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Littérature scientifique sur le sujet « MR-conditional device »

Auteur : Grafiati

Publié le 9 mars 2023

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Articles de revues sur le sujet "MR-conditional device"

Seewöster, Timm, Susanne Löbe, Sebastian Hilbert, Andreas Bollmann, Philipp Sommer, Frank Lindemann, Justinas Bacevičius et al. « Cardiovascular magnetic resonance imaging in patients with cardiac implantable electronic devices : best practice and real-world experience ». EP Europace 21, n^o 8 (25 mai 2019) : 1220–28. http://dx.doi.org/10.1093/europace/euz112.

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Abstract 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.

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Wineland, Adam, Yue Chen, Brian Boland, Kevin Chan et Zion Tse. « Magnetic Resonance Conditional Microinjector ». Journal of Imaging 5, n^o 1 (30 décembre 2018) : 4. http://dx.doi.org/10.3390/jimaging5010004.

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Glaucoma, one of the leading causes of blindness, has been linked to increases in intraocular pressure. In order to observe and study this effect, proposed is a specialized microinjector and driver that can be used to inject small amounts of liquid into a target volume. Magnetic resonance imaging (MRI) guided remotely activated devices require specialized equipment that is compatible with the MR environment. This paper presents an MR Conditional microinjector system with a pressure sensor for investigating the effects of intraocular pressure (IOP) in near-real-time. The system uses pressurized air and a linear actuation device to push a syringe in a controlled, stepwise manner. The feasibility and utility of the proposed investigative medical research tool were tested and validated by measuring the pressure inside an intact animal donor eyeball while precise, small volumes of water were injected into the specimen. Observable increases in the volume of the specimen at measured, specific target pressure increases show that the system is technically feasible for studying IOP effects, while the changes in shape were depicted in MRI scan images themselves. In addition, it was verified that the presence and operation of the system did not interfere with the MRI machine, confirming its conditional compatibility with the 3T MRI.

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GODEC, Matic, Jani IZLAKAR et Gašper PODOBNIK. « MRI SAFETY AND MANAGEMENT OF PATIENTS WITH CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES : LITERATURE REVIEW AND CASE PRESENTATION ». MEDICAL IMAGING AND RADIOTHERAPY JOURNAL 38, n^o 2 (17 décembre 2022) : 15–21. http://dx.doi.org/10.47724/mirtj.2021.i02.a002.

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Introduction: MRI has long been contraindicated in patients with CIED devices due to the risk of adverse eff ects through electromagnetic interference. Recent developments in engineering have led to the introduction of MRI conditional CIED devices that do not cause signifi cant clinical harm to patients undergoing MRI, when specifi c imaging conditions are met. Safe access to MRI has become a crucial need for patients with CIED devices. Aim: The purpose of this paper is to present an overview of how to manage patients with implanted CIED devices and to present a case report of a patient with CIED undergoing prostate MRI examination. Methods: This paper explores MRI Safety and the management of patients with implanted CIED devices through an extensive literature review and case presentation. The literature search was conducted using medical scientifi c electronic databases such as PubMed, Cinahl, Wiley Online Library and ScienceDirect. We examined a patient with a CIED device undergoing a prostate MRI examination. Results and discussion: We performed an examination of the described patient in accordance to the guidelines presented in this paper. The MR conditionality status was determined using the device identifi cation card and the manufacturer’s technical manual. The MRI examination of the patient was completed without complications; therefore, no adverse eff ects were reported. The MRI images were without artefacts. Conclusion: Recent clinical studies and published guidelines suggest that MRI of the patients with either an MRI conditional or MRI non-conditional CIED device is relatively safe under specifi c conditions. Multidisciplinary pre-procedure planning, a strict screening process, monitoring and device evaluation protocols are of key importance for ensuring safe MRI imaging in patients with CIED.

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Ryan, James W., Aoife S. Murray, Paddy J. Gilligan, James M. Bisset, Chris Nolan, Audrey Doyle, Barry Emerson, Joseph M. Galvin et John G. Murray. « MRI safety management in patients with cardiac implantable electronic devices : Utilizing failure mode and effects analysis for risk optimization ». International Journal for Quality in Health Care 32, n^o 7 (août 2020) : 431–37. http://dx.doi.org/10.1093/intqhc/mzaa067.

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Abstract Introduction Cardiac implantable electronic devices (CIEDs) are increasing in prevalence. Exposing patients with CIEDs to magnetic resonance imaging (MRI) can lead to adverse outcomes. This has led certain radiology departments to not accept MRI referrals related to patients with CIEDs. Patients with MR-conditional CIEDs can be safely scanned under specific conditions. Our institution has accepted such referrals since 2014. The aim of this study was to systematically identify and reduce risk in our CIED-MRI protocol using failure mode and effects analysis (FMEA). Methods A multidisciplinary FMEA team was assembled and included senior stakeholders from the CIED-MRI protocol. A process map was constructed followed by risk analysis and scoring. Targeted interventions were formulated and implemented; high-risk failure modes were prioritized. A new process map and protocol were drafted and repeat risk analysis was performed. Monitoring and re-evaluation of the CIED-MRI pathway were instigated at departmental quality assurance (QA) meetings. Results Interventions included direct CIED characterization using wireless technology pre-MRI, CIED programming and reprogramming in the MRI suite before and immediately after MRI reducing device downtime and continuous patient monitoring during MRI by a cardiac physiologist. The cumulative risk priority number (RPN) decreased from 1190 pre-FMEA to 492 post-FMEA. Discussion Despite the risk of exposing CIEDs to the MR environment, patients with MR-conditional CIEDs can be safely scanned with an appropriate multidisciplinary support. We found FMEA an indispensable tool in identifying and minimizing risk with no adverse events recorded since FMEA recommendations were implemented.

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Munawar, Dian A., Joel E. Z. Chan, Mehrdad Emami, Kadhim Kadhim, Kashif Khokhar, Catherine O’Shea, Shinsuke Iwai et al. « Magnetic resonance imaging in non-conditional pacemakers and implantable cardioverter-defibrillators : a systematic review and meta-analysis ». EP Europace 22, n^o 2 (30 janvier 2020) : 288–98. http://dx.doi.org/10.1093/europace/euz343.

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Abstract Aims There is growing evidence that magnetic resonance imaging (MRI) scanning in patients with non-conditional cardiac implantable electronic devices (CIEDs) can be performed safely. Here, we aim to assess the safety of MRI in patients with non-conditional CIEDs. Methods and results English scientific literature was searched using PubMed/Embase/CINAHL with keywords of ‘magnetic resonance imaging’, ‘pacemaker’, ‘implantable defibrillator’, and ‘cardiac resynchronization therapy’. Studies assessing outcomes of adverse events or significant changes in CIED parameters after MRI scanning in patients with non-conditional CIEDs were included. References were excluded if the MRI conditionality of the CIEDs was undisclosed; number of patients enrolled was <10; or studies were case reports/series. 35 cohort studies with a total of 5625 patients and 7196 MRI scans (0.5–3 T) in non-conditional CIEDs were included. The overall incidence of lead failure, electrical reset, arrhythmia, inappropriate pacing and symptoms related to pocket heating, or torque ranged between 0% and 1.43%. Increase in pacing lead threshold >0.5 V and impedance >50Ω was seen in 1.1% [95% confidence interval (CI) 0.7–1.8%] and 4.8% (95% CI 3.3–6.4%) respectively. The incidence of reduction in P- and R-wave sensing by >50% was 1.5% (95% CI 0.6–2.9%) and 0.4% (95% CI 0.06–1.1%), respectively. Battery voltage reduction of >0.04 V was reported in 2.2% (95% CI 0.2–6.1%). Conclusion This meta-analysis affirms the safety of MR imaging in non-conditional CIEDs with no death or implantable cardioverter-defibrillator shocks and extremely low incidence of lead or device-related complications.

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Elmouchi, Darryl A., Nagib Chalfoun et Andre Gauri. « Attitudes of Implanting Physicians about Cardiac Rhythm Management Devices and Their Features ». ISRN Cardiology 2013 (26 décembre 2013) : 1–6. http://dx.doi.org/10.1155/2013/247586.

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Modern cardiac rhythm management systems have become increasingly complex. The decision on which specific system to implant in a given patient often rests with the implanting physician. We conducted a multiple-choice survey to assess the opinions and preferences of cardiologists and electrophysiologists who implant and follow cardiac rhythm management systems. Reliability and battery longevity were viewed as the most important characteristics in device selection. Patient characteristics which most affected device choice were pacing indication and life expectancy. Remote technology was used in 47% of pacemaker patients, 64% of ICD patients, and 65% of CRT-D patients, with wireless (radiofrequency) remote patient monitoring associated with higher patient compliance rates (74% versus 64%, resp.). Wireless remote patient management with alerts for atrial tachyarrhythmias was felt to be important by 76% of respondents. When choosing an MR-conditional device, physicians deemed patients with prior orthopedic problems, a history of cancer, or neurological disorders to be more likely to require a future MRI. Device longevity and reliability remain the most important factors which influence device selection. Wireless remote patient monitoring with alerts is considered increasingly important when choosing a specific cardiac rhythm management system to implant.

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Savouré, Arnaud, Alexis Mechulan, Marc Burban, Audrey Olivier et Arnaud Lazarus. « The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging ». Clinical Medicine Insights : Cardiology 9 (janvier 2015) : CMC.S24976. http://dx.doi.org/10.4137/cmc.s24976.

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Background The impact of magnetic resonance imaging (MRI) on pacemakers is potentially hazardous. We present clinical results from a novel MRI conditional pacing system with the capability to switch automatically to asynchronous mode in the presence of a strong magnetic field. Aims The IKONE ( Assessment of the MRI solution: KORA 100™ and Beflex™ pacing leads system) study is an open-label, prospective, multicenter study aimed at confirming the safety and effectiveness of the system, when used in patients undergoing MRI of anatomical regions excluding the chest. Methods Primary eligibility criteria included patients implanted with the system, with or without a clinically indicated MRI. The primary endpoint was to confirm no significant change in pacing capture thresholds at 1 month after an MRI, with an absolute difference of ≤0.75 V between the pre- and 1-month post-MRI for both atrial and ventricular capture thresholds. Results Out of 33 patients enrolled (mean age: 72.8 ± 11.4 years, 70% male, implant indication or device), 29 patients implanted with the MRI conditional system underwent an MRI 6-8 week postimplant. The study reached its primary endpoint: the mean absolute difference in pacing capture threshold at 1-month post-MRI versus pre-MRI was less than 0.75 V in the atrium (Δ = 0.18 ± 0.16 V, P-value <0.001) and in the ventricle (Δ = 0.18 ± 0.22 V, P-value <0.001). There were no adverse events related to the MRI procedure nor were there reports of patient symptoms or discomfort associated. MR image quality was of diagnostic quality in all patients. Conclusion Lead electrical performance as measured by difference in capture thresholds were not impacted by MRI. This first clinical evaluation of a novel MRI conditional system demonstrates it is safe and effective for use in out-of-chest, 1.5-T MR imaging.

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Boarescu, Paul-Mihai, Iulia Diana Popa, Cătălin Aurelian Trifan, Adela Nicoleta Roşian et Ştefan Horia Roşian. « Practical Approaches to Transvenous Lead Extraction Procedures—Clinical Case Series ». International Journal of Environmental Research and Public Health 20, n^o 1 (26 décembre 2022) : 379. http://dx.doi.org/10.3390/ijerph20010379.

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Transvenous lead extraction (TLE) is regarded as the first-line strategy for the management of complications associated with cardiac implantable electronic devices (CIEDs), when lead removal is mandatory. The decision to perform a lead extraction should take into consideration not only the strength of the clinical indication for the procedure but also many other factors such as risks versus benefits, extractor and team experience, and even patient preference. TLE is a procedure with a possible high risk of complications. In this paper, we present three clinical cases of patients who presented different indications of TLE and explain how the procedures were successfully performed. In the first clinical case, TLE was necessary because of device extravasation and suspicion of CIED pocket infection. In the second clinical case, TLE was necessary because occlusion of the left subclavian vein was found when an upgrade to cardiac resynchronization therapy was performed. In the last clinical case, TLE was necessary in order to remove magnetic resonance (MR) non-conditional leads, so the patient could undergo an MRI examination for the management of a brain tumor.

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Zbinden, Rainer, Christian Wollmann, Johannes Brachmann, Jochen Michaelsen, Clemens Steinwender, Pramesh Kovoor, Sebastian Kelle et al. « Clinical safety of the ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 3 T : results of the ProMRI 3T ENHANCED Master study ». EP Europace 21, n^o 11 (19 juillet 2019) : 1678–85. http://dx.doi.org/10.1093/europace/euz189.

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Abstract Aims There have been no published studies on the safety of magnetic resonance imaging (MRI) at 3 Tesla (3 T) in patients with MRI-conditional implantable cardioverter-defibrillators (ICDs). The aim of this study was to assess clinical safety of the Biotronik ProMRI ICD system during non-diagnostic head and lower lumbar scans under 3 T MRI conditions. Methods and results The study enrolled 129 patients at 12 sites in Australia, Singapore, and Europe. Predefined head and lower lumbar MR scans (total duration ≈30 min) were performed in 112 patients. Three primary endpoints were evaluated from the pre-MRI to the 1-month post-MRI visit: (i) freedom from serious adverse device effects (SADEs) related to MRI (hypothesized to be >90%); (ii) pacing threshold invariance for all leads (geometric mean of the patient-wise ratios for 1 month vs. pre-MRI was hypothesized to be <1.07); and (iii) sensing amplitude invariance (geometric mean of the ratios was hypothesized to be >0.993). No MRI-related SADE occurred (SADE-free rate 100%, 95% confidence interval 95.98–100%). Pacing threshold and sensing amplitudes fulfilled the invariance hypotheses with high statistical significance (P < 0.0013). No threshold increase >0.5 V or sensing amplitude decrease by >50% was observed (secondary endpoints). Lead impedances, battery capacity, and detection and treatment of arrhythmias by ICDs were not affected by MRI scans. Conclusion The head and lower lumbar scans under specific 3 T MRI conditions were safe in the investigated MR-conditional ICD systems. There was no evidence of harm to the patients or any negative influence of the MRI scan on the implanted systems.

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Brown, M. S. « Regarding Off-Label Scanning of MR Conditional Devices ». American Journal of Neuroradiology 37, n^o 11 (18 août 2016) : 2001–2. http://dx.doi.org/10.3174/ajnr.a4932.

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Thèses sur le sujet "MR-conditional device"

GEBBIA, ANDREA. « Analisi delle variazioni nella qualità immagine di esami di risonanza magnetica per pazienti dotati di dispositivi impiantabili attivi MR-conditional ». Doctoral thesis, Università degli Studi di Milano, 2020. http://hdl.handle.net/2434/905729.

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Chapitres de livres sur le sujet "MR-conditional device"

Brown, James E., Paul J. Stadnik, Jeffrey A. Von Arx et Dirk Muessig. « RF-induced Heating Near Active Implanted Medical Devices in MRI : Impact of Tissue Simulating Medium ». Dans Brain and Human Body Modelling 2021, 125–32. Cham : Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-031-15451-5_8.

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AbstractRecent advances in the MR conditional safety assessment of active implantable medical devices (AIMDs) have begun providing guidelines in the development of transfer functions for evaluating risk to the patient due to RF-induced heating. This work introduces the complexity of the analysis of RF-induced heating and explores the impact of the computational human model (CHM) on the resulting analysis. Through historical analysis techniques, simplified structures, and real medical device geometries, the interaction of the AIMD lead with the tissue simulating medium (TSM) can be better understood. Finally, a general guiding principle for MR manufacturers is identified, whereby the thickness of the lead insulation can be used to determine the appropriate TSM for the most accurate in vivo predictions of RF-induced heating.

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Eggen, Michael D., et Cory M. Swingen. « Cardiovascular Magnetic Resonance Imaging and MR-Conditional Cardiac Devices ». Dans Handbook of Cardiac Anatomy, Physiology, and Devices, 411–35. Cham : Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-19464-6_24.

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Censi, Federica, Eugenio Mattei et Giovanni Calcagnini. « MRI interactions with medical devices ». Dans The EACVI Textbook of Cardiovascular Magnetic Resonance, sous la direction de Massimo Lombardi, Sven Plein, Steffen Petersen, Chiara Bucciarelli-Ducci, Emanuela R. Valsangiacomo Buechel, Cristina Basso et Victor Ferrari, 70–76. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198779735.003.0012.

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Given the particular environment created by a magnetic resonance imaging (MRI) scanner, various kinds of interaction can occur with other medical devices, depending on the nature of the device, active or passive, on the materials. Generally speaking, manufacturers of medical devices must analyse and indicate any potential risk related to reasonably foreseeable environmental conditions such as magnetic fields and to other medical treatments such as MRI. Thus, information about the compatibility of a medical device with MRI should be available on the device user manual. According to the latest international standard (ASTM 2503), a medical device can be magnetic resonance (MR) Safe, MR Conditional, and MR Unsafe. MR Safe poses no known hazards in all MRI environments; MR Conditional has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use; MR Unsafe is known to pose hazards in all MRI environments. Implanted medical devices are those raising major concerns in MR environments. Each implanted device must be clearly identified, and it is important to screen each patient before MRI examination. The prevalence of patients with various kinds of implants is increasing. For these devices, it could be important to refer not only to the user manual, but also to the scientific literature. Indeed, it could happen that it is necessary to perform an MRI examination which does not completely respect the MRI conditions indicated by the device manufacturer. In these cases, the clinical or in vitro experiences reported in the scientific literature could help in yielding elements to support the medical decision.

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Actes de conférences sur le sujet "MR-conditional device"

Brown, James E., Rui Qiang, Paul J. Stadnik, Larry J. Stotts et Jeffrey A. Von Arx. « MR conditional safety assessment of implanted medical devices : Advantages of computational human phantoms ». Dans 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2016. http://dx.doi.org/10.1109/embc.2016.7592209.

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Liu, Guanyun, Yanzhou Wang, Gang Li, Kevin Cleary et Iulian Iordachita. « Evaluation of Needle Driver Designs for Robot-Assisted Needle Insertions Under MRI Guidance ». Dans ASME 2022 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2022. http://dx.doi.org/10.1115/imece2022-96678.

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Abstract This paper presents the evaluation of two detachable MR-Conditional needle driver designs for our 4-degree-of-freedom (DOF) robotic platform for MRI-guided spinal injections. Compared to their predecessor, the new designs open up the possibility of intraoperative needle driver attachment, and in order to evaluate the feasibility of such an approach, force and torque requried during the needle driver attachment process are captured to evaluate which of the two designs are better suited for such purpose. A simulated clinical scenario is also carried out to measure the possible position change of the 4-DOF robot with respect to the patient due to intraoperative tool attachment, thus providing future guidance to the proposed clinical workflow in the framework of body-mounted robotic surgical devices.

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