Post-FDA approval “real-world” safety profile of different steerable sheaths during catheter ablation: A Food and Drug Administration MAUDE database study

Radiofrequency ablation is a universally accepted therapy for various atrial and ventricular arrhythmias. 1 Al-Khatib S.M. Stevenson W.G. Ackerman M.J. et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Heart Rhythm. 2018; 15: e190-e252 Google Scholar During radiofrequency ablation, catheter position and stability are essential and directly affect procedure outcomes. A steerable sheath enables the operator to manipulate the catheter effectively and access difficult anatomical locations while maintaining the catheter’s steadiness. There are several commercially available steerable sheaths; the most commonly used are as follows: Agilis (Abbott, St Paul, MN), a traditional steerable sheath; and Vizigo, a newly available bidirectional guiding sheath (Biosense Webster Inc., Irvine, CA). The Vizigo sheath was introduced in 2018 and provides a real-time visual assessment of the sheath position (in relation to the catheter), thereby reducing the fluoroscopy time. Although studies have demonstrated superior outcomes with Vizigo as compared with the conventional fixed sheath, 2 Guo R, Jia R, Cen Z, et al. Effects of the visualized steerable sheath applied to catheter ablation of paroxysmal atrial fibrillation [published online ahead of print November 30, 2021]. J Interv Card Electrophysiol. doi:10.1007/s10840-021-01096-7. Google Scholar data on real-life safety and device-related issues comparing Agilis and Vizigo sheaths are limited. Therefore, we aimed to assess sheath-related issues and associated adverse events from the Food and Drug Administration’s Manufacturer And User Facility Device Experience (MAUDE) database.