Acute outcomes and learning curve from the initial patients treated with the PulseSelect system: a real-world multicenter experience of pulsed field ablation.

Abstract

Introduction: Catheter ablation is a cornerstone in managing patients with symptomatic, drug-refractory atrial fibrillation (AF), and while effective, traditional thermal ablation techniques are associated with rare but significant complications due to a non-selective thermal energy transfer to all biologic tissues. Pulsed field ablation (PFA) offers a non-thermal approach, targeting myocardial tissue selectively while sparing adjacent structures. The PulseSelect system is a novel PFA platform, and this analysis examines the procedural outcomes, acute complications, and the learning curve associated with introduction of the PulseSelect system in six European centers.

Methods: The One Shot to Pulmonary Vein Isolation (1STOP) project prospectively included 131 patients with paroxysmal or persistent AF treated with the PulseSelect system across six centers. Procedural data, patient characteristics, and acute outcomes were summarized. Additionally, sedation protocols, fluoroscopic times, and acute success rates were reported.

Results: Patients (mean age 61.7 ± 9.7 years; 31.3% female) had predominantly paroxysmal AF (80.9%). Median procedural and fluoroscopy times were 55.0 and 16.0 min, respectively. General anesthesia was used in 75.5% of cases, while in the remaining 24.5% moderate sedation protocols allowed procedures (even in 15.1% without an anesthesiologist). Acute PVI success was 100%, and no major complications were observed. A short learning curve was noted, with significant reductions in procedural times after the initial 2-3 cases at each center.

Conclusion: The PulseSelect system showed short procedural times, with a rapid learning curve, thus leading with high procedural efficiency. In 1 out of 4 cases general anesthesia was not applied, and no major complications were observed.