The European TauroPace™ Registry

Area of Science:

• Cardiology
• Infectious Diseases
• Medical Device Technology

Background:

• Cardiac implantable electronic device (CIED) placement carries risks, including severe infections.
• While antibiotics and mesh envelopes reduce CIED infections, taurolidine's role is novel and not guideline-established.
• Clinical evidence is needed to support taurolidine's efficacy in preventing CIED infections.

Purpose of the Study:

• To prospectively evaluate the efficacy of taurolidine as an adjunct in preventing CIED infections.
• To gather robust data on CIED infection rates using taurolidine.
• To assess the safety and long-term effects of taurolidine in CIED procedures.

Main Methods:

• The European TauroPace registry (ETPR) prospectively collects data on CIED procedures using taurolidine adjunct.
• Follow-up includes assessments at 3, 12, and 36 months to capture acute, subacute, and long-term infections.
• Major CIED infections are defined by novel criteria; secondary endpoints include mortality and adverse events.

Main Results:

• The registry is designed as a multicentre, international project due to the expected low incidence of CIED infections.
• Data collected will inform future randomized controlled trials by providing case number calculations.
• Multiple reports are planned to disseminate findings over the registry's duration.

Conclusions:

• The ETPR will establish large case numbers for precise estimation of low CIED infection event rates.
• Long-term follow-up is intended to identify any potential late effects associated with taurolidine use.
• This registry will provide crucial evidence for the adjunctive use of taurolidine in CIED procedures.