Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w

European TauroPace™ Registry (ETPR) - first interim analyses. Incidence of cardiac implantable electronic device infections after more than 12 months follow-up in more than 500 procedures.
S. Borov1, B. Baldauf2, E. W. Lau3, M. Giaccardi4, P. Chevalier5, O. Assadian6, R. Vonthein7, H. Bonnemeier8, für die Studiengruppe: FLUSH-IT
1Medizinische Klinik I - Kardiologie, Pneumologie und internistische Intensivmedizin, Krankenhaus Landshut-Achdorf, Landshut; 2Medizinischen Fakultät, Christian-Albrechts-Universität zu Kiel, Kiel; 3Cardiology, Royal Victoria Hospital, Belfast, UK; 4Cardiology, Santa Maria Annunziata, Bagno a Ripoli FI, IT; 5Cardiology, Louis Pradel Hospital HCL, Bron, FR; 62. Medizinische Abteilung - Kardiologie und Nephrologie, Landesklinikum Wiener Neustadt, Wiener Neustadt, AT; 7IMBS Universität zu Lübeck, Lübeck; 8Klinik für Innere Medizin, Kardiologie, Elektrophysiologie, Helios Klinik Cuxhaven, Cuxhaven;

Background Cardiac implantable electronic device (CIED) infection is the most devastating adverse event related to CIED placement. To date, perioperative antibiotic administration and the use of an antibiotic envelope have shown preventative impact in randomized controlled trials. To plan such a trial for a new taurolidine containing antimicrobial wash (TauroPace™, Tauropharm, Bavaria, Germany), the rate of CIED infections after intraoperative CIED hardware irrigation with TauroPace™ needs to be shown to be even lower in prospective observational studies.

Methods The authors prospectively evaluate all consecutive CIED procedures performed with TauroPace™ in the contributing centres. Primary endpoint is major CIED infection according to the Novel 2019 CIED infection criteria. The registry issues reports, when superiority to published event rates may be established starting from registries and advancing to RCTs. adverse events of all grades and all-cause mortality are followed up as secondary endpoints. Follow up time for the first report was three months, as only acute and subacute CIED infections were of interest. Preoperative intravenous antibiotic administration is standard of care in the contributing centres. Patient and CIED and procedure related risk factors are recorded.

 

Results From January 2020 through July 2021 alltogether 585 of 1456  procedures were performed with adjunct TauroPace™ treatment and entered analysis. No infection occurred (0.0%, 95%-confidence interval 0.0%–0.629%) during 92 days of follow-up. 19 participants (3.25%, CI 1.97% to 5.03%) died during that time. 69 adverse events all grades related to CIED or procedure were observed (11.8%, CI 9.29% to 14.7%). No adverse events related to TauroPace™ were reported.

Conclusions Adjunct use of TauroPace™ during any CIED related surgical procedure seems safe. CIED infection rate after TauroPace™ irrigation is low enough to warrant further clinical investigation.


https://dgk.org/kongress_programme/jt2023/aP2047.html