CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC
Conditions
Brief summary
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these patients. Depending on the device type and patient's dependency, these guidelines recommend the intraoperative magnet use, reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable method) has become the standard approach in many centers, while CIED reprograming by trained personnel is required in most centers. Therefore, our objective is to compare in a prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS reprogramming vs. no intervention (in the appropriate subjects)
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* All subjects with cardiac implanted electronic device (CIED) who are candidates of non-cardio-thoracic surgery or endoscopy and anticipated use of electrocautery
Exclusion criteria
* Recent CIED implantation (less than 6 weeks) * Subjects with ICD who are pacemaker dependent * Cardio - thoracic surgery * Surgery over the CIED site * Surgery site that preclude use of magnet in efficient way * Subjects with Implanted unipolar leads
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any inappropriate sensing of EMI caused by electrocautery. | DURING SURGERY/PROCEDURE |
Secondary
| Measure | Time frame |
|---|---|
| Any significant change in CIEDS parameters | WITHIN 1 DAY OF SURGERY/PROCEDURE |
Countries
Israel