Advanced pulsed field ablation: comprehensive analysis of safety and efficacy in a real-world cohort

Abstract

Abstract Background Pulsed field ablation (PFA) represents a novel energy modality for catheter ablation of atrial fibrillation (AF). Initial preclinical and clinical studies indicate a higher safety profile with promising efficacy outcomes as well as shorter procedure times. Real world data are sparce and methods to improve clinical success rates are under development. Methods In this observational study 124 patients underwent pulmonary vein isolation with PFA (Farapulse, Boston) for paroxysmal and persistent AF. For anatomical visualization and optimal positioning of the PFA catheter a 3D mapping system was used (Ensite X, Abbott). Patients were followed over a 15-month period to evaluate both efficacy and safety of PFA in a real-world cohort using an advanced mapping technology. Results The patient cohort had a mean age of 67 ± 11 years, 38% females (n= 47), paroxysmal AF 53% (n = 66), persistent AF 47% (n = 58). Acute pulmonary vein isolation (PVI) rate was 100%. After a median FU of 6 months, 17 patients (14%) had a recurrence of AF. In our study population no esophageal complications, pulmonary vein stenosis, or persistent phrenic palsy occurred. Major complications were observed in 2.4% of the cases (3/124), involving two pericardial tamponades (1.6%) and one vascular complication with intervention (0.8%). There were no stroke events and no occurrences of death. Noteworthy was the absence of complications such as coronary arterial spasm or hemolysis-related acute renal failure. The average dose-area product and average procedure time were 9.54 ± 7.68 µGym² and 57.94 ± 18 minutes, respectively. Conclusion PVI with PFA in a real world cohort demonstrates a high safety profile. Furthermore, high clinical success rates can be achieved also in mixed paroxysmal/persistent AF populations. The use of 3D mapping systems might even improve clinical outcomes of PVI with PFA and will also help to guide more complex ablation strategies in the future. These findings pave the way for further exploration into the long-term benefits and broader applicability of PFA in AF ablation.