Clinical trial NCT02052453: ICD-ON Registry: Periop Management of Cardiac Devices
Official title: ICD-ON Registry: Perioperative Management of Pacemakers and Implanted Cardioverter Defibrillators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oversensing Cardiac Pacemaker
ICD
Surgery
Keywords: Pacemaker
ICD
Surgery
Electrocautery
Electromagnetic interference
Lead sponsor: Edward-Elmhurst Health System
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Abbott Medical Devices
name: Boston Scientific Corporation
First posted: 2014-02-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a PM or ICD undergoing procedures with anticipated electrocautery.

Brief summary: 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.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Incidence of EMI.
timeFrame: up to 90 days
Secondary outcomes:
measure: Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.
timeFrame: up to 90 days
Other outcomes:
measure: Incidence of device reset.
timeFrame: up to 90 days
Locations:
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Elmhurst
country: United States
facility: Elmhurst Hospital
state: Illinois
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
Study officials:
affiliation: Edward Hospital
name: Janet Gifford, MSN, NP
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: 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.