First clinical experience using a visualized sheath for atrial fibrillation ablation

Area of Science:

• Cardiovascular Medicine
• Medical Devices
• Electrophysiology

Background:

• Atrial fibrillation (AF) ablation is a common procedure to treat irregular heart rhythms.
• Conventional ablation methods utilize non-visualized sheaths, posing challenges in real-time navigation and potentially increasing procedure time and radiation exposure.
• A novel steerable sheath with real-time 3D-mapping visualization has been developed to enhance AF ablation procedures.

Purpose of the Study:

• To evaluate the safety and efficacy of AF ablation using a novel visualized sheath.
• To compare the performance of the visualized sheath against conventional, non-visualized sheaths in a matched patient cohort.
• To assess the impact of the visualized sheath on procedure duration, radiation exposure, and procedural success rates.

Main Methods:

• A prospective study included 100 patients undergoing AF ablation with the visualized sheath between September 2019 and February 2021.
• A control group of 99 matched patients who underwent ablation with conventional, non-visualized sheaths was retrospectively identified.
• Patients were followed up for arrhythmia recurrence, defined as AF or atrial tachycardia (AT) lasting longer than 30 seconds after a 3-month blanking period.

Main Results:

• No major complications were reported in either group.
• The visualized sheath group showed significantly reduced total procedure duration (108 vs. 112 min, p=0.045), fluoroscopy time (7 vs. 10 min, p<0.001), and radiation dose (507 vs. 783 cGy*cm², p<0.001).
• Procedural success rates were comparable between the groups (85% visualized sheath vs. 83% control, p=0.948) after a mean 12-month follow-up.

Conclusions:

• AF ablation using the novel visualized sheath is a safe and effective alternative to conventional methods.
• The visualized sheath significantly decreases procedure duration and radiation exposure, contributing to improved patient safety.
• Integration of this technology holds promise for further enhancing the safety and efficacy of AF ablation procedures.