Key result
KODEX-EPD mapping cuts fluoroscopy time ~80% vs conventional fluoroscopy during HBP lead implantation.
Why the study?
To assess pacing and electrophysiological parameters and mid-term outcomes among patients undergoing His bundle pacing guided by the novel KODEX-EPD mapping system.
Does KODEX-EPD mapping system-guided His bundle pacing reduce fluoroscopic time and dose compared to conventional fluoroscopy in patients with bradycardia indications?
RCT (n=40)
1:1 according to random number table
No
Does KODEX-EPD mapping system-guided His bundle pacing reduce fluoroscopic time and dose compared to conventional fluoroscopy in patients with bradycardia indications?
Absolute Event Rate: 3.8% vs 19.3%
p-value: p=<0.05
The KODEX-EPD 3D mapping system safely and effectively guides His bundle pacing lead implantation, significantly reducing fluoroscopy time and radiation dose without prolonging procedure time.
Reduces radiation exposure during His bundle pacing; confirms safety and utility of KODEX-EPD in this RCT.
To assess pacing and electrophysiological parameters, as well as mid-term outcomes, among patients undergoing His bundle pacing (HBP) guided by KODEX-EPD (a novel mapping system). Consecutive patients undergoing conduction system pacing (CSP) for bradycardia indications were evaluated. Procedural and fluoroscopic times and pacing characteristics were compared between conventional fluoroscopy (the standard group, N = 20 cases) and KODEX-EPD mapping system guided group (the KODEX group, N = 20cases) at CSP implantation and all patients were followed at 6-month. HBP was achieved in all patients (the standard group 20/20 and the KODEX group 20/20). There was no difference in the mean procedure time between the two groups (63.7 ± 9.3 vs. 78.2 ± 25.1 min, p = 0.33). Compared with the standard group, the KODEX group significantly reduced the intraoperative X-ray exposure time (3.8 ± 0.5 vs. 19.3 ± 5.1 min, p < 0.05) and X-ray dose (23.6 ± 5.4 vs. 120.2 ± 38.3 mGy, p < 0.05). There were no significant differences in atrial impedance (643.0 ± 98.8 vs. 591.5 ± 92.1 Ω, p = 0.09), atrial sensing (2.9 ± 0.8 vs. 2.5 ± 0.8 mV, p = 0.08), ventricular sensing (12.8 ± 2.4 vs. 13.3 ± 3.3 mV, p = 0.63),atrial pacing threshold (1.0 ± 0.2 vs. 1.0 ± 0.1 V/0.4 ms, p = 0.81) and ventricular pacing threshold (1.0 ± 0.2 vs. 0.9 ± 0.1 V/0.4 ms, p = 0.63) between two groups, There were statistical differences in ventricular impedance (640.0 ± 80.3 vs. 702.0 ± 86.1 Ω, p < 0.05). There was no statistical significance in pacing parameters between the two groups at 6 months after procedure (p > 0.05). During the 6-months follow-up period, no adverse events occurred in the two groups. It can be concluded that KODEX-EPD can safely guide His bundle branch pacing lead implantation with reduced fluoroscopic time and dose without lengthening the procedure time.
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Wang et al. (2023) conducted an RCT in Bradycardia requiring ventricular pacing therapy (n=40). KODEX-EPD mapping system guided His bundle pacing vs. Conventional fluoroscopy guided His bundle pacing was evaluated on Fluoroscopy time (min) (p=<0.05). The KODEX-EPD mapping system significantly reduced intraoperative fluoroscopy time (3.8 vs. 19.3 min) and X-ray dose compared to conventional fluoroscopy during His bundle pacing lead implantation.
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