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

Abstract

Background: Recent technologies enable real-time 3-dimensional intracardiac echocardiography (ICE) with the advantages of 2-dimensional ICE and imaging capabilities of transesophageal echocardiography. The purpose of this study is to evaluate the real-world, multicenter safety and performance of a novel 3-dimensional ICE system in a variety of cardiac interventions used in standard clinical practice.

Methods: This prospective, multicenter, observational, single-arm study enrolled patients who were scheduled for an invasive cardiac procedure involving guidance with ICE and followed until discharge or ≤48 hours postprocedure. Intracardiac imaging was performed with the 3-dimensional ICE catheter, VeriSight Pro (Philips Inc.). Fluoroscopy was used in all cases and transesophageal echocardiography was used in some cases. The primary safety end point was device-related adverse events. The primary efficacy end point included technical success, imaging success, and clinical success.

Results: Between October 2021 and November 2022, 155 patients were enrolled and screened. Percutaneous interventions performed included atrial septal defect/patent foramen ovale closures, left atrial appendage occlusion, catheter ablations, and valve procedures. No adverse events were related to the device or procedure. The technical, imaging, and clinical success rates were 98.7% (95% CI, 95.4%-99.8%), 96.1% (95% CI, 91.8%-98.6%), 94.8% (95% CI, 91.8%-98.6%), respectively. Overall, the VeriSight Pro ICE image quality was assessed to be "acceptable" or greater in relation to reference image modality among 96.2% (149 of 155) of procedures.

Conclusions: VeriSight ICE imaging is safe and effective in the guidance of a wide variety of percutaneous cardiovascular procedures and has provided successful and high-quality imaging of cardiac structures.