Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval Study

Michael R. Gold*, Johan D. Aasbo, Raul Weiss, Martin C. Burke, Marye J. Gleva, Bradley P. Knight, Marc A. Miller, Claudio D. Schuger, Nathan Carter, Jill Leigh, Amy J. Brisben, Mikhael F. El-Chami

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1993-2001
Number of pages9
JournalHeart rhythm
Issue number12
StatePublished - Dec 2022


  • Erosion
  • Implantable cardioverter-defibrillator
  • Infection
  • Risk score
  • Subcutaneous ICD

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)


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