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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: The CommandEP system improved physicians’ ability to navigate accuracy, reduced the number of communications, increased the quality of communications, and had high usability.