Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

NCT01572246 | Completed

• 1 other identifier: ISROTH20028
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Tachycardia, Ventricular

Keywords

electrosurgery; Cardiac surgical procedures; Surgical procedures, operative; Defibrillators

Outcome Measures

Primary Outcomes (1)

• 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.

  During surgery on day of enrollment

Secondary Outcomes (1)

• Incidence of unexpected preoperative ICD-related problems

  Up to 6 months prior to date of surgery

Study Arms (3)

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

Other: Optimal placement of return pad

Cardiac surgery

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

Below-the-waist surgery

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

Interventions

Optimal placement of return pad OTHER

The ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators.

Non-cardiac above-the-waist surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with ICDs (including cardiac resynchronization therapy system-defibrillators) scheduled for surgery involving ME.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (9)

• 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.

  PMID: 21245737 BACKGROUND

• 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.

  PMID: 21722856 BACKGROUND

• 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.

  PMID: 15064674 BACKGROUND

• 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.

  PMID: 17479032 BACKGROUND

• 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.

  PMID: 19617204 BACKGROUND

• 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.

  PMID: 18307631 BACKGROUND

• 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.

  PMID: 15009852 BACKGROUND

• 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.

  PMID: 9411221 BACKGROUND

• 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.

  PMID: 11907286 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Tachycardia, Ventricular; Hyperthermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Peter Schulman, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Charles Henrikson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 6, 2012
• Study Start: May 1, 2012
• Primary Completion: September 14, 2016
• Study Completion: September 14, 2016
• Last Updated: February 24, 2017

Record last verified: 2016-08

Locations

US (1)