Diagnostic Accuracy of 18FDG-PET-CT for Pacing or Defibrillation Lead Infection

NCT02251262 | Completed

• 1 other identifier: CHUBX 2013/31
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 6

Brief Summary

With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection. The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction. The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives. Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity. For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required. The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.

Conditions

Infections of the Implanted Material; Endocarditis

Keywords

Pacemaker; Endocarditis; 18FDG-PET-CT; Diagnostic accuracy; Pacing or defibrillation lead

Outcome Measures

Primary Outcomes (1)

• A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device.

  Index tests will be interpreted by nuclear medicine physician from the center where the patient was included with a semi-quantitative visual score. Moreover, all 18FDG-PET-CT recordings will be sent to the coordinating center for centralized interpretation blind to the preceding one. All 18FDG-PET-CT recordings will be stored until interpretation, and not used for the clinical management of the patient. Index test interpretations will be carried out blind to any other information on the patient (clinical, biology,…).

  up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)

Study Arms (1)

Whole-body 18FDG-PET-CT scan

EXPERIMENTAL

18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.

Device: Whole-body 18FDG-PET-CT scan

Interventions

Whole-body 18FDG-PET-CT scan DEVICE

18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.

Whole-body 18FDG-PET-CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders
• Age \> 18 years
• Patient referred for extraction of cardiac material (box and lead(s)) in the context of suspicion of material infection, including a patient with pocket infection.
• Possibility of carrying out PET-CT no more than 48 hours before extraction (or, exceptionally, no more than 7 days if the patient is not under antibiotic therapy).
• Informed written consent
• Affiliation to a social security system

You may not qualify if:

• Pregnant or breastfeeding women
• Patients with recent implantation (less than 2 months)
• Subjects placed under judicial protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (6)

CHU de Grenoble - Hôpital A. Michallon

Grenoble, 38043, France

Location

CHRU de Lille - Hôpital R. Salengro

Lille, 59037, France

Location

AP-HM - Hôpital La Timone

Marseille, 13385, France

Location

CHU de Bordeaux

Pessac, 33604, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHU de Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Pierre BORDACHAR, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Paul PEREZ, MD, PhD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 29, 2014
• Study Start: June 22, 2015
• Primary Completion: June 19, 2018
• Study Completion: June 19, 2018
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

FR (6)