Scripps Clinic, La Jolla, CA, USA.
Am Heart J. 2013 Mar;165(3):266-72. doi: 10.1016/j.ahj.2012.12.004. Epub 2013 Jan 28.
Until recently, the presence of a permanent pacemaker or an implantable cardioverter-defibrillator has been a relative contraindication for the performance of magnetic resonance imaging (MRI). A number of small studies have shown that MRI can be performed with minimal risk when patients are properly monitored and device programming is modified appropriately for the procedure. However, the risk of performing MRI for patients with implanted cardiac devices has not been sufficiently evaluated to advocate routine clinical use. The aim of the present protocol is to prospectively determine the rate of adverse clinical events and device parameter changes in patients with implanted non-MRI-conditional cardiac devices undergoing clinically indicated nonthoracic MRI at 1.5 T.
The MagnaSafe Registry is a multicenter, prospective cohort study of up to 1500 MRI examinations in patients with pacemakers or implantable cardioverter-defibrillators implanted after 2001 who undergo clinically indicated nonthoracic MRI following a specific protocol to ensure that preventable potential adverse events are mitigated. Adverse events and changes in device parameter measurements that may be associated with the imaging procedure will be documented.
Through August 2012, 701 MRI studies have been performed, representing 47% of the total target enrollment.
The results of this registry will provide additional documentation of the risk of MRI and will further validate a clinical protocol for screening and the performance of clinically indicated MRI for patients with implanted cardiac devices.
直到最近，永久性心脏起搏器或植入式心脏复律除颤器的存在一直是磁共振成像（MRI）的相对禁忌证。一些小型研究表明，当患者得到适当的监测并且设备编程为该程序进行适当修改时，MRI 可以以最小的风险进行。然而，尚未充分评估对植入式心脏设备患者进行 MRI 的风险，因此不能提倡常规临床使用。本方案的目的是前瞻性地确定在植入非 MRI 条件的心脏设备的患者中，在 1.5 T 下进行临床指征性非胸部 MRI 时发生不良临床事件和设备参数变化的发生率。
MagnaSafe 注册研究是一项多中心、前瞻性队列研究，共纳入 2001 年后植入起搏器或植入式心脏复律除颤器的患者，最多 1500 例，他们根据特定方案接受临床指征性非胸部 MRI，以确保减轻可预防的潜在不良事件。将记录与成像程序相关的不良事件和设备参数测量变化。
截至 2012 年 8 月，已进行了 701 项 MRI 研究，占总目标入组人数的 47%。
该注册研究的结果将提供 MRI 风险的额外证据，并进一步验证用于筛查和对植入式心脏设备患者进行临床指征性 MRI 的临床方案。
