Repeated procedures at the generator pocket are a determinant of implantable cardioverter‐defibrillator infection

Abstract

Background Rates of cardiac‐device infections have increased in recent years, but the current incidence and risk factors for infection in patients with implantable cardioverter‐defibrillators (ICDs) are not well known. Hypothesis The increasing number of ICD infections is related to accumulated pocket manipulations over time. Methods This single‐center, prospective study included patients that underwent ICD implantation from 2008 to 2015. The endpoint was time to infection. Multivariate analysis was performed to identify independent risk factors related to infection. Results The study included a total of 570 patients, of whom 419 (73.5%) underwent a first implantation. Mean age was 59 ± 14 years, and 80% were male. During a median follow‐up of 36 months (interquartile range, 18–61 months; 1887 patient‐years), infection was identified in 26 patients (4.56%), an incidence of 14.9 × 1000 patient‐years. Median time to infection was 9.7 months (interquartile range, 1.35–23.4 months), and 38.5% were late infections (beyond 12 months of follow‐up). In patients with replacement implants, the incidence was 3‐fold higher than in first implantations (27.7 vs 9.1 × 1000 patient‐years; P = 0.002). Cox regression identified 2 independent predictors of ICD infection: cumulative number of interventions at the generator pocket (hazard ratio: 1.92, 95% confidence interval: 1.42‐2.6, P < 0.001) and pocket hematoma (hazard ratio: 7.0, 95% confidence interval: 2.7‐17.9, P < 0.0001). Conclusions The incidence of infection in ICD patients is greater than previously reported, largely due to late infections. Each new cumulative intervention at the same generator pocket nearly doubles the risk of infection.

Successful defibrillation verification in subcutaneous implantable cardioverter‐defibrillator recipients by low‐energy shocks

“…A 95% success rate at 45 J would enable to decrease the maximum S‐ICD output at 60 J, thereby increasing its longevity to state‐of‐the‐art transvenous ICDs, or could promote manufacturing of smaller devices meeting the clinical needs of pediatric as well as of small body habit patients . Indeed, although it has been recently shown that S‐ICD implantation is safe and effective in children and young adults, they would either benefit of a smaller can for acceptability or of long‐lasting S‐ICDs to avoid frequent replacements, that increase infection risk …”

“…15 Indeed, although it has been recently shown that S-ICD implantation is safe and effective in children and young adults, 15 they would either benefit of a smaller can for acceptability or of long-lasting S-ICDs to avoid frequent replacements, that increase infection risk. 16 The demonstration that the safety margin of currently adopted S-ICD is frequently higher than what generally accepted for transvenous ICDs is also reassuring in situations where the defibrillation test is not performed.…”

The never‐ending story of CIED infection prevention: Shall we WRAP‐IT and go?

“…Indeed, the 67% reduction in ICD/CRTD “second surgery” was the cornerstone of the WRAP‐IT success (Table ). CIED infection is strongly associated with repeated surgery, exceeding 15% at the 4th pocket entry in small series . This thought should bring us back to the practice of CIED infection prevention at the “individual” level.…”

Strategies to Prevent Cardiac Implantable Electronic Device Infection

“…30,33,34 In particular, the incidence of infection in conjunction with replacement procedures was at least twofold higher than that of infection presenting in relation to de novo implantations. 35 Procedure-related factors have also been shown to lead to a significantly increased risk for infections. The lack of preoperative antibiotic prophylaxis has been identified as an independent risk factor for CIED infections.…”