Pulse field ablation in patients with paroxysmal and persistent atrial fibrillation using the circular multielectrode array catheter: first outcome data in a real-world prospective study
摘要
Pulsed field ablation (PFA) is an innovative option for the treatment of atrial fibrillation (AF). As different PFA technologies are now available, the safety and efficacy of each ablation system must be individually demonstrated. For the circular multielectrode array catheter, only the pivotal trial to date has been published showing efficacy and safety comparable to other PFA technologies. This study aimed to evaluate outcomes of this technology in a real-world cohort.
MethodsConsecutive patients undergoing their first pulmonary vein isolation (PVI) using the circular multielectrode array catheter were included. All patients were prospectively enrolled in the Berlin Best-Ablate registry. Follow-up evaluations were performed at 3, 6, and 12 months using 24-hour Holter electrocardiography.
ResultsA total of 81 patients (37 with paroxysmal AF and 44 with persistent AF) were included. Acute PVI was achieved in all patients (median age, 69 years; 64.2% male). After a mean follow-up of 6.7 ± 5.1 months, recurrence of any atrial arrhythmia was observed in 23 of 81 patients (28.4%). Four patients (three with atrial tachycardia (AT) and one with AF) underwent a repeat ablation procedure. In both AT cases, PVI was found to be intact, whereas in the AF case, re-isolation of the pulmonary veins was required. One patient experienced a major complication (stroke).
ConclusionIn this prospective real-world study, PFA using the circular multielectrode array catheter (PulseSelect catheter) proved to be effective in patients with both paroxysmal and persistent AF, corroborating the findings of the pivotal trial.
Graphical Abstract