Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w

A novel saline-based occlusion tool allows for dye-less cryoballoon-based pulmonary vein isolation and fluoroscopy reduction
L. Rottner1, J. Obergassel1, K. Borof1, F. Moser1, M. Lemoine2, J. Wenzel1, P. Kirchhof1, F. Ouyang1, B. Reißmann3, A. Metzner2, A. Rillig2
1Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 2Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 3Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg;

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.



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