Head-to-head comparison of two pulsed field ablation systems for atrial fibrillation: one-year outcomes from a large multicenter registry

Research on pulsed field ablation (PFA) systems for atrial fibrillation (AF) ablation has expanded rapidly in recent years, particularly with respect to short-term safety and efficacy outcomes. In contrast, evidence regarding long-term efficacy comparing different PFA systems remains limited.

To evaluate and compare long-term efficacy outcomes of two commercially available PFA systems in performing pulmonary vein isolation (PVI) for AF in a multicenter clinical setting.

We conducted an international, multicenter, registry study of patients with paroxysmal or persistent AF, undergoing a first ablation between January 29th, 2024 and September 1st , 2024. Patients were treated with either the FARAPULSE (FP) or the PulseSelect (PS) - PFA system. Endpoints included acute isolation of ablation targets, freedom from adverse events, recurrence of atrial arrhythmias following a 2-month blanking period and repeat ablation outcomes.

We included a total of 428 patients, of whom 232 (54.2%) were treated with the FP system and 196 (45.8%) with the PS system. Baseline and procedural characteristics are presented in Table 1. Median total procedural times were higher in the PS group (55.5 vs. 38.0 min, p < 0.001). Multivariate regression showed that procedure time was significantly associated with the use of a 3D mapping system and with differences between centers, whereas the type of PFA system did not independently predict procedure duration. Both groups had low rates of major adverse events within 30 days post-procedure. During a median follow-up of 364 days, a total of 159 patients (34.1%) experienced recurrence of atrial arrhythmias, with comparable incidence between groups (see Figure 1). During follow-up, 33 patients in the FP group underwent repeat ablation compared to 30 patients in the PS group (p = 0.776). Most patients had reconnection of at least one vein in both groups, with higher rates of reconnection of the left pulmonary veins in the PS group (LSPV: 85% vs. 40%, p = 0.004; LIPV: 79% vs. 35%, p = 0.007).

In this study, we compared the efficacy outcomes of two commercially available PFA systems for primary PVI in patients with AF. Although procedural characteristics differed, often driven by operator preferences, our results demonstrated comparable long-term efficacy up to one year after PVI.