Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

Study Overview
=================
Brief Summary
-----------------
This observational protocol will evaluate the effects of monopolar electrocautery (ME) on implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will be used to prevent patients from receiving inadvertent shocks. This requires the presence of someone trained in ICD programming, but a trained person is not always readily available. In this study the investigators will reprogram ICDs prior to surgery according to current practice, but will also record what would have happened had the ICD reprogramming not occurred (detection on but therapy off). In addition, the investigators will evaluate the effect of the location of the electrosurgery unit (ESU) return pad on the incidence of EMI. The investigators hypothesize that directing the current return path away from the ICD will result in lower EMI rates than previously described.

Official Title
-----------------
Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol

Conditions
-----------------
Heart Failure, Tachycardia, Ventricular

Intervention / Treatment
-----------------
* Other: Optimal placement of return pad


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult individuals of both genders, 18 years of age and older For patients undergoing surgery about the waist, previous implantation of a functioning Boston Scientific or Medtronic ICD For patients undergoing surgery below the waist, previous implantation of a functioning Boston Scientific, Medtronic, St. Jude Medical, or Biotronik ICD Signed informed consent Exclusion Criteria: Surgery involving the ICD pocket (generator change out procedure) Surgery or procedures exclusively involving bipolar electrocautery (such as ophthalmic surgery) Patients undergoing surgery above the waist with ICDs not manufactured by Medtronic or Boston Scientific (other ICDs do not allow reprogramming to allow EMI detection without the potential for inadvertent ICD discharge)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-cardiac above-the-waist surgery<br>Subjects with an implanted ICD who present for a non-cardiac above-the-waist surgical procedure involving monopolar electrocautery | Other: Optimal placement of return pad<br>* The ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators.<br>|
| Cardiac surgery<br>Subjects with an implanted ICD who present for a cardiac surgical procedure involving monopolar electrocautery | |
| Below-the-waist surgery<br>Subjects with an implanted ICD who present for a below-the-waist surgical procedure involving monopolar electrocautery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of electromagnetic interference (EMI) | Evaluation of occurence of EMI when monopolar electrocautery is used in surgical procedures when the patient has an existing ICD. | During surgery on day of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of unexpected preoperative ICD-related problems | Determine the incidence and nature of unexpected preoperative ICD-related problems, such as inadequate pacing or sensing thresholds, battery at or near elective replacement interval, and lead fracture, as detected by preoperative ICD interrogation. | Up to 6 months prior to date of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrosurgery, Cardiac surgical procedures, Surgical procedures, operative, Defibrillators