Clinical trial NCT01572246: Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
Official title: Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Tachycardia, Ventricular
Keywords: electrosurgery
Cardiac surgical procedures
Surgical procedures, operative
Defibrillators
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2012-04-06
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with ICDs (including cardiac resynchronization therapy system-defibrillators) scheduled for surgery involving ME.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of electromagnetic interference (EMI)
timeFrame: During surgery on day of enrollment
Secondary outcomes:
measure: Incidence of unexpected preoperative ICD-related problems
timeFrame: Up to 6 months prior to date of surgery
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Peter Schulman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Charles Henrikson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Society of Anesthesiologists. Practice advisory for the perioperative management of patients with cardiac implantable electronic devices: pacemakers and implantable cardioverter-defibrillators: an updated report by the american society of anesthesiologists task force on perioperative management of patients with cardiac implantable electronic devices. Anesthesiology. 2011 Feb;114(2):247-61. doi: 10.1097/ALN.0b013e3181fbe7f6. No abstract available.
citation: Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available.
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