Multicenter Practice of Non/Minimized Fluoroscopy Ablation for Paroxysmal AF in China: The PAF-ICE Trial.

Abstract

Background: Intracardiac echocardiography (ICE)-guided non/minimized-fluoroscopy catheter ablation for atrial fibrillation (AF) has been reported, but its effectiveness and safety still lack multicenter evidence.

Objectives: The authors sought to evaluate the effectiveness and safety of ICE-guided non/minimized-fluoroscopy catheter ablation compared with the traditional fluoroscopy-guided approach in patients with paroxysmal AF.

Methods: A total of 448 patients with paroxysmal AF, from 15 centers in China, were randomly assigned in a 1:1 ratio to a non/minimized-fluoroscopy group (n = 223) and a traditional approach group (n = 225). The primary efficacy endpoint was freedom from AF recurrence after a single ablation procedure. The primary safety endpoint was a composite of death from any cause, stroke or transient ischemic attack, and other serious adverse events.

Results: Pulmonary vein isolation was achieved in all patients. After a median follow-up of 12.2 (Q1-Q3: 8.8-17.7) months, 184 of 223 patients (82.5%) in the non/minimized-fluoroscopy group and 189 of 225 (84.0%) in the traditional approach group remained free from arrhythmia. Cox analysis showed a HR of 0.949 (95% CI: 0.774 to 1.164); P = 0.858, demonstrating the noninferiority of the non/minimized-fluoroscopy approach. The primary safety endpoint did not differ significantly in the 2 groups (P = 0.975). This protocol enabled near zero-radiation procedures (mean <1 mGy) in 7 of 15 centers (46.7%), and radiation-free AF ablation in 125 of 223 patients (56.1%), significantly reducing x-ray exposure and operator radiation protection equipment usage.

Conclusions: ICE-combined non/minimized-fluoroscopy AF ablation was noninferior in effectiveness compared to traditional AF ablation, with no significant difference in safety endpoints, indicating its potential of widespread adoption.