Learning Curve and Procedural Efficiency of the Variable-Loop, 3D-Integrated Circular PFA Catheter in Pulmonary Vein Isolation

M. Lüsebrink (Bad Nauheim)1, J. Yogarajah (Bad Nauheim)2, P. Kahle (Bad Nauheim)2, J. Hutter (Bad Nauheim)2, M. Tomic (Bad Nauheim)2, S. T. Sossalla (Gießen)3, M. Kuniss (Bad Nauheim)2, T. Neumann (Bad Nauheim)2
1Kerckhoff-Klinik Kardiologie Bad Nauheim, Deutschland; 2Kerckhoff Klinik GmbH Abteilung für Kardiologie Bad Nauheim, Deutschland; 3Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland

Background:
Recent data suggest that pulsed field ablation (PFA) is associated with progressively shorter procedure times, particularly with fluoroscopy-only PFA systems. The Varipulse™ PFA platform combines 3D electroanatomical mapping (EAM) with pulsed field delivery via a variable-loop circular catheter (VLCC). While its safety is increasingly reported, data on the learning curve and procedural efficiency remain limited.

Objective:
To assess the learning curve and procedural efficiency associated with a variable-loop circular catheter PFA system.

Methods:
Fifty-three patients (mean age 62 ± 10.5 years; 75.5% male; 72% paroxysmal atrial fibrillation) underwent PVI-only procedures using the Varipulse™ PFA system. The mean CHA₂DS₂-VA score was 1.8 ± 1.2, and the mean left ventricular ejection fraction (LVEF) was 57.7 ± 6.3%. Left atrial size was normal (<20 cm²) in 43.4% and mildly dilated in 22.6%. Sinus rhythm was present at the start of the procedure in 94.3%. Four experienced electrophysiologists performed all procedures. For each operator, the first three procedures were defined as the training phase and compared with subsequent post-training cases. Total procedure time, LA dwell time, fluoroscopy time, area dose product, and procedural success were analysed.

Results:
Across the total cohort, mean procedure time decreased from 86.7 ± 15.7 min in the training phase to 73.9 ± 21.0 min post-training (–14.7%; p = 0.031; Cohen’s d = 0.64).
 LA dwell time showed a pronounced reduction from 76.7 ± 14.1 min to 61.6 ± 15.8 min (–19.6%; p = 0.005; d = 0.97). Fluoroscopy time decreased modestly (10.5 ± 5.8 min to 9.0 ± 4.6 min; p = 0.341), and radiation dose remained unchanged (3.41 ± 2.14 Gy·cm² vs. 3.72 ± 2.68 Gy·cm²; p = 0.676).
In operator-specific analyses, similar results were observed: LA dwell time improved significantly after the first three cases (F = 4.24, p = 0.045), while no significant differences were found for total procedure time, fluoroscopy time, or radiation dose.
In multivariate analysis, learning curve significantly affected LA dwell time (F = 6.55; p = 0.014; η² = 0.141), whereas operator and BMI influenced radiation exposure but not procedural duration. Acute PVI was achieved in all patients without RF-touch-up.

Conclusion:
The learning curve for the Varipulse™ PFA system is short. Procedural efficiency, particularly in LA dwell time, improves after only a few cases, while radiation parameters did not decline.