Randomized controlled trial of perioperative ICD management: magnet application versus reprogramming.

BACKGROUND: There are insufficient data to guide perioperative implantable cardioverter-defibrillator (ICD) management for patients undergoing surgical procedures using electrocautery.
METHODS: We conducted a multicenter randomized controlled trial of patients with ICDs undergoing surgery with monopolar electrocautery. Subjects were randomized to an "Off" group (ICD therapy programmed off, then postoperatively programmed on) or a "Magnet" group (ICD therapy suspended with a magnet and no immediate postoperative ICD interrogation). Also, a registry was maintained of ICD patients with procedures within 6 inches of the ICD (all programmed off). The primary endpoint was ICD off time with secondary endpoints being caregiver handoffs and incidence of electromagnetic interference (EMI).
RESULTS: All patients (n = 80) had pectoral ICDs. Subject demographics were well matched in each group, and duration of electrocautery was similar (80 minutes vs 64 minutes, P = 0.58). The mean "excess" ICD off time (ICD off time - electrocautery time) was significantly higher in the Off group than the Magnet group (115 minutes vs 28 minutes, P < 0.001). Mean number of caregiver handoffs were higher in the Off group (6.6 vs 5.5, P < 0.001). There was no EMI in any lower abdominal or lower extremity procedures. Neither group had arrhythmic events or device reset.
CONCLUSION: A magnet protocol simplifies perioperative ICD management for procedures using electrocautery more than 6 inches from the ICD. This protocol results in significantly shorter time with ICD therapy off, fewer provider handoffs, no risk of inadvertently discharging patients home with ICD therapies off, and no device reset. ©2014 Wiley Periodicals, Inc.

RCT Entities:   Population Interventions Outcomes