Antibacterial devices efficacy in high-risk CIED recipients: propensity score matching analysis

Background

Cardiac implantable electronic device (CIED) infections remain a serious complication, particularly in high-risk recipients undergoing complex or replacement procedures. Antibacterial envelopes have been developed to reduce infection risk, but comparative real-world data across different systems are limited.

Purpose

To evaluate the incidence of CIED infections and identify factors associated with infection reduction in a large, high-risk cohort implanted with or without antibacterial envelopes.

Methods

We retrospectively analyzed 1,699 consecutive patients undergoing ICD or CRT-D implantation or revision between 2017 and 2024.

Patients were grouped as no envelope (n=1,211), Tirex (n=241), and Tauropace (n=247).

To account for baseline clinical and procedural differences, 1:1 propensity score matching was performed including age, sex, device type, procedure type, left ventricular ejection fraction, diabetes, renal dysfunction, structural heart disease, procedure duration, and anticoagulant therapy.

The primary endpoint was CIED-related infection during follow-up.

Results

Before adjustment, infection occurred in 25 (2.1%) patients without envelope, 2 (0.83%) with Tirex, and 2 (0.81%) with Tauropace. As showed in figure 1, we enrolled high risk patients.

After propensity matching, baseline differences were balanced (488 matched controls vs. 488 envelope recipients).

In the matched cohort, infection occurred in 12 (2.4%) controls and 4 (0.8%) envelope recipients, corresponding to an ≈80% relative risk reduction.

Multivariable logistic regression confirmed that envelope use was independently associated with lower infection risk (adjusted OR 0.19, 95% CI 0.07–0.57, p=0.003).

Conclusion

In this large real-world cohort of high-risk CIED recipients, antibacterial envelopes (Tirex and Tauropace) were associated with a marked reduction in device-related infections after propensity adjustment for clinical and procedural factors.

These findings support the systematic use of infection-prevention systems in complex or high-risk CIED procedures.