A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Postoperative atrial fibrillation
研究概览
简要总结
Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative normal sinus rhythm
- •Procedures:
- •CABG + concomitant valve or aortic replacement/repair
排除标准
- •Emergent operation
- •Procedures:
- •MAZE or PVI performed
- •Isolated valve replacement or repair
- •Isolated aortic procedures
- •Heart transplant
- •Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use
- •PR interval > 240 ms
- •2nd or 3rd degree heart block
- •QTc > 550ms
- •2nd or 3rd degree heart block
- •Liver impairment (INR > 1.7, AST/ALT > 2x normal)
- •Uncontrolled hypothyroidism/hyperthyroidism
- •Interstitial lung disease
- •Allergy to amiodarone
结局指标
主要结局
Postoperative atrial fibrillation
时间窗: Prior to patient discharge or within 30 days after surgery.
At least 1 minute duration detected by continuous telemetry or 12-lead electrocardiogram.
次要结局
- Persistence of atrial fibrillation at discharge(At postoperative surgical visit (around 4-6 weeks))
- Postoperative hospital length of stay(Up to 90 days)
- Transient ischemic attack(Either in-hospital or within 30 days of procedure)
- Symptomatic bradycardia(Either in-hospital or within 30 days of procedure)
- Operative mortality(Either in-hospital death or death within 30 days of discharge)
- Readmission(Within 30 days of procedure)
- Postoperative pleural effusions requiring intervention(Either in-hospital or within 30 days of procedure)
- Initiation of systemic anticoagulation(Either in-hospital or within 30 days of procedure)
- Stroke(Either in-hospital or within 30 days of procedure)
- Number of patients with Amiodarone-related pulmonary toxicity(Either in-hospital or within 30 days of procedure)
研究者
Asishana A Osho
Assistant Professor of Surgery
Massachusetts General Hospital