一种MRI条件兼容的植入式心脏复律除颤器系统的临床安全性：一项前瞻性单中心ICD-磁共振成像可行性研究（MIMI）

Clinical safety of an MRI conditional implantable cardioverter defibrillator system: A prospective Monocenter ICD-Magnetic resonance Imaging feasibility study (MIMI).

作者信息

Kypta Alexander, Blessberger Hermann, Hoenig Simon, Saleh Karim, Lambert Thomas, Kammler Juergen, Fellner Franz, Lichtenauer Michael, Steinwender Clemens

机构信息

Department of Cardiology, Linz General Hospital, Johannes Kepler University School of Medicine, Linz, Austria.

Department of Radiology, Linz General Hospital, Johannes Kepler University School of Medicine, Linz, Austria.

出版信息

J Magn Reson Imaging. 2016 Mar;43(3):574-84. doi: 10.1002/jmri.25037. Epub 2015 Sep 3.

DOI:10.1002/jmri.25037

PMID:26335332

Abstract

BACKGROUND

The aim of this study was to evaluate the safety and efficacy of the Lumax 740(®) Implantable Cardioverter Defibrillator (ICD) system in patients undergoing a defined 1.5 Tesla (T) MRI.

MATERIALS AND METHODS

Between November 2013 and April 2014, eighteen patients (age range, 41-78 years; mean age, 64 years) implanted with a Lumax 740(®) ICD system for at least 6 weeks before an MRI were enrolled into this single-center feasibility study. The local ethics committee approved the study before patients gave written informed consent. Patients underwent defined MRI 1.5T of the brain and lower lumbar spine with three safety follow-up evaluations obtained during the 3-month study period. Data were analyzed descriptively. Study endpoints were the absence of either MRI and pacing system related serious adverse device effects (SADE), or of a ventricular pacing threshold increase >0.5V, or of an R-wave amplitude attenuation < 50%, or of an R-wave amplitude < 5.0 mV at 1-month follow-up. The assessment of safety and efficacy was supported by recording of all adverse events, changes in pacing threshold, R-wave sensing, pacing impedances and in battery status.

RESULTS

Sixteen patients completed the MRI and the follow-up period. As no SADE occurred, the SADE free rate was 100%. Freedom from ventricular pacing threshold increase was 100% (16/16; 95%CI: 82.9%; 100.0%). There were no significant differences between baseline and follow-up measurements of sensing amplitudes (-0.58 ± 2.07 mV, P = 0.239, -0.41 ± 1.04 mV, P = 0.133, and -0.25 ± 1.36 mV, P = 0.724, for immediately after, 1 month and 3 months after MRI scan, respectively) and pacing thresholds (-0.047 ± 0.18 V, P = 0.317, -0.019 ± 0.11 V, P = 0.490, and 0.075 ± 0.19 V, P = 0.070, for immediately after, 1 month and 3 months after MRI scan, respectively). Lead impedances after the MRI scan were significantly lower as compared with baseline values (-22.8 ± 21.69 Ω, P = 0.001, -21.62 ± 39.71 Ω, P = 0.040, and -33.68 ± 57.73 Ω, P = 0.018, for immediately after, 1 month and 3 months after MRI scan, respectively).

CONCLUSION

MRI scans in patients with MRI conditional ICD system (Lumax 740(®) ) are feasible and can be performed safely under defined conditions in a hospital setting.

摘要

背景

本研究旨在评估Lumax 740®植入式心脏复律除颤器（ICD）系统在接受1.5特斯拉（T）磁共振成像（MRI）检查患者中的安全性和有效性。

材料与方法

2013年11月至2014年4月期间，18例植入Lumax 740® ICD系统且在MRI检查前至少已植入6周的患者（年龄范围41 - 78岁；平均年龄64岁）被纳入本单中心可行性研究。当地伦理委员会在患者签署书面知情同意书之前批准了该研究。患者接受了脑部和下腰椎的1.5T MRI检查，并在为期3个月的研究期间进行了三次安全性随访评估。对数据进行描述性分析。研究终点为在1个月随访时不存在与MRI和起搏系统相关的严重不良器械效应（SADE），不存在心室起搏阈值升高>0.5V，不存在R波振幅衰减<50%，不存在R波振幅<5.0 mV。通过记录所有不良事件、起搏阈值变化、R波感知、起搏阻抗和电池状态来支持安全性和有效性评估。

结果

16例患者完成了MRI检查及随访期。由于未发生SADE，SADE无发生率为100%。心室起搏阈值未升高的比例为100%（16/16；95%置信区间：82.9%；100.0%）。MRI扫描后即刻、1个月和3个月时的感知振幅（分别为-0.58±2.07 mV，P = 0.239；-0.41±1.04 mV，P = 0.133；-0.25±1.36 mV，P = 0.724）和起搏阈值（分别为-0.047±0.18 V，P = 0.317；-0.019±0.11 V，P = 0.490；0.075±0.19 V，P = 0.070）与基线测量值之间无显著差异。MRI扫描后的导线阻抗与基线值相比显著降低（分别为-22.8±21.69 Ω，P = 0.001；-21.62±39.71 Ω，P = 0.040；-33.68±57.73 Ω，P = 0.018）。