BIA and Cardiac Implantable Electronic Devices

Study Overview
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Brief Summary
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There are an increase number of patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this group of patients to avoid any electromagnetic interference. These recommendations restrict the use of BIA in many patients with heart failure in whom BIA might be of great interest in detecting peripheral congestion and in guidance of treatment. However, it is not well known whether BIA can affect the function of cardiac devices. Investigators aimed to test the incidence of electromagnetic interference between BIA and CIEDs.

Detailed Description
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Patients enrollment were during routine face-to-face consultations, scheduled for PM and ICDs interrogations. Investigators recorded before and after each BIA measure, the battery voltage of the device, lead impedance and stimulation thresholds. The device electrograms were monitored during BIA measurements to detect any electromagnetic interference or oversensing.

Official Title
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Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices

Conditions
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Performing Bioimpedance Analysis

Intervention / Treatment
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* Drug: Bioimpedance analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient having a cardiac device with or without cardiac resynchronization 18 years of age and above Patients with no pacing-dependent status Patients who read, understood and signed written informed consent letter Exclusion Criteria: Patients with acute heart failure Patients implanted in less than 2 months Dysfunction of the device in a follow-up visit or in the inclusion visit Patients with a particular device lead model prone to develop electronical problems such as Sprint Fidelis of Medtronic (Minneapolis, USA) or Riata of St. Jude Medical (St. Paul, USA) Pregnancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with cardiac implantable electronic devices<br> | Drug: Bioimpedance analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing a change in CIEDs function while and after bioimpedance analysis |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead noise loss, over or under sensing of CIEDs |  | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioimpedance analysis, implantable cardioverter-defibrillators, pacemakers