Kun Xiang1, John N Catanzaro2, Claude Elayi2, Zerelda Esquer Garrigos3, Muhammad R Sohail4. 1. Cardiology, University of Florida College of Medicine, Gainesville, USA. 2. Cardiology, University of Florida College of Medicine - Jacksonville, Jacksonville, USA. 3. Internal Medicine/Infectious Disease, Mayo Clinic College of Medicine, University of Mississippi Medical Center, Rochester, USA. 4. Cardiovascular Infectious Diseases, Baylor College of Medicine, Houston, USA.
Abstract
OBJECTIVE: Cardiac-implantable electronic device (CIED) infections are associated with significant morbidity and mortality. In this review, we describe the risk factors and pathogenesis of CIED infections and review the rationale and the evidence for the use of antibiotic-eluting envelopes (ABEs) in patients at increased risk for CIED infections. FINDINGS: The majority of CIED infections are caused by staphylococci that involve generator pocket and occur due to contamination of the device or the pocket tissues at the time of implantation. Clinical trials have shown that extending the duration of post-operative systemic antibacterial therapy is not beneficial in reducing CIED infection rate. However, ABEs that reduce device migration after implantation and provide sustained local delivery of prophylactic antibiotics at the pocket site, may provide benefit in reducing infection. Currently, there are two types of commercially available CIED envelope devices in the United States. The first ABE device (TYRX™, Medtronic Inc., Monmouth Junction, NJ) is composed of a synthetic absorbable mesh envelope that elutes minocycline and rifampin and has been shown to reduce CIED pocket infections in a large multi-center randomized clinical trial. The second ABE device (CanGaroo-G™, Aziyo Biologics, Silver Spring, MD) is composed of decellularized extracellular matrix (ECM) and was originally designed to stabilize the device within the pocket, limiting risk for migration or erosion, and providing a substrate for tissue ingrowth in a preclinical study. This device has shown promising results in a preclinical study with local delivery of gentamicin. Compared with artificial materials, such as synthetic surgical mesh, biologic ECM has been shown to foster greater tissue integration and vascular ingrowth, a reduced inflammatory response, and more rapid clearance of bacteria. CONCLUSIONS AND RELEVANCE: ABE devices provide sustained local delivery of antibiotics at the generator pocket site and appear beneficial in reducing CIED pocket infections. Given the continued increase in the use of CIED therapy and resultant infectious complications, innovative approaches to infection prevention are critical.
OBJECTIVE: Cardiac-implantable electronic device (CIED) infections are associated with significant morbidity and mortality. In this review, we describe the risk factors and pathogenesis of CIED infections and review the rationale and the evidence for the use of antibiotic-eluting envelopes (ABEs) in patients at increased risk for CIED infections. FINDINGS: The majority of CIED infections are caused by staphylococci that involve generator pocket and occur due to contamination of the device or the pocket tissues at the time of implantation. Clinical trials have shown that extending the duration of post-operative systemic antibacterial therapy is not beneficial in reducing CIED infection rate. However, ABEs that reduce device migration after implantation and provide sustained local delivery of prophylactic antibiotics at the pocket site, may provide benefit in reducing infection. Currently, there are two types of commercially available CIED envelope devices in the United States. The first ABE device (TYRX™, Medtronic Inc., Monmouth Junction, NJ) is composed of a synthetic absorbable mesh envelope that elutes minocycline and rifampin and has been shown to reduce CIED pocket infections in a large multi-center randomized clinical trial. The second ABE device (CanGaroo-G™, Aziyo Biologics, Silver Spring, MD) is composed of decellularized extracellular matrix (ECM) and was originally designed to stabilize the device within the pocket, limiting risk for migration or erosion, and providing a substrate for tissue ingrowth in a preclinical study. This device has shown promising results in a preclinical study with local delivery of gentamicin. Compared with artificial materials, such as synthetic surgical mesh, biologic ECM has been shown to foster greater tissue integration and vascular ingrowth, a reduced inflammatory response, and more rapid clearance of bacteria. CONCLUSIONS AND RELEVANCE: ABE devices provide sustained local delivery of antibiotics at the generator pocket site and appear beneficial in reducing CIED pocket infections. Given the continued increase in the use of CIED therapy and resultant infectious complications, innovative approaches to infection prevention are critical.
Authors: Bryan N Brown; Ricardo Londono; Stephen Tottey; Li Zhang; Kathryn A Kukla; Matthew T Wolf; Kerry A Daly; Janet E Reing; Stephen F Badylak Journal: Acta Biomater Date: 2011-12-02 Impact factor: 8.947
Authors: Matthew E Falagas; Konstantinos Fragoulis; Ioannis A Bliziotis; Ioannis Chatzinikolaou Journal: J Antimicrob Chemother Date: 2007-01-25 Impact factor: 5.790
Authors: G F Dall; S-T J Tsang; P J Gwynne; S P MacKenzie; A H R W Simpson; S J Breusch; M P Gallagher Journal: J Antimicrob Chemother Date: 2018-07-01 Impact factor: 5.790
Authors: Arnold J Greenspon; Jasmine D Patel; Edmund Lau; Jorge A Ochoa; Daniel R Frisch; Reginald T Ho; Behzad B Pavri; Steven M Kurtz Journal: J Am Coll Cardiol Date: 2011-08-30 Impact factor: 24.094
Authors: Matthew J Kolek; William F Dresen; Quinn S Wells; Christopher R Ellis Journal: Pacing Clin Electrophysiol Date: 2012-12-17 Impact factor: 1.976
Authors: Larry M Baddour; Andrew E Epstein; Christopher C Erickson; Bradley P Knight; Matthew E Levison; Peter B Lockhart; Frederick A Masoudi; Eric J Okum; Walter R Wilson; Lee B Beerman; Ann F Bolger; N A Mark Estes; Michael Gewitz; Jane W Newburger; Eleanor B Schron; Kathryn A Taubert Journal: Circulation Date: 2010-01-04 Impact factor: 29.690