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Published on: February 28, 2012
Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval
Michael R Gold1, Johan D Aasbo2, Raul Weiss3
1Department of Medicine, Medical University of South Carolina, Charleston, South Carolina.
Insights
Subcutaneous implantable cardioverter-defibrillator (S-ICD) infections are uncommon, with most occurring within a year. A risk score using diabetes, age, prior ICD, and ejection fraction can identify high-risk patients for S-ICD infection.
Area of Science:
- Cardiology
- Medical Devices
- Infectious Disease
Background:
- Early subcutaneous implantable cardioverter-defibrillator (S-ICD) studies featured younger patients with fewer comorbidities.
- Recent S-ICD studies have included patient populations with a higher comorbidity burden.
Purpose of the Study:
- Determine the incidence and predictors of S-ICD-related infection over a 3-year follow-up.
- Develop an S-ICD infection risk score.
Main Methods:
- A prospective registry of 1637 patients (S-ICD Post Approval Study) was analyzed.
- Compared baseline characteristics and outcomes between patients with and without device-related infection.
- Derived a risk score from multivariable proportional hazards analysis of 22 variables.
Main Results:
- Infection occurred in 3.3% of patients, with 69% within 90 days and 92.7% within 1 year.
- Late infections (>1 year) were uncommon, primarily involving device erosion.
- An infection risk score was developed using diabetes, age, prior transvenous ICD, and ejection fraction as predictors. A score ≥3 indicated an 8.8-fold increased risk of infection.
Conclusions:
- S-ICD infection rates are similar to other S-ICD populations and not linked to systemic infections.
- Late S-ICD infection is infrequent and associated with system erosion.
- A high-risk infection cohort can be identified, aiding preventive strategies.
Background:
Early subcutaneous implantable cardioverter-defibrillator (S-ICD) studies included atypical cohorts of patients who were younger with fewer comorbidities. Recent S-ICD studies included patient populations with more comorbidities.
Objectives:
The goals of this study were to determine the incidence and predictors of S-ICD-related infection over a 3-year follow-up period and to use these results to develop an infection risk score.
Methods:
The S-ICD Post Approval Study is a US prospective registry of 1637 patients. Baseline demographic characteristics and outcomes with 3-year postimplantation follow-up were compared between patients with and without device-related infection. A risk score was derived from multivariable proportional hazards analysis of 22 variables.
Results:
Infection was observed in 55 patients (3.3%), with 69% of infections occurring within 90 days and a vast majority (92.7%) within 1 year of implantation. Late infections more likely involved device erosion; no infections occurred after year 2. The annual mortality rate postinfection was 0.6%/y. No lead extraction complications or bacteremia related to infection were observed. An infection risk score was created with diabetes, age, prior transvenous ICD implant, and ejection fraction as predictors. Patients with a risk score of ≥3 had an 8.8 hazard ratio (95% confidence interval 2.8-16.3) of infection compared with a 0 risk score.
Conclusion:
Infection rates in the S-ICD Post Approval Study were similar to other S-ICD populations and not associated with systemic blood-borne infections. Late infection (>1 year) is uncommon and associated with system erosion. A high-risk infection cohort can be identified that may facilitate preventive measures.
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