Real-world data on the effectiveness of TYRX and TauroPace for preventing CIED infections.

Abstract

The implantation of cardiac implantable electronic devices (CIEDs) carries a known risk of infection. Two devices (TYRX and TauroPace) have been proposed to reduce this risk. The aim of our study was to compare the effectiveness of TauroPace and TYRX. Real-world comparative studies were included. Data analysis was based on reconstruction of individual patient data from Kaplan-Meier curves using an artificial intelligence algorithm. The endpoint was CIED infection or systemic infection. Statistical tests included heterogeneity assessment, superiority testing, and non-inferiority testing. The primary outcome measure was the hazard ratio (HR) with confidence interval (CI). Our literature search identified two real-world studies suitable for our analysis. Follow-up was 12 months for TauroPace (654 patients) and 60 months for TYRX (872 patients), with a total of 2,083 controls. There was no heterogeneity among controls. Compared to the pooled control group, patients treated with TYRX or TauroPace had fewer CIED infections (HR, 0.3892; 95% CI, 0.2042-0.7419; P=0.00414; HR, 0.3313; 95% CI, 0.1005-1.0925; P=0.06958, respectively). When testing for non-inferiority of TauroPace vs. TYRX, the comparison yielded a HR of 0.8494 (in favor of TYRX) with a 90% CI of 0.27-2.63; this CI of TauroPace did not meet the non-inferiority criterion set at HR>0.75 (i.e., relative difference ≤25%). Both treatments had some important drawbacks. Regarding TYRX, more selective use in higher-risk patients should be advocated to improve its cost-effectiveness, but robust evidence is still lacking. Regarding TauroPace, our analysis testing for a non-inferiority margin of ≤25% did not meet this demonstration.