Perioperative Management of Patients With Pacemakers

Study Overview
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Brief Summary
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Traditionally, when a patient who received permanent pacemaker undergoes surgery, physicians change pacemaker mode to DDD and recommend to use bipolar electrocautery to minimize electromagnetic interference. However, pacemaker function is improving and there's diverse suggestions for such situations. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in case group and VOO is applied before surgery in control group. Perioperative adverse event would be compared in both groups.

Detailed Description
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It has been more than 50 years after pacemaker device is developed. The subjects receiving permanent pacemaker has been increased and the number of patients with pacemaker undergoing surgery has been increased in company. However, in cases using electrocautery during surgery, there is possibility of malfunction of pacemaker due to electromagnetic interference. The factors associated with pacemaker malfunction during surgery have been reported; type of pacemaker, intrinsic heart rate, pacemaker dependency, type of electrocautery, position of generator, distance between generator/lead and electrocautery, duration and power of electrical energy. Conventionally, mode change to VOO before surgery and use of bipolar electrocautery are recommended before surgery but diverse suggestions regarding perioperative pacemaker mode change has been raised. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change by prospective randomized trial. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in the case group and VOO mode is applied before surgery in the control group. Exclusion criteria is thoracic surgery, 100% pacemaker dependency and unipolar pacing. The investigators will compare perioperative adverse events. The primary endpoint is asystole and the secondary endpoint is cardiac arrest, pacing inhibition, torsades de pointes and R on T.

Official Title
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Perioperative Management of Patients With Pacemakers

Conditions
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Preoperative State, Presence of Pacemaker

Intervention / Treatment
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* Device: Case management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 19 years old Patients undergoing surgery using electrocautery who received permanent pacemaker Exclusion Criteria: Thoracic surgery (lung, esophagus, heart, breast) Totally pacemaker dependent patient. Unipolar pacing

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: No change group<br>Case management consists keeping patient's current pacemaker mode during surgery | Device: Case management<br>* Case management consists keeping patient's current pacemaker mode during surgery<br>|
| No Intervention: Control: Mode change group<br>Usual care consists changing pacemaker mode to VOO before surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of asystole |  | Perioperative period |