Cryoballoon ablation guided by a novel wide-band dielectric imaging system

Abstract

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.

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

“…Of note, real-time electroanatomic mapping with a mean mapping time of 5 ± 2 min in this patient population enabled visualization of PVanatomy and catheter navigation within the LA without compromising overall procedure duration (Table 2). Acute efficacy of KODEX-EPD guided cryoablation has been demonstrated recently, however treatments were based on previous software versions where PV occlusion was assessed via the KODEX-EPD occlusion tool but still depending on dye injection (12,19). Since introduction of the saline-based occlusion assessment, only one smaller study evaluated KODEX-EPD's novel saline injection workflow in a small cohort of 38 patients with promising results (20).…”

“…Recently, KODEX-EPD (EPD Solutions, Philips, Netherlands), a novel high-resolution cardiac imaging system was introduced, providing an occlusion tool using dielectric sensing to assess PV occlusion nonfluoroscopically (9,10). Previous studies have shown a trend towards fluoroscopy reduction when using KODEX-EPD and its occlusion tool for CB-based PVI when using the dye-based approach (11,12). A single smaller study on saline based CB ablation has shown promising results regarding feasibility, however comparison to conventional CB approaches have not been reported yet.…”

Practical guidance to reduce radiation exposure in electrophysiology applying ultra low-dose protocols: a European Heart Rhythm Association review

“… 57 , 59 Recently, a new 3D-mapping system (Kodex-EPD™) was used in conjunction with the CB and the circular mapping catheter (Achieve™) for PVI, leading to further reduction of radiation dose. 60 Comparison of CB-PVI and laserballoon (LB) PVI at highly experienced centres revealed similar fluoroscopy times between both techniques in a cohort of 200 patients. 75 Huang et al reported fluoroscopy time and radiation dose during conventional LB-PVI and during low-dose LB-PVI utilizing ICE, a 3D-mapping system and a multipolar mapping catheter.…”

Incidence of cryoballoon expansion dislodgement during pulmonary vein isolation–An underappreciated frequent cause of incomplete isolation

“…The assessment of PV occlusion was conducted using ICE and a novel, dielectric imaging‐based occlusion tool (DIOT) integrated with the Kodex mapping system. The workflow of DIOT (version 1.4.8) for PV occlusion assessment has been described previously 6–9 …”

“…The workflow of DIOT (version 1.4.8) for PV occlusion assessment has been described previously. [6][7][8][9] In brief, an electric field is created by driving non-stimulatory cur- sion was assessed pre-ablation as the baseline evaluation, followed by 8-12 mL 0.90% saline injection to confirm PV occlusion status. In the case of partial occlusion, defined as one or more red electrodes, the balloon was repositioned to obtain complete occlusion if possible.…”