The first-in-human experience of a novel integrated intracardiac echocardiography system with 3D electroanatomic mapping

Integration of intracardiac echocardiography (ICE) with electroanatomic mapping software can potentially improve procedural efficiency and safety, increase procedure confidence, and reduce radiation exposure. Here, we present the initial clinical experience of a novel ICE system integrating a sensor-enabled ICE catheter into a 3D electroanatomic mapping software.

Evaluate the experience with a novel integrated ICE system during electrophysiology procedures.

The ViewFlex X study is a prospective, first-in-human, non-significant risk study evaluating integration of a sensor-enabled ICE catheter (ViewFlex X ICE Catheter, Sensor Enabled) with a 3D electroanatomic mapping system (EnSite X EP System) in patients undergoing an EP procedure. Per protocol, ICE was used to visualize the chamber of interest; additional visualization was at operator’s discretion. Following ICE, high-density mapping catheters were used to create voltage-based models that informed treatment. Subjects were followed through discharge for safety monitoring. This study is actively enrolling.

At the time of this report, 85 patients have enrolled in the ViewFlex X study with data available for 73 patients. There were 73 ablation procedures, including 4 concomitant ablation procedures with LAAO device placement and 1 lead placement. The patient population was 68% (n=50) male (mean 67 years, BMI 29.7) and 32% (n=23) female (mean 65 years, BMI 31.2).

The most common indication was paroxysmal AF (30/73, 41%), followed by persistent AF (22/73, 30%), atrial flutter (7/73, 10%), PVC (6/73, 8%), SVT (4/73, 5%), and VT (4/73, 5%). A flexible-tip RF ablation catheter was the most common ablation catheter (n=37/73, 51%), followed by PFA catheters (n=30/73, 41%). Acute success was achieved in 100% of procedures.

Procedural uses of ICE are shown in Table 1. Physician feedback highlighted the ease of operability of the ICE catheter with one hand, ability to reach desired intracardiac locations, and catheter responsiveness. The average perceived accuracy of the ICE models compared to maps created using a high-density mapping catheter was 85±11%. Feedback from several cases noted the ICE catheter was able to visualize anatomical locations not accessible with the mapping catheter, likely resulting in more accurate chamber geometry in the ICE model. Case images of the real-time simultaneous ICE and 3D electroanatomic map are shown in Figure 1.

A novel integrated ICE system was used to support left atrial and ventricular procedures in a real-world setting with a high degree of efficacy for a variety of workflows, which may speak to its utility in minimizing fluoroscopy usage. Operator feedback emphasized the high degree of accuracy of the ICE models and operability of the ICE catheter. These initial results highlight the versatility of a novel integrated ICE system in a variety of real-world workflows and indications.