ICD-ON Registry: Periop Management of Cardiac Devices

ICD-ON Registry: Perioperative Management of Pacemakers and Implanted Cardioverter Defibrillators

The purpose of this registry is to document incidence of electrical magnetic interference (EMI), change in programmed parameters or device related events in patients with Pacemakers (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol) will be used.

Study Overview

• Status: Completed
• Conditions: Surgery; ICD; Oversensing Cardiac Pacemaker

Detailed Description

Patients with PMs and ICDs have traditionally been considered at risk for electrical magnetic interference (EMI) from electrocautery. EMI can cause oversensing, pacing inhibition, or inappropriate ICD therapies. In July 2011, the Heart Rhythm Society /American Society of Anesthesiologists (HRS/ASA) published an Expert Consensus Statement on the perioperative management of PM and ICDs.

The purpose of this registry is to collect data on patients with PMs and ICDs undergoing procedures requiring electrocautery using a standardized device management protocol (ICD-ON Protocol). Decisions about management of patients with these devices will be made based on surgical location, programmed magnet response and pacemaker dependence.

This registry will document incidence of EMI, changes in programmed parameters or device related events associated with the procedures. Observational data will be collected on participants including: medical history, device parameters, surgical/cautery data, and postoperative device follow-up. For procedures not requiring reprogramming, postoperative PM and ICD interrogation will be either routine in office follow-up or remote monitoring, as per the subject's routine.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
    • Elmhurst, Illinois, United States, 60126
      • Elmhurst Hospital
    • Naperville, Illinois, United States, 60174
      • Edward Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have a PM or ICD undergoing procedures with anticipated electrocautery.

Description

• Have a implanted PM or ICD
• Be scheduled for a procedure with anticipated electrocautery
• Be able to speak, read and understand English
• Be willing to sign consent form

Exclusion Criteria:

• Have an ICD from Boston Scientific under Product Advisory related to magnet performance
• Have an ICD or PM from Biotronik or Sorin
• Surgical procedures with two or more electrocautery operators.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of EMI.	Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.	Percentage of patients with pacing inhibition recorded intraoperative or on postoperative electrograms during time of electrocautery.	up to 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of device reset.	Percentage of total patients enrolled with device reset requiring reprogramming on their first postoperative interrogation. Either immediately postoperative for reprogramming group, in office or remote for all others.	up to 90 days

Collaborators and Investigators

• Sponsor: Edward Hospital
• Collaborators: Boston Scientific Corporation; Medtronic; Abbott Medical Devices
• Investigators: Principal Investigator: Janet Gifford, MSN, NP, Edward Hospital

Publications and helpful links

General Publications

• 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.
• Gifford J, Larimer K, Thomas C, May P, Stanhope S, Gami A. Randomized controlled trial of perioperative ICD management: magnet application versus reprogramming. Pacing Clin Electrophysiol. 2014 Sep;37(9):1219-24. doi: 10.1111/pace.12417. Epub 2014 May 7.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Surgery; ICD; Pacemaker; Electrocautery; Electromagnetic interference
• Other Study ID Numbers: ICDON2013