Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
NCT ID: NCT01572246
Last Updated: 2017-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
167 participants
OBSERVATIONAL
2012-05-31
2016-09-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-cardiac above-the-waist surgery
Subjects with an implanted ICD who present for a non-cardiac above-the-waist surgical procedure involving monopolar electrocautery
Optimal 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.
Cardiac surgery
Subjects with an implanted ICD who present for a cardiac surgical procedure involving monopolar electrocautery
No interventions assigned to this group
Below-the-waist surgery
Subjects with an implanted ICD who present for a below-the-waist surgical procedure involving monopolar electrocautery
No interventions assigned to this group
Interventions
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Optimal 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Oregon Health and Science University
OTHER
Responsible Party
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Peter Schulman
Assistant Professor
Principal Investigators
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Peter Schulman, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Charles Henrikson, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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References
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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.
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.
Stone KR, McPherson CA. Assessment and management of patients with pacemakers and implantable cardioverter defibrillators. Crit Care Med. 2004 Apr;32(4 Suppl):S155-65. doi: 10.1097/01.ccm.0000115622.73988.6e.
Rozner MA. The patient with a cardiac pacemaker or implanted defibrillator and management during anaesthesia. Curr Opin Anaesthesiol. 2007 Jun;20(3):261-8. doi: 10.1097/ACO.0b013e32814f1c4a.
Korantzopoulos P, Letsas KP, Grekas G, Goudevenos JA. Pacemaker dependency after implantation of electrophysiological devices. Europace. 2009 Sep;11(9):1151-5. doi: 10.1093/europace/eup195. Epub 2009 Jul 16.
Cheng A, Nazarian S, Spragg DD, Bilchick K, Tandri H, Mark L, Halperin H, Calkins H, Berger RD, Henrikson CA. Effects of surgical and endoscopic electrocautery on modern-day permanent pacemaker and implantable cardioverter-defibrillator systems. Pacing Clin Electrophysiol. 2008 Mar;31(3):344-50. doi: 10.1111/j.1540-8159.2008.00996.x.
Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. doi: 10.1111/j.1540-8159.2004.00430.x.
Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997 Nov 27;337(22):1576-83. doi: 10.1056/NEJM199711273372202.
Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
Other Identifiers
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ISROTH20028
Identifier Type: -
Identifier Source: org_study_id
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