Evaluating lesion durability following pulsed field ablation: one-year insights from the FARADISE registry

Pulsed field ablation (PFA) has emerged as a leading catheter ablation modality for the treatment of atrial fibrillation (AF), producing durable lesions in the myocardium. Long-term outcomes for PFA patients are promising; however, a small subset of patients will undergo a repeat procedure. Although previous clinical reports have demonstrated stable lesion durability through mandated remapping, clinical insight into repeat procedures performed under real-world clinical practice remains limited.

To characterize pulmonary vein (PV) lesion durability after PFA in the context of a real-world, standard-of-care registry.

FARADISE is a global, prospective registry enrolling AF patients clinically indicated for treatment with the pentaspline PFA catheter. In this sub-analysis, de novo patients (defined as those receiving their first ablation) who received a repeat procedure within one year of index ablation were compared to those who did not. Patients with reported use of 3 dimensional (3D) electroanatomical mapping at the time of repeat ablation were evaluated for PV lesion durability. Here, one-year outcomes are reported, while the FARADISE registry will follow patients out to three years.

In total, 1158 patients received PFA treatment, including 1043 de novo patients. From the de novo cohort, 965 (92.5%) patients had single procedures. Of the 78 patients returning for a repeat procedure, 67 were supported by 3D mapping. Patients who returned for a repeat ablation were more likely to have non-paroxysmal AF (47.4% vs. 32.3%, p<0.01) and had a lower left ventricular ejection fraction (53±9.7 vs. 58±8.9, p<0.01). Skin-to-skin procedure time (45 [35-61] minutes vs. 50 [40-67] minutes, p<0.01) was modestly shorter and use of intracardiac echocardiography (ICE) was less frequent in patients who received a repeat ablation (6.4% vs. 17%, p=0.02). Serious adverse events (SAEs) at the index procedure were limited, with 1.3% in the repeat ablation cohort and 1.6% in the single procedure cohort (p=1.0). Of the 67 patients with 3D mapping used during repeat procedures, durable lesions were achieved in 108 of 138 PVs in paroxysmal AF (PAF) patients and 94 of 129 PVs in non-paroxysmal AF (non-PAF) patients (Figure 1). Consistent with these outcomes, 75% of patients had one or fewer PV reconnections.

Over 90% of patients treated with the pentaspline PFA catheter did not require a repeat ablation. Of the repeat ablation patients, the majority had one or fewer PV reconnections and strong lesion durability. These findings emphasize the robust durability of PFA lesions in real-world practice and highlight the need for continued evaluations at repeat procedures for improved AF management.

Szeplaki et al Figure 1