PFA appears safe and effective, but whether it is better than radiofrequency or cryoablation remains unclear.

Pulsed-field ablation (PFA) is currently the darling of electrophysiology, and various PFA systems are under development and testing. Preliminary results from the prospective, multicentre, single-arm inspIRE trial (NCT04524364) of the non-FDA-approved Varipulse system showed effectiveness and safety for paroxysmal atrial fibrillation (AF). Now, the investigators report final one-year results.

The cohort included 186 patients (mean age, 59 years; 30% women; mean CHA2DS2-VASc score, 1.3).

Results were as follows:

• only one acute adverse event – a case of urinary retention – was reported
• the primary effectiveness endpoint – complete pulmonary vein isolation and freedom from any atrial arrhythmia at 12 months – was achieved in 76% of patients
• freedom from any symptomatic recurrence was achieved in 82%
• in a multivariable analysis, left ventricular ejection fraction 60% or greater and receiving 48 or more total PFA applications were independent predictors of primary effectiveness end-point success
• of the 14 patients who underwent repeat ablation, pulmonary vein reconnections were seen in 37 of 51 veins (73%).

Comment: This prospective study shows that PFA is safe and effective but does not examine whether it is superior to radiofrequency or cryoablation in either regard. Results cannot be generalised beyond patients with paroxysmal AF, who are known to have a relatively high degree of success with ablation. Although caution is needed in comparing results across trials, this study’s one-year success rate of 76% is not different than previously observed success rates of other modalities. Moreover, the 73% reconnection rate seems high. Although these data add to the limited literature on PFA results, they will not change my current AF ablation practice.

Mark S. Link, MD, Professor of Medicine and Director, Cardiac Electrophysiology, UT Southwestern Medical Center, Dallas, USA.

De Potter T, et al. Predictors of success for pulmonary vein isolation with pulsed-­field ablation using a variable-­loop catheter with 3D mapping integration: complete 12 ­month outcomes from inspIRE. Circ Arrhythm Electrophysiol 2024; 17: e012667.

This summary is taken from the following Journal Watch title: Cardiology.