Background: Advanced 3D electroanatomic mapping (EAM) systems have revolutionized atrial fibrillation (AF) ablation by significantly reducing the use of fluoroscopy. In this study, we aimed to compare the initial experience of AF ablation procedures using the VIZIGO™ steerable sheath, which is visible on the 3D EAM, with the conventional approach involving a fixed sheath that is not visible on the 3D EAM. Methods: A total of 50 consecutive patients undergoing AF ablation were enrolled in a prospective observational study. The patient population was divided in two groups: the first group consisted of 25 consecutive patients treated with a fixed sheath that is not visualized on the mapping system (standard group), and the second group consisted of 25 consecutive patients treated using the VIZIGO™ steerable sheath (VIZIGO group). Baseline characteristics of patients, procedural, fluoroscopy, and ablation time were included in the analysis. Primary endpoints were the evaluation of procedural and fluoroscopy time. Study protocol was approved by the local ethics committee and is registered on ClinicalTrials.gov (identifier: NCT05319769). Results: No differences in baseline characteristics were present between the two groups. The median procedural and fluoroscopy time were 130 (IQR 117-181) minutes and 2.2 (IQR 0.0-8.1) minutes respectively. In the VIZIGO group, both procedural time and fluoroscopy time were significantly lower than in the standard group (118[IQR 100-120] vs. 180[ IQR 132-202] minutes, p < 0.001, respectively and 0.0 [IQR 0.0-0.5] vs.8.1 [4.7-12.6] minutes, p < 0.001, respectively). At 12 months follow up, recurrences were significantly lower in the VIZIGO group compared to the group where a standard fixed sheath was used (8% vs. 32 %, p = 0.034). Conclusions: Atrial fibrillation ablation with the use of steerable sheath visible on the 3DEAM system eliminates the need of fluoroscopy and reduces procedural time without compromising safety and efficacy.
Non Fluoroscopic Approach in Atrial Fibrillation Ablation Procedures: The APRONLESS-AF Study
Matteo Bertini
;Martina De Raffele;Maria Angela Deserio;Federico Marchini;Marta Cocco;Francesco Vitali;
2023
Abstract
Background: Advanced 3D electroanatomic mapping (EAM) systems have revolutionized atrial fibrillation (AF) ablation by significantly reducing the use of fluoroscopy. In this study, we aimed to compare the initial experience of AF ablation procedures using the VIZIGO™ steerable sheath, which is visible on the 3D EAM, with the conventional approach involving a fixed sheath that is not visible on the 3D EAM. Methods: A total of 50 consecutive patients undergoing AF ablation were enrolled in a prospective observational study. The patient population was divided in two groups: the first group consisted of 25 consecutive patients treated with a fixed sheath that is not visualized on the mapping system (standard group), and the second group consisted of 25 consecutive patients treated using the VIZIGO™ steerable sheath (VIZIGO group). Baseline characteristics of patients, procedural, fluoroscopy, and ablation time were included in the analysis. Primary endpoints were the evaluation of procedural and fluoroscopy time. Study protocol was approved by the local ethics committee and is registered on ClinicalTrials.gov (identifier: NCT05319769). Results: No differences in baseline characteristics were present between the two groups. The median procedural and fluoroscopy time were 130 (IQR 117-181) minutes and 2.2 (IQR 0.0-8.1) minutes respectively. In the VIZIGO group, both procedural time and fluoroscopy time were significantly lower than in the standard group (118[IQR 100-120] vs. 180[ IQR 132-202] minutes, p < 0.001, respectively and 0.0 [IQR 0.0-0.5] vs.8.1 [4.7-12.6] minutes, p < 0.001, respectively). At 12 months follow up, recurrences were significantly lower in the VIZIGO group compared to the group where a standard fixed sheath was used (8% vs. 32 %, p = 0.034). Conclusions: Atrial fibrillation ablation with the use of steerable sheath visible on the 3DEAM system eliminates the need of fluoroscopy and reduces procedural time without compromising safety and efficacy.I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
