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Magnetic resonance imaging in patients with cardiac pacemakers: era of MR Conditional designs

机译:心脏起搏器患者的磁共振成像: MR条件式设计时代

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摘要

Advances in cardiac device technology have led to the first generation of magnetic resonance imaging (MRI) conditional devices, providing more diagnostic imaging options for patients with these devices, but also new controversies. Prior studies of pacemakers in patients undergoing MRI procedures have provided groundwork for design improvements. Factors related to magnetic field interactions and transfer of electromagnetic energy led to specific design changes. Ferromagnetic content was minimized. Reed switches were modified. Leads were redesigned to reduce induced currents/heating. Circuitry filters and shielding were implemented to impede or limit the transfer of certain unwanted electromagnetic effects. Prospective multicenter clinical trials to assess the safety and efficacy of the first generation of MR conditional cardiac pacemakers demonstrated no significant alterations in pacing parameters compared to controls. There were no reported complications through the one month visit including no arrhythmias, electrical reset, inhibition of generator output, or adverse sensations. The safe implementation of these new technologies requires an understanding of the well-defined patient and MR system conditions. Although scanning a patient with an MR conditional device following the strictly defined patient and MR system conditions appears straightforward, issues related to patients with pre-existing devices remain complex. Until MR conditional devices are the routine platform for all of these devices, there will still be challenging decisions regarding imaging patients with pre-existing devices where MRI is required to diagnose and manage a potentially life threatening or serious scenario. A range of other devices including ICDs, biventricular devices, and implantable physiologic monitors as well as guidance of medical procedures using MRI technology will require further biomedical device design changes and testing. The development and implementation of cardiac MR conditional devices will continue to require the expertise and collaboration of multiple disciplines and will need to prove safety, effectiveness, and cost effectiveness in patient care.
机译:心脏设备技术的进步导致了第一代磁共振成像(MRI)条件设备的问世,它为使用这些设备的患者提供了更多的诊断成像选项,但也带来了新的争议。对接受MRI程序的患者进行起搏器的先前研究为改进设计提供了基础。与磁场相互作用和电磁能传递相关的因素导致特定的设计更改。铁磁含量最小化。簧片开关已修改。重新设计了导线,以减少感应电流/发热。实施电路滤波器和屏蔽是为了阻止或限制某些有害电磁效应的传递。评估第一代MR条件性心脏起搏器安全性和有效性的前瞻性多中心临床试验表明,与对照组相比,起搏参数没有明显改变。在一个月的随访中,没有任何并发​​症的报道,包括心律不齐,电复位,发电机输出抑制或不良感觉。这些新技术的安全实施需要了解明确定义的患者和MR系统的状况。尽管遵循严格定义的患者和MR系统条件对MR条件设备进行扫描似乎很简单,但是与使用现有设备的患者相关的问题仍然很复杂。直到MR条件设备成为所有这些设备的常规平台之前,对于需要使用MRI诊断和管理可能危及生命或严重状况的现有设备进行成像,仍然存在挑战性的决策。其他许多设备,包括ICD,双心室设备和可植入的生理监护仪,以及使用MRI技术的医疗程序指南,都将需要进一步的生物医学设备设计变更和测试。心脏MR条件设备的开发和实施将继续需要多个学科的专业知识和协作,并且需要证明患者护理的安全性,有效性和成本效益。

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