Three-dimensional electromagnetic navigation vs. fluoroscopy for endovascular aneurysm repair: a prospective feasibility study in patients.

PURPOSE: To evaluate the in vivo feasibility of a 3-dimensional (3D) electromagnetic (EM) navigation system with electromagnetically-tracked catheters in endovascular aneurysm repair (EVAR).

METHODS: The pilot study included 17 patients undergoing EVAR with a bifurcated stent-graft. Ten patients were assigned to the control group, in which a standard EVAR procedure was used. The remaining 7 patients (intervention group) underwent an EVAR procedure during which a cone-beam computed tomography image was acquired after implantation of the main stent-graft. The 3D image was presented on the navigation screen. From the contralateral side, the tip of an electromagnetically-tracked catheter was visualized in the 3D image and positioned in front of the contralateral cuff in the main stent-graft. A guidewire was inserted through the catheter and blindly placed into the stent-graft. The placement of the guidewire was verified by fluoroscopy before the catheter was pushed over the guidewire. If the guidewire was incorrectly placed outside the stent-graft, the procedure was repeated. Successful placement of the guidewire had to be achieved within a 15-minute time limit.

RESULTS: Within 15 minutes, the guidewire was placed correctly inside the stent-graft in 6 of 7 patients in the intervention group and in 8 of 10 patients in the control group. In the intervention group, fewer attempts were needed to insert the guidewire correctly.

CONCLUSION: A 3D EM navigation system, used in conjunction with fluoroscopy and angiography, has the potential to provide more spatial information and reduce the use of radiation and contrast during endovascular interventions. This pilot study showed that 3D EM navigation is feasible in patients undergoing EVAR. However, a larger study must be performed to determine if 3D EM navigation is better than the existing practice for these patients.