Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

Oregon Health and Science University167 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

167

Conditions

Heart Failure Tachycardia, Ventricular

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: During surgery on day of enrollment

Secondary Outcomes

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.

Time frame: Up to 6 months prior to date of surgery