DGK Herztage 2025. Clin Res Cardiol (2025). https://doi.org/10.1007/s00392-025-02737-x
1Segeberger Kliniken GmbH Herz- und Gefäßzentrum Bad Segeberg, Deutschland
Background:
Catheter ablation is a standard atrial fibrillation (AF) treatment, traditionally using radiofrequency (RF) or cryoablation, which is suggested damaging nearby structures. In contrast pulsed field ablation (PFA) therefore may offer partly tissue-selective energy application with minimal collateral damage. This study evaluated a near-zero fluoroscopy workflow with the novel VARIPULSE™ catheter, combining advanced mapping for optimized PFA delivery and reduced radiation. Here we investigate the safety, efficiency, and effectiveness of this approach in the first 70 consecutive patients treated.
Objective:
To assess the procedural characteristics, safety, and acute efficacy of pulmonary vein isolation (PVI) using the VARIPULSE™ PFA catheter in patients with AF, while specifically evaluating a near-zero fluoroscopy workflow to minimize radiation exposure during the procedure.
Methods:
70 consecutive patients with paroxysmal or persistent AF underwent pulmonary vein isolation (PVI) using the VARIPULSE™ PFA catheter. Procedures were conducted under general anesthesia or deep sedation. Key procedural endpoints included acute pulmonary vein isolation, total procedure time, LA dwell time, fluoroscopy time and dose, and safety outcomes, with a focus on assessing the feasibility of a near-zero fluoroscopy workflow.
Results:
70 patients underwent near-zero fluoroscopy atrial fibrillation ablation using the novel VARIPULSE™ Pulsed Field Ablation catheter. Patients had a median age of 67 years and typical cardiovascular comorbidities, with 56% presenting with paroxysmal AF. 60 of 70 patients (86%) had a normal left ventricular systolic function (>60%). The median CHA2DS2-VA score was 2 (IQR: 1–3). Sinus rhythm was observed in 71% of cases at procedure start. Median fluoroscopy time was 0.5 minutes, total median procedure time 44.5 minutes, median LA dwell time 31.5 minutes, and median fluoroscopy dose 10.9 µGym². Pulmonary vein isolation was achieved in 100% of cases without radiofrequency touch-up. No major complications occurred until discharge.
Conclusion:
The VARIPULSE™ Pulsed Field Ablation system enables an efficient, nearly fluoroscopy-free atrial fibrillation ablation with a simple, easily integrable workflow in the EP lab. Complete pulmonary vein isolation was achieved in all cases without radiofrequency touch-ups, and the procedure was safe with no major complications. This demonstrates the potential for widespread adoption of this technology and workflow.