Renal safety of high-dose pulsed field ablation of atrial fibrillation: A prospective real-world analysis

Background: Pulsed field ablation (PFA) may lead to acute kidney injury (AKI), which is believed to be mediated by hemolysis. Although a dose-dependent response has been suspected, only a few small studies have examined the dose-range effect relationship between the number of PFA applications and renal injury. Objective: This study aimed to assess the incidence of PFA-induced AKI in real-world practice and identify risk factors for AKI after PFA for atrial fibrillation (AF) with a high number of applications. Methods: Data of 115 consecutive patients treated with PFA for AF were prospectively collected. Pre- and 24-hour postprocedural laboratory parameters were used to determine the development of hemolysis and AKI and were analyzed for correlation with number of PFA applications. Results: Although biochemical hemolysis was ubiquitously observed after the PFA procedure, 8 patients (7%) developed AKI with only 1 case of clinically significant renal dysfunction. There was no statistical difference in PFA applications between the AKI (88.25 ± 35.37) and non-AKI groups (70.12 ± 16.94, P = .5). The change in serum creatinine (SCr) 24 hours after the procedure was comparable across 4 subgroups based on PFA applications in quartiles (P = .1). A clinically relevant increase in SCr of 0.004 mg/dL per pulse was observed only when patients received more than 38 PFA applications, leading to approximately 140 pulses being required to produce 0.3 mg/dL increase in SCr to meet the criteria of AKI. Conclusion: The safety margin for the number of PFA applications seems to be higher in real-world practice; delivering 70–100 PFA applications via a pentaspline catheter during AF ablation remains a relatively low risk of AKI.