Background: The EnSite Precision™ Cardiac Mapping System (Abbott) is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional and sensor enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and dynamic 3D maps of cardiac chambers.
Objective: The EnSite Precision™ Observational Study (NCT-03260244) was designed to quantify and characterize the use of the EnSite Precision Cardiac Mapping System for mapping and ablation of cardiac arrhythmias in a real-world environment and evaluate procedural and subsequent clinical outcomes.
Methods: 1065 patients were enrolled at 38 centers in the U.S. and Canada between 2017-18 and were followed for 12 months post procedure for arrhythmia recurrence, medication use, and quality-of-life changes. Eligible subjects were adults undergoing a cardiac electrophysiology mapping and radiofrequency ablation procedure using the EnSite Precision System.
Results: Of 989 patients who completed the protocol, acute procedural success was high for both AF (n=485 of 495, 98.0%) and atrial flutter (n=432 of 443, 97.5%). Overall median procedure, fluoroscopy and mapping time were 104 minutes (IQR 61.5-155.0), 13.0 minutes (IQR 6.0-18.0), and 11.2 minutes (IQR 5.0-15.0), respectively. In the majority of cases, fluoroscopy was utilized (n=864, 87.4%) with a median time of 11.0 min (IQR 6.0-18.0). Additional procedural details are presented in [FIGURE].
Conclusion: In a real-world study analysis, use of the EnSite Precision mapping system was associated with a high prevalence of acute procedural success and overall low fluoroscopy and mapping times.