Background
A novel coronary imaging and navigation system (IC-PRO Guidance, Paieon Medical, Israel) was developed to enable the operator identification of balloon/stent location in real time based on fluoroscopic images. The purpose of this study was to assess, for the first time, the accuracy of stent localization using this navigation system.
Methods and results
The IC-PRO Guidance system was employed for navigation and positioning of devices during percutaneous coronary intervention (PCI) procedures. The system enables the operator to identify a device on a dynamic “real-time” fluoroscopic image and registers its location upon a previously acquired static and dynamic reference image. The study group included patients undergoing PCI at two medical centers. After each procedure, the case was analyzed by a team of two physicians. A cine run with a test injection was presented, and the physicians were asked to specify the location of the device on the roadmap image. The results of this assessment were compared to the results of the IC-PRO Guidance system to evaluate the system’s precision and accuracy. For each case, the offset error was calculated as the device’s location minus the reference location, where a location proximal to the reference location received a minus sign and a location distal to it a plus sign. A total of 51 PCI procedures were performed among 30 patients. The mean patient’s age was 63.8±12.7 years (70% men). The distribution of the treated arteries, LAD, LCX and RCA, was 25 (49%), 15 (29.4%) and 11 (21.6%), respectively. The reference vessel diameter was 2.9±0.64 mm, and the mean diameter stenosis was 78%. Mean stenosis area was 6.6±0.32 mm 2 . The mean lesion length was 15.26±5.25 mm. The calculated guidance accuracy was −0.14±1.76 mm.