Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital

Completed

• Conditions: Cardiac Implantable Electronic Device Infections
• Interventions: Other: Diagnostic and treatment evaluation

• Registration Number: NCT04501835
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The frequency of cardiac implantable electronic devices (CIED) is constantly increasing.

Devices infections are one of the most serious complications in terms of morbidity and mortality. Although the frequency of cardiac implantable devices infections is difficult to derminate due to divergent definitions, cohort studies report a trend of increasing.

The infection can be localized at the pocket of the implantation, at intravascular or intra-cardiac portion of leads. Infectious endocarditis defined by involvement of the intra-cardiac portion of leads is the most serious form. The diagnosis is based on clinical, biological and multimodal imagery data. Early diagnosis and specific management are necessary to reduce mortality and morbidity.

Since the last European recommendations on infectious endocarditis in 2015, the HeartRythm Society of patient described an algorithm to treat CIED infections and extraction indications.

However, in practice, management of CEID infections remains center-dependent and data from robust international studies are missing.

The main objective of our study is to evaluate the management of CEID suspected infections and the prognosis at 1 year in terms of survival according to the methods of treatment at the Nancy University Hospital and to compare the treatment with the latest recommendations in force

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-31
• Status Verified: 2020-05
• Study First Submitted: 2020-07-20
• Primary Completion: 2020-07-30
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-06
• Study Completion: 2020-09-30
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• All patients who have been hospitalized in Nancy University Hospital between January 2014 et July 2019 for suspected infection of cardiac implantable electronic device

Exclusion Criteria

• Minor patients
• Epicardial CIED

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac implantable electronic device infections	Diagnostic and treatment evaluation	Patients hospitalised in Nancy University Hospital for suspected cardiac implantable electronic device infections

Primary Outcome Measures

Name	Time	Method
Description of the practice	From January 2014 to July 2020	Describe the diagnostic and therapeutic practices of patients hospitalized for CIED suspected infection

Secondary Outcome Measures

Name	Time	Method
Evaluation of local practices against current recommendations	From January 2014 to July 2020	* Classify patients in 3 groups (1 = Cardiac implantable electronic device infection ; 2 Pocket infection without proof of lead involvements ; 3 = systemic infection related to infective valvular endocarditis or not without proof of lead involvements according to our local practices and criteria, to EHRA criteria and modified Duke Li criteria).; * Compare diagnostic management in our center with EHRA recommendations in each groups; * Compare therapeutic management including removal/extraction of cardiac implantable electronic device, antibiotic therapy; * Assessment of adhering to EHRA recommendations; * Pronostic evaluation according to removal/extraction or not based on survival curve

Trial Locations

Locations (1)

De Ciancio; 🇫🇷 Vandœuvre-lès-Nancy, France