Impact of Concomitant Surgical Atrial Fibrillation Ablation in Patients Undergoing Double Valve Replacement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Current European Society of Cardiology Guidelines recommend concomitant atrial fibrillation (AF) ablation for all symptomatic patients undergoing other cardiac surgeries, but the safety and potential benefits of concomitant atrial fibrillation (AF) ablation at the time of double valve replacement remains unexamined. A retrospective review of patients with AF who underwent double valve replacement with or without concomitant surgical ablation in our institute starting from April 2006.
详细描述
Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Concomitant surgical AF ablation was offered to suitable patients as determined by the surgeon, and patients then decided whether to undergo the additional procedure.
The operations were performed through median sternotomy and under cardiopulmonary bypass. The bipolar ablation clamp was positioned precisely around the pulmonary veins (PV) for bilateral circular ablation. After Marsh ligament cutting and cross-clamping the ascending aorta, the left atrial appendage was resected and left atrial cavity exposed through an incision behind the interatrial groove. Then, linear ablations were performed between the left and right inferior PVs, between the left and right superior PVs, between the left superior PV and the opening of the left atrial appendage, and between the line connecting bilateral inferior PVs and the mitral valve isthmus. Ablation at the right atrium was then performed. Briefly, the bipolar ablation clamp was positioned around the inferior vena cava (IVC) and right atrial appendage for circular ablation. An L-shaped incision was then made on the anterior wall of the right atrium and linear ablations were performed vertically from the incision to the interatrial groove and tricuspid annulus, to the ablation ring around the right atrial appendage, and from the superior vena cava to the ablation ring around the inferior vena cava.
The left atrial appendage was always excluded by resection and the incision was closed with continuous running stitches. Temporary pacemakers were placed in all patients and activated when heart rate was less than 70 beats per minute.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presented to our institute with valvular heart disease requiring double valve replacement and also present with persistent or long-standing persistent atrial fibrillation.
- •Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. First cardiac surgery, age<70 years. left atrium diameter measured by transthoracic echocardiography<7cm. Left ventricular ejection fraction > 40%
排除标准
- •>70 years old, with LA diameter >7 cm, or with LV ejection fraction < 40% , repeated cardiac surgery, concomitant tricuspid valve replacement
结局指标
主要结局
mortality
时间窗: from the date of the surgery until the date of death, assess up to 120 months
mortality from any cause
third degree heart block requiring permanent pacemaker implantation
时间窗: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
third degree heart block diagnosed via ECG
stroke
时间窗: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
perioperative stroke
sinus rhythm rate
时间窗: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
sinus rhythm rate examined by 24h holter monitoring
次要结局
- New York Heart Function classification(from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months)
- warfarin requirement(from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months)
- perioperative morbidities(from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 30 days)
- Thromboembolic events(from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months)
- left atrium diameter(from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months)
- Warfarin-related bleeding(from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months)
- left ventricular ejection fraction(from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months)
研究者
Weida Zhang
Director of Cardiovascular Surgery
Guangzhou General Hospital of Guangzhou Military Command