Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Heart Failure; Tachycardia, Ventricular

Treatments: Other: Optimal placement of return pad

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01572246

ISROTH20028

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

167 participants in 3 patient groups

Non-cardiac above-the-waist surgery

Description:

Subjects with an implanted ICD who present for a non-cardiac above-the-waist surgical procedure involving monopolar electrocautery

Treatment:

Other: Optimal placement of return pad

Cardiac surgery

Description:

Subjects with an implanted ICD who present for a cardiac surgical procedure involving monopolar electrocautery

Below-the-waist surgery

Description:

Subjects with an implanted ICD who present for a below-the-waist surgical procedure involving monopolar electrocautery