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

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

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.

Publication types

  • Observational Study

MeSH terms

  • Anti-Infective Agents* / adverse effects
  • Defibrillators, Implantable* / adverse effects
  • Heart Diseases* / etiology
  • Humans
  • Hydrogen Peroxide / adverse effects
  • Pacemaker, Artificial* / adverse effects
  • Prospective Studies
  • Prosthesis-Related Infections* / diagnosis
  • Prosthesis-Related Infections* / etiology
  • Prosthesis-Related Infections* / prevention & control

Substances

  • Anti-Infective Agents
  • Hydrogen Peroxide
  • taurolidine

Associated data

  • ClinicalTrials.gov/NCT05576194