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Incidence of Device-Related Infection in 97,750 Patients
Study Questions:
What is the long-term incidence of device-related infection (DRI), and what are the incidence rates of DRI for different types of cardiac implantable electronic devices (CIED)?
Methods:
All patients undergoing CIED implantation or reoperation were entered in a nationwide registry since its inception in 1982. Multiple-record and multiple-event per subject proportional hazard analysis was performed.
Results:
Between 1982 and 2018, 97,750 device patients underwent an implantation. There were 128,045 operations and the follow-up was 566,275 device years (DY). There were 1,827 DRIs resulting in device removals. DRI incidence during device lifetime was 1.19% for pacemaker (PM), 1.91% for implantable cardioverter-defibrillator (ICD), 2.18% for cardiac resynchronization therapy (CRT)-pacemakers (CRT-P), and 3.35% for CRT-defibrillators (CRT-D). Incidence rates in de novo implantations were 2.04/1,000 DY for PM, 3.84 for ICD, 4.38 for CRT-P, and 6.76 for CRT-D. Implantation of complex devices (ICD and CRT), reoperations, prior DRI, male gender, and younger age were significantly associated with higher DRI risk.
Conclusions:
Overall risk of infection was low in PM implantations, but considerably higher in CRT systems and after reinterventions.
Perspective:
The advantages of this study include its large size, the use of a nationwide system which tracks virtually all device procedures and reoperations, and very long follow-up. Patients who did not undergo device removal or extraction were not captured by the database. Over a period of 20 years, the cumulative lifetime risk of DRI in different types of devices was as low as 5% for PM and up to 20% for CRT-D. The risk was lowest in de novo implantations and several-fold higher in all types of reoperations. Both ICD and CRT systems were statistically significant independent risk factors as compared to pacemakers. Other independent risk factors were young age, male sex, and prior DRI. Of note, other risk factors related to comorbidity, which have not been examined in this study, such as diabetes mellitus and renal insufficiency, would also be expected to be of consequence.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Cardiac Surgical Procedures, Cardiac Resynchronization Therapy, Defibrillators, Implantable, Device Removal, Heart Failure, Infections, Pacemaker, Artificial, Reoperation, Risk Factors, Secondary Prevention
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