Evaluation of Hemolysis Risk, Renal Function, and Safety Among Two Pulsed Field Ablation Systems: A Systematic Review and Meta-Analysis.

This study investigated the hemolysis risk, renal, and safety outcomes between two pulsed field ablation (PFA) systems. A systematic review and meta-analysis were performed using PubMed, Cochrane, and ScienceDirect databases for all studies comparing circular to pentaspline PFA systems. Pooled markers evaluated included procedural characteristics, haptoglobin, lactate dehydrogenase (LDH), bilirubin, hemoglobin, and creatinine, with glomerular filtration rate (GFR) and safety markers qualitatively discussed. A total of 11 studies were included, comprising 1517 individuals. While differences in procedural, left atrial dwelling, and fluoroscopy times were statistically insignificant between the two PFA systems, the pentaspline system was significantly associated with lower post-procedural haptoglobin levels (SMD: 0.59; 95% CI: 0.25 to 0.93), higher LDH (SMD: -0.87; 95% CI: -1.49 to -0.253), and higher bilirubin levels (SMD: -0.77; 95% CI: -1.13 to -0.42) compared to circular catheters. No significant differences were observed in total hemoglobin levels (SMD: 0.13; 95% CI: -0.17 to 0.44; p = 0.206) or the magnitude of creatinine change (SMD: -0.02; 95% CI: -0.07 to 0.030; p = 0.270) between the systems. However, the incidence of acute kidney injury (AKI) was more pronounced in the pentaspline cohort with five documented cases, and more peri/post-procedural complications were recorded for the pentaspline system than for circular catheters. Pentaspline systems were associated with more pronounced laboratory markers of hemolysis, although clinically significant renal dysfunction remained uncommon and evidence regarding clinical consequences remains limited. Future studies are encouraged to standardize both reporting and data collection procedures to facilitate direct comparisons and tests of validity.