Safety and Clinical Impact of MRI in Patients with Non- MRI-conditional Cardiac Devices
Safety and Clinical Impact of MRI in Patients with Non- MRI-conditional Cardiac Devices
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DOI：
10.1148/ryct.2020200086
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发表时间：
2020-10-01
期刊：
影响因子：
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通讯作者：
Saeed, Ibrahim M.
中科院分区：
文献类型：
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作者：
Gupta, Sanjaya K.;Ya'qoub, Lina;Saeed, Ibrahim M.
目的：通过建立非批准器械磁共振成像患者登记（PROMeNADe），探索MRI在植入非MRI特定条件安全心脏植入式电子器械的受试者中的安全性和临床效用。材料和方法：从2015年9月至2019年6月，PROMeNADe登记研究（ClinicalTrials.gov标识符：NCT 03081364）前瞻性入组了532例受试者（211例女性），平均年龄为69岁6 14岁（标准差），共进行了608次MRI检查（61次心脏MRI检查）。所有参与者在每次MRI之前和之后都进行了器械询问。起搏器依赖患者接受异步起搏。植入心律转复除颤器（ICD）的患者在MRI期间禁用了心动过速治疗。电生理学护士监测参与者的任何血流动力学或心律异常。就MRI的临床效用对转诊医生进行了调查。标准的描述性分析包括百分比和means.Results的汇总统计：心脏设备包括起搏器（46%），ICD（30%），心脏起搏治疗（CRT）起搏器（4%），CRT起搏器（17%），以及废弃的导线（2%）。起搏器依赖患者占所有MRI检查的27%。无患者或器械相关并发症。MRI检查的临床效用调查由150名物理学家完成。根据调查结果，这些MRI检查改变了25%的疑似诊断，26%的参与者改变了疑似预后，42%的参与者改变了计划的内科或外科治疗。本登记研究证明，MRI检查（包括胸部MRI检查）可在植入非MRI特定条件安全器械的患者中安全进行，植入ICD的起搏器依赖性患者和植入废弃电极导线的患者。这些MRI检查可以对患者护理产生重大影响，证明用于执行这些检查的广泛资源是合理的。
Purpose: To explore the safety and clinical utility of MRI in participants with non-MRI-conditional cardiac implantable electronic devices, by establishing the Patient Registry of Magnetic Resonance Imaging in Non-Approved DEvices (PROMeNADe). Materials and Methods: From September 2015 to June 2019, 532 participants (211 women) with a mean age of 69 years 6 14 (standard deviation) were enrolled prospectively in the PROMeNADe registry (ClinicalTrials.gov identifier: NCT03081364) and underwent a total of 608 MRI examinations (61 cardiac MRI examinations). All participants had device interrogations performed before and after each MRI. Pacemaker-dependent patients received asynchronous pacing. Patients with an implantable cardioverter defibrillator (ICD) had tachycardia therapies disabled during the MRI. An electrophysiology nurse monitored participants for any hemodynamic or rhythm abnormalities. Referring physicians were surveyed regarding the clinical utility of the MRI. Standard descriptive analyses included summary statistics with percentages and means.Results: Cardiac devices included pacemakers (46%), ICDs (30%), cardiac resynchronization therapy (CRT) pacemakers (4%), and CRT defibrillators (17%), as well as abandoned leads (2%). Pacemaker-dependent patients comprised 27% of all MRI examinations. There were no patient-or device-related complications. Clinical utility surveys of MRI examinations were completed by 150 physi-cians. According to the survey responses, these MRI examinations changed the suspected diagnosis 25% of the time and changed sus-pected prognosis in 26% of participants, with planned medical or surgical treatment being changed 42% of the time.Conclusion: This registry demonstrates that MRI examinations, including thoracic MRI examinations, can be performed safely in pa-tients who have non-MRI-conditional devices, in pacemaker-dependent patients with ICDs, and in patients with abandoned leads. These MRI examinations can have a substantial impact on patient care, justifying the extensive resources used to perform them.