TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

Study Overview
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Brief Summary
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To compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal cord stimulation or coronary artery bypass grafting alone

Detailed Description
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The study includes 60 patients. Patients are randomized into 2 groups: coronary artery bypass grafting plus b-blocker treatment (according to guidelines; group I) and coronary artery bypass grafting plus b-blocker treatment (according to guidelines) plus temporary spinal cord stimulation (group 2). Temporary spinal cord stimulation is performed for 3 days before surgery and 7 days after coronary artery bypass grafting. Continuous ECG during intensive care unit stay, daily ECG and 24-h Holter monitor recordings at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit until 30 days after coronary artery bypass grafting. Rhythm status and clinical outcome assessment at 12 month follow up

Official Title
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TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)

Conditions
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Atrial Fibrillation, Coronary Artery Disease

Intervention / Treatment
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* Device: Temporary spinal cord stimulation
* Procedure: Coronary artery bypass grafting
* Drug: B-blockers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 years; indications for coronary artery bypass grafting according to guidelines; pre-operative history of paroxysmal atrial fibrillation; absent of contraindications for spinal cord stimulation; signed inform consent. Exclusion Criteria: previous heart surgery or atrial fibrillation ablation procedure; emergency coronary artery bypass grafting; left ventricle ejection fraction <35%; unstable angina or heart failure; persistent atrial fibrillation or atrial fibrillation at the time of screening; planned Maze procedure or pulmonary vein isolation; use of class I or III antiarrhythmic drugs within 5 elimination half-lives of the drug; need for concomitant valve surgery; Inability to control the device for spinal cord stimulation; coagulopathy, immunosuppression, or other condition associated with an unacceptable surgical risk for spinal cord stimulation; Need for therapeutic diathermy in the area of leads placement; Need for pacemaker/ICD/CRT-D implantation; unwillingness to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CABG + b-blockers<br>Standart coronary artery bypass grafting is performed with b-blockers treatment. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting. | Procedure: Coronary artery bypass grafting<br>* Standart coronary artery bypass grafting procedure.<br>Drug: B-blockers<br>* Standart b-blocker therapy will be administered in each group for AF prophylactics<br>|
| Experimental: CABG + b-blockers + temporary SCS<br>Before coronary artery bypass grafting in the experimental group, 3 days of temporary spinal cord stimulation is performed than device turned off and coronary artery bypass grafting procedure is made. The device for spinal cord is turned on in intensive care unit for 7 days. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting. | Device: Temporary spinal cord stimulation<br>* Percutaneous trial (temporary) electrodes are placed through a 14-gauge needle.The skin is entered at the medial aspect of the pedicle with the Tuohy needle usually angled 30-45° toward the midline for optimal entry into the epidural space at the interlaminar edge 1 or 2 levels of cephalad (usually, Th5-Th6 level). The 14-gauge needle is then passed with the bevel facing up at a 30-45° oblique angle to reach the depth of the midline laminar target.The Tuohy needle is then carefully removed and the operative site is cleaned with chlorhexidine and alcohol. Temporary stimulation is carried out till coronary artery bypass grafting surgery for 3 days, then stimulation turns off during surgery. At the end of coronary artery bypass grafting the temporary stimulation turns on in the intensive care unit and continues for 7 days. After that, the temporary leads will be removed.<br>Procedure: Coronary artery bypass grafting<br>* Standart coronary artery bypass grafting procedure.<br>Drug: B-blockers<br>* Standart b-blocker therapy will be administered in each group for AF prophylactics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury | 30 days | 
| Occurrence of atrial tachyarrhythmias | Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec during 30 days after surgery | 30 days | 
| Occurrence of tachyarrhythmias | Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marker of myocardial injury - high-sensitive Troponin I |  | 30 days | 
| Marker of myocardial injury - CK-MB |  | 30 days | 
| Marker of kidney injury - Creatinine |  | 30 days | 
| Hemodynamic parameter - Blood pressure | Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure | 30 days | 
| Hemodynamic parameter - Heart rate |  | 30 days | 
| Hemodynamic parameter - Cardiac index |  | 30 days | 
| Hemodynamic parameter - Vascular resistance | Systemic vascular resistance, pulmonary artery resistance | 30 days | 
| Acute pain assessment | The Wong-Baker Faces Pain Rating Scale | 30 days | 
| Inotropic score |  | 30 days | 
| Duration of mechanical ventilation |  | 30 days | 
| Duration of intensive care unit stay |  | 30 days | 
| Renal-replacement therapy |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Spinal cord stimulatoin, Coronary artery bypass grafting