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

Research output: Contribution to journalArticlepeer-review

10 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
Pages (from-to)1993-2001
Number of pages9
JournalHeart rhythm
Issue number12
StatePublished - Dec 2022


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


Dive into the research topics of 'Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval Study'. Together they form a unique fingerprint.

Cite this