ICD-ON Registry: Periop Management of Cardiac Devices

Overview

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.

Full Title of Study: “ICD-ON Registry: Perioperative Management of Pacemakers and Implanted Cardioverter Defibrillators”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

  • 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.

    Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Edward Hospital
    • Collaborator
      • Medtronic
    • Provider of Information About this Clinical Study
      • Principal Investigator: Janet Gifford, Nurse Practitioner, Cardiology – Edward-Elmhurst Health System
    • Overall Official(s)
      • Janet Gifford, MSN, NP, Principal Investigator, Edward Hospital

    References

    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.

    Gifford J, Larimer K, Thomas C, May P, Stanhope S, Gami A. (abstract). Randomized controlled trial of magnet application vs reprogramming for perioperative ICD management – preliminary results.

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