ProMRI 植入式心脏复律除颤器系统在 1.5T 头和下腰椎磁共振成像中的临床安全性。

Clinical safety of ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 1.5 Tesla.

机构信息

Department of Internal Medicine I, Universitätsklinikum Würzburg, Würzburg, Germany.

Centre for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.

出版信息

Sci Rep. 2019 Dec 3;9(1):18243. doi: 10.1038/s41598-019-54342-4.

Abstract

Magnetic resonance imaging (MRI) has long been contraindicated in patients with implanted pacemakers, defibrillators, and cardiac resynchronisation therapy (CRT) devices due to the risk of adverse effects through electromagnetic interference. Since many recipients of these devices will have a lifetime indication for an MRI scan, the implantable systems should be developed as 'MRI-conditional' (be safe for the MRI environment under predefined conditions). We evaluated the clinical safety of several Biotronik ProMRI ('MRI-conditional') defibrillator and CRT systems during head and lower lumbar MRI scans at 1.5 Tesla. The study enrolled 194 patients at 22 sites in Australia, Canada, and Europe. At ≥9 weeks after device implantation, predefined, non-diagnostic, specific absorption rate (SAR)-intensive head and lower lumbar MRI scans (total ≈30 minutes per patient) were performed in 146 patients that fulfilled pre-procedure criteria. Three primary endpoints were evaluated: freedom from serious adverse device effects (SADEs) related to MRI and defibrillator/CRT (leading to death, hospitalisation, life-threatening condition, or potentially requiring implanted system revision or replacement), pacing threshold increase, and sensing amplitude decrease, all at the 1-month post-MRI clinical visit. No MRI-related SADE occurred. Lead values remained stable, measured in clinic and monitored daily by the manufacturer home monitoring technology.

摘要

磁共振成像(MRI)在很长一段时间内都被禁忌用于植入心脏起搏器、除颤器和心脏再同步治疗(CRT)设备的患者,因为存在电磁干扰导致不良反应的风险。由于这些设备的许多接受者将终生需要进行 MRI 扫描,因此植入系统应被开发为“MRI 条件性”(在预定义条件下对 MRI 环境安全)。我们在澳大利亚、加拿大和欧洲的 22 个地点评估了 194 名患者使用 Biotronik ProMRI(“MRI 条件性”)除颤器和 CRT 系统进行头部和下腰椎 1.5T MRI 扫描的临床安全性。在设备植入后至少 9 周,符合预先规定的非诊断性、特定吸收率(SAR)密集型头部和下腰椎 MRI 扫描(每位患者总共约 30 分钟)在 146 名符合预程序标准的患者中进行。评估了三个主要终点:与 MRI 和除颤器/CRT 相关的无严重不良设备事件(SADE)的自由(导致死亡、住院、危及生命的情况或可能需要植入系统修订或更换)、起搏阈值增加和感测幅度降低,所有这些都在 MRI 后 1 个月的临床就诊时进行。没有发生与 MRI 相关的 SADE。在诊所测量和制造商家庭监测技术每天监测时,导联值保持稳定。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5582/6890633/6c9ddf362714/41598_2019_54342_Fig1_HTML.jpg

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