Multicenter Experience With a Novel Real-Time 3-Dimensional Intracardiac Echocardiography Catheter to Guide...

Area of Science:

• Cardiovascular Imaging
• Medical Devices
• Interventional Cardiology

Background:

• Real-time 3D intracardiac echocardiography (ICE) combines benefits of 2D ICE and transesophageal echocardiography.
• Novel 3D ICE systems offer advanced imaging capabilities for cardiac interventions.

Purpose of the Study:

• To evaluate the real-world safety and performance of a new 3D ICE system.
• Assess the system's utility in diverse standard clinical cardiac procedures.

Main Methods:

• Prospective, multicenter, observational, single-arm study.
• 155 patients undergoing invasive cardiac procedures guided by VeriSight Pro 3D ICE.
• Primary safety endpoint: device-related adverse events; Efficacy endpoints: technical, imaging, and clinical success.

Main Results:

• No device or procedure-related adverse events were reported.
• High success rates: technical (98.7%), imaging (96.1%), and clinical (94.8%).
• 96.2% of procedures had acceptable or greater image quality compared to reference modalities.

Conclusions:

• VeriSight Pro 3D ICE is safe and effective for guiding diverse percutaneous cardiovascular interventions.
• The system provides high-quality imaging of cardiac structures, supporting clinical decision-making.