Fehmi Keçe

A bstract Background Pulmonary vein isolation (PVI) with the Pulmonary Vein Ablation Catheter (PVAC) is associated with asymptomatic cerebral embolism (ACE). The second-generation PVAC (PVAC-Gold) was designed to avoid this complication. Objective The purpose of this study was to randomly compare ACE incidence between the PVAC-Gold and the irrigated Thermocool catheter. Methods Patients with paroxysmal atrial fibrillation were 1:1 randomized to PVI with the PVAC- Gold or Thermocool catheter. Cerebral MRI was performed the days before and after ablation and repeated after 3 months in case of a new lesion. Monitoring for micro-embolic signals (MES) was performed by transcranial Doppler ultrasonography. Parameters of coagulation were determined before, during and after ablation. Neuropsychological tests and questionnaires were applied 10 days before and 3 months after ablation. Results Seventy patients were included (61±9 years, 43 male, CHA 2 DS 2 -VASc score 1.6±1.2, INR 2.7±0.5, ACT 374±24s, P>0.05 for all parameters). Procedural duration was shorter in the PVAC-Gold group (140±34 vs. 207±44 min, p<0.001). Eight (23%, 7 infarcts) patients in the PVAC-Gold group showed a new ACE, compared to 2 (6%, no infarcts) patients in the Thermocool group (p=0.042). Median number of MES was higher in the PVAC-Gold group (1111 [IQR 715-2234] vs. 787 [IQR 532-1053], p<0.001). There were no differences between groups regarding coagulation and neuropsychological outcomes. Conclusion PVI with the new PVAC-Gold catheter was associated with a higher incidence of ACE/ cerebral infarcts and number of MES. Both catheters induced a comparable pro-coagulant state. As there were no measurable differences in neuropsychological status, the clinical significance of ACE remains unclear. Clinical Trial Registration Cerebral Embolism [CE] in Catheter Ablation of Atrial Fibrillation [AF] [CE-AF]; at clinicaltrials. gov- NCT01361295