Rising infection rate in cardiac electronic device implantation; the role of the AIGISRx® antibacterial envelope in prophylaxis

The implantation of cardiac implantable electronic devices (CIED) to prevent sudden cardiac death, ameliorate chronic congestive heart failure, and correct bradycardia has grown rapidly in the past decade. Bacterial infection of the device hardware (pacemaker or implantable cardioverter defibrillator [ICD] pulse generator, and intravascular wires or leads), including the tissue pocket, is rising at an even faster rate. The source infection inoculation typically occurs at the time the device is implanted, revised, or when a device generator replacement occurs. This risk is clearly related to patient and procedure-specific factors, and is reviewed in the present paper. Prophylactic preoperative antibiotics, strict sterile technique, and limiting procedure times may reduce infection risk. A novel Antibacterial Envelope (AIGISRx®, TYRX Inc., Monmouth Junction, NJ, USA) that is directly implanted with the device generator to provide site-specific therapy could significantly lower infection risk in certain high-risk cases. This may potentially reduce inpatient mortality related to endocarditis and sepsis, and lower healthcare costs related to CIED extraction and re-implantation, which can exceed $1 million per case.