 磁共振成像在心脏病患者中的安全性 摘 要 背景 ：除非设备符合美国食品和药品管理局（称为“MRI-conditional”设备）规定的某些标准，否则由于安全考虑装有起搏器或除颤器的患者经常被拒绝进行磁共振成像（MRI）检查。 BACKGROUND：Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed 'MRI-conditional' devices). 方法：我们进行了一项前瞻性、非随机性研究，评估了1509例装有起搏器（58％）或植入式心脏复律除颤器（42％）的患者在磁场强度为1.5特斯拉MRI的安全性，这些起搏器及心脏复律除颤器被认为不符合MRI条件（称为“遗留”装置）。总体而言，患者接受了2103次胸部和非胸部MRI检查，这些被认为是临床上必要的检查。对于起搏依赖患者，起搏模式改变为非同步模式，其他患者则为按需模式。快速性心律失常功能被禁用。结果评估包括不良事件和变量的变化，这些变量表明电极和发生器的功能以及与周围组织（装置参数）的相互作用。 METHODS：We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI- conditional (termed a 'legacy' device).Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary.The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients.Tachyarrhythmia functions were disabled.Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). 结果：没有报告有长期临床意义的不良事件。在9次MRI检查中（0.4％; 95％置信区间，0.2〜0.7），患者的设备重置为后备模式。9次检查中有8次重置是短暂的。在一例中，电池寿命还剩不到1个月的起搏器重置为心室抑制性起搏，不能重新编程;该设备随后被更换。设备参数中最常见的显著变化（从基线变化大于50％）是在MRI后立即减少了P波振幅，这发生在1％的患者中。在长期的随访中（63％的患者有可用的结果），最常见的显著变化是P波振幅（4％患者）、心房收缩阈值增加（4％）、右室俘获阈值增加（4％）和左室俘获阈值增加（3％）。所观察到的电极参数的变化不具有临床意义，并且不需要设备修改或重新编程。 RESULTS：No long-term clinically significant adverse events were reported.In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode.The reset was transient in eight of the nine examinations.In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed;the device was subsequently replaced.The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients.At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold ( 4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%).The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. 结论：我们使用预先设定的安全性方案，在1509名装有传统起搏器或传统植入式心脏复律除颤器系统的患者中评估了MRI检查的安全性。没有报告具有长期临床意义的不良事件。（由约翰霍普金斯大学和国立卫生研究院资助; ClinicalTrials.gov编号，NCT01130896）。 CONCLUSIONS：We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter- defibrillator system.No long-term clinically significant adverse events were reported.(Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials.gov number, NCT01130896.) |
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