Surgery Clinical Trial
Official title:
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.
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.
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