Objective To observe the performance and safety of self-developed real-time three-dimensional intracardiac echocardiography(ICE)system(system).Methods The self-developed system was constructed using disposable sterile real-time three-dimensional ICE catheter(catheter)and multifunctional cart-mounted digital ultrasound imaging host(ultrasound host).The diameter of catheter was 10F,with effective length of 90 cm and two-dimensional array transducer array(840 elements)integrated at tip.The ultrasound host was connected to the catheter through matching connector.The performance of this system was evaluated with self-made experimental equipment and standard phantom,and live animal experiment was performed to observe its safety and imaging quality.Results The maximum imaging depth of this system was ≥60 mm.Its axial resolution was ≤1 mm and lateral resolution was ≤1 mm within the depth of 40 mm,the horizontal and vertical geometric position accuracy errors were ≤10％and ≤5％,respectively,while the image geometric distortion was ≤10％,and the measurement volume error was ≤30％.The catheter was successfully inserted into right atrium of pig through femoral vein under ultrasound guidance,smoothly passing through the vascular pathway without any bending or jamming with good controllability.The cardiac images of this system were clear,which completely displayed cardiac chamber structures,and the image resolution met diagnostic requirement.No injury related to interventional procedures was found in laboratory tests nor anatomical results.Conclusion The self-developed ICE system was stable and safe,and initial results showed it could meet clinical application expectations.

Objective To observe the performance and safety of self-developed real-time three-dimensional intracardiac echocardiography(ICE)system(system).Methods The self-developed system was constructed using disposable sterile real-time three-dimensional ICE catheter(catheter)and multifunctional cart-mounted digital ultrasound imaging host(ultrasound host).The diameter of catheter was 10F,with effective length of 90 cm and two-dimensional array transducer array(840 elements)integrated at tip.The ultrasound host was connected to the catheter through matching connector.The performance of this system was evaluated with self-made experimental equipment and standard phantom,and live animal experiment was performed to observe its safety and imaging quality.Results The maximum imaging depth of this system was ≥60 mm.Its axial resolution was ≤1 mm and lateral resolution was ≤1 mm within the depth of 40 mm,the horizontal and vertical geometric position accuracy errors were ≤10％and ≤5％,respectively,while the image geometric distortion was ≤10％,and the measurement volume error was ≤30％.The catheter was successfully inserted into right atrium of pig through femoral vein under ultrasound guidance,smoothly passing through the vascular pathway without any bending or jamming with good controllability.The cardiac images of this system were clear,which completely displayed cardiac chamber structures,and the image resolution met diagnostic requirement.No injury related to interventional procedures was found in laboratory tests nor anatomical results.Conclusion The self-developed ICE system was stable and safe,and initial results showed it could meet clinical application expectations.