Yes. TauroPace™ has been certified for adjunct use during any CIED procedure and on any uncoated or silicon-, epoxy- or polyurethane-coated CIED (including its components, e.g. leads) made of titan or stainless steel. The certification includes reviewing safety data and biocompatibility.
No. TauroPace™ has been designed specifically for CIEDs. It has been tested on uncoated or silicon-, epoxy- or polyurethane-coated CIEDs (including components, e.g. leads) made of titan or stainless steel as well as on impregnated or drug-releasing CIED leads.
No. There have not been any reports about AE or severe AE for the adjunct use of TauroPace™ for its intended purposes. A solution of 2 % taurolidine and PVP has been applied intravenously with up to 1,000 ml (equal to 20 g of pure taurolidine) per day for four days in 32 participants without any AE being recorded. [16]
When you are using TauroPace™ during a CIED placement/procedure, the patient might experience a mild sensation of warmth – but only if the local anaesthesia has not fully taken effect before TauroPace™ comes into contact with the pacemaker pocket.
There are no side effects that have been reported for adjunct use of TauroPace™ during CIED procedures.
We do not recommend the simultaneous use of TauroPace™ and other substances or devices inside the pocket and/or on the CIED and its components. Please use TauroPace™ only inside the pocket and on the CIED. Before the incision and after closing the wound, we recommend using your preferred antiseptic agent.
Although TYRX™ and TauroPace™ are unlikely to interfere with each other, we do not recommend using both simultaneously. There are no data supporting simultaneous use.
Do not use PVP iodine inside the pocket. It contains ethanol, which enhances biofilm formation in the presence of Staph. aureus colony forming units. Simultaneous use of PVP iodine and TauroPace™ will result in the formation of an acid. Please use TauroPace™ only on the CIED and inside the pocket.
CanGaroo® and TauroPace™ can be used simultaneously. However, there is no data confirming whether TauroPace™ effectively prevents CIED infections when used together with CanGaroo®.
Using TauroPace™ and hydrogen peroxide simultaneously is strongly discouraged.
TauroPace™ is an antimicrobial solution designed to prevent infections of cardiac implantable electronic devices (CIED) such as pacemakers or implantable cardioverter defibrillators. [10]
TauroPace™ contains taurolidine and polyvinylpyrrolidone (PVP). Taurolidine has an antimicrobial effect, while PVP alters the kinetic of the release of taurolidine.
TauroPace™ may prevent CIED infections that might otherwise put the patient’s life at risk. [10]
According to current data, TauroPace™ can reduce the risk of developing a local CIED infection down to 0.33 % in the first year post placement. [10]
There are no known side effects caused by the use of TauroPace™.
When TauroPace™ enters the body, it will be degraded to taurine (a nonessential amino acid).
TauroPace™ does not interfere with the functions of a CIED.
TauroPace™ interferes with different antimicrobial substances such as polyhexanide, octenidine, hydrogen-peroxide, or hypochlorous acid. Therefore, we do not recommend using TauroPace™ and other antimicrobial substances simultaneously inside the surgical site or on the CIED.
TauroPace™ can be used during any CIED placement (i.e. surgical procedures of implantation, lead implantation, or extraction, with the aim of up- or downgrading, revision, or generator substitution).
You can always ask your attending physician if it is possible to use TauroPace™ in your case.
Pre-operative intravenous administration of antibiotics is the standard of care for CIED placements. Peri- or post-operative antibiotic administration does not have a preventative effect with respect to CIED infections.
While antibiotics are commonly used to treat infections, their efficacy for preventative purposes is limited:
- They only kill certain types of germs.
- They induce bacterial resistance.
TauroPace™, on the other hand, prevents infections without unwanted side effects. [10] Thanks to the active ingredient taurolidine, it kills a wide range of bacteria and fungi (incl. MRSA and VRE).
For maximum protection, we recommend the use of TauroPace™ during rhythm surgery combined with intravenous administration of antibiotics before the procedure.