Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery - A Single-centre, Prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 466
- 试验地点
- 1
- 主要终点
- Incidence of clinically recognized peri- and post-operative atrial fibrillation
研究概览
简要总结
Background and purpose Post-operative AF (POAF) is considered a phenomenon rather than a definite diagnosis and the current clinical guidelines have no specific recommendations regarding its management. Few prospective studies have been performed in non-cardiac conditions and the consequences of POAF in patients without known heart disease are not well described. However, recent data suggest an association between POAF in relation to non-cardiac surgery and increased post-operative mortality and stroke. POAF in relation to abdominal surgery seems common (incidence: 8-18%); however, the true incidence is uncertain. The available studies are few, heterogeneous, and often methodologically inadequate. The study aims at reporting the incidence of atrial fibrillation (AF), and associated complications, in relation to abdominal surgery.
Material and methods Designed as a prospective, single-centre, cohort study of consecutive adult patients undergoing acute* abdominal surgery at the Department of Abdominal Surgery at Bispebjerg Hospital. Patients who are pregnant or where follow-up is not possible will be excluded. Patients will be examined pre-operatively by ECG and signal processed surface ECG (wavECG). A subset of patients admitted to the Department in the time interval of 7 AM to 11 PM$, will be offered heart rhythm monitoring from admission and until discharge (preferably ≥72 hours post-operatively). Additional follow-up will be based on a review of patient charts at discharge and one# month postoperatively. The primary endpoint is the occurrence/recurrence of AF. The study will include 400-500 patients of which an estimated 2/3 will wear heart rhythm monitoring corresponding to 264-330 patients.
Perspective If more thorough heart rhythm monitoring of patients undergoing abdominal surgery leads to the identification of more patients with AF, routine continuous heart rhythm monitoring should be considered recommended in upcoming guidelines to prevent associated complications.
Footnote(s): See 'Detailed Description' below.
详细描述
Background and rationale Post-operative AF (POAF), i.e. atrial fibrillation (AF) that occurs secondarily to surgery is considered a phenomenon rather than a definite diagnosis, and continuous anti-coagulation is not recommended in AF of short duration and non-persistent AF.1,2 The most recent guidelines from the European and American Societies of Cardiology have no specific recommendation regarding the management of secondary AF, though referral to an outpatient cardiology clinic can be considered if the condition is not self-limiting.3,4 Despite this, recent data from the Framingham population suggest that secondary AF is not a benign condition,5,6 and some studies have found POAF in relation to non-cardiac surgery to be associated with increased post-operative mortality and stroke.7-9 Currently few prospective studies have been performed in non-cardiac conditions and the consequences of secondary AF in patients without known heart disease are not well described. POAF in relation to non-cardiac surgery is common with an average incidence of 10.94%.10 However, the true incidence of POAF in relation to non-cardiac surgery is uncertain, as the available studies are few, heterogeneous, and often methodologically inadequate.10 Different risk-stratification models exist, however it is still challenging to accurately predict which patients will develop AF both perioperatively and in the years following surgery.11-14 Important risk factors for developing POAF are: age (age 65-74, OR 2.08; age >85, OR 3.56), hypertension (OR 3.66), heart failure (OR 1.64), thyroid disease (OR 6.29), laparotomy vs laparoscopy (OR 3.30) and duration of surgery (> 600 min, OR 1.38).10 The use of electrocardiogram (ECG) in risk stratification for AF and stroke is not yet incorporated in clinical guidelines. However, short and prolonged p-wave and p-wave terminal force in lead V1 (PTFV1) is correlated with AF.15 Myovista (HeartSciences, Southlake, Texas, USA) is a novel ECG utilizing continuous wavelet transform signal processing (wavECG) and can be used to prove left ventricular diastolic dysfunction (LVDD).16 LVDD is in other studies associated with AF.17-20 These new biomarkers might improve the identification of patients at risk of developing POAF.
Purpose The study aims at reporting the incidence of AF, and associated complications, in relation to acute abdominal surgery. Concurrently, patients will be characterized by specialized ECG analysis and wavECG.
Methods Prospective, single-centre, cohort study of consecutive patients undergoing acute* abdominal surgery. Patients will be identified among acute referrals for the Department of Abdominal Surgery at Bispebjerg-Frederiksberg Hospital. The Investigator (Department of Cardiology at Bispebjerg-Frederiksberg Hospital) will ensure signed informed consent prior to any study-related examinations. Surgery will be performed at the Department of Abdominal Surgery at Bispebjerg-Frederiksberg Hospital independently of study enrolment. A subset of patients will be enrolled in a feasibility study of continuous cardiac rhythm monitoring (C3+, Cortrium, Copenhagen, Denmark). Heart rhythm monitoring will be worn from admission and until discharge (preferably ≥72 hours post-operatively) in patients admitted to the Department in the time interval of 7 AM to 11 PM$. Additional follow-up will be based on a review of patient charts at discharge and one# month postoperatively.
No randomization or placebo will be used. ECG measurements will be compared to existing data from a healthy population.
Measurements
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute abdominal surgery (non-oesophageal)
- •Age ≥ 16 years
排除标准
- •Pregnancy
- •Follow-up not possible
结局指标
主要结局
Incidence of clinically recognized peri- and post-operative atrial fibrillation
时间窗: In-hospital, defined as occurring from termination of surgery and until discharge from the hospital. Assessed up to 7 days from surgery.
Occurrence of clinically recognized POAF, defined as recognized by clinical staff and verified by a 12-lead electrocardiogram and adjudicated by Cardiology specialists.
次要结局
- Incidence of clinically recognized post-operative atrial fibrillation(Out-of-hospital, defined as within 30 days from index surgery)
- Number of patients with left ventricular diastolic dysfunction(Before surgery)
- Incidence of peri- and post-operative atrial fibrillation by cardiac rhythm monitoring(In-hospital, defined as occurring from termination of surgery and until discharge from the hospital. Assessed up to 7 days from surgery.)
- Number of patients with abnormal p-wave indexes(Before surgery)
- Incidence of clinical events after surgery(Out-of-hospital, defined as within 30 days from index surgery)
研究者
Christoffer Valdorff Madsen
Primary Investigator
Frederiksberg University Hospital