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

Author:

Borov Stefan12ORCID,Baldauf Benito23ORCID,Henke Jana2,Pavaci Herribert4ORCID,Perani Arben4,Zrenner Bernhard4ORCID,Dietl Josef4,Mehilli Julinda4ORCID,Lau Ernest W5,Vonthein Reinhard6ORCID,Bonnemeier Hendrik2378ORCID

Affiliation:

1. Department of Cardiology, Klinikum Freising , Alois-Steinecker-Straße 18 , Freising 85354, Germany

2. Medical Faculty, Christian-Albrechts University , Christian-Albrechts-Platz 4 , Kiel 24118, Germany

3. Institute of Life Science, Hochschule Bremerhaven , An der Karlstadt 8 , Bremerhaven 27568, Germany

4. Krankenhaus Landshut Achdorf , Achdorfer Weg 3 , Landshut 84036, Germany

5. Department of Cardiology, Royal Victoria Hospital , Grosvenor Road , Belfast BT12 6BA, UK

6. Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck , Ratzeburger Allee 160 , Lübeck 23562, Germany

7. Department of Cardiology, Helios Klinikum Cuxhaven , Altenwalder Ch 10 , Cuxhaven 27474, Germany

8. Department of Cardiology, Helios Klinikum Wesermarsch , Mildred-Scheel-Straße 1 , Nordenham 26954, Germany

Abstract

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

Funder

TauroPace™.

TauroPace™

Publisher

Oxford University Press (OUP)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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