title: New diagnostic pathways urgently needed. Protocol of PET Guidance I pilot study: positron emission tomography in suspected cardiac implantable electronic device-related infection.
abstract: BACKGROUND
  Cardiovascular implantable electronic device (CIED) infection is a complication of increasing incidence. We present a protocol of an observational case control clinical trial "Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiac Implantable Electronic Device Infection, a Pilot Study - PET Guidance I" (NCT02196753).
  
  
  OBJECTIVE
  The aim of this observational clinical trial is to assess and standardise diagnostic algorithms for CIED infections (lead-dependent infective endocarditis, generator pocket infection, fever of unknown origin) with PET CT in Poland.
  
  
  RESULTS
  Study group will consist of 20 patients with initial diagnosis of CIED-related infection paired with a control group of 20 patients with implanted CIEDs, who underwent PET CT due to other non-infectious indications and have no data for infectious process in follow-up. All patients included in the study will undergo standard diagnostic pro-cess. Conventional/standard diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, blood cultures; imaging studies: echocardiography: transthoracic (TTE), and, if there are no contraindications transoesophageal, computed tomography scan for pulmonary embolism if indicated; if there are abnormalities in other systems, decisions concerning further diagnostics will be made at the physician's discretion. As well as standard diagnostic procedures, patients will undergo whole body PET CT scan to localise infection or inflammation. Diagnosis and therapeutic decision will be obtained from the Study Committee. Follow-up will be held within six months with control visits at three and six months. During each follow-up visit, all patients will undergo laboratory tests, two blood cultures collected 1 h apart, and TTE. In case of actual clinical suspicion of infective endocarditis or local generator pocket infection, patients will be referred for further diagnostics. Endpoints for the results assessment - primary endpoints are to standardise PET CT in the diagnostic process: sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET CT; secondary endpoints are: assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli), incidence of particular localisations of infection, influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT, safety and complications of diagnostic process of CIED-related infections with PET CT.
  
  
  CONCLUSIONS
  Evaluation of PET CT use for device-related infections in a case control study may be conclusive and improve diagnostic pathway.
authors.forename: Marta Barbara
authors.initials: MB
authors.lastname: Marciniak-Emmons
authors.affiliation: Institute of Cardiology, Warsaw. msterlinski@poczta.onet.pl.
authors.forename: Maciej
authors.initials: M
authors.lastname: Sterliński
authors.forename: Paweł
authors.initials: P
authors.lastname: Syska
authors.forename: Aleksander
authors.initials: A
authors.lastname: Maciąg
authors.forename: Michał Mirosław
authors.initials: MM
authors.lastname: Farkowski
authors.forename: Bohdan
authors.initials: B
authors.lastname: Firek
authors.forename: Mirosław
authors.initials: M
authors.lastname: Dziuk
authors.forename: Dariusz
authors.initials: D
authors.lastname: Zając
authors.forename: Mariusz
authors.initials: M
authors.lastname: Pytkowski
authors.forename: Hanna
authors.initials: H
authors.lastname: Szwed
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004696:Endocarditis / Q000000981:diagnostic imaging* / Q000209:etiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D010865:Pilot Projects; D011044:Poland; D000072078:Positron Emission Tomography Computed Tomography / Q000379:methods*; D016459:Prosthesis-Related Infections / Q000000981:diagnostic imaging* / Q000209:etiology; D055815:Young Adult
keywords: cardiac implantable electronic device; infection; positron emission computed tomography