Pulsed field ablation and the risk of hemolysis-driven acute kidney injury: a systematic review and meta-analysis.

BACKGROUND

Pulsed-field ablation (PFA) has emerged as a potentially safer alternative to radiofrequency ablation (RFA). However, recent studies have raised concerns that PFA may induce hemolysis, which could contribute to the development of acute kidney injury (AKI).

METHODS

The PubMed, Embase, Scopus, and Cochrane databases were searched for randomized clinical trials (RCTs) and non-RCTs that reported AKI incidence and hemolysis biomarkers after PFA. Random-effects models were used to calculate pooled odds ratio (OR) and mean differences (MDs) with 95% confidence intervals (CIs). Substantial heterogeneity was defined as I2 > 25%.

RESULTS

Ten studies, including one RCT, comprising a total of 3,843 patients, were included, with 1,859 in the PFA group and 1,994 in the RFA group. In the primary endpoint analysis related to AKI and renal function, no significant differences were found between the PFA and RFA groups, with PFA having a total prevalence of 2.1% (95% CI [0.90; 4.84]). The leave-one-out analysis, specifically the exclusion of one outlier study, led to the comparative results having statistical significance statistical significance (OR 3.70, 95% CI [2.49; 5.51], p = 0.0019; I² = 0%), indicating no heterogeneity, and with the total prevalence increasing to 2.4% (95% CI [0.96; 5.93]). Regarding hemolysis, all evaluated biomarkers were significantly elevated in the PFA group, although with high heterogeneity.

CONCLUSION

PFA appears to be associated with a slightly higher risk of AKI than RFA. Renal injury is mostly mild-degree and transient. PFA is associated with significant peri-procedural hemolysis.