scholarly journals Category-2 Shunt Valve Marketed as MRI-Conditional Malfunction Following Routine 3T Magnetic Resonance Imaging

2021 ◽  
pp. 101355
Author(s):  
Caroline Davidson ◽  
Mattew White ◽  
Aviva Abosch ◽  
Miki Katzir
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Resonance Imaging ◽  
Shunt Valve ◽  
Mri Conditional

scholarly journals A systematic review of the use of magnetic resonance imaging in non-conditional pacemakers and implantable defibrillators

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
R Murphy ◽  
R K Kerley ◽  
P K Kearney
Keyword(s):  
Magnetic Resonance Imaging ◽  
Systematic Review ◽  
Magnetic Resonance ◽  
Case Reports ◽  
Case Series ◽  
Adverse Outcomes ◽  
Resonance Imaging ◽  
Cardiac Implantable Electronic Devices ◽  
Relative Safety ◽  
Mri Conditional

Abstract Background Cardiac implantable electronic devices (CIEDs) were long considered a contraindication for magnetic resonance imaging (MRI). Modern devices are now MRI conditional, but still the majority of CIEDs in the population are legacy devices and are classified as unsafe for MRI. There is growing consensus that MRI is also safe in these patients. Purpose The purpose of this study was to perform an up to date systematic review of the evidence evaluating the use of MRI in patients with non-conditional CIEDs. Methods Searches of the PubMed, CINAHL and Embase databases were performed. Studies that assessed the rate of adverse outcomes after MRI in patients with non-conditional CIEDs were included. Studies were excluded if they did not disclose the conditionality of patients CIEDs. Case reports or case series were not included. Results 36 cohort studies were identified. No patient in these studies died during or immediately after MRI. Symptom associated with either torque or heating occurred in <1% of patients. Electrical resets occurred 1–2% of patients. There were no cases of non-conditional lead or generator failure. Inappropriate pacing occurred in <1% of patients. No ICD shocks occurred during MRI. Changes in CIED parameters occurred in 1–4% of patients. Conclusions This systematic review highlights the relative safety of the use of MRI in patients with non-conditional CIEDs. Demonstrated be the fact that no deaths or device shocks have been suffered as a consequence of MRI in any of these studies, and the extremely low incidence of device or lead related complications. Still strict selection and monitoring protocol should be used when imaging these patients. FUNDunding Acknowledgement Type of funding sources: None.

Prospective evaluation of the utility of magnetic resonance imaging in patients with non‐MRI‐conditional pacemakers and defibrillators

2020 ◽  
Vol 31 (11) ◽  
pp. 2931-2939
Author(s):  
Deepak Padmanabhan ◽  
Danesh Kella ◽  
Ameesh Isath ◽  
Nidhi Tandon ◽  
Siva Mulpuru ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Prospective Evaluation ◽  
Resonance Imaging ◽  
Mri Conditional

scholarly journals The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging

2015 ◽  
Vol 9 ◽  
pp. CMC.S24976 ◽  
Author(s):  
Arnaud Savouré ◽  
Alexis Mechulan ◽  
Marc Burban ◽  
Audrey Olivier ◽  
Arnaud Lazarus
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Primary Endpoint ◽  
Electrical Performance ◽  
Absolute Difference ◽  
P Value ◽  
Resonance Imaging ◽  
Open Label ◽  
Mri Conditional ◽  
The Impact

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.

scholarly journals Canadian Heart Rhythm Society and Canadian Association of Radiologists Consensus Statement on Magnetic Resonance Imaging with Cardiac Implantable Electronic Devices

2014 ◽  
Vol 65 (4) ◽  
pp. 290-300 ◽  
Author(s):  
Atul Verma ◽  
Andrew C.T. Ha ◽  
Carole Dennie ◽  
Vidal Essebag ◽  
Derek V. Exner ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Electronic Devices ◽  
Heart Rhythm ◽  
Resonance Imaging ◽  
Cardiac Implantable Electronic Devices ◽  
Canadian Association ◽  
Mri Environment ◽  
Magnetic Resonance Imaging Mri ◽  
Mri Conditional

Magnetic resonance imaging (MRI) has historically been considered contraindicated for individuals with cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable defibrillators. Magnetic resonance scanners produce magnetic fields that can interact negatively with the metallic components of CIEDs. However, as CIED technology has advanced, newer MRI conditional devices have been developed that are now in clinical use and these systems have had demonstrated safety in the MRI environment. Despite the supportive data of such CIED systems, physicians remain reluctant to perform MRI scanning of conditional devices. This joint statement by the Canadian Heart Rhythm Society and the Canadian Association of Radiologists describes a collaborative process by which CIED specialists and clinics can work with radiology departments and specialists to safely perform MRI in patients with MRI conditional CIED systems. The steps required for patient and scanning preparation and the roles and responsibilities of the CIED and radiology departments are outlined. We also briefly outline the risks and a process by which patients with nonconditional CIEDs might also receive MRI in highly specialized centres. This document supports MRI in patients with MRI conditional CIEDs and offers recommendations on how this can be implemented safely and effectively.

scholarly journals Is diversity harmful?—Mixed-brand cardiac implantable electronic devices undergoing magnetic resonance imaging

2021 ◽  
Author(s):  
Christoph Alexander König ◽  
Florian Tinhofer ◽  
Thomas Puntus ◽  
Achim Leo Burger ◽  
Nikolaus Neubauer ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Electronic Devices ◽  
Resonance Imaging ◽  
Cardiac Implantable Electronic Devices ◽  
Primary Endpoints ◽  
Increased Risk ◽  
Secondary Endpoints ◽  
Magnetic Resonance Imaging Mri ◽  
Mri Conditional

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.

scholarly journals Is diversity harmful? - Mixed-brand cardiac implantable electronic devices undergoing magnetic resonance imaging

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
C Koenig ◽  
P Hellebart ◽  
J Koch ◽  
F Egger ◽  
T Puntus ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Primary Endpoint ◽  
Complication Rate ◽  
Electronic Devices ◽  
Resonance Imaging ◽  
Cardiac Implantable Electronic Devices ◽  
Increased Risk ◽  
Secondary Endpoints ◽  
Mri Conditional

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Many patients with cardiac implantable electronic devices (CIED) need to undergo magnetic resonance imaging (MRI). However, a significant proportion has a CIED system in place that has not been classified "MRI-conditional" because of generators and leads from different brands ("mixed-brand" group), although the individual components per se are MRI-conditional. There is only limited data available concerning the outcome of these patients with "mixed-brand" CIED systems undergoing MRI. Purpose To analyse complications or adverse effects in "mixed-brand" CIED patients undergoing MRI, compared to patients with a fully "MRI-conditional" CIED system. Methods A retrospective single-centre study was performed, including patients undergoing MRI between January 2013 until May 2020. Short- and long-term outcomes were compared between both groups. We defined the primary endpoint as death or any adverse event necessitating hospitalization or CIED revision in association with the MRI examination. Secondary endpoints were the occurrence of any surrogate 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 a range of 1-9 MRIs per patient. Mean age was 73 years and 52 (32.9%) patients were female. We identified 38 patients undergoing 54 procedures in the "mixed-brand" group and 89 patients undergoing 134 MRI procedures in the "MRI-conditional" group. In 31 patients undergoing 39 MRI examinations the MRI-conditionality could not be determined. "Mixed-brand" patients were older than MRI-conditional patients (mean 77 vs. 72 years, p = 0.003). The primary endpoint occurred in 0% in the "mixed-brand" group and in 2.2% in the "MRI conditional" group (p = 1.000). Complications were as follows: Two patients had first diagnosed atrial fibrillation directly associated with the procedure, of whom one additionally had a transient CIED dysfunction. No patient in the "mixed-brand" group and three patients (3.4%) in the "MRI conditional" group met the secondary endpoints (p = 0.554). In patients with undeterminable MRI conditionality the complication rate was similar (0% for both the primary and secondary endpoints). Conclusion The complication rate of CIED patients undergoing MRI was low. There was no signal for increased risk of adverse events in patients with a CIED without MRI certification due to mixed brands systems compared to patients with "MRI-conditional" CIED systems.

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