When low is not low enough: zero-fluoroscopy atrial fibrillation ablation using the VARIPULSE™ pulsed field system-a prospective single-center study.

Abstract

Background: Pulsed field ablation (PFA) has emerged as a non-thermal, tissue-selective modality for pulmonary vein isolation (PVI) in atrial fibrillation (AF) treatment, potentially minimizing collateral damage to adjacent structures. The VARIPULSE™ PFA system, integrated with the CARTO™ 3 electroanatomical mapping system, facilitates real-time catheter visualization, enabling procedures with minimal or no fluoroscopy. The objective is to evaluate the feasibility and acute safety of performing zero-fluoroscopy AF catheter ablation using the VARIPULSE™ PFA system in a cohort of consecutive patients with paroxysmal or persistent AF for 1 year.

Methods: A prospective, single-center study was conducted involving consecutive patients undergoing AF ablation (PVI ± linear ablations) with the VARIPULSE™ system. Procedures were guided exclusively by the CARTO™ 3 system, without the use of fluoroscopy as well as intracardiac echocardiography (ICE). Data on procedural parameters, acute success rates, and complications were collected and analyzed.

Results: A total of 121 consecutive patients were included in the study during 1 year with 60% of paroxysmal AF. Additional extra-pulmonary vein ablation (CTI or posterior wall isolation or both) was performed in 93 patients (76.9%). The mean time procedure was 44.5 ± 15.2 min and the success rate of zero-fluoroscopy was 98.4%. Two patients had an acute complication (1 TIA and 1 cardiogenic shock).

Conclusion: This study demonstrates the feasibility, safety, and time-efficiency of a fully standardized fluoroscopy-free workflow, including posterior wall and CTI ablation. The use of TEE instead of ICE enhances cost-efficiency, potentially facilitating broader adoption of the protocol. However, the single-center nature of the study and the lack of a comparative fluoroscopy group represent important limitations.