Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement
- Conditions
- Atrial FibrillationValvular Heart Disease
- Interventions
- Procedure: double valve replacementProcedure: surgical ablation
- Registration Number
- NCT03163836
- Lead Sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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%
- >70 years old, with LA diameter >7 cm, or with LV ejection fraction < 40% , repeated cardiac surgery, concomitant tricuspid valve replacement
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description surgical ablation group double valve replacement Patients received aortic+mitral valve replacement at Guangzhou General Hospital of Guangzhou Military Command with persistent or long-standing atrial fibrillation(AF) and received concomitant surgical ablation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. double valve replacement group double valve replacement Patients received aortic+mitral valve replacement at Guangzhou General Hospital of Guangzhou Military Command with persistent or long-standing atrial fibrillation(AF) but did not received concomitant AF ablation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Exclusion criteria for consideration for concomitant AF ablation includes \>70 years old, left atrium (LA) diameter \>7 cm, or preoperative left ventricle (LV) ejection fraction \< 40% and patients falls in these criteria were excluded from this group. surgical ablation group surgical ablation Patients received aortic+mitral valve replacement at Guangzhou General Hospital of Guangzhou Military Command with persistent or long-standing atrial fibrillation(AF) and received concomitant surgical ablation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months.
- Primary Outcome Measures
Name Time Method mortality 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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 New York Heart Function classification
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 oral warfarin requirement over 6 moths after the surgery
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 thromboembolic events
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 Redo for bleeding; Low cardiac output syndrome; Renal failure requiring dialysis; Pneumonia;
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 left atrium diameter measured by transthoracic echocardiography
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 bleeding events occurred during the period when warfarin was used
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 left ventricular ejection fraction measured by transthoracic echocardiography
Trial Locations
- Locations (1)
Guangzhou General Hospital of Guangzhou Military Command
🇨🇳Guangzhou, Guangdong, China