Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-05-30

Brief Summary

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The goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is:

Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol.

This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study.

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Detailed Description

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Background: Most patients with atrial fibrillation (AF) continue to experience AF following cardiac surgery, which is not conducive to postoperative circulatory stability. Intraoperative active cardioversion has rarely studied due to uncertainty regarding the efficacy of pharmacological cardioversion and the recurrence rate of AF in patients with persistent AF.

Objective: To assess the effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF.

Methods: This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with AF who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study. These patients undergoing pharmacological cardioversion during surgery were matched with untreated patients in a 1:1 ratio based on age, sex, weight, diagnosis, beta blocker and digoxin usage, indicators from cardiac ultrasound and blood gas analysis. The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. The choice between these drugs depends on the patient's blood pressure and heart rate. The incidence of cardioversion in patients who underwent the tetralogy of medication regimen approach was compared with that of untreated patients.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TMR group

The treatment regimen for the tetralogy of medication regimen group (TMR group）commences with the administration of amiodarone during rewarming. In the event of cardiac relapse, a combination of the following drugs may be utilized: aminophylline, ephedrine, and isoproterenol. The selection of these medications is contingent upon the patient's blood pressure and heart rate.

The tetralogy of medication regimen

Intervention Type DRUG

During the rewarming process, the study group received an injection of 0.15g amiodarone via the extracorporeal circulation oxygenator. After heart re-beating：

1. If the heart rate is ≥70 beats per minute without specific therapy and in sinus rhythm or atrioventricular junctional rhythm, no special treatment is required. If the heart rate \<70 beats/min, intravenous injection of isoproterenol 2 ug may be administered.
2. In cases where there is sinus rhythm or atrioventricular junctional rhythm with a heart rate \<70 beats/min and perfusion pressure \<60mmHg, intravenous injection of ephedrine 10 mg + aminophylline 0.15 g should be given.
3. For patients with atrioventricular junctional rhythm or sinus rhythm and a heart rate \<70 beats/min but perfusion pressure ≥60mmHg, intravenous injections of aminophylline (0.15g) and ephedrine (10 mg) .
4. In cases where there is atrial fibrillation (AF), and the heart rate is ≥70 beats/min without special treatment.

Control group

Patients in the control group did not receive treatment with antiarrhythmic drugs.

No interventions assigned to this group

Interventions

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The tetralogy of medication regimen

During the rewarming process, the study group received an injection of 0.15g amiodarone via the extracorporeal circulation oxygenator. After heart re-beating：

1. If the heart rate is ≥70 beats per minute without specific therapy and in sinus rhythm or atrioventricular junctional rhythm, no special treatment is required. If the heart rate \<70 beats/min, intravenous injection of isoproterenol 2 ug may be administered.
2. In cases where there is sinus rhythm or atrioventricular junctional rhythm with a heart rate \<70 beats/min and perfusion pressure \<60mmHg, intravenous injection of ephedrine 10 mg + aminophylline 0.15 g should be given.
3. For patients with atrioventricular junctional rhythm or sinus rhythm and a heart rate \<70 beats/min but perfusion pressure ≥60mmHg, intravenous injections of aminophylline (0.15g) and ephedrine (10 mg) .
4. In cases where there is atrial fibrillation (AF), and the heart rate is ≥70 beats/min without special treatment.

Intervention Type DRUG

Other Intervention Names

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aminophylline ephedrine isoproterenol amiodarone

Eligibility Criteria

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Inclusion Criteria

* ASA Ⅱ-Ⅲ,
* Aged 18-70 years,
* Who were scheduled for elective cardiac surgery under general anesthesia,
* Who were diagnosed with atrial fibrillation by preoperative 12-lead electrocardiogram or 24-hour holter electrocardiogram.

Exclusion Criteria

* Allergic to iodine, amiodarone or its excipients
* Pulmonary fibrosis
* Keratopathy or severe loss of vision or blindness
* Patients with sick sinus syndrome, severe bradycardia (heart rate \<50bpm), second- or higher-degree atrioventricular block
* Preoperative intravenous infusion of amiodarone
* Intraoperative radiofrequency ablation of atrial fibrillation
* The patient is participating in another interventional clinical study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No