https://doi.org/10.1007/s00392-024-02526-y
1Agaplesion Markus Krankenhaus Medizinische Klinik III - CCB Frankfurt am Main, Deutschland; 2CCB am AGAPLESION BETHANIEN KRANKENHAUS Medizinisches Versorgungszentrum Frankfurt am Main, Deutschland
Objective
Pulsed Field Ablation (PFA) is a promising modality for atrial fibrillation (AF) ablation that has proven to be safe and effective. The standard approach with the FARAPULSE ablation system (Boston Scientific) consists of a total of 8 applications for each pulmonary vein (PV) divided into two different poses - flower and basket - ensuring ostial isolation. Adding two extra applications in a closer basket configuration, the so called “olive”, could lead to a deeper isolation of the vein. Given the association of PFA with increased risk of acute kidney injury (AKI) secondary to induced haemolysis, probably linked to the number of applications, this study aims to evaluate the feasibility and acute safety of this modified approach.
Methods
A retrospective analysis was conducted on 200 consecutive patients who underwent AF ablation with PFA from May to December 2023 in our centre. Of these patients, 100 were treated with the conventional approach (8 applications per PV) and 100 patients were treated with the olive strategy (10 applications per PV). Baseline characteristics and procedural data were collected for both groups and pre- and post-ablation levels of creatinine were assessed. The primary safety end point comprised acute procedural serious adverse events and the incidence of AKI.
Results
No major serious adverse events were observed in either group. The increase in creatinine levels after the procedure was not found to be statistically significant in the 10-applications group (mean creatinine level preprocedural: 0,95 mg/dl, postprocedural: 0,96 mg/dl, p=0,45) while it was statistically significant in the 8-applications group (preprocedural: 0,98 mg/dl, postprocedural: 1,04 mg/dl, p=0,010), where a single case of AKI occurred.
Conclusions
Our study confirms the overall safety of the olive strategy for PVI with PFA. The incorporation of two additional applications in the olive configuration demonstrates no heightened risk for the patient and does not increase the likelihood of AKI. Ongoing research is underway to evaluate the impact on durable PV isolation and clinical outcomes of this new approach.