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Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection.
- Source :
-
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology [Europace] 2023 Oct 05; Vol. 25 (10). - Publication Year :
- 2023
-
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.<br />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).<br />Conclusion: TauroPace is safe but more effective than H2O2 in reducing CIED infection.<br />Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT05576194.<br />Competing Interests: 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.<br /> (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Subjects :
- Humans
Hydrogen Peroxide adverse effects
Prospective Studies
Anti-Infective Agents adverse effects
Defibrillators, Implantable adverse effects
Heart Diseases etiology
Pacemaker, Artificial adverse effects
Prosthesis-Related Infections diagnosis
Prosthesis-Related Infections prevention & control
Prosthesis-Related Infections etiology
Subjects
Details
- Language :
- English
- ISSN :
- 1532-2092
- Volume :
- 25
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 37831737
- Full Text :
- https://doi.org/10.1093/europace/euad306