Evaluation of the Impact of Irrigation Flow Rate on Clinical Outcomes During Pulsed Field Ablation

ABSTRACT Introduction This prospective, non‐randomized study assessed the impact of irrigation flow rates on silent cerebral events (SCEs) during pulsed field ablation (PFA) using the VARIPULSE catheter. Methods Twenty patients underwent pulmonary vein isolation with either 4 mL/min ( l ‐group) or 30 mL/min (H‐group) irrigation. Results SCEs occurred in 2/10 patients in the l ‐group and 0/10 in the H‐group. Given the small sample and rare events, we report descriptive estimates with exact (Clopper–Pearson) 95% CIs ( l ‐group 20.0% [95% CI: 2.5–55.6]; H‐group 0.0% [95% CI: 0.0–30.9]) and a Newcombe (Wilson) 95% CI for the risk difference ( − 20.0% [95% CI: − 51.0 to +22.1]); no hypothesis testing was performed for SCEs. Despite a larger irrigation volume in the H‐group, no hemodynamic worsening was observed. Conclusion In this exploratory series, SCEs were not observed with 30 mL/min irrigation, but the study is underpowered to determine comparative safety.