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February 6, 2026European Heart Journal0 citations

What is the long term incidence and the natural history of infection of subcutaneous implantable cardioverter-defibrillators? Results from a nationwide cohort

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JMJ MansouratiFKFawzi KerkouriRGR Garcia

Key Result

S-ICD infections occurred in 2.3% of patients over a mean 4.2 years, mostly in the first year; patients requiring device removal had higher sudden cardiac death rates (9.6% vs. 1.2%, p=0.030).

Key Points

  • This study aims to describe the incidence and characteristics of infections in patients with S-ICD devices.
  • Enrolled 4,924 patients from 150 hospitals between 2012-2019
  • Collected and adjudicated infection cases
  • Classified outcomes using standardized criteria
  • Managed infections with conservative treatment and device extraction
  • 113 patients (2.3%) had 116 infections during a mean follow-up of 4.2 years
  • Highest incidence of infections occurred within the first year (84%)
  • Female gender, diabetes, and pocket hematoma identified as significant risk factors
  • Conservative management was effective in 41.5% of cases
  • Device removal was needed in 81% of infection cases, with higher rates of sudden cardiac death in removed devices (9.6% vs. 1.2%)

Study Design

Type

Cohort (n=4,924)

Multicenter

Yes

Structured PICO

What is the incidence, risk factors, and natural history of infections in patients implanted with subcutaneous implantable cardioverter-defibrillators?

P
Population
4,924 patients implanted with subcutaneous implantable cardioverter-defibrillators (S-ICD) from 150 nationwide hospitals (HONEST cohort)
I
Intervention
Subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation
O
Outcome
Incidence, site, severity, bacteriological findings, risk factors, management and outcome of S-ICD infectionssafety

S-ICD infections are primarily an early complication strongly associated with pocket hematomas, and device removal is associated with a significantly higher rate of sudden cardiac death.

Abstract

Abstract Background Subcutaneous implantable cardioverter-defibrillators (S-ICD) infections remain poorly studied. Objective The aim of this study to describe infections occurring in patients implanted with S-ICD (incidence, site, severity, bacteriological findings, risk factors, management and outcome) within the HONEST cohort. Methods We enrolled 4,924 patients (from 150 nationwide hospitals, 2012-2019) with ongoing follow-up. Infection cases were meticulously collected and adjudicated. Outcomes were classified using standardized criteria. Infection management included conservative treatment (antibiotics ± surgical revision) and device extraction. Results 113 patients (2.3%) experienced 116 infections through a mean follow-up of 4.2 ± 2.2 years. Infection incidence was 1.8% at 1 year, 2.4% at 5 years and 3.6% at 8 years). The majority of infections occurred within the first year (84%). Risk factors included female gender (HR 2.17), diabetes (HR 2.19), associated pacemaker (HR 3.55), three incisions (HR 1.55), and pocket hematoma (HR 7.52). We report the occurrence of recurrent infection (3 cases, 2.7%), systemic infections (8 cases ,6.9%), infective endocarditis (1 cases, 0.9%), septic shock (2 cases, 1.8%), and infection related mortality (2 cases, 1.8%). Staphylococcal infections were the most common. Conservative management was effective in 41.5% of cases. Device removal was necessary in 81.0% of cases, with 67.0% new ICD implantation. Patients who underwent S-ICD removal had a higher rate of sudden cardiac death than those with preserved ICDs (9.6% vs. 1.2%, p = 0.030). Conclusion S-ICD infections remain an early complication. Efforts should be made to reduce the incidence of pocket hematoma. Conservative management may be considered. S-ICD reimplantation should be considered when extraction is unavoidable.

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Cite This Study

Mansourati et al. (2025) conducted a cohort in Subcutaneous implantable cardioverter-defibrillator (S-ICD) infections (n=4,924). Subcutaneous implantable cardioverter-defibrillators (S-ICD) was evaluated on Incidence of S-ICD infections. S-ICD infections occurred in 2.3% of patients over a mean 4.2 years, mostly in the first year; patients requiring device removal had higher sudden cardiac death rates (9.6% vs. 1.2%, p=0.030).

synapsesocial.com/papers/698586118f7c464f23009ea0https://doi.org/10.1093/eurheartj/ehaf784.699
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