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. 2019 Nov 8;22(4):515–549. doi: 10.1093/europace/euz246

Table 5.

Recommendations for diagnosis of CIED infections and/or infective endocarditis: the Novel 2019 International CIED Infection Criteria

Consensus statement Statement class Scientific evidence coding Reference

  • ‘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 graphic file with name euz246ilf1.jpg E 59
Microbiology

  • A. Blood cultures positive for typical microorganisms found in CIED infection and/or IE (Coagulase-negative staphylococci, S. aureus)

  1. B. Microorganisms consistent with IE from 2 separate blood cultures:

  2.  a. Viridans streptococci, Streptococcus gallolyticus (S. bovis), HACEK group, S. aureus; or

  3.  b. Community-acquired enterococci, in the absence of a primary focus

  1. C. Microorganisms consistent with IE from persistently positive blood cultures:

  2.  a. ≥2 positive blood cultures of blood samples drawn >12 h apart; or

  3.  b. All of 3 or a majority of ≥4 separate cultures of blood (first and last samples drawn ≥1 h apart); or

  4.  c. Single positive blood culture for Coxiella burnetii or phase I IgG antibody titre >1:800

Imaging positive for CIED infections and/or IE

  1. D. Echocardiogram (including ICE) positive for:

  2.  a. CIED infection:

  3.    i. Clinical pocket/generator infection

  4.    ii. Lead-vegetation

  5.  b. Valve IE

  6.    i. Vegetations

  7.    ii. Abscess, pseudoaneurysm, intracardiac fistula

  8.    iii. Valvular perforation or aneurysm

  9.    iv. New partial dehiscence of prosthetic valve

  1. 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

  1. F. Definite paravalvular leakage by cardiac CT

Minor criteria graphic file with name euz246ilf1.jpg E 59

  • a. Predisposition such as predisposing heart condition (e.g. new onset tricuspid valve regurgitation) or injection drug use

  • b. Fever (temperature >38°C)

  • c. Vascular phenomena (including those detected only by imaging): major arterial emboli, septic pulmonary embolisms, infectious (mycotic) aneurysm, intracranial haemorrhage, conjunctival haemorrhages, and Janeway’s lesions

  • d. Microbiological evidence: positive blood culture which does not meet a major criterion as noted above or serological evidence of active infection with organism consistent with IE or pocket culture or leads culture (extracted by non-infected pocket)

Based on merging of the modified Duke and ESC 2015 Guidelines criteria, see text.59,60 Green text refers to CIED-related infection criteria.

CIED, cardiac implantable electronic device; CT, computerized tomography; E, expert opinion; ICE, intracardiac echocardiography; IE, infective endocarditis; M, meta-analysis; O, observational studies; R, randomized trials; SPECT, single-photon emission tomography; WBC, white blood cell.