Comparison of a MAGNET Protocol Versus off-on Protocol for Patients With Implantable Cardioverter Defibrillators

Study Overview
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Brief Summary
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The purpose of this study is to compare the two options for management of ICDs (internal cardioverter defibrillators) in patients undergoing procedures with electrocautery: (1) programming ICD therapies off, or (2) use of a magnet to suspend ICD therapies By comparing these two techniques the investigators hope to demonstrate the efficiency of using an ICD magnet protocol during perioperative management of patients undergoing electrocautery procedures. Secondary purposes are to gain further information on health care resources, incidence of EMI, handoff communications and to document lack of adverse events in either group. Primary objective will be: ICD therapy off times will be less with the use of a magnet protocol compared to an off-on protocol. Secondary objectives will be: (1) Healthcare resources (time and costs of skilled personnel) will be less using a magnet protocol compared to an off-on protocol, and (2) there will be no difference between adverse events in the magnet protocol compared to an off-on protocol. The incidence of EMI and number of handoff communications will be documented. The investigators hypothesis is that the number of minutes with ICD therapies off will be significantly less with magnet use. The investigators also expect health care resources to be less with magnet use compared to reprogramming.

Detailed Description
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The study design will be a prospective multi-center randomized controlled trial where subjects will be randomized to either a control group (ICD off-on group) or to the experimental group (magnet group) within blocks of type of procedure and site. Subjects will be enrolled at the time of their procedure and will remain in the study until their post operative device interrogation. This could take place that same day (off on group or registry) or at their next ICD clinic visit or remote transmission (no more than 3 months from the procedure). The study duration from first enrollment to closure is expected to last approximately 12 months. There will be only two enrolling centers and the target sample size is 150 subjects from various manufacturers. No specific sample size was calculated as this is a pilot study.

Official Title
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Comparison of a MAGNET Protocol Versus off-on Protocol for Patients With Implantable Cardioverter Defibrillators Undergoing Procedures Requiring Electrocautery

Conditions
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Sudden Cardiac Death, Arrhythmia, Heart Failure

Intervention / Treatment
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* Other: Magnet or Off-On


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age > 18 years Have a pectorally implanted ICD Be scheduled for surgical procedure with anticipated electrocautery, OR Be scheduled for endoscopic procedure with anticipated electrocautery, OR Be scheduled for interventional radiology procedure with anticipated electrocautery Have a planned procedure with anticipated EC > 15 cm (6 in) from ICD generator* Have an ICD from the following manufacturer: Medtronic, Inc., OR Boston Scientific (formerly Guidant/CPI), OR St. Jude Medical Be able to speak and understand English Be willing to sign consent form While subjects having procedures < 15 cm (6 in) from generator will be excluded from the main study they will qualify to be placed in the registry. Exclusion criteria Be scheduled for a surgical, endoscopic or radiologic procedure where electrocautery is not anticipated Be scheduled for a surgical, endoscopic or radiologic procedure where only bipolar electrocautery is planned (ophthalmologic procedures) Have an ICD from Boston Scientific under Product Advisory related to magnet performance. Have an ICD from the manufacturer ELA or Biotroniks

Ages Eligible for Study
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Minimum Age: 19 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Magnet<br>group treated by disabling ICD during procedure | Other: Magnet or Off-On<br>* Randomized to ICD suspension using a magnet or turning the ICD off and then back on.<br>|
| Off-On<br>Group having ICD turned off during the procedure | Other: Magnet or Off-On<br>* Randomized to ICD suspension using a magnet or turning the ICD off and then back on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of minutes ICD therapy suspended will be less using a magnet protocol compared to number of minutes ICD therapy suspended using an off-on protocol. |  | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare resources will be less using a magnet protocol compared to an off-on protocol. Measures: Cost in dollars | Cost of skilled personnel (cost is defined as number of minutes skilled personnel engaged in active management or waiting to be engaged in active management [and not otherwise productive] in management of subject) and cost of equipment (ie. transport monitor, defibrillator and pads) or any equipment necessary to man-age the subject that is unique to either magnet protocol or off-on protocol. | Up to 90 days | 
| There will be no difference between adverse events using the magnet protocol compared to using an off-on protocol. | proportion of subjects with arrhythmias requiring therapy proportion of subjects with inappropriate ICD therapies proportion of subjects with pacing inhibition proportion of subjects with magnet not secured during procedure | Up to 90 days | 
| The incidence of EMI will be documented in relation to surgical locations: head/neck, thorax, abdomen/pelvis, upper extremity, lower extremity. | Number of episodes of EMI | Up to 90 days | 
| Number of handoff communication quantified. | Handoff communications defined as an exchange of information between staff regarding the ICD subject. | Up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, internal cardioverter defibrillator, electrocautery