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Taurolidine-containing solution for reducing cardiac implantable electronic device infection-early report from the European TauroPace™ registry.
- Source :
-
Journal of cardiothoracic surgery [J Cardiothorac Surg] 2024 Oct 04; Vol. 19 (1), pp. 592. Date of Electronic Publication: 2024 Oct 04. - Publication Year :
- 2024
-
Abstract
- Introduction: Infection is a significant complication of cardiac implantable electronic device (CIED) therapy. The European TauroPace™ Registry investigates the safety and efficacy of TauroPace™ (TP), an antimicrobial solution containing taurolidine, designed to prevent CIED infections.<br />Methods: This multicenter study included patients undergoing CIED procedures at participating centers where TP was used as a disinfectant for external hardware surfaces and an antiseptic for irrigating surgical sites. All patients eligible for CIED placement with adjunctive TP as the standard of care were included. Other aspects of CIED procedures adhered to current guidelines. Data on CIED-related infective endocarditis, CIED pocket infection, device and procedure-related complications, adverse events, and all-cause mortality were prospectively collected for 12 months. In cases of revision, the previous procedure was censored, and a new procedure was created. Binomial and Kaplan-Meier statistics were employed to analyze event rates.<br />Results: From January 2020 to November 2022, TP was used in 822 out of 1170 CIED procedures. Among patients who completed the 3-month follow-up, no CIED pocket infections were observed, and one case of CIED-related infective endocarditis was reported. In the 12-month follow-up cohort, two additional local pocket CIED infections were observed, resulting in a total of three major CIED infections within 1 year after the CIED placement procedure. The 3-month and 12-month major CIED infection rates were 0.125% and 0.51%, respectively. During the observation a complication rate of 4.4% was reported. No adverse events related to TP were observed.<br />Conclusions: TP appears to be effective and safe in preventing CIED infections.<br />Clinicaltrials: gov Identifier: NCT04735666.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Male
Female
Aged
Middle Aged
Europe
Prospective Studies
Anti-Infective Agents, Local therapeutic use
Thiadiazines therapeutic use
Taurine analogs & derivatives
Taurine therapeutic use
Prosthesis-Related Infections prevention & control
Registries
Defibrillators, Implantable adverse effects
Pacemaker, Artificial adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1749-8090
- Volume :
- 19
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of cardiothoracic surgery
- Publication Type :
- Academic Journal
- Accession number :
- 39367427
- Full Text :
- https://doi.org/10.1186/s13019-024-03059-1