Cardiovascular Implantable Electronic Device Infections

Publication Date: December 4, 2023
Last Updated: December 6, 2023


Prevention Overview

  • Hematoma formation, regardless of size, is associ-ated with a high risk of CIEDI; thus, prevention is critical.
  • Continued or interrupted DOAC at the time of CIED implantation/revision are both acceptable because both are associated with a low risk of hematoma formation.
  • In patients receiving warfarin, it is reasonable to perform CIED implantation with a therapeutic international normalized ratio between 2 and 3.5.

Procedural Antibiotic Prophylaxis

  • The use of preprocedural cefazolin is a data-sup-ported standard practice.
  • Vancomycin is an alternative in specific situations such as when the patient has a penicillin or β-lactam allergy, a history of methicillin-resistant S aureusinfection, or a center has an unusually high rate of methicillin-resistant S aureus or methicillin-resistant coagulase-negative staphylococci infections on the basis of historical data. It is important to administer vancomycin 120 minutes before incision and weight-based dose of 20 mg/kg. Consider pharmacy guid-ance in patients with renal failure or obesity.Figure 2. Microbiology of cardiovascular implantable electronic device infections.Reprinted with permission from Sohail et al.19 Copyright 2007, by the American College of Cardiology Foundation. Published by Elsevier.
  • The routine use of postoperative antibiotics is not supported by published data.
  • Pocket irrigation with saline is reasonable for patients undergoing CIED implantation or genera-tor replacement.
  • Avoidance of capsulectomy to reduce hematoma formation and infection risk is advised.

Antibiotic-Eluting Envelope for CIEDI Prevention

  • Risk factors associated with CIEDI are well-defined and evaluation by a risk score may be use-ful in defining high risk (see Management section for details regarding risk score).
  • Use of the antimicrobial envelope may be consid-ered in patients at high risk of CIEDI, including patients at high risk of perioperative hematoma formation.


Diagnosis Overview

  • Physical examination changes at the genera-tor pocket, such as fluctuance, purulent drainage, device erosion through skin, or sinus tract forma-tion, are considered definite pocket infection.
  • Patients with persistent S aureus or coagulase-negative staphylococcal bloodstream infection are at high risk of CIEDI and therefore should undergo timely device removal and antimicrobial therapy.
  • Persistent bloodstream infection despite appropri-ate antimicrobial therapy due to nonstaphylococcal organisms raises concern for CIEDI, and treatment for such with complete device removal and contin-ued antimicrobial therapy is reasonable if no alter-native source of infection is established.

Suspected CIED Generator Pocket Infection

  • TEE remains an important diagnostic tool for eval-uating patients with valvular infection or suspected CIEDI.
  • A limitation of TEE is that this imaging modality cannot reliably distinguish between infectious and noninfectious lead echodensities or exclude lead infection without an echodensity.
  • Although TEE may be deferred in patients with CIED pocket infection and negative blood cultures without previous antibiotics, it remains a useful tool for surgical planning for patients with a high suspicion of CIEDI where conventional imaging techniques have failed to provide a definitive diag-nosis. [18F]FDG PET/CT is a reasonable option to consider.
  • [18F]FDG PET/CT has reduced sensitivity in patients with low-grade pocket infection, lead infection, and in those who have received antibiotic therapy before imaging. As such, these tests might be considered in conjunction with other diagnostic tests and clinical judgment to ensure an accurate diagnosis and appropriate treatment.
  • In patients with possible CIEDI who are medically stable at community hospitals without access to [18F]FDG PET/CT, we suggest early referral to centers with access to these imaging modalities. If this is not feasible, an evaluation by a multidisci-plinary team of experts in the diagnosis and man-agement of CIEDI is advised.

Clinical Laboratory Advances in Pathogen Detection

  • A vortexing sonication technique of extracted CIED can improve the recovery of pathogens but is not available in all clinical settings.
  • Due to limited availability in clinical laboratories, cost, and delayed culture results, selective use of molecular techniques may be considered in chal-lenging cases; however, the results require careful interpretation within the clinical context.

Role of Inflammatory Markers in the Diagnosis of CIEDI

  • The diagnostic accuracy of procalcitonin in CIEDI deserves further investigation. Use of procalcitonin may be considered in conjunction with other clini-cal, laboratory, and imaging data.

American Heart Association Clinical Definitions of Cardiovascular Implantable Electronic Device Infection

These definitions are provided to support clinicians in their practice but are not intended as a substitute for clinical judgment. [18F]FDG PET/CT indicates fluorine-18-fludeoxyglucose positron emission tomography/computerized tomography scanning; PCR, polymerase chain reaction; SIRS, systemic inflammatory response syn-drome; and TEE, transesophageal echocardiography. *Not required to establish a diagnosis.†A negative TEE for lead echodensities does not rule out cardiovascular implantable electronic device lead infection.‡Alternative explanations may include superficial cellulitis at the surgical site without device involvement, retained suture, contact dermatitis, or allergy to device components.§Includes mainly nonstaphylococcal gram-positive organisms, Pseudomonas aeruginosa, Serratia marcescens, and Candida species.‖SIRS criteria defined ≥ of the following: temperature ≥38.3 °C or ≤36 °C, pulse rate >90/min, respirations >20/min, and peripheral white blood cell count >12 000/μL or <4000/μL or >10% immature forms.


Management Overview

  • Clinical trial data are lacking regarding optimal choice and duration of antimicrobial therapy.
  • Early device removal has been associated with improved outcomes.
  • Delay reimplantation until signs and symptoms of local and systemic infection have resolved.
  • Weigh the potential risks of early reimplantation with device dependency, and LPM or subcutane-ous alternative devices.
  • A wearable defibrillator and temporary-permanent pacemaker are reasonable strategies for patients in whom permanent device reimplantation is delayed.
  • Consider delaying reimplantation up to 14 days when there is evidence of valvular IE.

Implantation of a New Device

  • It is reasonable to use LPM and S-ICD in patients at high risk of infection.
  • The use of LPM after extraction of infected CIEDs might shorten the delay to reimplantation in the setting of systemic infection.

Role of Percutaneous Mechanical Aspiration for Vegetation Removal

  • Percutaneous mechanical aspiration has been done in select cases, but clinical trial data are needed to better define the role of this procedure.

Approach to Patients With Retention of an Infected CIED

  • Continuous, in situ-targeted, ultrahigh concentra-tion of antibiotics may be an alternative in patients with CIEDI due to non–S aureus in circumstances where the risk of complete device removal is unac-ceptably high or among patients who decline device removal. More investigation is clearly needed before continuous, in situ-targeted, ultrahigh concentration of antibiotics is considered a management option.

Approach to Patients With Incomplete CIED Removal

  • After completion of initial antibiotic therapy, CAS therapy may be considered in patients with CIEDI who are not candidates for complete device removal.
  • Patients receiving CAS need early follow-up to evaluate for infection relapse and adverse drug events.
  • In patients with incomplete device removal, [18F]FDG PET/CT may be useful to evaluate for resid-ual infection to determine whether CAS therapy is warranted.

Diagnosis and management algorithms for suspected CIED pocket infection (A) and suspected CIED lead/valvular infection without pocket infection (B)

BSI indicatesbloodstream infection; CIED,cardiovascular implantable electronic device; CoNS, coagulase-negative staphylococci; PET/CT, positron emission tomography/computerized tomography scanning; TEE, transesophageal echocardiography; TTE, transthoracic echocardiography; w/o, without; and w/up, work up

Recommendation Grading


The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.



Cardiovascular Implantable Electronic Device Infections

Authoring Organization

Publication Month/Year

December 4, 2023

Last Updated Month/Year

December 13, 2023

Document Type


Country of Publication


Document Objectives

The American Heart Association sponsored the first iteration of a scientific statement that addressed all aspects of cardiovascular implantable electronic device infection in 2010. Major advances in the prevention, diagnosis, and management of these infections have occurred since then, necessitating a scientific statement update. An 11-member writing group was identified and included recognized experts in cardiology and infectious diseases, with a career focus on cardiovascular infections. The group initially met in October 2022 to develop a scientific statement that was drafted with front-line clinicians in mind and focused on providing updated clinical information to enhance outcomes of patients with cardiovascular implantable electronic device infection. The current scientific statement highlights recent advances in prevention, diagnosis, and management, and how they may be incorporated in the complex care of patients with cardiovascular implantable electronic device infection.

Inclusion Criteria

Male, Female, Adolescent, Adult, Child, Older adult

Health Care Settings

Ambulatory, Hospital, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant


Diagnosis, Assessment and screening, Treatment, Management, Prevention

Diseases/Conditions (MeSH)

D017147 - Defibrillators, Implantable, D053821 - Cardiovascular Infections


cardiovascular implantable electronic device (CIED), CIED, CIED infections

Source Citation

Update on Cardiovascular Implantable Electronic Device Infections and Their Prevention, Diagnosis, and Management: A Scientific Statement From the American Heart Association
Larry M. Baddour, MD, FAHAChair, Zerelda Esquer Garrigos, MD, M. Rizwan Sohail, MD, Eva Havers-Borgersen, MD, Andrew D. Krahn, MD, Vivian H. Chu, MD, Connie S. Radke, MSN, NP, Jennifer Avari-Silva, MD, FAHA, Mikhael F. El-Chami, MD, Jose M. Miro, MD, PhD, Daniel C. DeSimone, MDVice Chair, on behalf of the American Heart Association Council on Lifelong Congenital Heart Disease and Heart Health in the Young (Young Hearts); and Council on Clinical Cardiology

Supplemental Methodology Resources

Data Supplement