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Observational Study
. 2023 Oct 5;25(10):euad306.
doi: 10.1093/europace/euad306.

Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection

Stefan Borov  1   2 , Benito Baldauf  2   3 , Jana Henke  2 , Herribert Pavaci  4 , Arben Perani  4 , Bernhard Zrenner  4 , Josef Dietl  4 , Julinda Mehilli  4 , Ernest W Lau  5 , Reinhard Vonthein  6 , Hendrik Bonnemeier  2   3   7   8
Affiliations
Observational Study

Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection

Stefan Borov et al. Europace. .

Abstract

Aims: TauroPace (Tauropharm, Bavaria Germany), a taurolidine solution for combating cardiac implantable electronic device (CIED) infection, was compared with a historical control of 3% hydrogen peroxide (H2O2) in a prospective observational study.

Methods and results: The device pocket was irrigated, and all hardware accessible within (leads, suture sleeves, pulse generator) was wiped with H2O2, TauroPace, or taurolidine in a galenic formulation during any invasive CIED procedure at the study centre. Only CIED procedures covered by TauroPace or H2O2 from 1 January 2017 to 28 February 2022 were included for analysis. Patients who underwent >1 procedure were censored for the last treatment group and reassigned at the next procedure. The primary endpoint was major CIED infection within 3 months. The secondary endpoints were CIED infection beyond 3 months, adverse events potentially related to the antimicrobial solutions, CIED system, procedure, and death, till the end of follow-up. TauroPace covered 654 procedures on 631 patients, and H2O2 covered 551 procedures on 532 patients. The TauroPace group had more patient risk factors for infection than the H2O2 group (P = 0.0058) but similar device and procedure-specific risk factors (P = 0.17). Cardiac implantable electronic device infection occurred in 0/654 (0%) of the TauroPace group and 6/551 (1.1%) of the H2O2 group (P = 0.0075). Death occurred in 23/654 (3.5%) of the TauroPace group and 14/551 (2.5%) of the H2O2 group (P = 0.33). Non-infection related adverse events were rarer in the TauroPace (3.8%) than the H2O2 (6.0%) group (P = 0.0802).

Conclusion: TauroPace is safe but more effective than H2O2 in reducing CIED infection.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT05576194.

Keywords: Cardiac implantable electronic device; Hydrogen peroxide; Infection; Taurolidine; Tauropace.

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Conflict of interest statement

Conflict of interest: B.B.: consultant/advisor: Abbott, Bioline Supply, Crosstec GmbH, Kapamed, Kimal PLC, M3 Medical/Ecclipse Medical, Medival SRL, Philips/Spectranetics, Sintec SRL, Tauro-Implant GmbH, Tauropharm GmbH, Transcutan; the other authors declare no conflict of interest in relation to this manuscript.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Enrolment, treatment, and follow-up of the CIED procedures. CIED, cardiac implantable electronic device.
Figure 2
Figure 2
Cumulative incidence curves for major CIED infection (top) and death (bottom) by cohort (H2O2, TauroPace™) with pointwise CIs (broken lines) as unadjusted competing risk estimates. CIED, cardiac implantable electronic device; CI, confidence interval.
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