A prospective randomized clinical comparison of catheter ablation of atrial fibrillation using the CENTAURI PEF system and standard radiofrequency ablation

Abstract Introduction Radiofrequency (RF) catheter ablation has been the standard treatment for atrial fibrillation (AF) in recent years. However, irreversible electroporation (pulse field ablation, PFA) is emerging as a promising alternative. The aim of this study was to present one-year results comparing the efficacy and safety of catheter ablation for AF using the point-to-point CENTAURI PEF System (CardioFocus Inc.) and the single-shot FARAPULSE System (Boston Scientific). Methods Patients referred for ablation of paroxysmal and persistent AF were enrolled in this study and randomly assigned to one of two groups. The CENTAURI PEF group underwent ablation with the EnSite Precision 3D mapping system (Abbott) for left atrial mapping and a TactiCath CF ablation catheter (Abbott) for point-to-point ablation using PFA generated by the CENTAURI generator. The FARAPULSE group underwent ablation with a specialized single-shot multipolar basket catheter under fluoroscopy and intracardiac ultrasound guidance. All procedures were performed under general anesthesia. Periprocedural parameters and follow-up results were compared between the two groups. Results Between May 3, 2023, and November 1, 2024, a total of 201 patients underwent catheter ablation for AF (127 with paroxysmal AF and 74 with persistent AF). Of these, 106 patients were treated with the CENTAURI system (CENTAURI group - CENT) and 95 with the FARAPULSE system (FARAPULSE group - FARA). The baseline characteristics of the two groups were similar: 27% of patients were women, the mean age was 61 years, and the mean left atrial size was 45 mm. The average total procedure time was 110 min for the CENT and 70 min for the FARA. The X-ray dose was 1500 mGy·cm² for the CENT and 2550 mGy·cm² for the FARA. The isolation time of the left pulmonary veins (LPVs) was 17 min for the CENT and 8 min for the FARA. The isolation time of the right pulmonary veins (RPVs) was 19 min for the CENTand 8 min for the FARA. Acute or subacute complications were not recorded in the CENT, while in the FARA was one stroke and one pericardial effusion requiring pericardiocentesis. A total of 29 patients from the CENT attended a follow-up visit at 12 months, 72% of patients maintained sinus rhythm. No patients in the FARA underwent a 12-month follow-up visit yet. The results for ablation of both paroxysmal and persistent AF were similar for the two groups. Conclusions Catheter ablation with both PFA systems appears to be comparably effective and safe. The complications observed in the FARAPULSE group are typical of those associated with catheter ablation of arrhythmias and may be attributed to the learning curve. Procedure times were longer with the CENTAURI system, primarily due to 3D mapping and point-by-point ablation, while the FARAPULSE system resulted in a shorter procedure time but a significantly higher X-ray dose. The assessment of long-term effectiveness is limited by the small number of patients with follow-up data.