Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator
Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator
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DOI：
10.1056/nejmoa1603265
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发表时间：
2017-02-23
影响因子：
158.5
通讯作者：
Wolff, Steven D.
中科院分区：
文献类型：
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作者：
Russo, Robert J.;Costa, Heather S.;Wolff, Steven D.
心血管植入式电子设备的存在长期以来一直是磁共振成像（MRI）性能的禁忌症。我们建立了一项前瞻性登记研究，以确定在磁场强度为1.5特斯拉的情况下，植入起搏器或植入式心律转复除颤器（ICD）的“非MRI条件”（即，未经食品和药物管理局批准用于MRI扫描）。方法登记处的患者被转诊进行临床指征的非胸部MRI，场强为1.5特斯拉。使用标准化方案在MRI前后询问器械，并在扫描前适当重新程控。主要终点为死亡、发生器或电极导线故障、诱发心律失常、失夺获或扫描期间电复位。在1000例植入起搏器的患者和500例植入ICD的患者中进行了TSMRI。MRI期间未发生死亡、电极导线失效、失夺获或室性心律失常。一个ICD发生器在MRI后无法询问，需要立即更换;该器械在MRI前未按照方案进行适当程控。我们观察到6例房颤或扑动自行终止和6例部分电重置。在少数情况下，电极导线阻抗、起搏阈值、电池电压以及P波和R波振幅的变化超过了预先规定的阈值。重复MRI与不良事件的增加无关。CONCLUSIONSIn this study，器械或电极导线故障未发生在任何非MRI条件性起搏器或ICD患者中，这些患者接受了1.5 T的临床非胸部MRI检查，进行了适当的筛选，并按照预先规定的方案对器械进行了重新程控。
BACKGROUNDThe presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverterdefibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning).METHODSPatients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings.RESULTSMRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events.CONCLUSIONSIn this study, device or lead failure did not occur in any patient with a non-MRIconditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol.