Strom Jordan B, Whelan Jill B, Shen Changyu, Zheng Shuang Qi, Mortele Koenraad J, Kramer Daniel B
Richard A. and Susan F. Smith Center for Cardiovascular Outcomes Research, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Harvard Medical School, Boston, Massachusetts; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Heart Rhythm. 2017 Aug;14(8):1138-1144. doi: 10.1016/j.hrthm.2017.03.039. Epub 2017 Apr 3.
Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility.
The purpose of this study was to define major and minor adverse events with off-label MRI scans.
We prospectively evaluated patients with non-MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months).
A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 56.9% [70] patients with implantable cardioverter-defibrillators; 33.3% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01-2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3-4.6). Nearly all studies (98.4% [186]) were interpretable, while 75.1% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories.
Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care.
由于对安全性的担忧以及诊断和预后效用不明确，心脏植入式电子设备患者的非标签磁共振成像（MRI）一直受到限制。
本研究的目的是确定非标签MRI扫描的主要和次要不良事件。
我们前瞻性地评估了根据严格临床方案转诊进行MRI扫描的非MRI条件适用的心脏植入式电子设备患者。主要安全结局是主要不良事件（起搏丧失、不适当的电击或抗心动过速起搏、需要系统修订或死亡）或次要不良事件（不适当的起搏、心律失常、上电复位事件、发生器部位发热或基线或6个月时设备参数变化）的发生率。
共对123例患者进行了189次MRI扫描（63.1%[78]为男性；中位年龄70±18.5岁；56.9%[70]为植入式心律转复除颤器患者；33.3%[41]为起搏器依赖患者），主要用于脑部或脊柱疾病。少数扫描（22.7%[43]）是出于紧急或急诊指征进行的。主要不良事件很少见：1例患者出现起搏丧失，无死亡或系统修订（总体发生率0.5%；95%置信区间0.01-2.91）。次要不良事件同样少见（总体发生率1.6%；95%置信区间0.3-4.6）。几乎所有研究（98.4%[186]）均可解读，而75.1%[142]根据预先设定的标准确定会改变治疗方案。与所有患者和设备类别的基线相比，MRI后急性或6个月时设备参数均未观察到具有临床意义的变化。
在严格方案下进行的非标签MRI扫描显示出优异的短期和中期安全性，同时提供了经常影响临床护理的可解读成像。
