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Randomized Controlled Trial
. 2023 May 19;25(5):euad086.
doi: 10.1093/europace/euad086.

Safety and efficacy of intracardiac echocardiography-guided zero-fluoroscopic cryoballoon ablation for atrial fibrillation: a prospective randomized controlled trial

Jinhee Ahn  1   2 , Dong Geum Shin  3 , Sang-Jin Han  4 , Hong Euy Lim  4
Affiliations
Randomized Controlled Trial

Safety and efficacy of intracardiac echocardiography-guided zero-fluoroscopic cryoballoon ablation for atrial fibrillation: a prospective randomized controlled trial

Jinhee Ahn et al. Europace. .

Abstract

Aims: The development of intracardiac echocardiography (ICE) has enabled fluoroless atrial fibrillation (AF) ablation using three-dimensional electroanatomical mapping systems. However, fluoroless cryoballoon ablation (CBA) remains challenging, mainly because of the lack of a visual mapping system. Hence, this study aimed to investigate the safety and efficacy of fluoroless CBA for AF under ICE guidance.

Methods and results: Patients (n = 100) who underwent CBA for paroxysmal AF were randomly assigned to zero-fluoroscopic (Zero-X) and conventional groups. Intracardiac echocardiography was used to guide the transseptal puncture and catheter and balloon manipulation in all enrolled patients. The patients were prospectively followed for 12 months after CBA. The mean age was 60.4 years, and the left atrial (LA) size was 39.4 mm. Pulmonary vein isolation (PVI) was achieved in all patients. In the Zero-X group, fluoroscopy was used in only one patient because of unstable phrenic nerve capture during right-sided PVI. The procedure time and LA indwelling time in the Zero-X group were not statistically different compared with that in the conventional group. Fluoroscopic time (9.0 vs. 0.008 min) and radiation exposure (29.4 vs. 0.02 mGy) were significantly shorter in the Zero-X group than in the conventional group (P < 0.001). The complication rate did not differ between the two groups. During a mean follow-up of 663.3 ± 172.3 days, the recurrence rate was similar (16.0 vs. 18.0%; P = 0.841) between the groups. Multivariate analysis revealed that LA size was the only independent predictor of clinical recurrence.

Conclusion: Intracardiac echocardiography-guided fluoroless CBA for AF was a feasible strategy without compromising acute and long-term success or complication rates.

Keywords: Atrial fibrillation; Cryoballoon ablation; Intracardiac echocardiography; Radiation exposure.

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Conflict of interest statement

Conflict of interest: None declared.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Intracardiac echocardiographic images. Colour Doppler images during pulmonary vein (PV) occlusion and blood bubbles (arrows) from PV after deflation of cryoballoon at the LSPV (A and E), LIPV (B and F), RSPV (C and G), and RIPV (D and H). LA, left atrial; LIPV, left inferior pulmonary vein; LSPV, left superior pulmonary vein; PA, pulmonary artery; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein.
Figure 2
Figure 2
Fluoroscopy time and radiation exposure during cryoballoon ablation between the Zero-X and conventional groups. Data are presented as mean ± standard deviation. aRadiation exposure during catheter manipulation for phrenic nerve capture in one patient assigned to the Zero-X group.
Figure 3
Figure 3
Kaplan–Meier curve presenting atrial tachyarrhythmia-free survival in the Zero-X and conventional groups.
See this image and copyright information in PMC

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