A novel saline-based occlusion tool allows for dye-less cryoballoon-based pulmonary vein isolation and fluoroscopy reduction

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: None. BACKGROUND: Cryoballoon (CB)- based pulmonary vein isolation (PVI) remains guided by fluoroscopy and dye. The novel saline injection-based occlusion tool allows for pulmonary vein (PV)-occlusion assessment without the need for dye injection. AIM: To compare KODEX-EPD guided CB-PVI using the novel saline injection-based workflow with conventional cryoablation for acute efficacy, fluoroscopy exposure and dye volume. METHODS: Consecutive atrial fibrillation (AF)- patients undergoing CB-PVI in conjunction with KODEX-EPD (CryoEPD group) were analyzed. A left atrial image was created to visualize pulmonary vein (PV) anatomy prior to ablation. PV-occlusion was assessed with the KODEX-EPD occlusion tool along with saline injection. Patients undergoing conventional CB-PVI (CryoCONV group) in the same time period acted as controls. RESULTS: One hundred forty patients (91/140 (65%) persistent AF) were studied. Seventy patients underwent CryoEPD procedures (64 ± 13 years, 21 (30%) female) and seventy patients underwent CryoCONV procedures (68 ± 10 years, 27 (39%) female). A total of 560 PVs were identified and successfully isolated. Mean procedure time was 66 ± 15 minutes for the CryoEPD group, and 65 ± 19 minutes for the CryoCONV group (p=0.3). Fluoroscopy time (CryoEPD 6 ± 4 minutes; CryoCONV 13 ± 6 minutes, p<0.001) and dose area product (CryoEPD 193 [111; 297] cGycm2; CryoCONV 381 [268; 614] cGycm2, p<0.001) were lower in patients undergoing CryoEPD compared with CryoCONV procedures. No dye was needed in the CryoEPD group while 53 ± 18 ml dye per patient were administered for the CryoCONV group (p<0.001). The overall complication rate was comparable between both groups (p=0.5). CONCLUSION: KODEX-EPD guided AF-ablation enables dye-free CB-based PVI with reduced fluoroscopy exposure when compared to conventional CB-ablation, without differences in acute procedural outcomes or procedure duration.