Key result
Atrial fibrillation ablation using a visualized steerable sheath significantly reduced procedure and fluoroscopy times compared to conventional sheaths, while maintaining comparable 12-month freedom from arrhythmia recurrence (85% vs 83%).
Why the study?
A novel steerable sheath allowing real-time visualization within a 3D-mapping system was recently introduced, but its safety and efficacy compared to conventional non-visualized sheaths required clinical assessment.
Does a visualized sheath reduce procedure duration and radiation exposure without compromising efficacy in patients undergoing AF ablation compared to conventional sheaths?
Observational (n=199)
No
Does a visualized sheath reduce procedure duration and radiation exposure without compromising efficacy in patients undergoing AF ablation compared to conventional sheaths?
The use of a visualized sheath during AF ablation significantly reduces procedure duration and radiation exposure while maintaining comparable safety and efficacy to conventional sheaths.
May shorten AF ablation procedures and fluoroscopy time; hypothesis-generating for randomized confirmation.
Introduction Recently, a novel steerable sheath allowing its real‐time visualization within a 3D‐mapping system was introduced to facilitate atrial fibrillation (AF) ablation. Aim This study aimed to assess safety and efficacy of AF ablation using the visualized sheath and to compare its performance with a matched control group of patients who received ablation with conventional and non‐visualized sheaths. Methods The study included consecutive patients between 09/2019 and 02/2021 who underwent routine AF ablation using the visualized sheath. Patients were regularly followed‐up in our outpatient's clinic. Arrhythmia recurrence was defined as any atrial fibrillation (AF)/ atrial tachycardia (AT) episode lasting > 30 s after a blanking period of 3 months. Results A total number of 100 patients undergoing ablation using the visualized sheath were compared to a group of 99 matched patients. No major complications were observed. Total procedure duration (108 ± 22 min vs. 112 ± 12 min; p = 0.045), fluoroscopy time (7 ± 3 min vs. 10 ± 5 min; p < 0.001) and –dose (507 ± 501 cGy*cm2 vs. 783 ± 433 cGy*cm2; p < 0.001) were significantly lower using the visualized sheath. The benefit in terms of procedure duration was mainly driven by a shortened left atrial dwell time (73 ± 13 min vs. 79 ± 12 min; p = 0.001). During a mean follow‐up of 12 months, the overall procedural success was 85% in the visualized sheath group versus 83% in the control group (p = 0.948). Conclusion AF ablation using the novel visualized sheath is safe and effective and leads to a measurable decrease of procedure duration and radiation exposure. The integration of the novel sheath might help to further improve safety and efficacy of AF ablation.
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Khalaph et al. (2022) conducted an observational in Symptomatic, drug-refractory atrial fibrillation (n=199). Visualized steerable sheath (Carto Vizigo) vs. Conventional non-visualized sheaths was evaluated on Freedom from symptomatic atrial fibrillation or atrial tachycardia at 12 months (p=0.948). Atrial fibrillation ablation using a visualized steerable sheath significantly reduced procedure and fluoroscopy times compared to conventional sheaths, while maintaining comparable 12-month freedom from arrhythmia recurrence (85% vs 83%).
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