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

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• The clinical effectiveness of nanosecond pulsed field ablation (nsPFA) for pulmonary vein isolation in paroxysmal atrial fibrillation requires further investigation.
• Current ablation techniques for atrial fibrillation have limitations that necessitate exploring novel approaches.

Purpose of the Study:

• To compare the efficacy and safety of nsPFA against ablation index (AI)-guided radiofrequency ablation (RFA) for treating symptomatic atrial fibrillation.
• To evaluate nsPFA as a potential alternative to RFA in pulmonary vein isolation procedures.

Main Methods:

• A prospective, multicenter, randomized controlled trial (InsightPFA) comparing nsPFA and AI-guided RFA.
• Patients were randomized 1:1 to nsPFA or AI-guided RFA for pulmonary vein isolation.
• Primary endpoint: freedom from atrial tachyarrhythmia recurrence without antiarrhythmic drugs at 12 months; safety assessed via adverse events.

Main Results:

• Noninferiority of nsPFA to AI-guided RFA was demonstrated, with 65.5% vs 64.1% achieving the primary endpoint (P=0.0019).
• No significant difference in procedure-related adverse events between groups; acute procedural success was 100% in both.
• nsPFA showed shorter total procedure time, left atrial dwell time, and ablation time, but longer fluoroscopy times and higher radiation exposure.

Conclusions:

• nsPFA is noninferior in efficacy and comparable in safety to AI-guided RFA for atrial fibrillation treatment.
• nsPFA obviates the need for general anesthesia and significantly reduces procedure and left atrial dwelling times.
• The InsightPFA trial supports nsPFA as a viable alternative for pulmonary vein isolation.