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Review
. 2015 Jan 12:8:71-8.
doi: 10.2147/MDER.S58278. eCollection 2015.

Clinical use of antibacterial mesh envelopes in cardiovascular electronic device implantations

David S Hirsh  1 , Heather L Bloom  1
Affiliations
Review

Clinical use of antibacterial mesh envelopes in cardiovascular electronic device implantations

David S Hirsh et al. Med Devices (Auckl). .

Abstract

Cardiovascular implantable electronic device system infection is a serious complication of cardiac device implantation and carries with it a risk of significant morbidity and mortality. In the last 15 years, expansions of indications for cardiac devices have resulted in much higher volumes of much sicker patients being implanted, carrying significant risk of infection. Coagulase (-) Staphylococcus and Staphylococcus aureus are responsible for the majority of these infections, and these organisms are increasingly resistant to methicillin. The Aigis™ envelop is a Food and Drug Administration-approved implantable mesh that is impregnated with antibiotics that can be placed in the surgical incision prior to closure. The antibiotics elute off the mesh for 7-10 days, providing in vivo surgical site coverage with rifampin and minocyclin. This paper reviews the three retrospective clinical trials published in peer-reviewed journals and the interim analysis of the two ongoing prospective trials that have been presented at international conferences. Overall consensus is that the Aigis™ offers significant risk reduction for cardiovascular implantable electronic device infection. We then give a comprehensive discussion of how to use the Aigis™ envelop in the clinical setting, comparing the manufacturer's recommendations with our extensive clinical experience.

Keywords: Aigis™; cardiac electronic implantable device; defibrillator; infection; pacemaker.

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Figures

Figure 1
Figure 1
Explanted device with Aigis™ envelop abandoned, dehiscence.
See this image and copyright information in PMC

References

    1. Greenspon AJ, Patel JD, Lau E, et al. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011;58:1001–1006. - PubMed
    1. Baddour LM, Bettmann MA, Bolger AF, et al. Nonvalvular cardiovascular device-related infections. Circulation. 2003;108:2015–2031. - PubMed
    1. Baddour LM, Epstein AE, Erickson CC. Update on cardiovascular implantable electronic device infections and their management. Circulation. 2010;121:458–477. - PubMed
    1. Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Reiser C. Clinical study of the laser sheath for lead extraction: the total experience in the United States. Pacing Clin Electrophysiol. 2002;25:804–808. - PubMed
    1. Ferguson TB, Jr, Ferguson CL, Crites K, Crimmins-Reda P. The additional hospital costs generated in the management of complications of pacemaker and defibrillator implantations. J Thorac Cardiovasc Surg. 1996;111:742–775. - PubMed

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