DGK Herztage 2025. Clin Res Cardiol (2025). https://doi.org/10.1007/s00392-025-02737-x
1Städtisches Klinikum Karlsruhe gGmbH Med. IV, Schwerpunkt Kardiologie, Angiologie und Internistische Intensivmedizin Karlsruhe, Deutschland
Background:
The use of pulsed field energy (PFA) for pulmonary vein isolation (PVI) is of growing importance. For each available Device the ablation protocol varies. Modified protocols often aim to further reduce procedure times. The aim of this study was to evaluate the efficacy of additional PFA lesion and their impact on success rates.
Methods:
Consecutive patients undergoing first ablation for atrial fibrillation were enrolled. For PVI, the 31mm FARAPULSE™ Pulsed Field Ablation System was used in all patients. After PV angiography, in group A, eight PFA lesions were delivered for each PV: four in a basket and four in a flower configuration. The catheter was rotated after every second energy delivery. In Group B, an extra four PFA lesions were administered in a flower configuration, resulting in a total of 12 applications per PV. At the end of the procedure, demonstration of either exit or entry block was mandatory for all PVs. In the event of reconnection, an additional set of ablations in flower configuration was applied. An additional ablation of the cavotricuspidal isthmus was allowed in both groups.
Results:
Baseline: A total of 218 patients were included. Group A N=94; Group B N=128. Baseline characteristics were not different between groups. Mean age was 60 years (37% female), mean left atrial diameter was 41mm, left ventricular ejection fraction 60%. Paroxysmal AF was present in 57%. Procedural data: Mean procedure time for group A was 66±23 min, and for group B 63±23 min. Mean fluoroscopy time and dosage was 16±6 min / 536±693 cGy*cm2. for group A and 14±5 min / 462±1560 cGy*cm2 for group B. Additional Isthmus-ablation was 20% / 24% in group A and B, respectively. Complications: Pericardial effusions requiring pericardial puncture occurred in two patients in group A in the early phase of device application. Outcome: Freedom from any arrhythmia after 12 month was 71.3% in group A versus 82,3% in Group B. Mean time without AF recurrence was 10.5 months in Group A (95% CI: 9.97–10.97) vs 11.5 months (95% CI: 11.31–11.73) in Group B. The curves diverged early, with Group B consistently showing higher AF-free probabilities. At six months, 99.2% of Group B remained AF-free versus 85.1% of Group A. Log-rank testing confirmed the statistical significance of these differences (χ² = 5.20, p = 0.0226).
Conclusions:
The 4x8 protocol, incorporating four additional flower-configuration PFA lesions, significantly improves 12 month success rates of PVI without extending procedure time.