New concepts and materials for the manufacturing of MR-compatible guide wires.

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.

Magnetic resonance-guided cardiac interventions using magnetic resonance-compatible devices: a preclinical study and first-in-man congenital interventions.

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.

Magnetic resonance imaging of the cardiac venous system and magnetic resonance-guided intubation of the coronary sinus in swine: a feasibility study.

OBJECTIVES: To visualize the coronary sinus using magnetic resonance (MR), and to demonstrate the feasibility of MR-guided intubation of the cardiac venous system (CVS) in swine. MATERIALS AND METHODS: A total of 6 pigs were investigated. All experiments were performed using an interventional 1.5-Tesla MRI system. The CVS was visualized using an inversion-recovery navigator-gated whole-heart steady-state free-precession sequence after administration of gadobenate dimeglumine contrast agent. The coronary sinus was then intubated under MR-guidance with a passive MR-compatible guidewire modified by incorporation of iron oxide markers for improved visualization and a nonbraided Cobra-catheter. MR-guided interventions were monitored using a steady-state free-precession real-time imaging sequence. Time needed was measured for MR-guided intubation of the CVS and compared with the time needed for fluoroscopy guided intubation of the CVS. RESULTS: Visualization and intubation of the coronary sinus and its site branches was feasible in all cases. Time spent for MR-guided intubation of the CVS was comparable to time spent for fluoroscopy-guided intubation (8.2 +/- 2 minutes vs. 8.3 +/- 1.3 minutes; P = 0.85). CONCLUSIONS: 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.

Rapid right ventricular pacing with MR-compatible pacemaker lead for MR-guided aortic balloon valvuloplasty in swine.

PURPOSE: To assess the feasibility and effectiveness of rapid right ventricular pacing with a magnetic resonance (MR)-compatible pacemaker lead during MR-guided aortic valvuloplasty. MATERIALS AND METHODS: This study was approved by the institutional animal research committee. Seven pigs were investigated. All experiments were performed with an interventional 1.5-T MR system. Interventions were monitored with a steady-state free precession real-time imaging sequence. An MR-compatible pacemaker lead was placed in the right ventricular apex with MR guidance before valvuloplasty. After positioning the balloon in valve position, valvuloplasty was performed with rapid right ventricular rapid pacing at a heart rate of 180 beats per minute to minimize cardiac output. RESULTS: Positioning of the pacemaker lead with MR guidance was feasible in all swine (sensing, 6 mV +/- 1; threshold, 1 V +/- 0.5). The lead could be seen on steady-state free precession images without inducing any artifacts. Rapid right ventricular pacing was feasible in all swine, and balloon stability at the time of inflation was achieved with no balloon movement. Aortic valvuloplasty was successfully accomplished in all experiments. CONCLUSION: Rapid right ventricular pacing with an MR-compatible pacemaker lead is feasible and effective.