King's College London BHF Centre, Division of Imaging Sciences, NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
Circ Cardiovasc Interv. 2010 Dec;3(6):585-92. doi: 10.1161/CIRCINTERVENTIONS.110.957209. Epub 2010 Nov 23.
Percutaneous cardiac interventions are currently performed under x-ray guidance. Magnetic resonance imaging (MRI) has been used to guide intravascular interventions in the past, but mainly in animals. Translation of MR-guided interventions into humans has been limited by the lack of MR-compatible and safe equipment, such as MR guide wires with mechanical characteristics similar to standard guide wires. The aim of the present study was to evaluate the safety and efficacy of a newly developed MR-safe and compatible passive guide wire in aiding MR-guided cardiac interventions in a swine model and describe the 2 first-in-man solely MR-guided interventions.
In the preclinical trial, the new MR-compatible wire aided the performance of 20 interventions in 5 swine. These consisted of balloon dilation of nondiseased pulmonary and aortic valves, aortic arch, and branch pulmonary arteries. After ethics and regulatory authority approval, the 2 first-in-man MR-guided interventions were performed in a child and an adult, both with elements of valvar pulmonary stenosis. Catheter manipulations were monitored with real-time MRI sequence with interactive modification of imaging plane and slice position. Temporal resolution was 11 to 12 frames/s. Catheterization procedure times were 110 and 80 minutes, respectively. Both patients had successful relief of the valvar stenosis and no procedural complications.
The described preclinical study and case reports are encouraging that with the availability of the new MR-compatible and safe guide wire, certain percutaneous cardiac interventions will become feasible to perform solely under MR guidance in the future. A clinical trial is underway in our institution.
目前，经皮心脏介入治疗是在 X 射线引导下进行的。磁共振成像（MRI）过去曾用于指导血管内介入，但主要是在动物身上。将 MRI 引导的介入技术转化为人类应用，受到缺乏兼容磁共振且安全的设备的限制，例如具有与标准导丝类似的机械特性的 MRI 兼容导丝。本研究的目的是评估一种新开发的 MRI 兼容且安全的被动导丝在猪模型中辅助 MRI 引导心脏介入的安全性和有效性，并描述首例完全 MRI 引导的介入。
在临床前试验中，新的 MRI 兼容导丝辅助了 5 只猪的 20 次介入操作。这些介入操作包括非病变性肺动脉瓣和主动脉瓣、主动脉弓和分支肺动脉的球囊扩张。在获得伦理和监管机构批准后，在一名儿童和一名成人中进行了首例完全 MRI 引导的介入，均存在瓣周肺动脉狭窄的元素。通过实时 MRI 序列监测导管操作，并可实时修改成像平面和切片位置。时间分辨率为 11 到 12 帧/秒。导管插入程序时间分别为 110 分钟和 80 分钟。两名患者的瓣膜狭窄均成功缓解，且无手术并发症。
描述的临床前研究和病例报告令人鼓舞，随着新型 MRI 兼容且安全导丝的出现，未来某些经皮心脏介入将可以仅在 MRI 引导下进行。我们机构正在进行一项临床试验。
