Table 1.

Recommendations for diagnosis of CIED infections and/or IE: the Novel 2019 International CIED Infection Criteria³

“Definite” CIED clinical pocket/generator infection = generator pocket shows swelling, erythema, warmth, pain, and purulent discharge/sinus formation, or deformation of pocket, adherence and threatened erosion, or exposed generator or proximal leads “Definite” CIED/IE = presence of either 2 major criteria or 1 major + 3 minor criteria “Possible” CIED/IE = presence of either 1 major + 1 minor criteria or 3 minor criteria “Rejected” CIED/IE diagnosis = patients who did not meet the aforementioned criteria for IE
Major criteria
Microbiology:
A. Blood cultures positive for typical microorganisms found in CIED infection and/or IE (coagulase-negative staphylococci, S. aureus) B. Microorganisms consistent with IE from 2 separate blood cultures:  a. Viridans streptococci, Streptococcus gallolyticus (S. bovis), HACEK group, S. aureus; or  b. Community-acquired enterococci, in the absence of a primary focus C. Microorganisms consistent with IE from persistently positive blood cultures:  a. ≥ 2 positive blood cultures of blood samples drawn >12 h apart; or  b. All of 3 or a majority of ≥ 4 separate cultures of blood (first and last samples drawn ≥ 1 h apart); or  c. Single positive blood culture for Coxiella burnetii or phase I IgG antibody titre > 1:800
Imaging positive for CIED infections and/or IE:
D. Echocardiogram (including ICE) positive for:  a. CIED infection: i. Clinical pocket/generator infection ii. Lead-vegetation b. Valve IE i. Vegetations ii. Abscess, pseudoaneurysm, or intracardiac fistula iii. Valvular perforation or aneurysm iv. New partial dehiscence of prosthetic valve E.18F-FDG PET/CT (caution should be taken in case of recent implants) or radiolabelled WBC SPECT/CT detection of abnormal activity at pocket/generator site, along leads or at valve site F. Definite paravalvular leakage by cardiac CT
Minor criteria
a. Predisposition such as predisposing heart condition (eg, new-onset tricuspid valve regurgitation) or injection drug use b. Fever (temperature > 38oC) c. Vascular phenomena (including those detected only by imaging): major arterial emboli, septic pulmonary emboli, infectious (mycotic) aneurysm, intracranial hemorrhage, conjunctival hemorrhages, and Janeway’s lesions d. Microbiologic evidence: positive blood culture that does not meet a major criterion as noted above or serologic evidence of active infection with organism consistent with IE or pocket culture or leads culture (extracted by noninfected pocket)

¹⁸F-FDG PET/CT, whole body fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography; CIED, cardiovascular implantable electronic device; HACEK, Haemophilus aphrophilus, (now called Aggregatibacter aphrophilus), Aggregatibacter actinomycetemcomitans, Cardiobacterium hominis, Eichenella corrodens, and Kingella kingae; ICE, intracardiac echocardiography; IE, infective endocarditis; S. aureus, Staphylococcus aureus; WBC SPECT/CT, ^99mTc-hexamethypropylene amine oxime labeled autologous white blood cell single-photon emission computerized tomography/computerized tomography.