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有心脏装置的患者进行磁共振成像的安全性
Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices


Saman Nazarian ... 心脑血管疾病 • 2017.12.28
相关阅读
• 关于植入式装置患者接受MRI检查安全性的更多数据 • 置入起搏器或除颤器的患者接受MRI检查的相关危险评估 • 置入型心脏装置成功通过了MRI检查

摘要


背景

出于安全考虑,有心脏起搏器或除颤器的患者经常不被允许进行磁共振成像(MRI)检查,除非装置符合美国食品药品监督管理局(FDA)的特定标准(称为“MRI兼容型”装置)。

 

方法

我们进行了一项前瞻性非随机研究,在1,509例有非MRI兼容型起搏器(58%)或植入式心脏复律除颤器(42%)(称为“传统”装置)的患者中评估在磁场强度为1.5 T时MRI的安全性。总体而言,患者接受了被认为是临床必要的2,103次胸部和非胸部MRI检查。对于起搏依赖患者,起搏模式改变为异步模式,对于其他患者则为按需模式。快速性心律失常功能被禁用。结局评估包括不良事件和变量的变化,这些变量表明电极导线和发生器功能以及与周围组织的相互作用(装置参数)。

 

结果

研究中并无有临床意义的长期不良事件的相关报告。在9次MRI检查中(0.4%;95%置信区间[CI],0.2~0.7),患者的装置重置为备份模式(backup mode)。其中的8次重置是短暂的。在1例MRI检查中,电池寿命不足1个月的起搏器重置为心室抑制型起搏且不能重新程控;该装置随后被更换。MRI后即刻装置参数中最常见的明显变化(与基线相比变化大于50%)为P波振幅减少,发生于1%的患者。在长期随访(63%的患者获得了结果)中,与基线相比最常见的明显变化是P波振幅减小(4%的患者)、心房夺获阈值升高(4%)、右心室夺获阈值升高(4%)和左心室夺获阈值升高(3%)。所观察到的电极导线参数的变化不具有临床意义,并且不需要装置修改或重新程控。

 

结论

我们在1,509例有传统起搏器或传统植入式心脏复律除颤器的患者中,评估了使用预设的安全方案进行MRI的安全性。研究中并无有临床意义的长期不良事件的相关报告(由约翰霍普金斯大学和美国国立卫生研究院资助;在ClinicalTrials.gov注册号为NCT01130896)。





作者信息

Saman Nazarian, M.D., Ph.D., Rozann Hansford, R.N., M.P.H., Amir A. Rahsepar, M.D., Valeria Weltin, M.S., Diana McVeigh, B.S., Esra Gucuk Ipek, M.D., Alan Kwan, M.D., Ronald D. Berger, M.D., Ph.D., Hugh Calkins, M.D., Albert C. Lardo, Ph.D., Michael A. Kraut, M.D., Ph.D., Ihab R. Kamel, M.D., Ph.D., Stefan L. Zimmerman, M.D., and Henry R. Halperin, M.D.
From the Department of Medicine–Cardiology, University of Pennsylvania Perelman School of Medicine, Philadelphia (S.N.); and the Departments of Medicine–Cardiology (S.N., R.H., A.A.R., V.W., D.M., E.G.I., A.K., R.D.B., H.C., A.C.L., H.R.H.), Epidemiology (S.N.), Radiology (A.C.L., M.A.K., I.R.K., S.L.Z., H.R.H.), and Biomedical Engineering (R.D.B., A.C.L., H.R.H.), Johns Hopkins University, Baltimore. Address reprint requests to Dr. Nazarian at the University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., Founders 9, Philadelphia, PA, 19104, or at saman.nazarian@uphs.upenn.edu.

 

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