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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
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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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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of EMI. | Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery. | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device. | Percentage of patients with pacing inhibition recorded intraoperative or on postoperative electrograms during time of electrocautery. | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device reset. | Percentage of total patients enrolled with device reset requiring reprogramming on their first postoperative interrogation. Either immediately postoperative for reprogramming group, in office or remote for all others. | up to 90 days |
Exclusion Criteria:
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Patients who have a PM or ICD undergoing procedures with anticipated electrocautery.
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| Name | Affiliation | Role |
|---|---|---|
| Janet Gifford, MSN, NP | Edward Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | United States | ||
| Elmhurst Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21722856 | Background | 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. | |
| 24802626 |
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| Elmhurst |
| Illinois |
| 60126 |
| United States |
| Edward Hospital | Naperville | Illinois | 60174 | United States |
| Background |
| 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. |