Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/25/2017 |
| Start Date: | May 2012 |
| End Date: | September 14, 2016 |
Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol
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.
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.
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)
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Peter Schulman, MD
Phone: 503-494-7641
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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