans must be performed they are complicated by the need for burdensome and costly personnel and monitoring requirements that have the net effect of restricting access to scans. Several small studies, enrolling a total of 344 patients, suggest that some patients with conventional systems may undergo MR examinations without clinically overt adverse events. However, a number of potential interactions exist between implantable cardiac devices and the static and gradient magnetic fields and modulated radio frequency (RF) fields generated during MR scans; nearly all studies have reported pacing capture threshold changes, troponin elevations, ectopy, unpredictable reed switch behaviour, and other ‘subclinical’ issues with pacemakers and implantable cardioverter-defibrillators (ICDs) in patients who have undergone MRI. Attention has turned to devices that are specifically designed to be safe in the MRI environment. A clinical study of one such device documented its ability to be exposed to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function. Such new technologies may enable scanning of pacemaker and ICD patients with reduced concerns regarding the short- and long-term effects of MRI. As importantly, these devices may increase the number of centres that are able to safely perform MRI and, thus, expand access to scans for patients with these devices. [ABSTRACT FROM PUBLISHER]

The presence of temporary myocardial pacing leads is considered a safety contraindication for magnetic resonance imaging (MRI). The aim of this ex vivo tissue study was to measure the heating effects at the tip of the leads using proton magnetic resonance spectroscopy (HMRS) thermometry. The tissue effects were verified by histological analyses. Pig hearts with implanted temporary pacemaker myocardial pacing leads were examined by whole-body MRI at 1.5 Tesla. The tests were performed either by a sequence with high specific absorption rate (SAR) or by standard clinical sequences with lower SAR. Temperature changes were detected via HMRS thermometry, by monitoring the frequency difference between water protons and the reference signals of N-methyl protons of creatine/phosphocreatine (Cr/PCr) and trimethylamine (TMA). Histology was performed using several staining techniques. Standard low-SAR and high-SAR sequences did not cause significant temperature increases in the myocardial tissue surrounding the implanted leads. There were no histopathological signs of thermal damage around the tips of the leads in any of the hearts or in a control implanted heart not subjected to MRI. The present data suggest that temporary pacemaker myocardial pacing leads may be compatible with MR scanning at 1.5 Tesla. However, further in vivo studies and carefully monitored patient studies are needed before final safety recommendations can be made. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM PUBLISHER]

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. [ABSTRACT FROM AUTHOR]

Purpose: Electromagnetic articulography (EMA) uses a helmet to create alternating magnetic fields for tracking speech articulator movement. An important safety consideration is whether EMA magnetic fields interfere with the operation of speakers' pacemakers or implantable cardioverter-defibrillators (ICDs). In this investigation, individuals with pacemaker/ICD devices were exposed to EMA fields under controlled conditions while potential interference was examined. Method: Twelve adults with pacemaker/ICD devices from 3 major manufacturers were assessed for device function before, during, and after exposure to magnetic fields from a Carstens AG100 EMA system. Potential interference was probed, with EMA transmitters positioned at varying distances from the implantable devices and with the EMA system set at different operating strengths. Results:No adverse affects in device operation were observed under any conditions. The only potential complication was temporary telemetry-link interference during device testing in some cases. Conclusion: The results suggest that EMA technology maybe safely used with patients who have pacemakers and ICDs. However, the present findings do not rule out potential interference with other pacemaker/ICD manufacturers or with different articulography systems. Precautions are suggested for testing individuals with pacemaker/ICDs under EMA conditions. [ABSTRACT FROM AUTHOR]

Background: Magnetic resonance imaging (MRI) is a standard of care in evaluating many disease processes. Given concerns about device damage or movement, programming changes, lead heating, inappropriate pacing, and image artifact, MRI is contraindicated in pacemaker patients. Despite this, studies have demonstrated safety and efficacy of MRI in adults with acquired heart disease and endocardial pacing leads. We sought to evaluate MRI use in congenital heart disease (CHD) patients with predominantly epicardial pacing leads. Methods: From July 2007 to October 2008, MRI (1.5 Tesla) was performed in 11 patients without alternative imaging modality who were not pacemaker dependent or possessing abandoned leads. Pacing was disabled during MRI. An electrophysiologist monitored electrocardiogram and hemodynamic parameters throughout each study. Device and lead function were evaluated before and after MRI, and at subsequent clinic visits. Results: Eleven MRIs (four cardiac, seven noncardiac) were performed in eight patients. Mean patient age was 16.5 ± 9.2 years (range 1.7–24.5) with five patients under the age of 16 years. Diagnoses included structural CHD in six patients and long QT syndrome and congenital heart block in one each. There were three dual- and five single- (three atrial, two ventricular) chamber devices, two endocardial, and nine epicardial leads. No inappropriate pacing or significant change in generator or lead parameters was noted. All MRI studies were of diagnostic quality. Conclusion: Diagnostic quality MRI can be performed safely in nonpacemaker-dependent CHD patients with predominantly epicardial leads. Further studies will define safe practice measures in this population, as well as in CHD patients with pacemaker dependency. [ABSTRACT FROM AUTHOR]

Background: A relaxation of the prohibition of scanning cardiac rhythm device patients is underway, largely because of the growing experience of safe scanning events at 1.5T. Magnetic resonance imaging (MRI) at 3T is becoming more common and may pose a different risk profile and outcome of MRI of cardiac device patients. Methods: No restrictions were placed on pacemaker dependency, region scanned, device type, or manufacturer. Sixteen scans at 3T were performed with an electrophysiologist present on 14 patients with a variety of devices from various manufacturers. An “MRI-S” strategy was used. Multimodal monitoring was required. Device interrogation was performed prior to, immediately after, and 1–3 months after the MRI. For nonpacemaker-dependent device patients, attempts were made to turn all device features off (with OOO programming the goal) conceptually rendering the device “invisible.” In pacemaker-dependent patients, the device was programmed to asynchronous mode at highest output for the duration of the scan with the goal of rendering the device conceptually “invulnerable” to MRI effects. The specific absorption rate (SAR) was limited to 2W/kg. Results: All patients were successfully scanned. No arrhythmias were noted. No significant change in the programmed parameters, pacing thresholds, sensing, impedance, or battery parameters was noted. The insertable loop recorder (ILR) recorded prolonged artifactual asystole during MRI. One patient noted chest burning during the scan. Conclusions: Device patients may undergo carefully tailored 3T MRI scans when pre-MRI reprogramming of the device occurs in conjunction with extensive monitoring, supervision, and follow-up. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM PUBLISHER]

Copyright of La Radiologia Medica is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Cardiovascular magnetic resonance (CMR) yields important clinical information which often cannot be obtained from other imaging modalities. Cardiac pacemakers have conventionally been considered a contraindication to CMR, and relatively few data exist on CMR in such patients. Methods and results: We present 5 patients who underwent 6 CMR scans in a 0.5 Tesla scanner. The patients were non-pacemaker dependent, and the pacemakers were reprogrammed prior to scanning to have sub-threshold output. Spin echo, gradient echo and real-time sequences were used with specific absorption rates of up to 0.1 W/kg. A cardiologist was present during each scan, and the patient had continuous electrocardiographic and non-invasive monitoring of vital signs. Five of the scans were carried out without incident providing useful diagnostic information, which was not compromised by obvious artifact from the pacemaker box. In one case, the pacemaker began pacing at maximum voltage at a fixed rate of 100. This patient was removed from the magnet, and there were no clinical sequelae. The mean pre-and post-scan ventricular lead voltage threshold was the same (2.28 V vs 2.28 V). Conclusion: Our experience is that CMR at 0.5T in non-pacemaker dependent patents can be performed in closely supervised circumstances where the benefit-risk assessment is considered positive. [ABSTRACT FROM AUTHOR]

There has been great controversy related to performance of magnetic resonance imaging in patients with pacemakers and implantable cardiac defibrillators. Recent questions have been raised regarding whether contraindications are absolute or relative. Although there are theoretical as well as documented issues relating to device malfunction, data suggest that scanning patients with devices may be feasible when important clinical questions need to be addressed by following strict guidelines. Advanced knowledge and understanding of electrophysiologic as well as magnetic resonance imaging-related issues, and a multidisciplinary, collaborative approach is required to further define the role of MR in patients with pacemakers and implantable cardiac defibrillators. [ABSTRACT FROM AUTHOR]

Rationale and Objectives: To evaluate the effect of Magnetic Resonance Imaging (MRI) performed at 1.5-Tesla on current generation pacemakers and ICDs to identify safe parameters for MRI examinations. Methods: Pacemakers (Identity ADx XL DR+ 5386 and Identity ADx DR + 5380 generators; 1688T/52-cm atrial and ventricular leads) and ICDs (Atlas + V-243, Epic + V-236, and Epic + HF V-350 generators; Riata 1581/65-cm and QuickSite 1056K/75-cm leads; St. Jude Medical, Sylmar, California, USA) were evaluated for magnetic field interactions. MRI-related heating was assessed using various levels of RF power (SARs) and conditions that included scans on different body regions. Functional aspects of the devices were evaluated immediately before and after MRI procedures utilizing nine different pulse sequences. Induced currents were measured using a custom built system. Results: Magnetic field interactions will not create a hazard for these pacemakers and ICDs. All scans of the “head” and “lumbar” regions resulted in temperature changes ≤0.5°C at SARs ranging from 2.0 to 3.0-W/kg. For the “chest” area, temperature increases ranged from 0.4°C to 3.6°C at an SAR of 2.0-W/kg. No memory corruption, hardware changes, or changes in device parameters were seen. Magnetic field gradients have a low likelihood of inducing currents that would stimulate the heart. Conclusions: No hazardous magnetic field interactions or physiologically significant heating occurred for certain conditions. There was no permanent effect on device function. By following specific conditions, these pacemakers and ICDs may be safe for patients scanned at 1.5-Tesla. [ABSTRACT FROM AUTHOR]

Longer electrically conducting parts are needed for various instruments such as pacemakers, defibrillators, deep brain stimulators and interventional instruments. Magnetic resonance imaging in the presence of these instruments can be potentially harmful, due to resonance effects and heating of conducting wires. A review of the literature revealed that neither manufacturers of pacemakers and defibrillators nor the FDA consider these medical instruments to be MR‐safe, despite the fact that there are some reports about MR scanning of pacemaker patients without critical incidents. MR‐guided angiographic interventions require not only high quality real‐time imaging, but also MR compatible and MR‐safe instruments. Consequently, metallic guidewires as used for angiographic interventions were examined during in vitro experiments in the MR environment. Heating of guidewires to>70° was reported during in vitro experiments. Our own in vivo experiments using commercially available metallic guidewires observed heating to up to 35° at the guidewire tip, despite the cooling effect of blood flowing around the guidewire. Moreover, we saw the development of sparks at the end of the guidewire if it was bent inside of the MR scanner and touched to the animal. But it was not possible to reliably repeat these heating results. We conclude that longer metallic parts have to be avoided inside the MR scanner to guarantee patient safety. In order to exploit more sophisticated technologies such as active tip tracking, solutions without the need for conducting wires have to be further developed before interventional MR can safely move into the clinical setting. [ABSTRACT FROM AUTHOR]

Mammography and ultrasound indicated a cancer of the right breast in a 77-year-old woman with a dual-chamber demand pacemaker. The patient was not pacemaker-dependent. She underwent breast 1.5T magnetic resonance imaging (MRI) (dynamic gradient echo sequence with Gd-DOTA 0.1 mmol/kg). Before the patient entered the MR room, the configuration of the device was changed (the response to magnet was switched from asynchronous to off and the rate-responsive algorithm was disabled). No relevant modifications of heart rhythm or rate were observed during the MR examination. No symptom was reported. Immediately after the examination, the pacemaker interrogation showed neither program changes nor alert warnings. MRI detected a bifocal cancer in the right breast which allowed tailored breast-conserving treatment to be initiated. Histopathology confirmed a bifocal invasive ductal carcinoma. [ABSTRACT FROM AUTHOR]

Objective: To determine if strategies used to safely scan nonpacemaker-dependent patients could be applied to facilitate safe MRI of pacemaker-dependent patients. Interventions: Ten pacemaker-dependent patients underwent a total of 11 MRI scans of the head and neck. Screening, reprogramming VOO or DOO at 60 ppm, and monitoring strategies were used to facilitate MRI. A transmit-receive coil was used and MRI pulse sequences were modified to limit the whole-body specific absorption rate (SAR). Results: All scans proceeded uneventfully. No difficulties in post-MRI telemetry or interrogation were seen and no post-MRI programming changes were noted. No patient experienced arrhythmia or symptoms during or immediately after MRI. Battery status remained unchanged. No patient experienced post-MRI change in sensing thresholds. Three patients showed no change in the atrial or ventricular pacing thresholds when the pre-MRI values were compared to the immediate post-MRI values and the 3-month follow-up values. All other patients showed a rise or fall of 0.5 V in their chamber threshold values when the pre-MRI, post-MRI, and 3-month follow-up values were compared. More patients showed a fall in their pacing thresholds than a rise post-MRI. Conclusion: While clearly a higher risk group, like nonpacemaker-dependent patients, MRI might be performed in pacemaker-dependent patients if appropriate pacemaker reprogramming, patient monitoring, and MRI scanning techniques are implemented. [ABSTRACT FROM AUTHOR]

GIMBEL, J.R.,et al.: Outcome of Magnetic Resonance Imaging (MRI) in Selected Patients with Implantable Cardioverter Defibrillators (ICDs). Objective:To determine if simple strategies used to safely scan pacemaker patients could be applied to implantable cardioverter defibrillator (ICD), patients undergoing MRI allowing ICD patients to undergo MRI as well.Interventions:Screening, reprogramming, and monitoring strategies were used to facilitate MRI.Results:Seven patients underwent eight MRI scans at 1.5 T. Post-MRI, all devices demonstrated no change in pacing, sensing, impedances, charge times, or battery status. The patient undergoing a lumbar spine scan experienced a“power-on-reset” of his ICD without permanent impairment of his device.Conclusion:Scanning of ICD patients might be performed if appropriate reprogramming and monitoring is implemented.(PACE 2005; 28:270–273) [ABSTRACT FROM AUTHOR]

Aims Magnetic resonance imaging (MRI) is well 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. In this study, heating effects at the myocardium–pacemaker lead tip interface have been investigated in a chronic animal model during MRI at 1.5 Tesla. [ABSTRACT FROM PUBLISHER]

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 MBI 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. [ABSTRACT FROM AUTHOR]