Impact of taurolidine use during cardiac electronic implantable device implantation in heart failure patients

Abstract

Abstract Background Cardiac Implantable Electronic Device (CIED) infections represent a critical health threat with potentially fatal consequences. The TauroPace™ is an innovative solution that contains taurolidine specifically formulated to eradicate environmental microbial contamination on the surface of CIEDs. To date, scarce data are available in literature about Taurolidine’s effect on preventing CIED infections. Aims To investigate the ability of the TauroPace™ to reduce major CIED infections through 12 months follow-up in fragile patients such as heart failure (HF) patients. Methods This prospective cohort study included patients with HF and an ejection fraction ≤ 35%, who were referred for de novo implantation, upgrading or battery replacement of Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy with defibrillator (CRT-D), to the EP labs of two tertiary care hospitals. Patients with previous CIED infections were excluded. During the procedures, the catheters were submerged in the TauroPace™ solution and the pocket was irrigated with taurolidine. Starting from the main risk factors for the development of CIED-related infections as identified in the literature (including individuals with heart failure, diabetes, chronic kidney disease, and those undergoing defibrillators implantation, especially upgrades or revisions procedure), we conducted a meta-analysis and meta-regression to evaluate the relationship between the treatment effect's magnitude and various predictors. To estimate the incidence of CIED infections in high-risk subgroups, we utilized the percentage of patients with diabetes, chronic renal failure, or those undergoing replacement, upgrade, or revision procedures, along with other risk factors for CIED infections, as continuous variables and we were able to modify our comparison parameters based on the real percentage of risk factors that we obtained. Results The study included 69 consecutive patients (53 male [76.8 %], 34 ischemic [49,3 %], median [IQR] age 68 [59-73] years, 19 diabetic [27.5 %] and 34 [49.2 %] with chronic renal failure), of whom 39 (56.5 %) received ICD and 30 (43.5 %) CRT-D, with 28 (40.6 %) replacement procedures, 2 (2.9 %) upgrades, and 39 (57%) de novo implantations. During the one-year follow-up period, 1 [1.45 (Standard Error, SE 0.014) %] patient undergoing a CRT replacement developed an infection. The available data from the literature estimate an incidence rate of 6% (SE 0.0106) when considering a selected patient population with a very high risk of infection similar to our population. This is significantly higher than our cohort (z-score -2.5447, p value = 0.011). Conclusions Taurolidine has yielded promising results, demonstrating a low incidence rate of infections within our cohort of high-risk patients, which is below that reported in the literature. Further data will be necessary to validate and confirm these initial findings.