Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

Completed

• Conditions: Tachycardia, Ventricular; Heart Failure
• Interventions: Other: Optimal placement of return pad

• Registration Number: NCT01572246
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Study Start: 2012-05
• Status Verified: 2016-08
• Primary Completion: 2016-09-14
• Study Completion: 2016-09-14
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-cardiac above-the-waist surgery	Optimal placement of return pad	Subjects with an implanted ICD who present for a non-cardiac above-the-waist surgical procedure involving monopolar electrocautery

Primary Outcome Measures

Name	Time	Method
Incidence of electromagnetic interference (EMI)	During surgery on day of enrollment	Evaluation of occurence of EMI when monopolar electrocautery is used in surgical procedures when the patient has an existing ICD.

Secondary Outcome Measures

Name	Time	Method
Incidence of unexpected preoperative ICD-related problems	Up to 6 months prior to date of surgery	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States