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. 2023 Sep 15;6(5):86.
doi: 10.3390/mps6050086.

The European TauroPace™ Registry

Reinhard Vonthein  1 , Benito Baldauf  2   3 , Stefan Borov  3   4 , Ernest W Lau  5 , Marzia Giaccardi  6 , Roberto Cemin  7 , Ojan Assadian  8   9 , Philippe Chévalier  10 , Kerstin Bode  11 , Hendrik Bonnemeier  2   3   12   13
Affiliations

The European TauroPace™ Registry

Reinhard Vonthein et al. Methods Protoc. .

Abstract

Background: Cardiac implantable electronic device (CIED) placement comes with certain complications. CIED infection is a severe adverse event related to CIED placement. In randomised controlled trials, the preoperative intravenous administration of antibiotics and the adjunctive use of an antibiotic mesh envelope resulted in significant reduction in infections related to cardiac implantable electronic devices. The adjunctive use of taurolidine for this purpose is relatively novel and not considered in the guidelines. The required evidence may consist of a set of clinical studies.

Methods: The European TauroPaceTM registry (ETPR) prospectively evaluates every consecutive invasive procedure involving any CIED with adjunct TauroPace™ use in the contributing centres. As the estimation of the infection rate needs to be defensible, only interventions registered prior to the procedure will be followed-up. The endpoint is a major cardiac implantable electronic device infection according to the novel CIED infection criteria (1). Secondary endpoints comprise all-cause mortality, complications, adverse events of all grades, and major CIED infections during all follow-up examinations. The follow-up times are three months, twelve months, and eventually 36 months, as acute, subacute, and long-term CIED infections are of interest.

Results: As the rate of CIED infections is expected to be very low, this registry is a multicentre, international project that will run for several years. Several reports are planned. The analyses will be included in the case number calculations for future randomised controlled trials.

Conclusions: The ETPR will accumulate large case numbers to estimate small event rates more precisely; we intend to follow up on participants for years to reveal possible late effects.

Keywords: cardiac implantable electronic device; infection; taurolidine.

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Conflict of interest statement

Reinhard Vonthein: research grant received through his employer from the manufacturer of TauroPaceTM. Benito Baldauf: consultant/advisor: manufacturer of TauroPaceTM, Kimal plc, Kappamed, Crosstec, Bioline Supply, MCM Ag, Tauro-Implant, Medival SRL, Spectranetics. Abbott Stefan Borov: research grant received through his employer from the manufacturer of TauroPaceTM. Ernest W. Lau: none. Marzia Giaccardi: none. Roberto Cemin: none. Kerstin Bode: none. Philippe Chévalier: none. Ojan Assadian: none. Hendrik Bonnemeier: none.

Figures

Figure 1
Figure 1
Enrolment and follow-up of ETPR participants; CIED denotes cardiac implantable electronic device.
See this image and copyright information in PMC

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