MRI Information for Commonly Used Otologic Implants: Review and Update

Azadarmaki, Roya; Tubbs, Rhonda; Chen, Douglas A.; Shellock, Frank G.

doi:10.1177/0194599813518306

Cited by 46 publications

(26 citation statements)

References 34 publications

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“…Its rings are made from high‐density polyethylene, and the pins are made of nonferromagnetic surgical stainless steel. Stainless steel is a nonferromagnetic material found to be safe against magnetic deflection and heating with magnetics up to 3.0 T . This is consistent with current literature concerning MRI safety of other nonferromagnetic metal implants placed within the head and neck, such as dental implants, otologic prostheses, cochlear implants, and cerebral aneurysm clips .…”

Section: Discussionsupporting

confidence: 86%

Safety and Efficacy of MRI Scans in Patients With Implanted Microvascular Coupling Devices

et al. 2019

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Objective: To demonstrate the safety and compatibility of microvascular couplers in patients undergoing postoperative magnetic resonance imaging (MRI) scans.Study Design: Retrospective case series. Methods: A consecutive review of 1,252 patients undergoing free tissue transfer for head and neck reconstruction at Oregon Health and Sciences University (OHSU) between 2010 and 2017 who had microvascular coupler Synovis, Baxter Deerfield, IL (Synovis Life Technologies, Saint Paul, MN) implantation were reviewed. One hundred fifteen patients had a subsequent MRI scan, which consisted of a variety of Phillips (Amsterdam, Netherlands) MRI machines ranging from 1.0 to 3.0 Tesla (T) in magnetic strength.Results: These 115 patients underwent 121 free flaps with 131 couplers (including 32 flow couplers) utilized for venous anastomoses. Couplers ranged in size from 1.5 to 4.0 mm (3.0 mm [42%] followed by 3.5 mm [21%], 2.5 mm [19%], 2.0 mm [10%], 4.0 mm [6%], and 1.5 mm [2%]. Three hundred fifty-nine MRI scans (2 days to 91 months postoperatively) were obtained with 233 MRIs for cancer surveillance, and the remaining were obtained for neurologic disease, injury, or evaluation for metastases. No complications occurred related to the MRI and the metallic components of the coupler or other metal implants, such as reconstruction bars, vascular clips, or metallic surgical mesh. Additionally, no radiology report commented on MRI distortion due to the coupler placement, which contrasts the distortion seen with the other metallic implants.Conclusion: Microvascular couplers and their constitutive stainless-steel pins have not been found to cause any complications in a large series of consecutive patients undergoing multiple MRIs with magnetic strength up to 3 T. The U.S. Food and Drug Administration advocates medical alert notification for patients with couplers; however, hesitation regarding potential MRI scanning for surveillance or otherwise is unwarranted.

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Section: Discussionsupporting

confidence: 86%

Safety and Efficacy of MRI Scans in Patients With Implanted Microvascular Coupling Devices

et al. 2019

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“…Metallic implants are a significant concern because of their interaction with the complex MR environment, which can introduce significant force, voltage, heat, image artifact, demagnetization, and potential device malfunction . With the rise in CI recipients requiring diagnostic MRI, the U.S. Food and Drug Administration (FDA) assigned MR conditional designation to most CI systems up to 1.5 tesla (T), and MED‐EL Synchrony (MED‐EL, Innsbruck, Austria) up to 3.0 T, with and without magnet removal with proper head splint securement …”

Section: Introductionmentioning

confidence: 99%

“…[5][6][7][8] With the rise in CI recipients requiring diagnostic MRI, the U.S. Food and Drug Administration (FDA) assigned MR conditional designation to most CI systems up to 1.5 tesla (T), and MED-EL Synchrony (MED-EL, Innsbruck, Austria) up to 3.0 T, with and without magnet removal with proper head splint securement. [9][10][11] The path that CI MRI safety has taken from one of complete contraindication to MR conditional safety recommendations has been quick and without any robust scientific data. With the ever-increasing rise in CI recipients undergoing diagnostic MRI over the last decade, patient MRI safety has emerged into the limelight.…”

Section: Introductionmentioning

confidence: 99%

Magnetic resonance imaging with cochlear implants and auditory brainstem implants: Are we truly practicing MRI safety?

et al. 2018

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Objective Our objective is to evaluate the safety in patients with cochlear implants (CIs) and auditory brainstem implants (ABI) undergoing 1.5 Tesla (T) magnetic resonance imaging (MRI). Secondly, we want to raise awareness on CI and MRI safety, and advocate for continued improvement and advancement to minimize morbidity for our CI patients. Methods Retrospective case series from 2006 to 2018 at a single tertiary academic center. Data was collected on patients with CI or auditory brainstem implants undergoing MRI. Outcomes collected include demographic data, age at time of MRI, MRI characteristics, complications, CI manufacturer, and image quality. Results Eighteen patients with CI or ABI collectively underwent a total of 62 MRI scans. Five of 15 (33%) CI patients with magnet had complications: five total of 24 MRI scans (21%). Two patients had magnet removal prior to 29 MRI scans without complications. Four of five MRI‐related complications were equipped with a U.S. Food and Drug Administration‐approved head wrap. Three of five required a trip to the operating room to explore and reposition the CI magnet; two could not complete MRI secondary to pain. Of the complications, two were Cochlear (Sydney, Australia), two Advanced Bionics (Valencia, CA), and one MED‐EL (Innsbruck, Austria). Synchrony model (MED‐EL) had 0 of seven complications, with a total of 19 MRI scans, which features a freely rotating and self‐aligning magnet. Conclusion Our series offers a diverse number of CI manufacturers and is in accordance with other literature that CI MRI‐related adverse events are occurring at an unacceptable frequency. We can promote CI MRI safety through our institutions' MRI CI patient protocols, raise awareness that diagnostic MRI benefits must outweigh CI‐related complications, and advocate for continued industry technological innovation. Level of Evidence 4 Laryngoscope, 129:482–489, 2019

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“…The primary reason is that CIs contain internal magnets and ferromagnetic components, including a coil used to transcutaneously relay data from the external processor to the surgically implanted components (Doucet et al, 2006; Gilley et al, 2008; Majdani et al, 2008). Such ferromagnetic implants exposed to electromagnetic fields or radiofrequency energy may heat, induce a current, or become dislocated (Azadarmaki et al, 2014; Portnoy and Mattucci, 1991; Teissl et al, 1999). Thus, the most important concern in using fMRI to study a subject with a CI is patient safety.…”

Section: Neuroimaging Options In Cochlear Implant Usersmentioning

confidence: 99%

“…Other models of CI have MRI-conditional internal magnets that do not need to be removed prior to scanning. Regardless of the status of the internal magnet, the external processors for all CI devices are MRI unsafe (Azadarmaki et al, 2014) and the radiofrequency fields generated by the MRI interfere with the transcutaneous radiofrequency link between the external and internal coils (Lazeyras et al, 2002; Seghier et al, 2005). Auditory stimulation by the implant during imaging is therefore generally precluded, though anatomical images can be acquired for medical purposes (Baumgartner et al, 2001; Crane et al, 2010; Gubbels and McMenomey, 2006).…”

Section: Neuroimaging Options In Cochlear Implant Usersmentioning

confidence: 99%

Functional near-infrared spectroscopy for neuroimaging in cochlear implant recipients

et al. 2016

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Functional neuroimaging can provide insight into the neurobiological factors that contribute to the variations in individual hearing outcomes following cochlear implantation. To date, measuring neural activity within the auditory cortex of cochlear implant (CI) recipients has been challenging, primarily because the use of traditional neuroimaging techniques is limited in people with CIs. Functional near-infrared spectroscopy (fNIRS) is an emerging technology that offers benefits in this population because it is non-invasive, compatible with CI devices, and not subject to electrical artifacts. However, there are important considerations to be made when using fNIRS to maximize the signal to noise ratio and to best identify meaningful cortical responses. This review considers these issues, the current data, and future directions for using fNIRS as a clinical application in individuals with CIs.

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MRI Information for Commonly Used Otologic Implants: Review and Update

Abstract: This monograph provides a current reference for physicians on MRI issues for commonly used otologic implants.

Cited by 46 publications

References 34 publications

Safety and Efficacy of MRI Scans in Patients With Implanted Microvascular Coupling Devices

Safety and Efficacy of MRI Scans in Patients With Implanted Microvascular Coupling Devices

Magnetic resonance imaging with cochlear implants and auditory brainstem implants: Are we truly practicing MRI safety?

Functional near-infrared spectroscopy for neuroimaging in cochlear implant recipients

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