Key result
Balloon-in-basket PFA for PVI is linked to clinically silent cerebral lesions in ~21% of patients.
Why the study?
Differences in catheter design and waveform characteristics among pulsed field ablation systems may influence thromboembolic risk, microbubble formation, and the incidence of silent cerebral lesions or events.
What is the incidence of silent cerebral lesions following pulmonary vein isolation using a balloon-in-basket pulsed field ablation system in patients with atrial fibrillation?
Observational (n=29)
What is the incidence of silent cerebral lesions following pulmonary vein isolation using a balloon-in-basket pulsed field ablation system in patients with atrial fibrillation?
Pulmonary vein isolation using a balloon-in-basket pulsed field ablation system is associated with a 20.7% incidence of silent cerebral lesions on MRI, which were all clinically silent, suggesting a favorable cerebral safety profile comparable to other PFA technologies.
Post-PFA silent lesions without clinical stroke are hypothesis-generating; comparative trials across systems needed to clarify thromboembolic risk.
Background Several ablation systems using pulsed field ablation (PFA) are now available, differing in catheter design and waveform characteristics. These features may influence thromboembolic risk and microbubble formation, potentially affecting the incidence of silent cerebral lesions (SCL) or silent cerebral events (SCE). The aim of this study was to assess the incidence and characteristics of SCLs in patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation (PVI) using a balloon-in-basket PFA system. Methods In patients with paroxysmal or persistent atrial fibrillation undergoing PFA-based PVI using a balloon-in-basket system, cerebral magnetic resonance imaging (MRI) was performed within 48 hours after ablation. Findings were double-validated by two independent physicians. Procedural parameters, anticoagulation details, and peri-procedural events were recorded. All patients underwent a standardized neurological examination post-procedure to exclude clinical stroke. Results A total of 29 patients (15 male) were enrolled. Median age was 68 (interquartile range [IQR] 61-75) years, and median procedure time was 50 (IQR 43-60) minutes. The median number of applications was 24. New post-procedural SCLs were detected in 6 patients (20.7%), whereas cerebral MRI showed no acute lesions in 23 patients (79.3%). All lesions were small (<15 mm), predominantly subcortical, and clinically silent. No overt clinical stroke occurred. The incidence of SCLs did not correlate with procedure duration, anticoagulation status, or peri-procedural events. The observed rate of SCLs was comparable to our previous findings using the pentaspline PFA catheter (18.5%). Conclusion Pulsed field ablation using the balloon-in-basket system was associated with a low incidence of silent cerebral lesions, comparable to other PFA technologies. All lesions were clinically silent and not related to procedural or anticoagulation parameters, suggesting a favorable cerebral safety profile of this novel system.
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Hoelzl et al. (2026) conducted an observational in Paroxysmal or persistent atrial fibrillation (n=29). Balloon-in-basket pulsed field ablation (PFA) system was evaluated on Incidence of silent cerebral lesions (SCL). Pulmonary vein isolation using a balloon-in-basket pulsed field ablation system resulted in new silent cerebral lesions in 20.7% of patients, all of which were clinically silent.
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