Safety and Cost-Effectiveness of the FAM-DX Three-Dimensional CARTO Navigation System in Zero Fluoroscopy Electrophysiology Studies for Supraventricular Tachycardia: A Retrospective Cohort Study

Background The zero fluoroscopy (ZF) ablation technique reduces radiation exposure for both medical staff and patients but typically requires specialized navigation ablation catheters. The innovative FAM-DX Three-Dimensional CARTO Navigation System enables 3D mapping without the need for these specialized catheters. This study investigates the safety, feasibility, efficacy, and cost-effectiveness of using the FAM-DX system for ZF electrophysiology (EP) studies in patients with supraventricular tachycardia (SVT). Methods A retrospective analysis was performed at a single center on patients who underwent EP studies using the FAM-DX system between November 2021 and December 2023. Exclusion criteria included patients under 18, pregnant women, those with recent pacemaker implantation, and individuals requiring specific ablations. Clinical data, including patient characteristics, indications, procedure details, fluoroscopy use, ablation requirements, and any procedure-related adverse events, were collected. Results A total of 87 consecutive patients (mean age: 53 ± 18.9 years) were included in this retrospective cohort analysis. Of these, 86 patients (98.85%) successfully underwent ZF ablation using the FAM-DX 3D navigation system, with mapping conducted in various heart regions, including the right atrium, His bundle, coronary sinus, superior vena cava, and inferior vena cava. Only one patient required fluoroscopy due to vascular access issues. Notably, in 41% of cases (36 patients), the ablation catheter was not initially needed or used during the electrophysiological study, suggesting a potential cost-saving benefit given the catheter's cost of approximately $2,431. Conclusions Our study demonstrates that the FAM-DX system enables safe and efficient 3D mapping and ZF techniques for SVT EP studies. This cost-effective approach suggests that the use of ablation catheters may be unnecessary for certain patients. Further research is required to validate the broader adoption of ZF techniques and their application in more complex left-sided procedures.