Initial Clinical Experience With a Novel 4D Intracardiac Echocardiographic Imaging and Guidance System in Catheter...

Electroanatomic mapping (EAM) systems are commonly used to guide cardiac ablations. These systems have potential limitations, such as manual mapping process, map shifts, and low anatomical accuracy. This manuscript introduces a novel imaging and guidance system, designed to optimize anatomical guidance during catheter ablation procedures. This prospective study investigated usability and integration of the VERAFEYE Imaging and Guidance System (LUMA Vision Ltd.) used in catheter ablation procedures with the additional aim of post-processing collected data to evaluate high-resolution anatomical models.

Seventeen patients undergoing catheter ablation for AFL or AF were enrolled. The study objective was to evaluate the safety and adjunctive performance of VERAFEYE. A clinical evaluation was performed at 7 days follow up. Physician experience and imaging quality feedback were collected. Extensive 3D imaging data was analyzed post-procedure to demonstrate and validate future capabilities. Seventeen patients underwent AF, AFL or a combined AF and AFL catheter ablation with VERAFEYE as adjunctive imaging system. The mean age was 66.2 years, and 3 (17%) were women. Total mean procedural time was 1 h and 27 min. There were no device-related AEs. In 100% cases the system was assessed as easy to integrate into clinical workflow. 3D reconstruction data was assessed post-procedure.

This initial experience demonstrates easy integration of VERAFEYE in a standard workflow. Rapid, automated, high-fidelity imaging and anatomical guidance systems have the potential to replace EAM for anatomically based ablation workflows and to eliminate the requirement for pre-procedural CT imaging.