Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation

Background:

Pulmonary-vein isolation is effective for paroxysmal atrial fibrillation (AF). Pulsed field ablation (PFA) is a nonthermal method with potential safety advantages over cryoballoon ablation, but comparative efficacy data with continuous rhythm monitoring are limited.

Methods:

In this randomized noninferiority trial, 210 patients with symptomatic paroxysmal AF were assigned to PFA or cryoablation, with all receiving implantable cardiac monitors. The primary endpoint was atrial tachyarrhythmia recurrence between days 91–365 post-ablation. Noninferiority was assessed with a 20-percentage-point margin.

Results:

Recurrence occurred in 37.1% (PFA) vs. 50.7% (cryoablation) (difference: −13.6 percentage points; 95% CI: −26.9 to −0.3; P<0.001 for noninferiority, P=0.046 for superiority).

Safety events were rare (1.0% PFA vs. 1.9% cryoablation).

PFA procedures were shorter (mean 55 vs. 73 minutes).

Conclusions:

PFA was noninferior to cryoablation for AF recurrence and associated with fewer recurrences and shorter procedure times.

Background:

Pulmonary-vein isolation is effective for paroxysmal atrial fibrillation (AF). Pulsed field ablation (PFA) is a nonthermal method with potential safety advantages over cryoballoon ablation, but comparative efficacy data with continuous rhythm monitoring are limited.

Methods:

In this randomized noninferiority trial, 210 patients with symptomatic paroxysmal AF were assigned to PFA or cryoablation, with all receiving implantable cardiac monitors. The primary endpoint was atrial tachyarrhythmia recurrence between days 91–365 post-ablation. Noninferiority was assessed with a 20-percentage-point margin.

Results:

Recurrence occurred in 37.1% (PFA) vs. 50.7% (cryoablation) (difference: −13.6 percentage points; 95% CI: −26.9 to −0.3; P<0.001 for noninferiority, P=0.046 for superiority).

Safety events were rare (1.0% PFA vs. 1.9% cryoablation).

PFA procedures were shorter (mean 55 vs. 73 minutes).

Conclusions:

PFA was noninferior to cryoablation for AF recurrence and associated with fewer recurrences and shorter procedure times.