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 the balloon-in-basket Volt™ 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.
