NCT06553391

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-01-01
• Completion: 2025-05-30
• First posted: 2024-08-14
• Last updated: 2025-08-22

Locations

1 site across 1 country: China