Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial.

Summary

In 287 randomized patients with paroxysmal AF, nsPFA was noninferior to AI-guided RF ablation for 12-month arrhythmia freedom, with similar safety and 100% acute PVI success in both arms. nsPFA significantly shortened procedure, LA dwell, and ablation times, albeit with longer fluoroscopy time and higher radiation dose.

Key Findings

• Primary efficacy noninferiority met: 65.5% vs 64.1% 12-month drug-free arrhythmia freedom.
• Safety comparable; acute PVI success 100% in both groups.
• nsPFA reduced total procedure time, LA dwell time, and ablation time; fluoroscopy time and radiation dose were higher.

Clinical Implications

nsPFA can be considered as an alternative to RF for paroxysmal AF PVI where available, particularly when aiming to reduce procedure times; attention to fluoroscopy minimization strategies is needed.

Limitations

• Conducted in a single country; generalizability to other operator experience or systems needs evaluation.
• Fluoroscopy/radiation differences warrant optimization and may vary with learning curve.

Future Directions

Head-to-head trials versus cryoballoon and across AF substrates (persistent AF), durability mapping, collateral safety (esophagus/phrenic) with advanced imaging, and workflow/radiation optimization studies.