The Burden and Risk Factors for Infection of Transvenous Cardiovascular Implantable Electronic Device: a Nationwide Cohort Study

Abstract

Background and Objectives There are limited published data on the incidence and cost associated with cardiac implantable electrical device (CIED) infection for Asian patients. We analyzed the infection burden associated with the implantation of CIEDs in Korea. Methods In the Health Insurance Review & Assessment Service (HIRA) database during the period from January 1, 2014 to December 31, 2016, we identified 16,908 patients with CIED implantation. CIED infection was defined as either: 1) Infection-related diagnosis code by the Korean Standard Classification of Diseases after any CIED procedure; or 2) CIED removal along with systemic infection. Results The proportions of first implantation and replacement were 77.6% and 22.4%, respectively. During the follow-up period of 17.1±10.6 months, a total of 462 patients had CIED infection with incidence of 1.95 per 100 person-years with higher infection rate in replacement than first implantation (3.97 vs. 1.4 per 100 person-years, p<0.001). The average cost per person was US$ 16,584 (pacemaker, $13,736; implantable cardioverter defibrillator, $28,402; cardiac resynchronization therapy, $29,674). The risk factors of CIED infection were generator replacement (adjusted hazard ratio [aHR], 3.14; 95% confidence interval [CI], 2.60–3.78), diabetes mellitus (aHR, 1.94; 95% CI, 1.58–2.38), and congestive heart failure (aHR, 1.86; 95% CI, 1.51–2.28). Conclusions The rate of CIED infection in Korea was 1.95 per 100 person-years with average cost of US$ 16,584. The most important risk factor was generator replacement. This result suggests that generator replacement should be performed cautiously to avoid CIED infection.

Small but Persistent Infection of Cardiac Implantable Electronic Devices (CIED)

“…The infection rate of CIED is known to be around 1% to 2% among reported observational and registry studies,3)4) which were performed in the Western countries, but there is not much data in Korea. This study5) confirms the infection rate of CIED devices in Korea at a large scale using the National Health Insurance or Medical Aid data. It also showed that the replacement of CIED significantly increased the risk of CIED infection, which was similar to the previous report 6).…”

“…The incidence of infection after CIED replacement was 3.97 per 100 person-years in replacement, compared with 1.4 per 100 person-years in first implantation. According to this study,5) the rate of infection in the replacement was high within 30 days after the procedure, and after 30 days, it occurred at the same frequency as the first implantation, suggesting that the infection increased in relation to the replacement procedure itself. Therefore, efforts have been made to reduce the infection rate at replacement.…”

Epidemiology of cardiac implantable electronic device infections: incidence and risk factors

“…De novo CIED implants are associated with lower infection risk when compared with generator procedures or lead revisions and upgrades. 5 , 14 , 24 , 28 , 29 Pacemaker (PM) procedures are associated with lower infection risk compared to implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) procedures. 5 , 14 , 24 , 29 , 30 In a retrospective study of 78 267 French patients having a CIED procedure, the 36-month infection rate for de novo device implant was 0.5–1.6% [0.5% for PM, 1.6% for ICD, 1.0% for CRT-pacemaker (CRT-P) and 1.6% for CRT-defibrillator (CRT-D)] compared to an infection rate of 1.3–3.9% for generator change procedures (1.4% for PM, 2.9% for ICD, 1.3% for CRT-P, and 3.9% for CRT-D).…”

“… 5 , 14 , 24 , 28 , 29 Pacemaker (PM) procedures are associated with lower infection risk compared to implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) procedures. 5 , 14 , 24 , 29 , 30 In a retrospective study of 78 267 French patients having a CIED procedure, the 36-month infection rate for de novo device implant was 0.5–1.6% [0.5% for PM, 1.6% for ICD, 1.0% for CRT-pacemaker (CRT-P) and 1.6% for CRT-defibrillator (CRT-D)] compared to an infection rate of 1.3–3.9% for generator change procedures (1.4% for PM, 2.9% for ICD, 1.3% for CRT-P, and 3.9% for CRT-D). 5 Similarly, in a prospective, multicentre study of 19 599 patients having a CIED procedure, the 12-month infection rate for de novo device implant was 0.3–1.1% (0.3% for PM, 0.9% for ICD, 0.6% for CRT-P, and 1.1% for CRT-D) compared to an infection rate of 0.5–2.5% for generator procedures (0.5% for PM, 1.0% for ICD, and 2.5% for CRT) and an infection rate of 2.1% for lead revision or upgrade procedures.…”

“…In-hospital mortality is estimated to be ∼5–10%, 35–37 while 1-year all-cause mortality ranges between 16% and 36%, 36–39 although both appear to be reducing over time. 11 , 39 , 40 Hospitalization for CIED infection typically lasts 1–3 weeks, 11 , 29 , 35 , 36 , 40 , 41 with an associated reduction in quality of life. 39 …”