Fluoroscopy-free navigation of Guided–Stent using Medical Positioning System and 3D Guided–IVUS (GIVUS™) image

Abstract Purpose Conventional imaging and navigation during intravascular intervention employ fluoroscopic positioning of intracoronary devices. It may also include intravascular ultrasound (IVUS), allowing two-dimensional slice visualization of blood vessels for enhanced imaging, diagnosis, and stent placement. We report the use of an innovative 3D imaging system (GIVUS™), as well as stent placement (Guided Stent™) using a new non-fluoroscopic, intra-coronary Medical Positioning System (MPS™; MediGuide Ltd., Israel). Methods The GIVUS™ system consists of a miniaturized sensor that might be assembled on tips of various catheters (such as IVUS and stent delivery system) and provides accurate real-time position and orientation, enabling real-time tracking of a catheter tip in 3D space. GIVUS™ is the integration of two technologies, MPS™ and IVUS, thus providing automatic real-time quantitative 3D reconstruction of an inspected vessel. The GIVUS system was used to accurately navigate and deploy 12 stents in six adult pigs. 2D angiogram roadmaps and 3D reconstructed models were used to place stents at pre-defined locations in different coronary arteries close to bifurcations. Results GIVUS™ 3D image reconstruction was completed and displayed within 15 s after finishing pullback. MPS tracked the fluoroscopic image with a mean accuracy of 0.210 ± 0.306 mm. Pathologic measurements proved a high accuracy of stents deployment: 11 of 12 stents were less than 1 mm from selected bifurcation site, 1 was 2 mm into the bifurcation. Conclusions The MPS™ non-fluoroscopic system allows highly accurate computer-assisted stent navigation and deployment. The MPS™ system is a promising new method used to improve ease and accuracy of stent/device placement during intravascular interventions.