Background-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. Methods and Results-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. Conclusions-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. (Circ Cardiovasc Interv. 2010;3:585-592.)
MR-visualization and MR-guided intubation of the coronary sinus and its side branches is feasible. The feasibility of MR-guided intubation of the CVS might have relevance for procedures like cardiac resynchronization therapy and percutaneous transcatheter mitral annuloplasty, requiring improved 3-dimensional knowledge about cardiac vein anatomy in the near future.
This paper shows the development of a new magnetic resonance imaging (MRI)-compatible guide wire made from fiber-reinforced plastics. The basic material of the developed guide wire is manufactured using a specially developed micro-pullwinding technology, which allows the adjustment of tensile, bending, and torsional stiffness independent from each other. Additionally, the micro-pullwinding technology provides the possibility to vary the stiffness along the length of the guide wire in a continuous process. With the possibilities of this technology, the mechanical properties of the guide wire were precisely adjusted for the intended usage in MRI-guided interventions. The performance of the guide wire regarding the mechanical properties was investigated. It could be shown, that the mechanical properties could be changed independently from each other by varying the process parameters. Especially, the torsional stiffness could be significantly improved with only a minor influence on bending and tensile properties. The precise influence of the variation of the winding angle on the mechanical and geometrical properties has to be further investigated. The usability of the guide wire as well as its visibility in MRI was investigated by radiologists. With the micro-pullwinding technology, a continuous manufacturing technique for highly stressable, MRI-safe profiles is available and can be the trigger for a new class of medical devices.
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