Real-World Impact of Steerable Sheaths for Paroxysmal Atrial Fibrillation Catheter Ablation: The INSIGHT Study.

Abstract

Introduction: In atrial fibrillation (AF) ablation procedures, the CARTO VIZIGO Bidirectional Guiding Sheath has previously shown promising results in reducing fluoroscopy times without compromising clinical effectiveness or safety compared with non-steerable sheaths.

Methods: This non-randomized, multicenter, retrospective cohort study (INSIGHT) aimed to determine the real-world impact of the VIZIGO sheath on procedural efficiency, clinical effectiveness, and safety in paroxysmal AF (PAF) catheter ablation. Consecutive adults who underwent de novo radiofrequency (RF) ablation for PAF with a non-VIZIGO sheath (January 2019-July 2021) or VIZIGO sheath (January 2020-July 2021) were included. Procedural characteristics, primary adverse events (PAEs), and 12-month effectiveness (freedom from repeat ablation or recurrent atrial arrhythmia) were evaluated.

Results: Of 199 patients included (mean age, 69.7 years; 59.3% male), 97 had ablation with a VIZIGO sheath and 102 with a non-VIZIGO sheath. Significantly shorter mean times were achieved in the VIZIGO vs. non-VIZIGO group for time to left PVI (18.1 ± 7.5 vs. 19.9 ± 5.6 min, p = 0.046), right PVI (16.5 ± 6.1 vs. 23.1 ± 9.9 min, p < 0.001), total PVI (34.6 ± 9.7 vs. 42.9 ± 11.4 min, p = 0.002), and fluoroscopy time (7.3 ± 10.4 vs. 18.3 ± 13.3 min, p < 0.001). Mean fluoroscopy dose was significantly lower (45.9 ± 112.0 vs. 139.5 ± 251.5 mGy, p < 0.001) with VIZIGO vs. non-VIZIGO sheaths. Catheter stability was comparable between groups. PAE rates were similar in the VIZIGO (3.1%) and non-VIZIGO (4.9%) groups. Freedom from repeat ablation and recurrent atrial arrhythmia at 12 months were also similar in the two groups.

Conclusion: These real-world data demonstrate that use of the VIZIGO sheath in PAF ablation procedures allows for significantly lower fluoroscopy time and dose with significantly shorter PVI isolation time, without compromising acute and long-term effectiveness or safety.