Abstract
Cardiac device infection is a serious complication of implantable cardioverter-defibrillator (ICD) placement and requires complete device removal with accompanying antimicrobial therapy for durable cure. Recent guidelines have highlighted the need to better identify patients at high risk of infection to assist in device selection. To estimate the prevalence of infection in de novo transvenous (TV) ICD implants and assess factors associated with infection risk in a Medicare population. A retrospective cohort study was conducted using 100% Medicare administrative and claims data to identify patients who underwent de novo TV-ICD implantation (July 2016-December 2017). Infection within 720 days of implantation was identified using ICD-10 codes. Baseline factors associated with infection were identified by univariable logistic regression analysis of all variables of interest, including conditions in Charlson and Elixhauser comorbidity indices, followed by stepwise selection criteria with a P ≤ .25 for inclusion in a multivariable model and a backwards, stepwise elimination process with P ≤ .1 to remain in the model. A time-to-event analysis was also conducted. Among 26,742 patients with de novo TV-ICD, 519 (1.9%) developed an infection within 720 days post implant. While more than half (54%) of infections occurred during the first 90 days, 16% of infections occurred after 365 days. Multivariable analysis revealed several significant predictors of infection: age <70 years, renal disease with dialysis, and complicated diabetes mellitus. The rate of de novo TV-ICD infection was 1.9%, and identified risk factors associated with infection may be useful in device selection.
Highlights
Previous studies have identified patients at high risk of infection in clinical trials[7] for the broader cardiac implantable electronic device (CIED) category and limited follow-up to 1 year
The rate of de novo TV-implantable cardioverter-defibrillator (ICD) infection was 1.9%, and identified risk factors associated with infection may be useful in device selection
The objective of this study is to estimate the prevalence of device infection in de novo transvenous (TV) ICD implants and assess risk factors associated with device infection in a large, real-world, Medicare population with long-term (.1 year) follow-up
Summary
Previous studies have identified patients at high risk of infection in clinical trials[7] for the broader cardiac implantable electronic device (CIED) category and limited follow-up to 1 year. The objective of this study is to estimate the prevalence of device infection in de novo transvenous (TV) ICD implants and assess risk factors associated with device infection in a large, real-world, Medicare population with long-term (.1 year) follow-up. These data could be used to help guide clinical decisions for device type and patient selection.[11]. Recent guidelines have highlighted the need to better identify patients at high risk of infection to assist in device selection
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