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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, 518058, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The tetralogy of medication regimen

Drug

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

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.
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.
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) .
In cases where there is atrial fibrillation (AF), and the heart rate is ≥70 beats/min without special treatment.

Other names: aminophylline, ephedrine, isoproterenol, amiodarone

Primary outcomes

Sinus rhythm

Time frame: From the release of the aortic cross-clamp until 12 hours after surgery

Electrocardiogram monitoring

Secondary outcomes

Mean arterial pressure

Time frame: From the release of the aortic cross-clamp until the end of surgery

Invasive arterial blood pressure test
the use of temporary pacemakers

Time frame: From the release of the aortic cross-clamp until 12 hours after surgery

Postoperative record

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 14, 2024
Registry last updated: Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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