TauroPace™
TauroPace™ is an antimicrobial solution designed to prevent infections from cardiac implantable electronic devices (CIEDs). [10]
Indication and effect
TauroPace™ is certified for use during the procedure of placing or revising CIEDs with the aim to upgrade, downgrade, or substitute (i.e. during any surgical procedure). This includes (but is not limited to) the following CIEDs:
- pacemakers (PM)
- implantable cardioverter defibrillators (ICD)
- PMs and ICDs able to deliver cardiac resynchronisation therapy (CRT-P, CRT-D)
- cardiac contractility modulation (CCM)
- subcutaneous ICD (S-ICD)
- leadless PMs
- implantable or injectable loop recorders or monitors (ILR/ILM)
- all respective hardware (generator, leads, torque wrench, dilators, sheaths, wires, etc.)
TauroPace™ is designed to protect patients with CIEDs against related infections:
- It prevents bacterial and fungal adhesion to CIED hardware.
- It is antimicrobially active against all pathogens, with no resistance patterns having been observed.
Composition
The main active ingredient of TauroPace™ is taurolidine. Taurolidine has a broad antimicrobial activity against all relevant pathogens, including (but not limited to) multi-resistant superbugs (e.g. MRSA, MRSE, Klebsiella, Candida species). Polyvinylpyrrolidone (PVP) alters the kinetics of action by prolonging the efficacy, depending on the prevailing pH and the area to be treated.
Application
TauroPace™ is applied in a stepwise approach throughout the surgical procedure:
- after placement of the introduction sheath, lead, generator, lead fixation or suture sleeve, and suture
- via soaked swabs (positioning lead fixation sleeve, wiping down lead and generator before placement) or full immersion into the liquid (torque wrench, generator, lead, suture)
Expert recommendations
TauroPace™ is available in a majority of EMEA countries. With increasing use, the solution has become a standard of care in many implanting centres.
TauroPace™ is recommended for application in all procedures, irrespective of the anticipated risk for CIED infections.
Contraindications
Studies assessing the safety of TauroPace™ have found no severe adverse device effects (SADE). There are no contraindications known other than pre-existing allergies against taurolidine or polyvinylpyrrolidone (PVP) – either not reported to date.
Safety
If you consider using TauroPace™, please do not place any other liquid or antimicrobially active device inside the CIED pocket (TauroPace™ must be the only substance inside the pocket and on the hardware).
Package sizes
Tauropace™ is available in 100 ml vials. One vial should be used per patient/procedure.
Storage & transport
TauroPace™ must be stored at temperatures between 15 °C and 25 °C. Please note that freezing TauroPace™ will eventually destroy the solution and interfere with its antimicrobial activity.