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Safety of active auditory implants in magnetic resonance imaging.

ABSTRACT: Magnetic resonance imaging (MRI) has become the gold standard for the diagnosis of many pathologies. Using MRI in patients with auditory implants can however raise concerns due to mutual interactions between the implant and imaging device, resulting in potential patient risks. Several implant manufacturers have been working towards more MRI safe devices. Older devices are however often labelled for more stringent conditions, possibly creating confusion with patients and professionals. With this myriad of different devices that are implanted in patients for lifetimes of at least 20 years, it is crucial that both patients and professionals have a clear understanding of the safety of their devices. This work aims at providing an exhaustive overview on the MRI safety of active auditory implants. The available industry standards that are followed by manufacturers are outlined and an overview of the latest scientific developments focusing on the last five years is provided. In addition, based on the analysis of the adverse events reported to the Food and Drug Administration (FDA) and in literature within the past ten years, a systematic review of the most commonly occurring issues for patients with auditory implants in the MRI environment is provided. Results indicate that despite the release of more MRI conditional active hearing implants on the market, adverse events still occur. An extensive overview is provided on the MRI safety of active auditory implants, aiming to increase the understanding of the topic for healthcare professionals and contribute to safer scanning conditions for patients.

SUBMITTER: Fierens G

PROVIDER: S-EPMC8241703 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPatients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices).MethodsWe performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters).ResultsNo long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming.ConclusionsWe evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter-defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials.gov number, NCT01130896 .).

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Safety of active auditory implants in magnetic resonance imaging.

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