REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE project

Abstract

Background Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients’ and on health care systems. The use of TYRXTM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. Aims to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. Methods Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRXTM absorbable antibiotic-eluting envelope was used or not. Results Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs 0.8%, p = 0.007). The 5-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14-0.80, p = 0.010). Conclusions In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection.

Infections of cardiac implantable electronic devices: Epidemiology, mechanisms, and preventive measures

“…The benefit of AEE was sustained during long-term follow-up [83]. A meta-analysis summarizing a major observational and randomized trials and a recent real-world study demonstrated similar findings [84,85]. Further analyses of the WRAP-IT population showed a more than 11-fold higher risk of major CIED infection in patients with pocket hematoma and without the AEE [34].…”

Chronic kidney disease and transvenous cardiac implantable electronic device infection—is there an impact on healthcare utilization, costs, disease progression, and mortality?

“… 36 The efficacy of the envelope has since been corroborated in other settings. 37–39 The use of the antibacterial envelope in the WRAP-IT population and in high-risk subgroups and procedures was recommended in the 2019 European Heart Rhythm Association (EHRA) International Consensus document and in the 2021 ESC Pacing Guidelines in Pacemaker re-interventions (Class IIb). 18 , 40 …”

Measures to Prevent Infection in Cardiac Implantable Electronic Device Replacements or Upgrades

“…This benefit was reproduced in subsequent studies, such as the REINFORCE project which analyzed the outcomes of 1819 patients undergoing CIED procedures (872 with AE, 947 without), and demonstrated significantly lower infection event rates in the AE group (0.8% vs . 2.4%, respectively; p = 0.007) [ 70 ]. Furthermore, a meta-analysis conducted by Asbeutah et al .…”