Variable loop circular catheter pulsed field ablation in real-world practice: Low complication rates across patient and procedural characteristics in the REAL AF registry.

BACKGROUND

Pulsed field ablation (PFA) using a variable loop circular catheter (VLCC) is increasingly adopted for atrial fibrillation (AF) ablation. Early experience suggests a favorable safety profile, yet outcomes from complex procedures remain limited.

OBJECTIVE

This study aimed to evaluate the safety profile of the VLCC from a large, multicenter, real-world registry.

METHODS

Consecutive ablations performed with the VLCC in the prospective, multicenter Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL AF) registry were evaluated for safety events through 3 months follow-up. Events were categorized by investigator-assessed relationship to procedure and/or VLCC.

RESULTS

In 1014 index ablation cases, the procedure-attributed complication rate was 0.6% (6/1014). Complications included cardiac tamponade/pericardial effusion attributed to a concomitant left atrial appendage closure device, sinoatrial block after accessory pathway ablation, iliac artery dissection, fluid overload, blurred vision with normal magnetic resonance imaging, and transient ischemic attack. Half of the events occurred in cases involving adjunctive radiofrequency ablation. No strokes, coronary spasm, or deaths were reported. Complication rates were low in all AF types and ablation strategies. Same-day discharge occurred in 86.5% of cases, and short-term pulmonary vein isolation was achieved in 99.6%.

CONCLUSION

In a multicenter real-world cohort that included persistent AF and more complex strategies, the VLCC indicated a favorable early safety profile with no catheter-attributed adverse events and very low procedure-attributed complications. These findings support the feasibility of efficient, outpatient-focused PFA workflows whereas ongoing accrual will enable more granular assessment of rare events.