John de Heide

PADIT-score and device infection in pacemaker or defibrillator surgery 97 underwent either CIED reoperation or a CRT procedure. Infection risk is dependent on several patient-related, procedure-related, and device-related factors (17). Important preventive measures to reduce the risk of CIED infections are the use of antibiotic prophylaxis, chlorhexidine skin preparation, delaying the procedure in case of fever, avoidance of heparin bridging, avoidance of pocket hematoma, the use of strict sterile techniques, and having experienced operators. These preventive measures are summarized in the 2019 EHRA international consensus document (16). In comparison to the PADIT study population, our study population was younger (61 vs. 72 years), had a higher proportion of immunocompromised patients (5.4% vs. 1.6%), and had relatively more ICD implantation/replacement (42.6% vs. 21.6%). All these factors are independent predictors of a higher risk of CIED infection. However, the 1-year risk of CIED infection was low (0.43%, 95% CI 0.21–0.79%). Our results agree with a recent prospective single-center study using a real-world cohort (median age 77 years, median PADIT score 2 [IQR, 2–4]) which demonstrated a 1-year risk of CIED infection requiring hospitalization of 0.36% (18). Thus, it seems that strict adherence to preventive measures may result in CIED infection rates well below 1% in an all-comer population. 4.2. Identification of the high-risk patient The WRAP-IT study demonstrated that an absorbable antibiotic envelope (TYRX™, Medtronic, MN, USA) reduced the risk of major CIED infection by 40% in high-risk patients (11). It is important to realize that immunocompromised patients, patients with previous CIED infection, and hemodialysis patients were excluded in WRAP-IT. Cost-effectiveness studies in the USA and European health care systems demonstrated that the antibiotic envelope was cost-effective when the standard-ofcare infection risk was ≥ 1.0% (12) or when the PADIT score was ≥ 6 (7). The 2019 EHRA international consensus document recommends an antibiotic envelope in patients aligned with the WRAP-IT study population or other high-risk factors, in the context of the local incidence of CIED infections (16). This last aspect is important to note because different centers have different standard-of-care infection rates depending on their patient populations and local preventive measures. Risk stratification with risk score calculators could play a useful role by providing an objective way to identify high-risk patients (14,19,20). Such a calculator should be easy to use and be readily available for widespread adoption in clinical practice. We 6

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