Safety assessment of magnetic resonance imaging in patients with retained cardiac leads

保留心脏导线患者的磁共振成像安全性评估

• 批准号: 9762904
• 负责人: Laleh Golestani Rad
• 金额: $ 7.84万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-13 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9762904
• 关键词: 3-Dimensional; Anatomy; Arthritis; Benefits and Risks; Cardiac; Cardiovascular system; Characteristics; Clinical; Clinical Protocols; Coiled Bodies; Comorbidity; Computer Simulation; Computing Methodologies; Couples; Data; Databases; Defibrillators; Dependence; Deposition; Development; Devices; Diagnostic; Disease; Electromagnetic Energy; Electromagnetics; Electronics; Elements; Equation; Female; Frequencies; Future; Generations; Geometry; Goals; Growth; Guidelines; Head; Heart Transplantation; Heating; Human body; Image; Imaging Device; Implant; In Situ; In Vitro; Individual; Injury; Investigation; Label; Lead; Left; Length; Location; Magnetic Resonance Imaging; Malignant Neoplasms; Methodology; Modeling; Obesity; Pacemakers; Patient imaging; Patients; Physiologic pulse; Postoperative Period; Probability; Procedures; Property; Protocols documentation; RF coil; Reporting; Resolution; Risk; Safety; Somatotype; Stroke; Structure; Supercomputing; Surface; Temperature; Thoracic Radiography; Time; Tissues; United States; Variant; Ventricular Function; Work; X-Ray Computed Tomography; absorption; base; clinical imaging; clinical practice; cohort; computational platform; electric field; evidence base; experimental study; hazard; human model; imaging modality; in vivo; magnetic field; male; models and simulation; non-invasive imaging; operation; patient population; phenomenological models; radio frequency; repository; risk minimization; safety assessment; safety study; side effect; simulation; soft tissue

Project Summary/Abstract The number of patients with a cardiovascular implanted electronic device (CIED) is rapidly and constantly growing, now comprising several million patients worldwide. It is estimated that up to 75% of all patients with CIED will have the future need for a magnetic resonance imaging (MRI) investigation due to the high probability of comorbidities such as stroke, lumbar disease, arthritis, or cancer in this patient population. A few studies have assessed the safety of endocardial leads connected to working devices, but many patients require additional procedures which lead to “lead extraction”, leaving fractions of the device left in situ, in which case the original safety studies of the device/lead combination are not applicable. Magnetic resonance imaging (MRI) is considered the imaging tool of choice in a wide range of diagnostic tasks, however, MRI is currently a contraindication for patients with abandoned or retained cardiac leads. This is particularly alarming, considering that 50% of patients undergoing heart transplantation who significantly benefit from MRI in assessment of rejection and ventricular function have already abandoned or retained leads from a previously implanted CIED. The major safety concern is due to the so-called “antenna effect”, where the electric field of the MRI transmit coil couples with conductive implanted leads and amplifies energy deposition in the tissue which leads to excessive heating and potential tissue damage. Phantom experiments have highlighted the significant effect of lead geometry, location, and trajectory on MR-induced RF heating, yet almost nothing is known about the actual temperature rise in the tissue in a realistic patient population. A significant challenge is that the problem has a very large parameter space with many interacting factors that preclude the application of a systematic experimental approach to estimate heating in the worst case scenario. This proposal aims to develop, optimize, and validate computational methodologies that consistently and reliably predict tissue heating in patients with retained leads during high-field MRI. As a first step, we will complete development of a repository of 30 patient-derived realistic models of abandoned/retained leads that incorporate detailed features of the lead structure and trajectory, co-registered in high-resolution anatomically detailed models of human body. We will then use these patient-derived lead and body models along with experimentally validated models of MRI transmit coils and perform full-wave electromagnetic simulations to calculate tissue heating during MRI at both 1.5 T and 3.0 T. Dependency and sensitivity of results on parameters such as RF coil’s frequency (64 MHz, vs. 127 MHz), mode of operation (linear vs. quadrature), body model characteristics (size, number of tissues, electric and thermal properties), and lead trajectory will be examined. Finally, we will use this information to devise an evidence-based, patient-specific, and easy-to-use clinical guideline to help clinicians better assess risks and benefits of performing MRI on these patients based on the particular imaging landmark and the pulse sequence in use.

项目概要/摘要 心血管植入电子设备 (CIED) 患者的数量持续快速增长 不断增长，目前全世界有数百万患者，估计高达 75% 的患者患有此病。 由于高风险，CIED 未来将需要进行磁共振成像 (MRI) 调查 该患者群体中出现中风、腰椎疾病、关节炎或癌症等合并症的可能性。 研究评估了连接到工作装置的心内膜导线的安全性，但许多患者 需要额外的程序，导致“铅提取”，将设备的碎片留在原位，其中 在这种情况下，设备/导线组合的原始安全研究不适用。 (MRI) 被认为是多种诊断任务中首选的成像工具，然而，MRI 目前是一种 对于废弃或保留心脏导线的患者来说，这是特别令人震惊的禁忌症。 考虑到 50% 接受心脏移植的患者从 MRI 中显着受益 排斥反应和心室功能的评估已经放弃或保留了先前的导联 植入式 CIED 的主要安全问题是所谓的“天线效应”，即电场。 MRI 发射线圈与植入的导电导线耦合并放大组织中的能量沉积 这会导致过度加热和潜在的组织损伤。 引线几何形状、位置和轨迹对 MR 感应射频加热有显着影响，但几乎没有任何影响 了解现实患者群体中组织的实际温度升高是一个重大挑战。 该问题具有非常大的参数空间，并且存在许多妨碍应用的相互作用因素 该提案旨在采用系统的实验方法来估计最坏情况下的加热情况。 开发、优化和验证能够一致且可靠地预测组织的计算方法 在高场 MRI 期间对保留导线的患者进行加热 作为第一步，我们将完成开发 包含 30 个源自患者的废弃/保留导联真实模型的存储库，其中包含详细特征 引线结构和轨迹，共同注册在高分辨率的人体解剖学详细模型中 然后，我们将使用这些源自患者的引线和身体模型以及经过实验验证的模型。 MRI 发射线圈并执行全波电磁模拟以计算 MRI 期间的组织加热 在 1.5 T 和 3.0 T 下。结果对 RF 线圈频率等参数的依赖性和敏感性 (64 MHz，与 127 MHz）、操作模式（线性与正交）、人体模型特征（尺寸、数量 最后，我们将使用它。 信息来制定基于证据的、针对特定患者且易于使用的临床指南来帮助殖民者 根据特定的成像标志更好地评估对这些患者进行 MRI 的风险和益处 和使用的脉冲序列。

项目成果

RF heating of deep brain stimulation implants during MRI in 1.2 T vertical scanners versus 1.5 T horizontal systems: A simulation study with realistic lead configurations.

MRI 期间 1.2 T 垂直扫描仪与 1.5 T 水平系统中深部脑刺激植入物的射频加热：使用真实引线配置的模拟研究。

• 发表时间: 2020-07
• 作者: Kazemivalipour, Ehsan;Vu, Jasmine;Lin, Stella;Bhusal, Bhumi;Thanh Nguyen, Bach;Kirsch, John;Elahi, Behzad;Rosenow, Joshua;Atalar, Ergin;Golestanirad, Laleh
• 通讯作者: Golestanirad, Laleh

Device Configuration and Patient's Body Composition Significantly Affect RF Heating of Deep Brain Stimulation Implants During MRI: An Experimental Study at 1.5T and 3T.

设备配置和患者的身体成分显着影响 MRI 期间脑深部刺激植入物的射频加热：1.5T 和 3T 的实验研究。

• 发表时间: 2020-07
• 作者: Bhusal, Bhumi;Nguyen, Bach T;Vu, Jasmine;Elahi, Behzad;Rosenow, Joshua;Nolt, Mark J;Pilitsis, Julie;DiMarzio, Marisa;Golestanirad, Laleh
• 通讯作者: Golestanirad, Laleh

The effect of simulation strategies on prediction of power deposition in the tissue around electronic implants during magnetic resonance imaging.

模拟策略对磁共振成像期间电子植入物周围组织中功率沉积预测的影响。

• 发表时间: 2020
• 影响因子: 3.5
• 作者: Nguyen, Bach T;Pilitsis, Julie;Golestanirad, Laleh
• 通讯作者: Golestanirad, Laleh

Vertical open-bore MRI scanners generate significantly less radiofrequency heating around implanted leads: A study of deep brain stimulation implants in 1.2T OASIS scanners versus 1.5T horizontal systems.

垂直开孔 MRI 扫描仪在植入导线周围产生的射频加热显着减少：一项针对 1.2T OASIS 扫描仪与 1.5T 水平系统中的深部脑刺激植入物的研究。

• 发表时间: 2021
• 影响因子: 3.3
• 作者: Kazemivalipour, Ehsan;Bhusal, Bhumi;Vu, Jasmine;Lin, Stella;Nguyen, Bach Thanh;Kirsch, John;Nowac, Elizabeth;Pilitsis, Julie;Rosenow, Joshua;Atalar, Ergin;Golestanirad, Laleh
• 通讯作者: Golestanirad, Laleh

Effect of Device Configuration and Patient's Body Composition on the RF Heating and Nonsusceptibility Artifact of Deep Brain Stimulation Implants During MRI at 1.5T and 3T.

1.5T 和 3T MRI 期间设备配置和患者身体成分对深部脑刺激植入物的射频加热和不敏感伪影的影响。

• 发表时间: 2021
• 作者: Bhusal, Bhumi;Nguyen, Bach T;Sanpitak, Pia P;Vu, Jasmine;Elahi, Behzad;Rosenow, Joshua;Nolt, Mark J;Lopez;Pilitsis, Julie;DiMarzio, Marisa;Golestanirad, Laleh
• 通讯作者: Golestanirad, Laleh