Key result
Pulmonary vein isolation via a novel investigational PFA-based technology showed no evidence of clinically relevant hemolysis based on periprocedural biomarker changes in 16 patients.
Why the study?
Clinical use of pulsed field ablation has suggested potential involvement in red blood cell structural impairment, hemolysis, and acute kidney injury.
Does pulmonary vein isolation via a novel balloon-in-basket PFA catheter cause clinically relevant hemolysis or acute kidney injury in patients undergoing PVI?
Observational (n=16)
Does pulmonary vein isolation via a novel balloon-in-basket PFA catheter cause clinically relevant hemolysis or acute kidney injury in patients undergoing PVI?
Pulmonary vein isolation using a novel balloon-in-basket pulsed field ablation catheter does not appear to cause clinically relevant hemolysis at 24 hours post-procedure.
Supports hemolysis safety of novel balloon-in-basket PFA in this cohort; hypothesis-generating and requires randomized confirmation.
INTRODUCTION: The extensive use of pulsed field ablation (PFA) in clinical settings has unveiled new evidence suggesting potential involvement in red blood cell structural impairment resulting in hemolysis and potential acute kidney injury (AKI). METHODS: In this study, blood samples were collected from 16 patients before and 24 h after pulmonary vein isolation (PVI) via a novel investigational PFA-based technology. Biochemical analyses were performed to assess hemolysis and AKI, including total and indirect bilirubin, lactate dehydrogenase (LDH), haptoglobin, plasma free hemoglobin, urea, creatinine, and estimated glomerular filtration rate (eGFR). RESULTS: Based on the periprocedural changes in hemolysis biomarkers, none of the patients displayed evidence of clinically relevant hemolysis following PVI with the PFA catheter.
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Marcon et al. (2025) conducted an observational in Patients undergoing pulmonary vein isolation (n=16). Pulmonary vein isolation via a novel investigational PFA-based technology vs. Baseline (before procedure) was evaluated on Clinically relevant hemolysis based on periprocedural changes in biomarkers. Pulmonary vein isolation via a novel investigational PFA-based technology showed no evidence of clinically relevant hemolysis based on periprocedural biomarker changes in 16 patients.
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