Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01572246

Enrollment

167

Registered

2012-04-06

Start date

2012-05-31

Completion date

2016-09-14

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Tachycardia, Ventricular

Keywords

electrosurgery, Cardiac surgical procedures, Surgical procedures, operative, Defibrillators

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.

Interventions

OTHEROptimal placement of return pad

The ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026