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The purpose of this study is:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Electromagnetic oversensing will be reported as a percentage of the total enrolled patients | Assessed at time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective, non-thoracic surgical procedures will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| William T Katsyiannis, MD | Minneapolis Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15009852 | Background | Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. doi: 10.1111/j.1540-8159.2004.00430.x. | |
| 15851191 | Background | Hauser RG, Kallinen L. Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database. Heart Rhythm. 2004 Oct;1(4):399-405. doi: 10.1016/j.hrthm.2004.05.006. |
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