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TauroPace™

A safe solution for CIEDs

Cardiac implantable electronic devices (CIED) – e.g. pacemakers or implantable cardioverter defibrillators – can be life-saving for patients with arrhythmic heart conditions. But they also come with the risk of life-threatening infections. TauroPace™ is designed to prevent such infections without adverse events. [10]

The problem:

Infections related to CIEDs

The impact:

Additional costs due to CIED infections

The solution:

TauroPace™ to prevent CIED infections

The problem

Infections related to CIEDs

The use of CIEDs to treat bradycardia, tachycardia, and heart insufficiency has become increasingly common across the globe. At the same time, the number of infections related to CIEDs has grown drastically.  

  • Infections occur in 1–4 % of all CIEDs. [1,14]
  • 22–56 % of patients are considered to be at risk for CIED infections. [6,7]

Nowadays, more complex CIEDs are available, e.g. biventricular pacemakers for cardiac resynchronisation therapy (CRT) and implantable cardioverter defibrillators (ICD). These heavier and bulkier devices require more leads in each patient and may therefore result in longer surgical procedures. This in turn has elevated the risk of CIED infections [7] – which account for the majority of CIED-related complications. [4] The problem is exacerbated by other risk factors: [4]

  • more elderly patients 
  • more comorbidities 
  • more generator substitutions 
  • antibiotic resistance 
  • catheter laboratory vs. operational theatre  

CIED infections increase mortality rate

A large payer-perspective cohort study conducted with datasets of more than 200,000 patients admitted for CIED generator implantation, replacement, or revision surgery showed: Only about half of the patients lived longer than three years after the procedure if an infection had subsequently occurred. [2]

The impact

Additional costs due to CIED infections

Infected CIEDs not only pose a threat to patients’ lives – they also cause financial damage for the healthcare system at large. In-patient treatment of CIED infections includes the extraction of all hardware and parenteral antibiotic administration, which leads to a staggering amount of additional expenses. 

In the US, the risk-adjusted average length of stay for hospitalised patients with a CIED infection amounts to 15.5 to 24.3 days. In 2011, the average cost of combined medical and surgical treatment for a single CIED infection ranged between $28,676 and $53,349.

In the UK, the risk-adjusted average length of stay for hospitalised patients with a CIED infection amounts to 17 to 22 days. A 2019 study reported that the average costs for the treatment of CIED infections range between £5,130.20 (in case of PPM) and £24,315.80 (in case of CRT-D). [15]

In Germany, the risk-adjusted average length of stay for hospitalised patients with CIED infection amounts to 15 to 21 days. A 2018 study reported costs for the treatment of CIED infection as high as €31,000 for a primary implant and €33,000 for a generator substitution or upgrade/downgrade revision. In case of CIED-related infective endocarditis, the average incremental cost amounted to €59,000. The same study reported an average hospital margin loss of €10,000 per treated CIED infection. [3]

Quality management moving into focus


CIED infections increase both the mortality rate and morbidity among patients. This alarming trend has forced national institutions to establish stricter surveillance regarding the performance of medical facilities. 

 

  • Physician Quality Reporting Systems have already become mandatory in many countries including the United States, the United Kingdom, and Germany.
  • In Germany, the costs associated with the treatment of infections must be covered by the respective facility. 
  • In the US, the National Institutes of Health (NIH) go one step further by making reimbursements dependent on the reporting of performance measures: Hospital acquired infection leads to reduced imbursement rates.  

The solution

TauroPace™ to prevent CIED infections

TauroPace™ is an antimicrobial solution used during CIED placements – i.e. surgical procedures of implantation, lead implantation, or extraction, with the aim of up- or downgrading, revision, or generator substitution. Its main active ingredient is taurolidine, a substance commonly used for lock solutionsin central-venous access devices.  

Antibiofilm efficacy

  • Prevention of bacterial and fungal adhesion to the foreign body and body tissues [18-25]
  • Direct disruption of bacterial and fungal cell walls [18-25] 
  • Neutralisation of released endo- and exotoxins [18-25] 

Antimicrobial efficacy

  • Strong activity against MRSA and VRSA (no known gaps) [18-25] 
  • Gram-positive activity – including oxacillin and methicillin resistant S. aureus, coagulase (-) staphylococci (CoNS), and vancomycin-resistant enterococci (VRE) [18-25] 
  • Gram-negative activity – including Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and fungi [18-25] 

 

TauroPace™ is not an antibiotic compound. No adverse events or resistance patterns have been observed. 

No tissue or organ toxicity

After delivering all its activity, TauroPace™ fully absorbs into the body. You can apply it without adjusting standard surgical techniques during implant, replacement, or revision procedures. The solution does not provide nidi for pathogens to multiply. 

Adjunct use of TauroPace™ during any CIED procedure can effectively prevent CIED infections – and thereby reduce morbidity, mortality, and ensuing costs to a significant degree. [10] 

References

  1. Rennert-May et al. Epidemiology of cardiac implantable electronic device infections in the United States: A population-based cohort study. Heart Rhythm 2020. DOI: 10.1016/j.hrthm.2020.02.012 
  2. Sohail et al. Increased long-term mortality in patients with cardiovascular implantable electronic device infections. Pacing Clin Electrophysiol 2015. DOI: 10.1111/pace.12518
  3. Ludwig et al. Incidence and costs of cardiac device infections: retrospective analysis using German health claims data. J Comp Eff Res 2018. DOI: 10.2217/cer-2017-0080
  4. Blomström-Lundqvist et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections […]. EP Europace 2020. DOI: 10.1093/europace/euz246
  5. Tarakji et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med 2019. DOI: 10.1056/NEJMoa1901111
  6. Mittal et al. Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRx antibacterial envelope. Heart Rhythm 2014. DOI: 10.1016/j.hrthm.2013.12.013
  7. Eby et al. Predictors of cardiac implantable electronic device infection from a large United States healthcare organisation. EP Europace 2018. DOI: 10.1093/europace/euy015.306
  8. Unpublished WIDO data on file at CAU Medical Faculty (Kiel, Germany). 
  9. Henke et al. Taurolidine containing antimicrobial wash to prevent cardiac implantable electronic device infection. Abstract presented at Heart Rhythm Congress 2022. Eur J Arrhythm Electrophysiol 2022. (Abstract 129)
  10. Borov et al. Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection. EP Europace 2023. DOI: 10.1093/europace/euad306
  11. Wu et al. Collagen sponge prolongs taurine release for improved wound healing through inflammation inhibition and proliferation stimulation. Ann Transl Med 2019. DOI: 10.21037/atm-21-2739
  12. Radakovic et al. Taurolidine Acts on Bacterial Virulence Factors and Does Not Induce Resistance in Periodontitis-Associated Bacteria – An In-Vitro Study. Antibiotics (Basel) 2020. DOI: 10.3390/antibiotics9040166
  13. Ahsan et al. A simple infection-control protocol to reduce serious cardiac device infections. EP Europace 2014. DOI: 10.1093/europace/euu126
  14. Polyzos et al. Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis. EP Europace 2015. DOI: 10.1093/europace/euv053
  15. Ahmed et al. Cardiac implantable electronic device (CIED) infections are expensive and associated with prolonged hospitalisation: UK Retrospective Observational Study. PLoS One 2019. DOI: 10.1371/journal.pone.0206611
  16. Redmond et al. RandomiSed clinical trial assessing Use of an anti-inflammatoRy aGent in attenUating peri-operatiVe inflAmmatioN in non-meTastatic colon cancer - the S.U.R.G.U.V.A.N.T. trial. BMC Cancer 2018. DOI: 10.1186/s12885-018-4641-x
  17. Borov et al. Salvage of infected cardiac implantable electronic device with taurolidine—a case report. Cardiothorac Surg 2022. DOI: 10.1186/s43057-022-00068-5
  18. Browne et al. Taurolin, a new chemotherapeutic agent. J Appl Bacteriol 1976. DOI: 10.1111/j.1365-2672.1976.tb00647.x
  19. Pfirrmann et al. The anti-endotoxin activity of Taurolin in experimental animals. J Appl Bacteriol 1979. DOI: 10.1111/j.1365-2672.1979.tb02586.x
  20. Gidley et al. The mode of antibacterial action of some ‘masked’ formaldehyde compounds. FEBS Letters 1981. DOI: 10.1016/0014-5793(81)80211-6
  21. Gorman et al. Electron and light microscopic observations of bacterial cell surface effects due to taurolidine treatment. Lett Appl Microbiol 1987. DOI: 10.1111/j.1472-765X.1987.tb01593.x 
  22. Blenkharn et al. Sustained anti-adherence activity of taurolidine (Taurolin) and noxythiolin (Noxyflex S) solutions. J Pharm Pharmacol 1988. DOI: 10.1111/j.2042-7158.1988.tb05288.x
  23. Jacobi et al. Taurolidine—a new drug with anti-tumor and anti-angiogenic effects. Anticancer Drugs 2005. DOI: 10.1097/01.cad.0000176502.40810.b0
  24. Caruso et al. Taurolidine antiadhesive properties on interaction with E. coli; its transformation in biological environment and interaction with bacteria cell wall. PLoS One 2010. DOI: 10.1371/journal.pone.0008927 
  25. Dinçer et al. Effect of taurine on wound healing. Amino Acids 1996. DOI: 10.1007/BF00806093