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Background and aimTo investigate the feasibility, acute efficacy, periprocedural safety, and procedural parameters of CB-based PVI guided by KODEX-EPD using different occlusion tool software versions.Methods and resultsA total of 173 patients (60/173 (35%) paroxysmal AF, 64 ± 12 years, 66/173 (38%) female), underwent CB-based PVI guided by KODEX-EPD between August 2019 and October 2021. Acute PVI was achieved in all the patients. Total fluoroscopy time and dye volume were 13.9 [10.6–19.4] min and 47.5 [20–70] ml. Periprocedural complications occurred in 3 (2%) of the 173 patients. As part of the continued development program, different software versions were used, including 1.4.6 on 38 (22%), 1.4.6a on 33 (19%), 1.4.7 on 41 (24%), and 1.4.8 on 61 (35%) of the patients. Outcomes were compared between software versions by a univariate analysis. Sensitivity analyses were performed to account for confounders. Median fluoroscopy time was decreased by 6.4 min (37.3%), and the median volume of dye was decreased by 32.5 ml (52%) from versions 1.4.6 to 1.4.8. Software version was a significant predictor of fluoroscopy time and dye volume, while reductions in procedure duration and dose area product were observed but mainly explained via confounders.ConclusionCB-based PVI guided by KODEX-EPD is feasible and safe. Progressive software improvements appear to be associated with lower fluoroscopy duration and dye use. Further studies are needed to evaluate the advantage of KODEX-EPD-guided compared to conventional CB-PVI.

Background and Aim: To investigate the feasibility, acute efficacy, periprocedural safety, and procedural parameters of CB-based PVI guided by KODEX-EPD using different occlusion tool software versions., Methods and Results: A total of 173 patients (60/173 (35%) paroxysmal AF, 64 ± 12 years, 66/173 (38%) female), underwent CB-based PVI guided by KODEX-EPD between August 2019 and October 2021. Acute PVI was achieved in all the patients. Total fluoroscopy time and dye volume were 13.9 [10.6-19.4] min and 47.5 [20-70] ml. Periprocedural complications occurred in 3 (2%) of the 173 patients. As part of the continued development program, different software versions were used, including 1.4.6 on 38 (22%), 1.4.6a on 33 (19%), 1.4.7 on 41 (24%), and 1.4.8 on 61 (35%) of the patients. Outcomes were compared between software versions by a univariate analysis. Sensitivity analyses were performed to account for confounders. Median fluoroscopy time was decreased by 6.4 min (37.3%), and the median volume of dye was decreased by 32.5 ml (52%) from versions 1.4.6 to 1.4.8. Software version was a significant predictor of fluoroscopy time and dye volume, while reductions in procedure duration and dose area product were observed but mainly explained via confounders., Conclusion: CB-based PVI guided by KODEX-EPD is feasible and safe. Progressive software improvements appear to be associated with lower fluoroscopy duration and dye use. Further studies are needed to evaluate the advantage of KODEX-EPD-guided compared to conventional CB-PVI., Competing Interests: LR received travel grants and speaker's honoraria from EPD Solutions/Philips (KODEX-EPD). AR received travel grants from Biosense, Medtronic, St. Jude Medical, Cardiofocus, EP Solutions, Ablamap, and EPD Solutions/Philips (KODEX-EPD), and lecture and consultant fees from St. Jude Medical, Medtronic, Biosense, Cardiofocus, Novartis, and Boehringer Ingelheim. AM received speaker's honoraria and travel grants from Medtronic, Biosense Webster, Bayer, Boehringer Ingelheim, EPD Solutions/Philips (KODEX-EPD), and Cardiofocus. BR received speaker's honoraria and travel grants from Medtronic. PK received research support for basic, translational, and clinical research projects from the European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), and German Centre for Cardiovascular Research, from several drug and device companies active in AF, and has received honoraria from several such companies in the past but not in the last 3 years. PK is listed as inventor on two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Rottner, Obergassel, My, Kirchhof, Ouyang, Reissmann, Metzner and Rillig.)