Effectiveness of cardiac device envelopes in preventing infections among pacemaker patients: The REINFORCE Brady real-world project

Background

Infections related to cardiac implantable electrical devices are among the most challenging and costly complications. Although the absorbable antibiotic-eluting envelope has shown efficacy in reducing infection risk, data on its use in pacemaker (PM) and cardiac resynchronization therapy PM (CRT-P) devices are limited.

Objectives

This study aimed to assess the effectiveness of the TYRX envelope in preventing systemic and pocket infections in patients undergoing PM or CRT-P implantation or revision.

Methods

This retrospective, multicenter analysis included 896 patients undergoing PM or CRT-P implantation or revision between August 2020 and April 2024. Patients were categorized into 2 groups: the envelope group (n = 350), receiving the TYRX envelope, and the control group (n = 546).

Results

Over a mean follow-up of 2.2 ± 2.1 years, systemic or pocket infections occurred in 1.2% of patients, with significantly fewer infections in the envelope group (0.3%) than the control group (1.8%) (P = .05). The envelope was associated with an 89% reduction in infection risk (incidence rate ratio 0.11, 95% confidence interval 0.05–0.23, P < .001). Kaplan-Meier analysis showed that, at 4 years, the cumulative incidence of infection was 0.4% in the envelope group vs 2.5% in the control group (hazard ratio 7.36, P = .03).

Conclusions

In patients with PMs and CRT-Ps, the use of the TYRX envelope is associated with significantly lower occurrence of device-related infections. This benefit was sustained over long-term follow-up, supporting its effectiveness in routine clinical practice.