Sine wave electroporation in patients with atrial fibrillation: Initial results of the BURST-AF study.

BACKGROUND

Challenges or opportunities remain for improvement of pulsed field ablation (PFA) for atrial fibrillation (AF).

OBJECTIVE

BURST-AF evaluated safety and lesion durability of a novel PFA system, Coherent Sine Burst Electroporation (CSE).

METHODS

Patients with AF who failed ≥ 1 antiarrhythmic drug and undergoing de novo ablation were included. The CSE system includes a PFA generator and stylet-configurable catheter (circular, linear, focal). Pulmonary veins (PVs) were isolated with overlapping circular PFA applications. Ablation of additional lesions (posterior wall [PW]/cavotricuspid isthmus [CTI]) was performed at investigator discretion. Acute end point was isolation of PVs after a 20-minute waiting period. Chronic end point was isolation of PVs, bidirectional block (CTI), and/or absence of PW electrical activity at remap. Freedom from > 30 seconds of atrial arrhythmias was evaluated till 6 months.

RESULTS

A total of 90 patients were enrolled (54% men, 62 years old, 60% paroxysmal AF). Targeted PVs (344) were isolated with 6.5 ± 1.7 PFA lesions/PV. PFA lesions for CTI and PW were 8.3 ± 4.7 and 14.4 ± 3.9, respectively. Procedure, catheter dwell, and fluoroscopy times were 93 ± 28 minutes, 54 ± 28 minutes, and 13.3 ± 5.5 minutes, respectively. Per PV isolation was 94.1% (317/337), and per patient isolation was 78.4% (69/88). Additional lesion set durability was 94.4% (102/108). At 6-month follow-up, 92.6% (63/68 patients) were free from atrial arrhythmias. One primary safety event of renal insufficiency was reported.

CONCLUSION

CSE PFA system durably isolated PVs, PW, and CTI with a low rate of complications in this first-in-human study. (CSE System Pilot Study in Patients with Atrial Fibrillation - BURST-AF, NCT05572047).