Sex-based procedural differences with the novel ballon in a basket pulsed field ablation catheter ( VOLT- PFA ) in atrial fibrillation (AF) ablation. Insight from italian experience
V Ribatti, M Casella, S Riva, B Majocchi, M A Dessanai, R Sicuso, S Cellucci, G Vettor, Y Valeri, L D'angelo, Q Parisi, G Volpato, F Campanelli, C Tondo, A Dello RussoAbstract
Background
Women are typically underrepresented in clinical studies, focused on AF. To improve future AF research, it is important to recognize and overcome sex-related challenges that limit the use of recommended AF treatment.
Purpose
To evaluate gender-related differences in procedural workflow, acute results and safety in patients treated with the VOLT PFA catheter.
Methods
Consecutive patients who had undergone PFA of AF ablation from 2 high volume centers in Italy were included. The statistical analysis compares procedural parameters and outcomes between female and male patients undergoing PVI with the Volt system. Continuous variables are presented as mean ± standard deviation, and p-values are reported for the group comparisons. The Volt PFA system delivers energy through ultra-brief, high-intensity pulsed electric fields that selectively causes irreversible electroporation. This all-in-one platform integrates 3D mapping for precise lesion placement, reducing overall procedure time and patient risk Results : There were no statistically significant differences in the average number of PFA applications required for successful PVI between women (15.2±3.0) and men (14.4±3.3; p=0.40), nort for applications for substrate modification beyond PVI (4.3±2.4 in women vs 7.1±6.5 in men; p=0.34). Total ablation time was almost identical between the sexes (21.3±6.9 min for women, 21.3±8.9 min for men; p=0.99), indicating no gender-based disparities in procedural duration. The only statistically significant difference found was in total fluoroscopy time, which was higher on average for females (22.4±8.2 min) compared to males (17.2±5.6 min), with p=0.04. Procedural success was 100% for acute PVI, with no major complications reported in either group. .
Conclusion
No significant sex-based differences in procedural outcomes were identified within the treated cohort. Notably, procedures performed in female patients were associated with a greater fluoroscopy time in comparison to their male counterparts, suggesting a potential area for process optimization and further investigation in larger multicenter studies.