Heather L. Bloom

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.

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 AIGIS_Rx^® 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 (

Treatment of ventricular tachycardia: consider ablation sooner

Background: In-hospital cardiac arrest has a poor prognosis despite active electrocardiography monitoring. The initial rhythm of approximately 25% of in-hospital cardiopulmonary resuscitation (CPR) events is pulseless ventricular tachycardia/ventricular fibrillation (VT/VF). Early defibrillation is an independent predictor of survival in CPR events caused by VT/VF. The automated external cardioverter defibrillator (AECD) is a device attached by pads to the chest wall that monitors, detects, and within seconds, automatically delivers electric countershock to an appropriate tachyarrhythmia. Study Objectives: • To evaluate safety of AECD monitoring in hospitalized patients. • To evaluate whether AECDs provide earlier defibrillation than hospital code teams. Methods: The study is a prospective trial randomizing patients admitted to the telemetry ward to standard CPR (code team) or standard CPR plus AECD monitoring (PowerHeart CRM). The AECD is programmed to deliver one 150 J biphasic shock to patients in sustained VT/VF. Data is collected using the Utstein criteria for cardiac arrest. The primary endpoint is time-to-defibrillation; secondary outcomes include neurological status and survival to discharge, with 3-year follow-up. Results: To date, 192 patients have been recruited in the time period between 10/10/2006 to 7/20/2007. A total of 3,655 hours of telemetry data have been analyzed in the AECD arm. The AECD has monitored ambulatory telemetry patients in sinus rhythm, sinus tachycardia, supraventricular tachycardia, atrial flutter or fibrillation, with premature ventricular complexes and non-sustained VT without delivery of inappropriate shocks. One patient experienced sustained VT during AECD monitoring, who was successfully defibrillated (17 seconds after meeting programmed criteria). There are no events to report in the control arm. The patient survived the event without neurological complications. During the same time period, mean time to shock for VT/VF cardiac arrest occurring outside the telemetry ward was 230 ± 50 seconds. Conclusion: AECD monitoring is safe and likely results in earlier defibrillation than standard telemetry monitoring. Trial Registration: National Institutes of Health registration ID: NCT00382928