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

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.

Durable pulmonary vein isolation with optimized high‐power and very high‐power short‐duration temperature‐controlled ablation: A step‐by‐step guide

“…21,22 In the meantime, strategies to improve stability, like the use of general anesthesia, high-frequency low tidal volume, and the use of a steerable sheath visualizable in the electroanatomic mapping system that improves catheter stability by 10%, may be considered. 34,36,37 The efficiency, safety, and efficacy of QMODE+-guided PVI are comparable to the outcome after CLOSE-guided isolation with legacy power-controlled catheters or QDM in QMODE. In the POWER PLUS study, 22 the QMODE+ workflow resulted in a procedure time of 70 min, no safety concerns (no esophageal injury at endoscopy), and good clinical outcome.…”

“…Automatic ablation‐tagging modules incorporating tracking of cardiac and respiratory motion and enhanced stability algorithms with early visualization of ablation tags will improve instability detection once widely available 21,22 . In the meantime, strategies to improve stability, like the use of general anesthesia, high‐frequency low tidal volume, and the use of a steerable sheath visualizable in the electroanatomic mapping system that improves catheter stability by 10%, may be considered 34,36,37 …”

Zero-Fluoroscopy Catheter Ablation of Supraventricular Tachycardias in the Pediatric Population

“…Along with the use of ICE, we see the introduction of a visualizable steerable sheath as an additional valuable tool in achieving a zero-fluoroscopy CA approach. According to the recently published data, the use of 3D EAM visualizable steerable sheaths increased the number of procedures that could be performed in a zero-fluoroscopy setting, and reduced left atrial procedure time and RFA time by improving ablation catheter stability, without compromising the efficacy or safety profile of pulmonary vein isolation procedures in the adult population [ 36 , 37 ].…”

Visualizable vs. standard, non-visualizable steerable sheath for pulmonary vein isolation procedures: Randomized, single-centre trial

“…A recently published observational study by Rajendra et al compared PVI procedures performed by visualizable SS sheaths vs. a cohort, where no transseptal sheaths were used. They found no difference in clinical effectiveness, however, visualizable SS helped to improve catheter stability and to reduce ablation time, besides, more procedures could be performed without applying fluoroscopy ( 14 ).…”