Taurolidine-containing Solution for Reducing Cardiac Implantable Electronic Device Infection-early Report from the European TauroPace™ Registry

Overview

Journal J Cardiothorac Surg

Publisher Biomed Central

Specialties Cardiology & Vascular Diseases
General Surgery
Pulmonary Medicine

Date 2024 Oct 4

PMID 39367427

Authors

Reinhard Vonthein

Benito Baldauf

Stefan Borov

Ernest W Lau

Marzia Giaccardi

Ojan Assadian

Christelle Haddad

Philippe Chevalier

Kerstin Bode

Paul Foley

Honey Thomas

Niall G Campbell

Stephanie Fichtner

Luca Donazzan

Felix Pescoller

Rainer Oberhollenzer

Roberto Cemin

Hendrik Bonnemeier

Affiliations

Soon will be listed here.

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.

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.

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.

Conclusions: TP appears to be effective and safe in preventing CIED infections.

Clinicaltrials: gov Identifier: NCT04735666.

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