Department of Microsystems Engineering-IMTEK, University of Freiburg, Freiburg, Germany. BrainLinks-BrainTools, Freiburg, Germany.
J Neural Eng. 2018 Aug;15(4):041002. doi: 10.1088/1741-2552/aab4e4. Epub 2018 Mar 7.
Patients suffering from neuronal degenerative diseases are increasingly being equipped with neural implants to treat symptoms or restore functions and increase their quality of life. Magnetic resonance imaging (MRI) would be the modality of choice for the diagnosis and compulsory postoperative monitoring of such patients. However, interactions between the magnetic resonance (MR) environment and implants pose severe health risks to the patient. Nevertheless, neural implant recipients regularly undergo MRI examinations, and adverse events are rarely reported. However, this should not imply that the procedures are safe. More than 300 000 cochlear implant recipients are excluded from MRI, unless the indication outweighs the excruciating pain. For 75 000 deep brain stimulation (DBS) recipients quite the opposite holds true: MRI is considered an essential part of the implantation procedure and some medical centres deliberately exceed safety regulations, which they refer to as crucially impractical. Permanent MRI-related neurological dysfunctions in DBS recipients have occurred in the past when manufacturer recommendations were exceeded. Within the last few decades, extensive effort has been invested to identify, characterise and quantify the occurring interactions. Yet today we are still far from a satisfying solution concerning a safe and beneficial MR procedure for all implant recipients. To contribute, we intend to raise awareness of the growing concern, summon the community to stop absurdities and instead improve the situation for the increasing number of patients. Therefore, we review implant safety in the MRI literature from an engineering point of view, with a focus on cochlear and DBS implants as success stories of neural implants in clinical practice. We briefly explain fundamental phenomena which can lead to patient harm, and point out breakthroughs and errors made. Then, we end with conclusions and strategies to avoid future implants from being contraindicated in MR examinations. We believe that implant recipients should enter MRI, but before doing so, it should be made sure that the procedure is reasonable.
患有神经退行性疾病的患者越来越多地配备神经植入物,以治疗症状或恢复功能并提高生活质量。磁共振成像(MRI)将是诊断和强制性术后监测此类患者的首选方式。然而,磁共振(MR)环境与植入物之间的相互作用对患者构成严重的健康风险。尽管如此,神经植入物接受者经常接受 MRI 检查,很少报告不良事件。但是,这不应意味着这些程序是安全的。超过 300,000 名人工耳蜗植入者被排除在 MRI 之外,除非适应症超过了极大的痛苦。对于 75,000 名深部脑刺激(DBS)接受者来说情况恰恰相反:MRI 被认为是植入程序的重要组成部分,一些医疗中心故意违反安全规定,他们称之为极不切实际。过去,当制造商的建议被超过时,DBS 接受者就会出现与 MRI 相关的永久性神经功能障碍。在过去的几十年中,人们投入了大量的精力来识别、描述和量化发生的相互作用。然而,今天我们仍然远未找到一种安全且有益的磁共振程序解决方案,适用于所有植入物接受者。为此,我们打算提高对这一日益增长的担忧的认识,呼吁社会停止荒谬行为,转而改善越来越多患者的状况。因此,我们从工程角度审查了 MRI 文献中的植入物安全性,重点介绍了人工耳蜗和 DBS 植入物,因为它们是临床实践中神经植入物的成功案例。我们简要解释了可能导致患者伤害的基本现象,并指出了突破和错误。最后,我们得出结论并提出策略,以避免未来的植入物在 MRI 检查中被禁忌。我们认为,植入物接受者应该接受 MRI,但在进行 MRI 之前,应确保该程序是合理的。