ICD-ON Registry: Periop Management of Cardiac Devices

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.

- 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.