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Implantation Success and Infection in Cardiovascular Implantable Electronic Device Procedures Utilizing an Antibacterial Envelope


  • Funding Sources: This study was supported by TYRX, Inc.

  • Disclosures: Investigators (HLB, LC, DD, DBD,ME, KJG, FKH, NKK, AR, GRS, FOS) and CEC members (HLB, DBD, LIG, MRS) received research grant to conduct this study from the sponsor (TYRX, Inc.), administered according to a sponsored research agreement that prospectively defined the scope of the research effort and corresponding budget. None of the investigators, research coordinators, or CEC members has ever had a financial interest in TYRX, Inc. or received consulting or lecture fees from TYRX, Inc.

Address for reprints: Heather L. Bloom, M.D., Emory University School of Medicine – Division of Cardiology, 1639 Pierce Drive, Suite 319 WMB, Atlanta, GA 30322. Fax: 404.329.2211; e-mail:


Background:Cardiovascular implantable electronic device (CIED) infection rates are increasing faster than implantation rates. More effective antimicrobial prophylaxis may help reduce CIED infections and improve clinical outcomes. The AIGISRx® antibacterial envelope is a polymer mesh implanted in the generator pocket with the CIED. After implantation it releases two antibiotics, minocycline and rifampin, that have been shown to reduce infections associated with other medical devices. The purpose of this retrospective cohort study is to determine the rate of CIED implantation success and CIED infection in procedures utilizing the antibacterial envelope.

Methods:This study enrolled consecutive CIED procedures utilizing the antibacterial envelope at 10 US academic, community, and Veterans Affairs medical centers. Procedures following an explantation for a prior CIED infection or off-label use of the antibacterial envelope were excluded.

Results:The 624 eligible procedures (age 70 ± 13 years, 68.1% men, 27.2% renal insufficiency, 35.4% oral anticoagulant use, 67.8% replacement/revision procedures) utilized pacemakers (35%), implantable cardioverter-defibrillators (ICD)(29%), and cardiac resynchronization therapy with defibrillator devices (CRT-D)(36%). Nearly half of the patients (49%) had at least three predefined risk factors for CIED infection. CIED implantation was successful in 621 procedures (99.5%[95% confidence interval (CI) 98.8–99.9]). There were three major infections (0.48%[95%CI 0.17–1.40]) after 1.9 ± 2.4 months follow-up. The infections followed one ICD revision and two CRT-D replacements. There were seven deaths; none was a result of the antibacterial envelope or the CIED procedure.

Conclusions:CIED procedures that utilized an antibacterial envelope had a high rate of CIED implantation success (>99%). Although the follow-up to date is short, there was also a low rate of infection (<0.50%) in this population at high risk for CIED infection. (PACE 2011; 34:133–142)