Abstract

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). 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. 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. 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. 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.

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