Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy

Abstract

Abstract Background Advances in technology and workflows have facilitated substantial reductions in fluoroscopy utilization and procedure times for atrial fibrillation (AF) ablations. A recently available steerable sheath, visualizable on a 3D electroanatomical map (EAM), may further simplify low/zero fluoroscopy ablation workflows by facilitating understanding of the relative positions of the catheter and sheath. The objective of this study was to demonstrate feasibility, safety, procedural efficiency, and clinical effectiveness of incorporating the new visualizable sheath into a low-fluoroscopy workflow. Methods Consecutive de novo paroxysmal AF procedures were performed with a porous tip contact force catheter at a high-volume site between January 2018 and May 2019. Procedures performed with and without the VIZIGO™ EAM-visualizable sheath (Vizigo) were compared. All ablations employed the same standardized low-fluoroscopy workflow. Statistical analyses employed stabilized inverse probability of treatment weights (IPTW) to balance cohorts by operator and key patient characteristics. Results Cohorts of 142 Vizigo and 173 non-Vizigo patients were similar at baseline. Use of the Vizigo sheath was associated with approximately 10% improvement in catheter stability (p = 0.0005), 16% reduction in radiofrequency time (p < 0.0001), and 7% fewer ablations that used fluoroscopy (p = 0.0030). There was one cardiac tamponade in each cohort and no deaths, atrioesophageal fistulas, or strokes. Single-procedure freedom from atrial arrhythmia recurrence through 12 months was similar between cohorts (p = 0.9556). Conclusions Use of a 3D EAM-visualizable sheath resulted in improved catheter stability, reduced radiofrequency time, and more procedures performed without fluoroscopy, without compromise to safety or effectiveness.