Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Implantable Cardioverter-Defibrillators
- Sponsor
- Minneapolis Heart Institute Foundation
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Electromagnetic oversensing will be reported as a percentage of the total enrolled patients
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is:
- To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery.
- To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing.
- To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
Detailed Description
Electrocautery devices used during surgery generate a high electromagnetic field with a frequency that may result in ICD oversensing. Oversensing may in turn result in false detection of a ventricular arrhythmia and for the ICD to discharge. Because of this possibility, patients frequently have their ICDs inactivated prior to the procedure. Although oversensing appears to be highly unlikely in clinical practice, vast resources are utilized in the process of deactivating and reactivating ICDs for surgeries. In addition, there are reports of deaths from failure to reactivate ICDs following elective surgery. In this study we intend to document the incidence of oversensing, identify procedures with a higher likelihood of oversensing and evaluate the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with Medtronic or Boston Scientific single and dual chamber ICDs
Exclusion Criteria
- •Non-thoracic ICD generator placement (abdominal)
Outcomes
Primary Outcomes
Electromagnetic oversensing will be reported as a percentage of the total enrolled patients
Time Frame: Assessed at time of procedure
Secondary Outcomes
- Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing(Assessed at time of procedure)
- Incidence of dual chamber ICDs discriminating electromagnetic oversensing.(At time of procedure)