Computed tomography with positron emission tomography is more useful in local than systemic infectious process related to cardiac implanted electrotherapy device: a prospective controlled multicenter diagnostic intervention PET-Guidance Trial.

Assess the diagnostic value of 18-F FDG PET/CT in cardiac implantable electronic devices (CIED) infections in facilitating diagnostic process and optimizing decision-making process.Study group (n = 21) patients with initial suspected diagnosis of CIED-related infection or fever of unknown origin and patients referred for device removal due to infection. Control group (n = 13) patients with implanted CIED, who underwent PET/CT due to other non-infectious indications and had no data for infectious process in follow-up.PET/CT scan showed pocket infection in 12 patients (including 1 in whom infection was not finally diagnosed-the examination was performed early after the implantation procedure-1.5 months), increased tracer uptake in intravascular lead part in 3 patients, and increased uptake in intracardiac part in 5 patients.We found that sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET/CT in generator pocket infection was 91.7%, 70%, 78.6%, 87.5% and in lead-dependent intracardiac infection 100%, 47.1%, 35.7%, 100% respectively. PET/CT scan enabled reclassification of diagnosis from possible to definite CIED-related infection in 6 out of 9 patients, and to excluded in 3 out of 9.Establishing diagnosis of device related infections may be challenging due to non-specific symptoms. Incorporation of PET/CT scan in the diagnostic schema can improve accuracy and timing of the diagnosis and help to assess the extent of infection. PET/CT is more useful in local than systemic infectious process related to cardiac implanted electrotherapy device.Trial registration Consent of the bioethics committee nr IK-NP.-0021-85/1465/14. Registration in the www.clinicaltrials.gov database: NCT02196753.