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

Abstract

BackgroundCryoballoon (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.AimTo compare KODEX-EPD guided CB-PVI using the novel saline injection-based workflow with conventional cryoablation for acute efficacy, fluoroscopy exposure and dye volume.MethodsConsecutive atrial fibrillation (AF)- patients undergoing CB-PVI in conjunction with KODEX-EPD (CryoEPD group) were analyzed. Patients undergoing conventional CB-PVI (Cryo group) in the same time period acted as controls.ResultsOne 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 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 CryoEPD group, and 65 ± 19 min for the Cryo group (p = 0.3). Fluoroscopy time (CryoEPD 6 ± 4 min; Cryo 13 ± 6 min, p < 0.001) and dose area product (CryoEPD 193 [111; 297] cGycm2; Cryo 381 [268; 614] cGycm2, p < 0.001) were lower in patients undergoing CryoEPD compared with Cryo procedures. No dye was needed in the CryoEPD 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).ConclusionKODEX-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.

Cryoablation Utilizing the KODEX-EPD Mapping System Versus Conventional Cryoballoon Ablation in the Management of Patients With Atrial Fibrillation: A Literature Review and Meta-Analysis

“…The mean risk of bias score of the included observational studies [20][21][22][23][24], according to the NHLB quality assessment tool was 10.4 out of 14, as shown in Table 3. The overall risk of bias in the only randomized controlled trial [25], according to the Cochrane Risk of Bias tool, was moderate (Table 4).…”

“…Successful cryoballoon-based PVI: Two studies [22,23] reported this outcome. Both groups showed successful PVI in all included patients without any difference between both cohorts (RR = 1.00 (0.97, 1.03); P = 1.00).…”

“…Data were homogeneous (P = 1.00); I² = 0% (Figure 2). Procedural duration (min): A total of 362 patients from four studies [22][23][24][25] were analyzed regarding the total procedural time. Our analysis showed similar procedure times in both groups (MD = -0.12 (-3.73, 3.50); P = 0.95).…”

“…Sources: [22][23][24][25] Procedural complications: Four studies [22][23][24][25] evaluated the incidence of each procedure-related complication. The incidence of procedural complication was comparable in both groups, with an overall RR = 0.776 (0.295, 2.038) and P = 0.607.…”

“…Sources: [22][23][24][25] Recurrence: We analyzed 249 patients from four studies [21,22,24,25] investigating the risk of recurrence after each procedure. Our analysis showed a significantly lower incidence of recurrence in patients who underwent cryoablation guided by the KODEX mapping system (RR = 0.61 (0.39, 0.96), P = 0.03).…”