Magnetic positioning system in coronary angiography and percutaneous intervention: a feasibility and safety study.

OBJECTIVES: This study sought to evaluate the safety and feasibility of a magnetic medical positioning system (MPS) to determine the three-dimensional (3D) position and orientation of intracoronary wires and catheters and to guide angiography and percutaneous coronary intervention (PCI). BACKGROUND: Coronary angiography relies on fluoroscopy for catheter navigation and often fails to accurately portray vessel tortuosity, overlap, and length because of complex anatomy and foreshortening of curved coronary segments. METHODS: Forty adult participants underwent coronary angiography and/or PCI with MPS guidance. Two interventional cardiologists independently scored (1-5) the accuracy of MPS catheter tracking projected on live fluoroscopy, recorded cine loops, and 3D vessel reconstructions. Measurements from MPS reconstructions were compared to conventional two-dimensional (2D) quantitative coronary angiography (QCA) measurements. Device procedural success was defined as the ability of the MPS-enabled catheter to reach the target vessel, perform the intended operations, and be retrieved without major adverse cardiac events. RESULTS: Diagnostic coronary angiography was performed in 19 (47.5%) and PCI in 21 patients (52.5%). MPS procedural success was achieved in 36 (90%) of the cases. MPS accuracy was highest with the MPS superimposed on live fluoroscopy (4.9 ± 0.2/5) and the 3D vessel reconstruction (4.7 ± 0.5/5). MPS length measurements were more accurate than conventional QCA. CONCLUSIONS: This study demonstrates the feasibility and safety of magnetic catheter tracking with 3D positional data during diagnostic angiography and PCI. Catheter position was accurately projected on real-time fluoroscopy, recorded cine loops, and 3D reconstructions. An MPS may serve as a platform for device navigation and positioning during PCI.

First-in-man (FIM) experience with the Magnetic Medical Positioning System (MPS) for intracoronary navigation.

AIMS: To investigate the safety and feasibility of a newly developed magnetic navigation system for intracoronary tracking. METHODS AND RESULTS: The MediGuide Medical Positioning System (MPS) is a navigation system that was developed to facilitate the navigation of enabled devices within the coronary tree using a magnetic tracking technology. The current prospective, non-randomised, single-centre, first-in-man study was conducted at Universitätsklinikum Regensburg (UKR), Germany on an MPS-enabled AXIOM Artis dFC coronary angiography system (Siemens AG, Forchheim, Germany). We enrolled 20 patients who required IVUS assessment or treatment of a single de novo target lesion in a native coronary artery. The performance was evaluated on a semi-quantitative one-to-five scale where a score of five indicates an excellent superimposition with the vessel and a score of one an unacceptable performance. The mean score for tracking as assessed by projection on life fluoroscopy was 4.89 and 3.58 as assessed by projection on recorded cine-loop. Length measurement of a 20 mm distance was significantly better with the MPS (mean deviation of 0.6 mm=3%) as compared to standard QCA (1.5 mm=8%, p<0.05). Creating a 3D reconstruction was possible in 13 out of 20 cases with an average score of 4.68. No adverse events occurred. CONCLUSIONS: The MediGuide Medical Positioning System is safe and feasible in man, facilitates intracoronary navigation and allows 3D reconstruction of the investigated coronary segment.