Accuracy of Positron Emission Tomography as a Diagnostic Tool for Lead Endocarditis: Design of the Prospective Multicentre ENDOTEP Study.

Abstract

Background: Rates of pacemaker implantation are steadily increasing and as patients are living longer, endovenous leads remain implanted for an extended period of time thereby increasing the risk of cardiac implantable electronic device (CIED) infection. Investigating fever of unknown origin in patients with implanted pacemakers can be challenging. Recently, 18F-fluorodeoxyglucose positron emission tomography/computerised tomography (18F-FDG-PET/CT) scanning has been used as a diagnostic tool for lead endocarditis in small studies. Objectives: ENDOTEP is a prospective and multicentre study designed to evaluate the accuracy of 18F-FDG-PET/CT scanning in the diagnosis of lead endocarditis. Methods: A total of 250 patients referred for pacemaker extraction due to suspicion of an infected device will be prospectively enrolled in six French regional centres for investigation and treatment of CIED infection. 18F-FDG-PET/CT scanning (index test) will be performed in each patient in the 48 hours preceding lead extraction. Bacteriological cultures (reference standard) will assess the presence of lead endocarditis, blind to 18F-FDG-PET/CT results. Enrolment started in June 2015 and is expected to end by June 2017. The primary objective will be to establish the sensitivity of the 18F-FDG-PET/CT scan for lead endocarditis. Secondary objectives will include other accuracy parameters, inter-observer agreement in the interpretation of 18F-FDG-PET/CT scanning, the influence of previous antibiotic therapy on 18F-FDG-PET/CT diagnostic accuracy and assessment of septic emboli associated to lead endocarditis. Conclusion: The ENDOTEP study will examine the ability of 18F-FDG-PET/CT scanning to avoid possible false-positive results, as is common using the current usual diagnostic strategy and may lead to unnecessary extraction of implants in patients with suspected lead infection.