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Clinical impact & costs of CIED infections

TauroPace™ device irrigation

The problem

  • Infections occur in 1–4 % of all cardiac implantable electronic devices (CIED). [1,14]
  • 22–56 % of patients are considered to be at increased risk for CIED infections. [6,7]

The impact

  • 50 % excess mortality at three years [2]
  • €59,477 incremental cost to treat a major CIED infection [3]
  • €10,000 average hospital margin loss per CIED infection [8] 

The solution

  • TauroPace™ is designed to prevent infections. [9,10]
  • It therefore enhances wound healing. [11]
  • No antibiotics – no resistance. [12]
  • 67–100 % reduction of CIED infection risk in all patients. [9,10]

Current prophylaxis against CIED infections

Pre-operatively [4]

Preoperative antibiotic administration in 90 % of all CIED procedures with cephalosporins or vancomycin

Routinely
Peri-operatively [4,5]

Approximately 75–90 % conduct perioperative antibiotic or antimicrobial pocket (surgical site) irrigation

Typically
Post-operatively [4]

Prolonged antibiotic therapy postoperatively  
Postoperative IV antibiotic administration 

Occasionally

Device-related infection costs in Europe

  • €36,722 cost of infection (provider's perspective) [13]
  • 26–29 days average length of hospital stay

CRT-D ​
€44,000

ICD
€41,000

PM
€22,000

Re-implantation makes up ~ 50 % of device infection costs. Treating infections with high-power devices has a higher cost than low-power devices, due to the more expensive reimplantation. 

  • €59,419 incremental costs per CIED-related infective endocarditis (payer's perspective) [3]
  • €31,493–33,777 costs per CIED pocket infection (primary implant / revision) 

Major
€59,419

Revision
€33,777

Primary
€31,493

Re-hospitalisation makes up ~ 50 % of major infection costs. Treating major infections is more expensive than pocket infections, due to the prolonged duration of infective endocarditis treatment. 

TauroPace™

  • Locally delivered, adjunct antimicrobial protection designed to prevent CIED infections. [10]

 

  • Polyvinylpyrrolidone (PVP) locally elutes taurolidine and thereby prolongs the antimicrobial activity.

 

  • Does not contain antibiotics – no resistance patterns observed.

 

  • Liquid solution – no foreign body nidus for potential infection.

 

  • After delivering all antimicrobial actions, taurine is the only residual.  
Tauropace-100ml-Ampulle-Von-Oben

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