The PARADIGM Study: Procedural Augmented Reality Assessment in a 3-Dimensional Image-Guided Modality

The CommandEP system v2 (Sentiar, St. Louis, MO) utilizes an augmented reality headset (Magic Leap, Plantation, FL) to display a real-time 3-dimensional electroanatomic map, catheter locations, and ablation catheter contact force data to the electrophysiologist using a hands-free interface. In the intra-PARADIGM study (Procedural Augmented Reality Assessment in a 3-Dimensional Image Guided Modality), the impact of the CommandEP system on the electrophysiologist's ability to navigate accurately, intraprocedural communications, and system usability were studied.

CommandEP was used prospectively in patients undergoing electrophysiologist studies at 2 sites with 8 users. The electrophysiologist's ability to navigate accurately was calculated as catheter tip displacement from the target using CommandEP versus the electroanatomic mapping system. Physician-mapper interactions were quantified and classified as high- versus low-quality communications (high quality directly impacted navigation, medical decision-making, or patient care). Usability was assessed via survey.

A total of 102 patients completed the study with the following diagnoses: atrial fibrillation (n=78/102, 76%), atrial flutter (8/102, 8%), atrial tachycardia/supraventricular tachycardia (n=9/102, 9%), premature ventricular contraction (n=6/102, 6%), and cardiac neuroablation (1/102, 1%). The physician's ability to navigate was more accurate when using the CommandEP system with an average distance of 2.98±2 mm versus electroanatomic mapping system 3.27±2 mm (P=0.02); 21% of points navigated using CommandEP versus 28% of points navigated using electroanatomic mapping system were >4 mm from the target (P=0.03). In all, 393 communications during study tasks were counted with 30 events when using CommandEP versus 363 events when using electroanatomic mapping system. Subanalysis showed no difference in accuracy pre- versus postcontact force (p=ns) and a slight reduction in both low- and high-quality communications (p=ns). Notably, 94% agreed/strongly agreed that they felt comfortable using the system, and 72% agreed/strongly agreed they would be comfortable using the CommandEP system in most/all EPS.

The CommandEP system improved physicians' ability to navigate accuracy, reduced the number of communications, increased the quality of communications, and had high usability.