Effect of Venous Cannulation Technique on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Elective Coronary Artery Bypass Grafting. A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Atrial fibrillation
研究概览
简要总结
Context Atrial fibrillation is the most frequent arrhythmia following coronary artery bypass grafting. POAF is associated with worse outcomes following CABG. In addition, recurrence of AF is associated with longer hospital stay and higher rate of neurological and renal complications compared to a single episode of AF Objective To estimate the proportion of eligible people who are willing to participate, number of participants who drop out of the trial and use the results of this study to inform a larger study.
Study Design:
Pilot randomized controlled trial. Patients will be blinded to the intervention.
Participants:
The study population will include 40 patients. Patients admitted to the Jewish General Hospital for elective coronary artery bypass grafting from May 2021 will be included in the study. Patients will be included if they were in sinus rhythm with a HR ≥50 bpm, undergoing on-pump coronary artery bypass grafting and hemodynamically stable. Patients will be excluded from the study if they meet any of the following criteria: Second or third degree heart block, LVEF <35%, left atrial volume index ≥42 ml/m2, right atrial volume index > 47 ml/m2, any degree of tricuspid regurgitation, any degree of right ventricular dysfunction, emergency or minimally invasive operation, concurrent valve operation, history of atrial fibrillation or previous cardiac surgery
Study Interventions and Measures Patients will be randomly assigned to one of two treatment groups according to the venous cannulation technique used during surgery. Group A will undergo cavoatrial cannulation with a 2-stage venous cannula. Group B will undergo bicaval cannulation with snares. Similar surgical methods will be used in all treatment groups .
The primary endpoint will be defined as any episode of atrial fibrillation in any participant lasting >5 minutes in duration or any episode leading to hemodynamic compromise (SBP<90 mmHg) or causing symptoms (angina or dyspnea). Atrial fibrillation will be diagnosed using telemetry and a 12-lead ECG. Patients will be followed up in 1 month with a 12-lead ECG to determine their rhythm. The secondary endpoints are the development of RV dysfunction, tricuspid regurgitation and any increase in left atrial volume index as detected by post-operative transthoracic echocardiography.
详细描述
.Introduction
Atrial fibrillation is the most frequent arrhythmia following coronary artery bypass grafting. Its incidence following cardiac surgery is estimated to be between ~10-60%1-5 . The incidence is lower in patients undergoing isolated coronary artery bypass grafting (~25-30%) compared to valve operations 2,6,7. It most commonly occurs in the first four days following cardiac surgery1,5,8. Despite many efforts to predict and prevent postoperative AF, the incidence has not changed over the past decades1-5,9 .
Although in the past it was thought of as a benign self-limiting complication9, atrial fibrillation after cardiac surgery has been shown to be associated with worse outcomes compared to patients who remain in sinus rhythm postoperatively. It leads to increased length of hospital and ICU stay, higher rate of stroke, wound infection, renal failure, myocardial infarction and has a significant effect on early and long-term mortality2-4. In addition, recurrence of AF is associated with longer hospital stay and higher rate of neurological and renal complications compared to a single episode of AF 5.
1.2Mechanisms of POAF
Several studies have investigated the underlying mechanisms involved in development of post-operative atrial fibrillation. However, these mechanisms remain largely unclear. It is believed that atrial fibrillation is caused by reentry of multiple wavelets of excitation in the presence altered atrial refractoriness. This makes ectopic beats originating from foci in the pulmonary veins more likely to trigger an episode of atrial fibrillation 10-12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient will be blinded with regards to type of venous cannulation performed intra-operatively.
Measurement of outcome will be performed by an independent cardiologist, who is blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted for coronary artery bypass grafting under the care of the principal investigator at the Jewish General Hospital during the study period will be included if they meet all the following criteria:
- •Age >18 years
- •Sinus rhythm with HR >50bpm
- •Scheduled to undergo isolated elective on-pump CABG
- •Hemodynamically stable.
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •Second or third degree heart block
- •left atrial volume index ≥42 ml/m2
- •right atrial volume index > 47 ml/m2
- •any degree of tricuspid regurgitation
- •any degree of right ventricular dysfunction
- •emergency or minimally invasive operation
- •concurrent valve operation
- •history of atrial fibrillation
- •previous cardiac surgery
- •previous catheter ablation for atrial fibrillation
- •pre-operative use of class I or III anti-arrhythmics.
结局指标
主要结局
Atrial fibrillation
时间窗: During hospital admission and clinic visit at 30 days from hospital discharge date.
Number of participants who develop atrial fibrillation that requires treatment. Atrial fibrillation will be defined as any episode in any participant lasting \>5 minutes in duration or any episode leading to hemodynamic compromise (SBP\<90 mmHg) or causing symptoms (angina or dyspnea).
次要结局
- Increase in Left atrial index(on transthoracic echocardiogram performed on day 2-5 post-operatively)
- Tricuspid regurgitation(on transthoracic echocardiogram performed on day 2-5 post-operatively)
- Right ventricular dysfunction(on transthoracic echocardiogram performed on day 2-5 post-operatively)
研究者
Dr. Jean-Francois Morin
Surgical director, Division of Cardiac and Vascular surgery and Cardiology
Jewish General Hospital