Rate, Time Course, and Predictors of Implantable Cardioverter Defibrillator Infections: An Analysis From the SIMPLE Trial

Abstract

Background The number of implantable cardioverter defibrillator (ICD) infections is increasing due to an increased number of ICD implants, higher-risk patients, and more frequent replacement procedures, which carry a higher risk of infection. Reducing the morbidity, mortality, and cost of ICD-related infections requires an understanding of the current rate of this complication and its predictors. Methods The S hock Impl ant E valuation Trial (SIMPLE) trial randomized 2500 ICD recipients to defibrillation testing or not. Over an average of 3.1 years, patients were seen every 6 months and examined for evidence of ICD infection, which was defined as requiring device removal and/or intravenous antibiotics. Results Within 24 months, 21 patients (0.8%) developed infection. Fourteen patients (67%) with infection presented within 30 days, 20 patients by 12 months, and only 1 patient beyond 12 months. Univariate analysis demonstrated that patients with primary electrical disorders (3 patients, P = 0.009) and those with a secondary prevention indication (13 patients, P = 0.0009) were more likely to develop infection. Among the 2.2% of patients who developed an ICD wound hematoma, 10.4% developed an infection. Among the 8.3% of patients requiring an ICD reintervention, 1.9% developed an infection. Conclusions This cohort of ICD recipients at high-volume centres have a low risk of device-related infection. However; strategies to reduce wound hematoma and the need for ICD reintervention could further reduce the rate of infection.

Antibiotic-Eluting Envelopes for the Prevention of Cardiac Implantable Electronic Device Infections: Rationale, Efficacy, and Cost-Effectiveness

“…The most common manifestation of CIED infection is pocket infection ( 9 , 16 ). In the most typical clinical scenario (due to contamination) the pocket infection develops in the first 12 months following implantation although skin erosion late after implantation can also be seen ( 16 , 17 ). The infection spreads along the leads and eventually causes systemic infection resulting in device-related endocarditis.…”

Antibiotic eluting envelopes: evidence, technology, and defining high-risk populations

“…Pocket infections are responsible for the majority of CIED infections and most commonly occur within 12 months of CIED surgery. 11 , 12 Staphylococcal species are the responsible organism in about 70% of CIED infections while gram-negative bacilli account for another 9%. 13 , 14 While multiple strategies of CIED infection prophylaxis have been investigated, until recently, only preoperative intravenous antibiotics have been shown to reduce the risk.…”