Magnetic Positioning System in Coronary Angiography and Percutaneous Intervention: A Feasibility and Safety Study

摘要

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.