Key result
Variable-loop circular catheter PFA is linked to acute ischemic cerebral lesions in ~67% of patients.
Why the study?
Data on ischemic cerebral lesions after pulsed field ablation are limited, and because systems differ substantially in pulse characteristics, cerebral safety must be evaluated for each system.
Does pulsed field ablation using a variable-loop circular catheter cause ischemic cerebral lesions in patients with non-paroxysmal atrial fibrillation?
Cohort (n=21)
No
Does pulsed field ablation using a variable-loop circular catheter cause ischemic cerebral lesions in patients with non-paroxysmal atrial fibrillation?
Pulsed field ablation using a variable-loop circular catheter for non-paroxysmal atrial fibrillation was associated with a concerningly high rate (66.7%) of ischemic cerebral lesions, highlighting the need for system-specific safety evaluations.
Background Pulsed field (PF) energy is an increasingly adopted technology for ablation of atrial fibrillation (AF). Although clinical data on PF ablation is positive, data on ischemic cerebral lesions (ICL) after PF ablation is limited. Since the individual PFA systems differ substantially in pulse characteristics, cerebral safety should be studied separately for each system. Objectives To assess the incidence of ICLs after PFA for AF using a Variable-Loop Circular Catheter (VLCC). Methods The study was designed as a prospective, observational, cohort, single-center study. In non-paroxysmal AF patients, pulmonary vein and left atrial posterior wall isolation were performed. NIHSS scores were assessed within 24 hours post-ablation. Brain MRI (1.5T, diffusion-weighted imaging including) was conducted one day before and 24 hours after the procedure to detect acute ICL. The study initially aimed to enroll 40 patients but was terminated early due to safety concerns. Results Twenty-one patients were enrolled (age 66.1 ± 9.0 years, 38% females, all with non-paroxysmal AF). ICLs occurred in 14 (66.7%) patients, with a median of 2 (IQR 0–3) lesions per patient, and a median cumulative lesion burden of 10.5 mm (6.3–19.3). Most ICLs (28; 55.8%) were localized in the posterior territory. One patient experienced a transient ischemic attack, and one patient suffered a major peri-procedural stroke (NIHSS = 6; modified Rankin scale = 3 at the day 30 clinical follow-up). Conclusions PF ablation using VLCC was associated with a high rate of ICLs. More than half of the lesions were in the posterior cerebrovascular territory.
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Hozman et al. (2026) conducted a cohort in Non-paroxysmal atrial fibrillation (n=21). Pulsed field ablation using a Variable-Loop Circular Catheter (VLCC) was evaluated on Incidence of acute ischemic cerebral lesions (ICLs) detected by brain MRI 24 hours post-ablation. Pulsed field ablation using a Variable-Loop Circular Catheter for non-paroxysmal atrial fibrillation resulted in acute ischemic cerebral lesions in 66.7% of patients.
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