Incidence of device-related infection in 97 750 patients: clinical data from the complete Danish device-cohort (1982–2018)

Abstract

Aims Device-related infection (DRI) is a severe complication to cardiac implantable electronic devices (CIED) therapy. Device-related infection incidence and its risk factors differ between previous studies. We aimed to define the long-term incidence and incidence rates of DRI for different types of CIEDs in the complete Danish device-cohort and identify patient-, operation- and device-related risk factors for DRI. Methods and results From the Danish Pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Register, we included consecutive Danish patients undergoing CIED implantation or reoperation from January 1982 to April 2018, resulting in 97 750 patients, 128 045 operations and follow-up of in total 566 275 device years (DY). We identified 1827 DRI causing device removals. Device-related infection incidence during device lifetime was 1.19% (1.12–1.26) for PM, 1.91% (1.71–2.13) for ICD, 2.18% (1.78–2.64) for cardiac resynchronization therapy (CRT)-pacemakers (CRT-P), and 3.35% (2.92–3.83) for CRT-defibrillators (CRT-D). Incidence rates in de novo implantations were 2.04/1000 DY for PM, 3.84 for ICD, 4.38 for CRT-P, and 6.76 for CRT-D. Using multiple-record and multiple-event per subject proportional hazard analysis, we identified implantation of complex devices (ICD and CRT), reoperations, prior DRI, male sex, and younger age as significantly associated with higher DRI risk. Conclusion Overall risk of infection was low in PM implantations but considerably higher in CRT systems and after reinterventions. These data support the importance of evaluating all patients considered for CIED therapy thoroughly, in order to identify potential modifiable risk factors and reduce the risk of early reoperations.

Long‐term risk of cardiovascular implantable electronic device‐related infection after catheter ablation of atrial fibrillation

“…In all cases, at least 18 months passed after CA until the diagnosis of CIED‐related infection, and evidence relating them to CA was not found. Moreover, the overall rate of infections (2.6%) is in line with large studies have addressed this issue in patients without a history of CA . We congratulate Farkowski et al on contributing to another piece of the puzzle by going into depth of the current data collected supporting that the risk of CIED‐related infection after CA from present observational data appears low.…”

“…The authors bring up the potential risk of CIED‐related infections in patients undergoing CA. As rightfully mentioned, a little is known on this important subject, and CA in patients with CIED and TVL is not considered a risk factor for CIED‐related infections …”

Sex Differences in Complications and Outcomes of Cardiac Implantable Electronic Devices: Time to Evaluate Our Practice

“…The higher rate of device-related infections in men corroborates recent findings from the Danish National Registry in which male sex independently predicted infection. 6 Unequal distribution of comorbidities and higher use of complex devices in men are potential explanations. However, the present analysis extends the Danish study and dispels the latter possibility by demonstrating excess infection associated with male sex consistently across all device types.…”

Infection and migration incidence of cardiac implantable electrical devices in Japan: Web‐based survey results

“…The overall infection rate including in-definitive diagnosis was 2.0%. As a reference, Table 3 includes infection rate from recent report from Olsen et al 8 from Danish device-cohort. Table 4 shows preventive measures prior or during implant procedure and administering direct and/or indirect antibiotics were main method followed by pocket cleansing.…”