Why the study?
Cryoballoon-based PVI typically relies on fluoroscopy and dye, but a novel saline injection-based occlusion tool allows PV occlusion assessment without dye.
Does KODEX-EPD guided cryoballoon ablation with a saline injection-based occlusion tool reduce fluoroscopy exposure and dye volume compared to conventional cryoablation in patients with atrial fibrillation?
Does KODEX-EPD guided cryoballoon ablation with a saline injection-based occlusion tool reduce fluoroscopy exposure and dye volume compared to conventional cryoablation in patients with atrial fibrillation?
The use of a novel saline-based occlusion tool during cryoballoon pulmonary vein isolation eliminates the need for contrast dye and significantly reduces fluoroscopy exposure without compromising acute procedural efficacy or safety.
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Reduces fluoroscopy and dye use in CB-PVI without compromising acute efficacy; leaves open whether outcomes improve in randomized trials.
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 (Cryo EPD group) were analyzed. Patients undergoing conventional CB-PVI (Cryo group) in the same time period acted as controls. Results One hundred forty patients [91/140 (65%) persistent AF] were studied. Seventy patients underwent Cryo EPD procedures [64 ± 13 years, 21 (30%) female] and seventy patients underwent Cryo procedures [68 ± 10 years, 27 (39%) female]. A total of 560 PVs were identified and successfully isolated. Mean procedure time was 66 ± 15 min for the Cryo EPD group, and 65 ± 19 min for the Cryo group ( p = 0.3). Fluoroscopy time (Cryo EPD 6 ± 4 min; Cryo 13 ± 6 min, p < 0.001) and dose area product (Cryo EPD 193 [111; 297] cGycm 2 ; Cryo 381 [268; 614] cGycm 2 , p < 0.001) were lower in patients undergoing Cryo EPD compared with Cryo procedures. No dye was needed in the Cryo EPD group while 53 ± 18 ml dye per patient were administered for the Cryo 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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Rottner et al. (2023) studied this question.
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