Dataset Information

The European TauroPace™ Registry.

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 TauroPace^TM 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.

SUBMITTER: Vonthein R

PROVIDER: S-EPMC10514882 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

The European TauroPace™ Registry.

Vonthein Reinhard R Baldauf Benito B Borov Stefan S Lau Ernest W EW Giaccardi Marzia M Cemin Roberto R Assadian Ojan O Chévalier Philippe P Bode Kerstin K Bonnemeier Hendrik H

Methods and protocols 20230915 5

<h4>Background</h4>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 ...[more]

PMID: 37736969

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Dataset Information

The European TauroPace™ Registry.

Background

Methods

Results

Conclusions

Publications

The European TauroPace™ Registry.

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