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

• Published in: Pacing and clinical electrophysiology 2011-02, Vol.34 (2), p.133-142
• Main Authors: BLOOM, HEATHER L., CONSTANTIN, LUIS, DAN, DANIEL, De LURGIO, DAVID B., El-CHAMI, MIKHAIL, GANZ, LEONARD I., GLEED, KENT J., HACKETT, F. KEVIN, KANURU, NARENDRA K., LERNER, DANIEL J., RASEKH, ABDI, SIMONS, GRANT R., SOGADE, FELIX O., SOHAIL, MUHAMMAD R.
• Format: Article
• Language: English
• Subjects: Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Anti-Bacterial Agents - administration & dosage; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; clinical trials; CRT; defibrillation - ICD; Defibrillators, Implantable - utilization; Diseases of the cardiovascular system; Drug Implants - administration & dosage; Electronic equipment; Electrophysiology; Emergency and intensive cardiocirculatory care. Cardiogenic shock. Coronary intensive care; Envelopes; Female; Humans; Infection; Intensive care medicine; Male; Medical sciences; Myocarditis - epidemiology; Myocarditis - prevention & control; Pacemaker, Artificial - utilization; pacing; Pharmacology. Drug treatments; Prevalence; Prognosis; Prosthesis-Related Infections - epidemiology; Prosthesis-Related Infections - prevention & control; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Risk Assessment; Risk Factors; Treatment Outcome; United States - epidemiology
• ISSN: 0147-8389; 1540-8159
• DOI: 10.1111/j.1540-8159.2010.02931.x

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 (