ICD-ON Registry: Periop Management of Cardiac Devices

Edward Hospital

Status: Completed

Conditions: Oversensing Cardiac Pacemaker; Surgery; ICD

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02052453

ICDON2013

Details and patient eligibility

About

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 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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.