Heart Failure Clinical Trial
Official title:
Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol
Verified date | August 2016 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 167 |
Est. completion date | September 14, 2016 |
Est. primary completion date | September 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | Boston Scientific Corporation |
United States,
A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med. 1997 Nov 27;337(22):1576-83. — View 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. — View Citation
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. — View 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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Rozner MA. The patient with a cardiac pacemaker or implanted defibrillator and management during anaesthesia. Curr Opin Anaesthesiol. 2007 Jun;20(3):261-8. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of unexpected preoperative ICD-related problems | Determine the incidence and nature of unexpected preoperative ICD-related problems, such as inadequate pacing or sensing thresholds, battery at or near elective replacement interval, and lead fracture, as detected by preoperative ICD interrogation. | Up to 6 months prior to date of surgery |
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