NEAR-ZERO FLUOROSCOPY WORKFLOW FOR PULMONARY VEIN ISOLATION IN ATRIAL FIBRILLATION USING A VARIABLE LOOP, 3D-INTEGRATED CIRCULAR PFA CATHETER (VARIPULSE™): INITIAL EXPERIENCE

Background: 

Catheter ablation is a standard atrial fibrillation (AF) treatment, traditionally using radiofrequency (RF) or cryoablation, which carries the risk of damaging nearby structures. Pulsed field ablation (PFA) offers 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 patients treated. In this abstract, the first 35 patients are shown, the data will be expanded accordingly depending on availability of the device until Q2 2025.

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:

Thirty-five 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, fluoroscopy time and dose, and safety outcomes, with a focus on assessing the feasibility of a near-zero fluoroscopy workflow.

Results:

Thirty patients underwent near-zero fluoroscopy atrial fibrillation ablation using the novel VARIPULSE™ Pulsed Field Ablation catheter. Patients had a median age of 70 years and typical cardiovascular comorbidities, with 54% presenting with paroxysmal AF. 33 of 35 patients had a normal left ventricular systolic function (>60%). The median CHA₂DS₂-VA score was 2 (IQR: 1–3.75). Sinus rhythm was observed in 66% of cases at procedure start. Median fluoroscopy time was 0.8 minutes, total median procedure time 53 minutes, and median fluoroscopy dose 20.4 µGym². Pulmonary vein isolation was achieved in 100% of cases without radiofrequency touch-up. No major complications occurred.

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.